How can we balance public interest with the right to privacy when sharing personal data gathered through clinical and/or public health research?

1. Public interest in clinical study data
and the right to privacy
SpotOn London: November 2014
Dr Trish Groves
Head of Research, BMJ
& Editor-in-chief BMJ Open
@trished

2. Competing interests
I’m editor in chief of BMJ Open and Head of Research at BMJ, a
wholly owned subsidiary of the BMA
BMJ (the company) receives revenues from drug & device manufacturers
through advertising, reprint sales, & sponsorship
I receive a bonus based partly on the financial performance of The
BMJ. The BMJ is an open access journal that charges author fees
for publication of research articles, as does BMJ Open
The BMJ was a co-founder of the AllTrials campaign
The BMJ is campaigning for reproducible research

4. Advice to patients entering trials
Agree to participate in a clinical trial only if:
(1) the study protocol has been registered and made
publicly available;
(2) the protocol refers to systematic reviews of
existing evidence showing that the trial is justified;
and
(3) you receive a written assurance that the full study
results will be published and sent to all participants
who indicate that they wish to receive them.
Evans I, Thornton H, Chalmers I, Glasziou P. Testing treatments. Pinter and
Martin, 2011 www.testingtreatments.org

5. Should researchers share patient data?
To maximise fidelity of evidence
base ...and:
• allow testing of secondary
hypotheses
• aid design of future trials
• facilitate individual patient
data meta-analysis
• aid developing/evaluating
novel statistical methods
• ensure analyses can be
reproduced and checked
• provide incentive to ensure
accuracy of dataset
• reduce deliberate misconduct
Vickers A. Trials 2006;7:15
doi:10.1186/1745-6215-7-15

6. • How to minimize risks to privacy and confidentiality?
• Are anonymization or de-identification methodologies
sufficient?
• Could re-identification of trial participants ever be
beneficial?
• Any instances of re-identification of participants, with
what impacts?

7. Which data might reveal identity?
In a collection of patient observations used to
produce summary results of a study:
• identifying information is either direct or indirect
• publication of any direct identifiers could lead to
personal identification
• no indirect identