1. PRELIMINARY FINDINGS: resolution of barriers to implementing
early phase trials in parallel with routine care.
A report by Dr Sarah Markham (Visiting Researcher, Dept
Biostatistics, IoP, KCL)
BARRIER: Lack of motivation/competency/skills/experience in
clinical care staff in care settings:
Attitudes
• According to Paul Watts, Head of Mental Health Nursing
at Somerset Foundation Trust “There is a lack of
research knowledge within the workforce. In general
the BSc in Nursing only covers basic research methods
but we also need to recognise that the vast majority of
the workforce still do not have degree level
qualifications and it will be some time before they are in
the majority. It is only when this occurs or that we make
research modules more freely available to all staff that
we will engage staff more readily. I also think there
remains a mystique around research and the language
that we use, breaking down this barrier is crucial, but I am
not sure how we can achieve this. I am currently involved
in several pieces of research as the Chief Researcher and
Principle Researcher and although I think I took time to
explain to staff the processes and requirements it has
still been a struggle to engage people. Finally, it also
about how we enable people to translate research results
into practice. We have attempted this in our own
organisations through regular research seminars and
through the use of practice development where research
needs to be used and evidenced. This has changed the
culture slightly, but again we are not engaging with the
majority of staff and research informed change remains
slow.”
• Eneida Mioshi (Clinical Research Associate at
Department of Psychiatry, University of Cambridge)
believes that lack of confidence in clinical care staff
may be inhibiting their support for the implementation
of clinical trials. “My experience to date is that most

2. health professionals (I am referring here to nurses and
AHPs) do not have confidence in running research in
practice. This seems to stem from lack of appropriate
training and/or lack of appropriate support/supervision
within their teams. I also do not think all professionals
are bound to be excited by research, but we should
create mechanisms to support and nurture those who
would like to try/learn and also find ways to work well
with those who are "apparently" not keen on it.”
• However a seeming lack of enthusiasm and experience of
clinical teams in terms of engagement in clinical research
may not always be lack of knowledge about trials rather
that they just don't seem a priority when there is so
much else going on and also concerns that they (care
staff as well as nurses) would be held responsible if
things went wrong. According to David Heron (Matron
KCH) “it isn't necessarily that there is an enormous lack of
interest in research per se, I think often it just comes down
to priorities. Often clinical teams have a primary focus
on clinical practice and meeting the physical or other
health needs. Research of course feeds into this in the
sense that we want to deliver evidence based medicine,
but is often an add on that takes buy in from leaders and
managers. I think nurses are becoming more research
aware, nursing now being a graduate profession and often
courses of study may they be pre-reg or add-on specialist
courses have a research component. I think nurses often
are in nursing to care and may have less of an interest
in research. Possibly primarily due to lack of knowledge
but often as clinical research in settings I've worked in
trials are led by the medical team and nurses can feel
intimidated by the jargon and more complex
quantitative research methods which are almost like a
foreign language for the untrained. So some further
training at pre-registration stage would certainly better
equip nurses to get involved in research.”
• Belinda Theis (Clinical Research Delivery Manager
UCHL) has experienced significant difficulty in
implementing clinical research trials in secondary care
settings. “Our experience is that it's much easier to
implement clinical trials in primary rather than
secondary care settings. GP staff will refer patients and

3. introduce them to what the trial involves and give
researchers access to their patient database. The
research team will do the rest of the work.” She also adds
that collaborations with industry are advisable as this
can lead to sufficient funding for trained CRNs to be
deployed in routine care settings to perform the trials
implementation instead of the clinical care staff.
• Anna Massey (Associate Clinical Researcher, Institute of
Neuroscience, University of Newcastle) opines that PIs
have to be confident they can delegate responsibility
to nurses and other clinical team members. She claims it
is unrealistic to expect clinical team members to be
involved beyond liaising with, passing information to
and referring patients. Anna points to the need to
protect trial participants from harm, hence the need for
those who implement the trials to be (GCP)
competant.
• Linda Purandare (CRN) has experienced varying degrees
of engagement from clinical teams. “Within some
specialities where clinical trials teams are well established
we have fairly good engagement with the clinical side, with
some ward nurses being GCP trained and actively
participating in clinical trials. We have developed a new
streamlined management structure for our clinical trials
team and have discussed engagement with the clinical
teams and are developing strategies for this. I am also
negotiating with Bournemouth University for student
placement with our clinical research teams. We also have
two of our nurses currently undertaking NIHR MRes
programmes and are looking at how to utilise their new
skills.
• Alison Jenkins (CRF Research Nurse Manager NIHR)
also questions the competency of untrained clinical
care staff to be involved in implementing a research
protocol. “Regarding implementing Phase I trials into
routine care. In my personal opinion, Phase I trials are
safest implemented in appropriately set up units rather
than in routine care. Phase I studies being offered to
cancer patients happens in very specific circumstances.
The delivery of the early phase compounds usually
happens in badged Experimental Cancer Medicine

4. Centres or in centres where there are appropriate safety
measures in place. Other diseases where patients are
offered Phase I or early phase trial participation, again
usually receive the compound and care from a dedicated
research team in an area with appropriate safety
measures are in place. Regarding clinical ward or
outpatient staff delivering trial compounds or being
delegated trial specific tasks, as I’m sure you’re
aware, GCP states that all trial team members must be
“fit for purpose” with regard to education, training and
experience. In practice this would have to include
regularly updated GCP training and study specific
training and education. This carries with it a significant
cost implication. In addition ward managers and the
nursing hierarchy would need to be in agreement that the
ward team had time resource available to them to carry
out trial specific tasks at the time they were due to ensure
accuracy. There is also the challenge of ensuring staff
working on the wards maintain competence over time.
These challenges exist across the nursing spectrum not
only in mental health nursing.”
• Wendy L. Osborne (Neurology Research Manager,
Clinical Research Facility, Salford Royal NHS Foundation
Trust) also emphasizes the importance of GCP training for
all staff involved in the implementation of clinical trials.
“Research in clinical areas is often seen as an extra and
not a core responsibility. The ward environments are
already under pressure to deliver safe care and as an
ex ward nurse (10 years experience) the paperwork
involved had also increased therefore actual time to
do research activities is even farther away than ever
before. You also need to consider GCP in the equation
as all study procedures should be carried out by
someone in possession of a valid GCP certificate- to
address this in the clinical areas would be costly (both
in time and financially) requiring each nurse to be taken
out of the ward for a day to attend GCP training. I have
also found during my 8 years in research that studies
(especially academic) are often set up without input from
experienced NHS research staff with clinical experience
therefore immediately are starting off unlikely to meet the
Researchers targets or expectations. It is essential to

5. know how a clinical area operates prior to running a study
in the area.”
• Dylan Wright (Ward Manager, The Chichester Centre
Sussex) also highlights time pressures on the ward and
increasing audit and other administrative demands on staff
time. “We have so many audits to do; for the CQC, to
ensure CQUIN targets are met etc., we're hard pressed
to find the time for the patients let alone research.
• Alison's and Belinda's concerns are echoed by Alyson
Moyes (Biomedical CPD Co-Ordinator, University of
Chester) “It is sometimes hard to motivate the nurses
to help as they lack the understanding as to why they
are doing it, and simply see it as a burden of more
work.”
• Julia Boyle (Director of Surrey Clinical Research Centre)
has experienced difficulty in recruiting CRNs. “We are an
accredited Phase I Unit and we notice that when we are
recruiting for new nurses many applicants have had
limited exposure to clinical research. Those nurses that
have had experience have tended to be involved in later
Phase trials.” There seems to be a need to train more
CRNs.
• David Richards (Professor of Mental Health Services
Research and NIHR Senior Investigator, University of
Exeter Medical School) has a more positive view of
nurses' research potential and competency “There are
multiple trials that have used mental health trained
staff, including nurses, to deliver therapy to a protocol
when the researchers have applied proper training
and supervision, e.g.
http://bjp.rcpsych.org/content/198/1/66.abstract?ck=nck. If
any clinicians cannot follow a research protocol then my
advice would be to examine the protocol and its likely
future tractability in health care.”
Education
• Although most B.Sc. Nursing courses include basic research
methods (focusing on social science methodology -
qualitative and quantitative analysis, criteria for patient

6. inclusion/exclusion, etc.) and may touch on the
methodological framework around the implementation of
clinical trials, in real terms a student nurse will probably not
gain experience of implementing a clinical research protocol
unless they go on to pursue a M.Res. or Ph.D. course.
• However over the last 2 years there has been a growing
awareness of the need to train pre-registration nurses to
have a greater understanding and appreciation of the
importance of clinical research and its impact on
treatment. The RCN is working on this and acting to
provide more provision for students to have placements
in research facilities and gain direct experience of how
clinical trials work in practice. In the UK there are currently
approximately 14,000 CRNs working in supportive roles in
clinical trials, however many Trusts still struggle to recruit
qualified clinical research nurses. Most Trusts now employ
a Lead CRN who will act to standardise research training
placements for students. Many Nursing and Health
Science Faculties e.g. that at the University of Brighton (with
support from SPNFT nurse consultant Anita Green), are
looking very vigorously into how to expose students to
research and active researchers (nurse and AHP led
research).
• Many Clinical Research Facilities, BRC’s and BRU’s
now offer placements for student nurses and
secondments for staff nurses to their units. These
placements and secondments has been that they are
oversubscribed and feedback is extremely positive.
• Wendy Fraser (Head of Clinical Research at Surrey
Clinical Research Centre) is currently working with the
University of Surrey School of Health and Social Care to try
and get trainee nurses more exposed to Phase I clinical
research. “We would like to do this in a number of ways –
lectures as part of their undergraduate degree and
placements at our Phase I Unit with mentorship from our
experienced clinical research nurses.”
• Professor Tony Fryer (R&D Director, University Hospital of
North Staffordshire NHS Trust) is reports that his hospital is
involved in similar work. “UHNS have found a number of
challenges around this area, particularly in filling research

7. nurse posts with suitably qualified staff. This is partly
because there is little training in the core curriculum for
nursing. Consequently, our Lead Nurse for Clinical Trials,
Beryl Alcock has been exploring the opportunities for
placements for trainee nurses with the R&D department
here. I am pleased to say that this has been supported
locally and will commence with the next intake. While it will
take some time to move through the system, it is a positive
start not only in providing the spark to ignite interest in
research as a career option for nurses, but also in facilitating
secondment opportunities to fill shorter term gaps. In my
view, if we are to truly recognise research as a core NHS
activity, then this should be reflected at the training
curriculum level and reinforced with CPD requirements.
• Caveat: Dr Ian Taylor (University of Brighton) is aware that a
fair proportion of students struggle with the academic
level set by the pre-registration degree course and
indeed the entire concept of clinical trials. He is keen to
introduce a more hands on approach to the optional 'Careers
in clinical research' module with students gaining practical
experience of clinical trial implementation. However it has
proved difficult to persuade BSUH and SPNFT to
accommodate this and practical experience has only
occurred at an individual student level when a suitable a hub
and spoke opportunity has occurred. Anita Green is planning
to set up a pilot for mental health student nurses to gain
experience of clinical research but it is still very much in the
planning stage.
• There are also concerns that it would not be practicable
to modify current pre-registration nursing curricula to
accommodate clinical research training. Ben Hannigan
(Reader in Mental Health Nursing, School of Healthcare
Sciences, College of Biomedical and Life Sciences, Cardiff
University) is of the opinion that “Nursing curricula are jam-
packed and have to reflect NMC standards, and this can
leave little room for anything extra. In any case, a more
suitable preparation for practitioners might be for them to
know more of their obligations and responsibilities as
practitioners when any kind of research is proposed in the
workplace (trials being one, but not the only, example).”

8. • The NIHR are currently doing their best to influence HE
so there are more opportunities for undergraduate
nurses to experience the delivery of clinical trials and
are planning to hold a national seminar on the subject in
the autumn 2014. As Dr Susan Hamer (Organisational and
Workforce Development Director NIHR) reports, “We have a
work group active in this area and have been in
conversation with the Council of deans for health care.
We are already sharing best practice across our network
and raising the issue with directors of Nursing. There are
many facets to our strategy in this area but we are gathering
momentum. However as the nurse workforce only replaces
itself slowly we also have to have a strategy for existing staff
as they are so influential on culture and there too we are
making progress with a campaign of awareness raising and
influencing key opinion leaders. The DH have also been very
supportive to us funding a range of activities and the
workforce of CRNs is growing.
• However not everyone is quite so optimistic about the future.
Ben Hannigan opines “Even at MSc level the opportunities
to carry out research are less than they once were, for
all sorts of reasons (e.g. unfunded MSc research is not
eligible for portfolio entry, and can attract NHS demands for
NHS research costs to be covered). I think this situation also
reflects the idea that the majority of nurses are (and if they're
students, will be) research consumers but not producers.”
Brendon McCormack (Professor of Nursing Research and
Director of the Institute of Nursing and Health Research
(INHR) at University of Ulster) suggests some more
immediate measures. “The undergraduate curriculum for
mental health nursing (as with all the pre-registration
curricula) is extremely packed and so giving space to
this area when it is not a universal requirement/practice
would be largely seen as an unnecessary burden. It may
be the case that centres and universities where there are a
lot of trials happening could find a way to have something in
the curriculum specifically on this. The role of ‘everyday
nurses’ in Phase 1 trials in my view is largely one of
providing care in a specific situation but under research
conditions – so in may ways it is/should be no different
to the way that everyday practice happens anyway and
so maybe the issue is about ‘emphasis’ rather than a
separate/different training.”

9. • David Lewis (Professor of Clinical Vaccine
Immunology,Clinical Research Centre, University of Surrey),
believes that “one practical way to ensure more student
nurses get experience is to require them to identify an
ongoing trial during their ward placements. Most trusts
will have some trials ongoing. The student could then at least
write a short essay on it, or discuss with the research nurses.
They might also then understand better that being a
research nurse is not so daunting, and does not
necessarily require specialist statistical or scientific
knowledge (often a false perception), just good nursing
skills and excellent record keeping - essential basic
skills for any nurse.”
• Caroline Murphy (CTU Manager, King's College, London)
believes CRN training needs to be introduced at the post-
graduate and specialist nurse training level (a 6 month
full time lecture and practice based training course for
registered nurses) and for it to be focused on the
research needs of the specific specialism. “The
evaluation and appraisal of research can have very little
meaning to pre-registration nurses and soon be forgotten.”
She also thinks clinical research training should be
mandatory for all medical doctors in order that they
understand at the very least the importance of referring
appropriate patients to appropriate trials. Caroline also
questions the competency of many clinical research trainers.
“Research methods are often taught by clinicians who lack
the qualifications and experience to be able to teach the
subjects well.” As for poor nursing attitudes towards
engaging in the implementation for clinical trials she
suggests secondments for more senior nurses to CRFs
to allow them to gain an appreciation for the nature and
importance of clinical trials.”They will then be in a position
to disseminate it to their own teams and authorise staff time
to recruit and refer patients for clinical trials etc.
Career Development
• According to Gordon Hill (Associate Director at the
Edinburgh Academy of Clinical Research Education)
pressures and priorities of clinical care teams mean routine
clinical tasks take precedence over (imposed) clinical trials.

10. Furthermore over recent years the number of trained staff on
shift has been reduced so that staff struggle to provide
regular clinical care let alone support the implementation of
clinical trials. Therefore independent clinical trial units CTUs
have been set up as regional hubs to train and deploy CRN
(clinical research nurses) in routine care settings as needed
to support clinical trials and other research.
• NIHR Clinical Research Networks are also working to
engage student interest in careers in clinical research.
Claire Hall (DeNDRoN) has been involved with input into
nursing education locally with Oxford Brookes University and
University of Bedfordshire. “We offered day visits to nursing
students and also longer term (4-6 week placements) for
nursing students to get a more in-depth understanding of
what's involved in the recruitment and delivery of clinical
trials. Our feedback has been really positive, and students
seem really interested. Students perceive research to be
all about the modules on methods, data analysis etc.
and they just don't think of the practicalities and reality
of working in clinical research. We've disseminated our
programmes nationally amongst research nursing
colleagues, and I'm aware there are many different areas
that are now taking on nursing students in this way.
Obviously this impacts nurses qualifying at the moment, and
I think there is a lot more work to do with nurses who have
already been qualified for a while in order to break down
some of their perceptions about what we do, but it's a start.”
• Support is also beginning to come from the regional
Academic Health Science Networks. Andrew Rose (Head
of Programmes WMAHSN (West Midlands Academic Health
Science Network)) who was involved in setting up the MHRN
is determined to make clinical research a priority for his
region and, along with his colleagues is gathering economic
data support funding research. The WMAHSN plan to
promote clinical research education and training and set
up multi-agency collaborations between academia, the
NHS and industry involving placements for employees
with various partner organisations in order to share and
develop skills and resources. Another priority is to recruit
science graduates to perform certain CRN duties thereby
freeing up time for clinical research nurses to focus on using
their more specialist skills.

11. • Gillian Hornzee (Team Leader, Cancer Clinical Trials,
NCRN, St mary's hospital, London) believes that
engagement in research activity should be a feature of
every nurse's contract of employment. “Our experience is
that most nurses shy away from helping with recruitment and
implementation of clinical trials, mostly because they
perceive their workload doesn't allow for it. For example the
breast care nurses could well help to recruit to clinical trials
and participate in performing trial related activities, but in
spite of having received training, refuse to do so. The reason
it does not happen in oncology is that for the last ten years
there has been a dedicated team in each hospital (part of the
National Cancer Research Network) which often includes
research nurses who are specifically tasked with recruiting to
cancer trials. However this has not been the case for other
specialities. I think the only way to rectify this is to include
participation in research activity in the nurses' job
specification so they can not refuse to participate.”
• Gordon Hill (Associate Director Edinburgh Academy of
Clinical Research Education) is encouraged by the progress
that is currently being made in clinical research education for
nurses. “More and more undergraduate courses are
incorporating a clinical research component and many
are offering elective placements with clinical research
nurses. In addition there are more post registration courses
available. At Edinburgh Napier we offer a 'top up' degree in
clinical research (for nurses with diploma level qualifications)
and PG Cert in Clinical Research for students with a degree.
Both courses are aimed at Clinical Research Nurses and
relate very closely to running clinical trials.”
CRN/SN dyad
• Anne Croudass (Lead CRN Cancer Research UK) holds
that it can be an advantage for CTUs etc. to train potential
CRNs themselves selecting for enthusiasm, dedication and
ability. Belinda Theis (Research Delivery Manager at UCHL)
recommends recruiting from the nurse practitioner pool
rather than staff nurses as they are more likely to have the
necessary organisational and mental processing skills. For a

12. CRN working alongside clinical care nurses the principle
challenges are 1) mistrust or misunderstanding or the
work they do (the irregular hours, the undisclosed duties
they perform do outside the care environment) and 2)
problems of delays in handover from out of hours staff
to the CRN regarding the trial participants. The most
effective means of ensuring a successful collaboration
between CRNs and clinical care staff is for the CRN to
become integrated into the wider MDT allowing for them
and their work to become embedded into the care
environment over time.
• Sandie Wellman (Consultant Nurse, Oxford Radcliffe
Hospitals) experience has been that in terms of
implementing clinical trials the principal challenge has been
liaising with clinicians in the primary and secondary care
settings from which trial participants are drawn. Certain GPs
appear reluctant to refer their patients and may actively
discourage them from doing so.
Sandie has also encountered reluctance from healthcare
educators to allocate pre-registration nursing students
to placements at the CTU. In order to promote mutual
communication Sandie has been in direct contact with
medical
health educators to encourage more student engagement
with
the CTU. She has also been trying to raise the profile of the
CTU and educate fellow clinicians and clinical staff about
the
exact nature of the research work that is carried out there.
The CTU's profile on the Trust's website has been
reworked and posters placed in waiting rooms and
reception
areas. The CTU is now a regular presence at hospital open
days and the CTU staff now have their own logo.
Sandie is keen to point out that patients who participate in
trials receive a great deal of care and information about their
illness and also what is available to them in primary and
secondary care.
BARRIER: Cultural resistance in the NHS (Poor relational
dynamics between academics and clinicians) :

13. • Rather than researchers and clinicians being allies sharing a
purposeful approach to development of evidence, there
seems to be cultural resistance to research. This is likely
grounded in contextual complexities (including physical
and emotional distance between R&D departments and
the clinical ‘frontline’, and the burden and demands of
clinical work). The reported resistance may in part be
grounded in the redirection of funding from clinical services
to establish the NIHR to increase research capacity within
services. It may also reflect a lack of fit between services and
clinicians and the approaches taken by funding bodies e.g.
NIHR, MRC and research support networks e.g. MHRN.
• At a practical level, respect and reciprocity can be
promoted by effective communication. Ensuring that the
right information reaches the right people in a timely manner,
and that clinicians are provided with progress reports
and study findings, is essential. Offers of publication
involvement, though potentially encouraging activity, should
be made only as they align with ethics of authorship and the
mixed messages around incentives mean that these should
carefully be considered on a case-by-case basis.
• Justin Watts (Clinical Trials Manager, Qunitiles) emphasizes
the need for research to be ingrained in the culture of the
healthcare environment for research to succeed. “Qunitiles
works with a quarter of a million research sites worldwide,
including primary, secondary and tertiary care. We tend to
work to strict protocols and form strong collaborations with
Principle Investigators. The principle barriers to
implementation tend to be of an ethical or administrative
nature; sponsors taking too long to review documents etc.
Motivation can be a problem but only if research isn't
embedding in the culture of the site. At teaching hospitals we
don't have a problem and very often patients are matched to
trials when they're given their treatment options on
admission. Skill sets are also easy to provide through
training. If you're trying to embed research into the working
ethos of a healthcare environment, start small with say one
department. Set realistic goals and time targets. It is more of
a slow-burn process, but medics are notoriously competitive
and as long as they have a sense of ownership or at least a
stake in the process they will want to be on board.”

14. • Professor Tony Charman (Professor of Clinical Child
Psychology KCL) advocates that academic researchers
'putting in the time on the ground' talking to and working
alongside clinicians and other clinical staff helps to
develop mutual respect and support, open
communication and mutual confidence which will be of
benefit to current and future trials.
• Embedding new practices in clinical settings requires a
team based approach focused on research
implementation and the trial participants. Identifying and
adopting an innovative health technology, or a new way of
organizing professional work such as implementing clinical
trials in parallel with routine clinical care involves policy-
makers, managers, academics and clinicians facing two
important problems as they try to get innovations into
practice: 1) Process problems i.e. the implementation of
new ways of thinking, acting and organising in health care, 2)
Structural problems i.e. the integration of new systems of
practice into existing organisational and professional
settings. To understand implementation and integration, one
must focus on the dynamic processes that lead to
innovations becoming embedded in everyday work. Carl
May's Normalization Process Theory is an explanatory
model that helps managers, clinicians, and researchers
understand these processes. NPT starts with the formal
proposition that:
Complex interventions become routinely embedded
(implemented and integrated) in their organizational and
professional contexts as the result of people working,
individually and collectively, to implement them.
The routine embedding of a complex intervention is the
product of action (the things that people do), not necessarily
people's attitudes (how they feel about what they do), or their
intentions (what they say they are going to do).
The work of implementation is put into operation through
four generative mechanisms (coherence - people making
sense of the work of implementing and integrating a complex
intervention; cognitive participation -how they engage with it;
collective action - how they enact it) and reflexive monitoring
(how they appraise its effects).

15. The work of integration of a complex intervention requires
continuous investment by people in ensembles of action that
carry forward in time and space.
It is not enough to adopt and diffuse a complex intervention,
people need to keep investing in it or it will atrophy.
Continually investing in sense-making, commitment, effort,
and appraisal is part of the embedding of a complex
intervention. A complex intervention that is routinely
embedded in practices ceases to be a 'complex intervention'
at all, and instead disappears into the everyday world of
normal activities, the things that people just get on and do.
Normalization Process Theory focuses attention down on
how the work gets done - the everyday business of getting on
with the job in hand - and the often very creative work that
managers, academics and clinical staff do to normalize a set
of tasks in a health care setting.
• Magda Martinez, a CRN at the BRC, Guy's Hospital is keen
for the implementation of clinical trials in parallel with routine
clinical care to be the norm and not the exception. “Clinical
research has to become embedded into clinical care
otherwise it will remain very much a niche area of nursing
practice which occurs in isolation and of which little is
understood or appreciated.” Magda recommends the
following steps to embedding a clinical trial into routine care:
1) Build relationships with the clinical team Engage the
clinical staff so that they come to understand and believe in the
trials. This involves observing and working alongside the clinical
staff to learn how they work and who their patients are. It is
important to acknowledge the experience and expertise of
the clinical team and to seek and make use of their advice
whenever an opportunity arises. In doing so the CRN will
gain the trust of her clinical colleagues and become seen as an
integral part of the the clinical team and not as an unhelpful or
meaningless add-on. The clinical team are the ones to
consult as to how to approach their patients and of course
the ones to refer patients to the trial. In short they are
essential to the success of the trial. If their interest seems to be
flagging at any point in the trial, then motivate them e.g. with
friendly but purposeful emails congratulating them on their
successes and urging them on when the need arises!

16. 2) Create inviting, meaningful and trial materials Materials
used in the clinical trial e.g. information sheets and other forms
used in patient recruitment and the PIS (patient information
sheet) need to be patient friendly – written in plain English
and suitably embellished with e.g. picture and other illustrations
if for minors. Ideally feedback/outcome/observation sheets
should gather qualitative as well as quantitative data to give a
more complete picture of the effects of the intervention on trial.
When seeking participants do emphasize the positives e.g. that
travel expenses will be paid and whether there is flexibility as to
when/where patients participate.
3) Document everything Create comprehensive confidential
databases in line with GCP which capture any relevant patient
information. This may be of use when e.g. seeking participants
for further or follow-up trials.
4) Beware of social media Staff need to be cautioned
against posting confidential trial information or anything
else that might compromise a trial's integrity or success on
social media websites, e.g. Twitter. Similarly it is advisable to
monitor what patients are posting themselves and if necessary
advise them on the possible consequences of what they are
doing.
5) Feedback At all stages gather feedback from everyone
involved (clinicians and patients) and as a result do make any
necessary alterations to the trial.
6) Fruits of success One of the outcomes of successfully
embedding a clinical trial into routine clinical care is that it
opens the gate at all levels for further research to take
place.
• At research intensive centres (like SLaM and UCL) a
degree of research fatigue may develop and researchers
may often be at fault in not feeding back results to the
clinicians who have helped us with recruitment and other
aspects of carrying out research studies.
• Use of motivational levers such as 1) the sense of
satisfaction of engaging in a noble shared purpose or
organisational goal, e.g. to do what is best for our patients. 2) to
satisfy self-interest – provide financial or career based

17. incentives for achieving targets. 3) to earn respect from
colleagues and the Trust; this can be a powerful inducement to
improve co-operation and performance. 4) to embrace medical
tradition by promoting standards to align behaviours and
make adherence a requirement for peer respect and
acceptance.
• The most important predictor of success in a group is
the amount - not the content - of social interaction. Bruce
Lloyd (Professor of Strategic Management South Band
University) advocates the power and positive team building
efficacy of 'quality conversations' . Recent research that
has not been widely published throws some fascinating light
on the power of conversation. Having a friendly
conversation can boost your cognitive ability and
improve team performance by increasing the amount of
face-to-face communication regardless of the topic of
conversation. (Friends (and Sometimes Enemies) With
Cognitive Benefits - What Types of Social Interactions Boost
Executive Functioning? By Oscar Ybarra, Piotr Winkielman,
Irene Yeh, Eugene Burnstein, Liam Kavanagh
http://spp.sagepub.com/content/2/3/253)
Talking with people in a friendly way can make it easier
to solve common problems. But conversations that are
competitive in tone, rather than cooperative, have no
cognitive benefits. (Why is conversation so easy? By Simon
Garrod; Martin J. Pickering
http://www.bcs.rochester.edu/courses/crsinf/261/ARCHIVES/
S07 /GarrodPickering2004.pdf, Group Discussion as
Interactive Dialogue or as Serial Monologue: - The Influence
of Group Size - By Nicolas Fay; Simon Garrod; Jean Carletta
- http://citeseerx.ist.psu.edu/viewdoc/download?
doi=10.1.1.8.4 348&rep=rep1&type=pdf)
In small, 5-person groups, the communication is like
dialogue and members are influenced most by those
with whom they interact in the discussion. However, in
large, 10-person groups, the communication is like
monologue and members are influenced most by the
dominant speaker. (Evidence for a Collective Intelligence
Factor in the Performance of Human Groups
By Anita Williams Woolley, Christopher F. Chabris,
Alexander Pentland, Nada Hashmi,Thomas W. Malone
http://advance.njit.edu/doc/Gender,%20Collaboration%20&%
20Group%20Intelligence.pdf)

18. Performance is not strongly correlated with the average or
maximum individual intelligence of group members but is
correlated with the average social sensitivity of group
members, the equality in distribution of conversational
turn-taking, and the proportion of females in the group.
(The New Science of Building Great Teams By Alexander
Pentland April 2012 Harvard Business Review
http://www.timgroup.ethz.ch/education/Courses_at_TIMGRO
UP/sp ring_2013/pentland_team.pdf)
BARRIER: Patient Participant Recruitment:
• Research studies in the UK has indicated that in the mental
health context, researcher access to potential trial
participants is multiply influenced. Gate-keeping clinicians
are faced with competing priorities and resources constrain
research activity. As gatekeepers, clinicians may seek to
protect people for whom they provide care from the
perceived burden of research participation and/or an
intervention perceived to be futile for an intractable
condition. It seems that environmental adjustment
predicated on equitable resource allocation is needed if
clinicians in NHS mental health services are to fully support
the conduct of randomised controlled trials. Whilst cultural
transformation, requiring changes in assumptions and
values, is complex, findings suggest that attention to
practical matters can support this and highlight issues
requiring careful consideration.
• Symptom profiles also influence referral to studies and
sub-groups of the population may be under-represented.
• Despite government declaring a commitment to making
research core business of the NHS this may not be
facilitated at the clinical level. Rather than being enabled
to enact the pledge in the NHS constitution to inform patients
of studies in which they may be eligible to participate, the
majority of mental health clinicians charged with gate-
keeping access are struggling to cope with competing
demands and unable to prioritise research.
• Given recruitment is essentially a social activity, with
success dependent in part on interpersonal connection

19. between recruiting researchers and clinicians, it may
well be that some of the challenges described reflect
personal rather than systemic concerns. The key
message is that rapprochement between the NHS R&D
and clinical service factions and academia is needed to
support clinicians to participate fully in research activity.
Whilst cultural transformation, requiring changes in
assumptions and values, is complex, attention to practical
matters can support this and highlight issues requiring
careful consideration.
• Reciprocity, relevance, respect and realistic feasibility
studies are fundamental to ensuring that recruitment to
trials is to be efficient and clinician-related selection
bias is minimized. Rather than feeling ‘put upon’ by
disinterested researchers, gatekeepers should be involved
in the research process from the beginning and have
their contributions valued. It behoves researchers and
research support networks, e.g. MHRN to work actively to
support clinician and service engagement and minimise the
burden of research activity. In relation to relevance, the onus
is on investigators and NHS leaders to engage
collaboratively with clinicians to develop research questions
and design studies which have face validity and will garner
support.
• On a practical level flexibility about the location of the
trials will encourage participation from referred patients
e.g. if the participants are children some parents may prefer
a local institution around the corner rather than an academic
or clinical trials facility several miles away distance away.
Travel expenses should be funded and/or pre-paid taxis
booked. Experienced investigator will budget for this in
funding applications.
• Susan Paterson (Senior Lecturer RMIT) believes that the
“implementation of trials (at whatever stage) in routine
practice (in mental health) is fraught by the vexed and
uncertain nature of psychiatric diagnoses, (esp the absence
of clear causative explanations), the complex nature of
conditions and the associated disability and disadvantage,
uncertain status of people with mental illness in society, (esp
around protectiveness) personal issues.” Furthermore the
elusiveness of clinical gains amongst many mental

20. health service users, the fragility of these gains given
the high rates of relapse and the reality that when gains
are achieved they often require treatment over the long
term, may generate a conservative and cautious
approach to gate-keeping amongst mental health
workers who when invited to judge the potential positive
and negative consequences of participation may see the
scales tipped to often towards the negative. In response
to this Prof D. Lewis of the Surrey Research Centre
advocates a more “nuanced” pre-registration nursing
education with regard to gaining consent for clinical trials and
the nurse's role of allowing the patient to make informed
decisions and not taking that choice away from them.
“Looking at registered nurses I have also noticed some
perceived conflict between the nurse's identification as "the
patient's advocate" and clinical research. As you know
research protocols often require that people are randomised
to different regimes which may seem inferior, or to placebo,
or be in studies with no actual benefit. I have noticed that
many nurses are deeply uncomfortable with the idea that a
particular patient may not be getting the "best" care, and as a
result will not engage in research and may even advise the
patient not to engage either. Doctors in my experience do not
have this issue as they do not identify as strongly with the
"Patient's Advocate" concept. I think more nuanced
education on what it means to be an advocate to any
individual patient while balancing the benefits to future
and other patients, would strengthen nurse training and
encourage more nurses to participate in research. As it
stands too many nurses seem to identify with just the patient
in front of them and then see their responsibility to advocate
just narrowly for what seems to be in that patient's best
interests at the time.”
BARRIER: Pressure of Time and Resources:
• Protected time for clinical staff to engage in research
duties. Alternately recruit CRNs who are contracted to
partition their time between research and clinical duties.
• Adaptive use of research resources is critical. Because
the absence of dedicated resources (such as clinical time) or

21. return on investment (such as allocation of accrual funding to
team training) not only constrains the capacity of clinicians to
undertake research activity but undermines belief in policy
and sense that their roles are respected, research resources
must be seen to make a difference.
• Peter Brown (Professor of Experimental Neurology at the
Nuffield Department of Clinical Neurosciences, University of
Oxford) points to the administrative and organisational
barriers of implementation in routine clinical care settings.
“The enormous work involved in getting ethics in place,
insurance/sponsorship, trial governance and documentation.
Then there are issues of consistency/reproducibility of
observations made in these environments ...”
BARRIER: Suspicion of 'Big Pharma' (due to past cases of
lack of transparency around adverse reactions)
• There are also long-standing concerns that the methods
and results of many trials currently remain hidden from
public view. This lack of transparency, say campaigners,
undermines public trust, breaks the ethical pact between
scientists and those participating in trials and leads to
clinical decisions being made on the basis of incomplete
evidence, potentially leading to poorer outcomes for
patients. The topic of clinical trial transparency received
renewed attention in late 2012 with the publication of Bad
Pharma, a book by Dr Ben Goldacre that accused the
pharmaceutical industry of deliberately suppressing
unfavourable trial results from public view.
• There are current calls on government to ensure all data
from all clinical trials is published to foster greater
openness in medical research. This degree of
transparency would help to dissipate negative perceptions of
the pharmaceutical industry.
• There have been efforts by some members of the
pharmaceutical industry, particularly GSK, to increase
clinical trial transparency and hope fully other companies
will act in the same spirit in implementing industry-wide
principles for responsible clinical trial data sharing.

22. • Clinical staff awareness and training days and similar
provision in pre-registration nurse training would help to
address negative perceptions of the pharmaceutical industry.
• Trusts need to do far more to educate patients about the
benefits,
both to them and to the wider community, of
participating in research and allowing properly controlled
sharing of patient data.
Conclusion
Overcoming the barriers to the implementation of early phase
clinical trials in parallel with routine clinical care will require a
radical transformation, moving from a system organized around
individual CIs and PIs to a team-based approach focused on
patients. Such engagement requires more than mere
cooperation, i.e. an agreement not to sabotage and aims to
achieve full collaboration.
The leitmotif that runs through so much of the information
gathered is that the implementation of clinical trials in parallel with
routine clinical care is best facilitated when academic
researchers make determined efforts to win over heart, minds
and hands. In a more formal sense this is the application of Carl
May's NPT (Normalisation Process Theory) which explains how to
embed complex interventions into healthcare and other
organisational services. NPT encompasses the following 4
elements:
• coherence (i.e. comprehension - defines and organizes the
components of a practice)
• cognitive participation (i.e. engagement - defines and
organizes the people implicated in a complex intervention)
• collective action (i.e. team enactment - defines and
organizes the enacting of a practice)
• reflexive monitoring (defines and organizes assessment of
the outcomes of a practice)

23. The production and reproduction of a practice requires continuous
investment by agents in ensembles of action that carry forward in
time and space.
Academic researchers need to develop an understanding of
behavioural economics and social capital and be ready to put
in the ground work talking and listening to their clinical
colleagues as they work alongside them to develop robust,
open trusting working relationships.
To help academics engage clinicians and clinical staff in the
pursuit of clinical research one approach is to use
motivational tools to drive engagement and social action (that
is, action in response to others’ behaviour), such as a sense of
shared purpose, self-interest, respect for each other and the
pursuit of good standards of practice. Academics can use these
levers to win over clinical teams hearts minds and hands to induce
the change the system so urgently needs.
To help clinical staff to gain an appreciation of the impact and
practicalities involved in implementing clinical trials and make them
more ready to engage make research modules more freely
available to all staff. There also seems to be a need to train more
CRNs and for student nurses to gain direct experience of what is
involved in implementing clinical trials.
PIs and CIs need to be aware that it may take a significant
degree of time and effort to explain to clinical staff the
processes and requirements of the clinical trial and to engage
them. Engagement can be encouraged by translating research
results into practice, e.g. through active practice development and
regular research seminars.
For a CRN working alongside clinical care nurses the
principle challenges are 1) mistrust or misunderstanding or
the work they do (the irregular hours, the undisclosed duties
they perform do outside the care environment) and 2)
problems of delays in handover from out of hours staff to the
CRN regarding the trial participants. The most effective means
of ensuring a successful collaboration between CRNs and clinical
care staff is for the CRN to become integrated into the wider
MDT allowing for them and their work to become embedded
into the care environment over time.

24. Clinical teams have a primary focus on clinical practice and
meeting the healthcare needs of their patients. Ward managers
and the nursing hierarchy would need to be in agreement that the
ward team had time resource available to them to carry out
trial specific tasks at the time they were due to ensure
accuracy.
Research studies in the UK has indicated that in the mental health
context, researcher access to potential trial participants is multiply
influenced. Gate-keeping clinicians are faced with competing
priorities and resources constrain research activity. As
gatekeepers, clinicians may seek to protect people for whom
they provide care from the perceived burden of research
participation and/or an intervention perceived to be futile for
an intractable condition. Rather than feeling ‘put upon’ by
disinterested researchers, gatekeepers should be involved in the
research process from the beginning and have their contributions
valued.
There are also long-standing concerns that the methods and
results of many clinical trials currently remain hidden from
public view. This lack of transparency, say campaigners,
undermines public trust, breaks the ethical pact between scientists
and those participating in trials and leads to clinical decisions
being made on the basis of incomplete evidence, potentially
leading to poorer outcomes for patients.
Collaboration with industry can bring in extra funding which
can be used to recruit trained CRNs to implement the trials rather
than the clinical team. This obviates the need and cost of
facilitating GCP training for the clinical team. There are current
calls on government to ensure all data from all clinical trials
is published to foster greater openness in medical research.
This degree of transparency would help to dissipate negative
perceptions of the pharmaceutical industry.
According to one experienced CRN, embedding clinical trials
successfully in routine care settings involves the following steps:
1) Build relationships with the clinical team Engage the
clinical staff so that they come to understand and believe in the
trials. This involves observing and working alongside the clinical
staff to learn how they work and who their patients are. It is
important to acknowledge the experience and expertise of the
clinical team and to seek and make use of their advice whenever

25. an opportunity arises. In doing so the CRN will gain the trust of her
clinical colleagues and become seen as an integral part of the the
clinical team and not as an unhelpful or meaningless add-on. The
clinical team are the ones to consult as to how to approach their
patients and of course the ones to refer patients to the trial. In
short they are essential to the success of the trial. If their interest
seems to be flagging at any point in the trial, then motivate them
e.g. with friendly but purposeful emails congratulating them on
their successes and urging them on when the need arises!
2) Create inviting, meaningful and trial materials Materials
used in the clinical trial e.g. information sheets and other forms
used in patient recruitment and the PIS (patient information sheet)
need to be patient friendly – written in plain English and suitably
embellished with e.g. picture and other illustrations if for minors.
Ideally feedback/outcome/observation sheets should gather
qualitative as well as quantitative data to give a more complete
picture of the effects of the intervention on trial. When seeking
participants do emphasize the positives e.g. that travel expenses
will be paid and whether there is flexibility as to when/where
patients participate.
3) Document everything Create comprehensive confidential
databases in line with GCP which capture any relevant patient
information. This may be of use when e.g. seeking participants for
further or follow-up trials.
4) Beware of social media Staff need to be cautioned against
posting confidential trial information or anything else that might
compromise a trial's integrity or success on social media websites,
e.g. Twitter. Similarly it is advisable to monitor what patients are
posting themselves and if necessary advise them on the possible
consequences of what they are doing.
5) Feedback At all stages gather feedback from everyone
involved (clinicians and patients) and as a result do make any
necessary alterations to the trial.
6) Fruits of success One of the outcomes of successfully
embedding a clinical trial into routine clinical care is that it opens
the gate at all levels for further research to take place and creates
a clinical team who are open to this happening.

26. A report by Dr Sarah Markham (Visiting Researcher, Dept
Biostatistics, IoP, KCL)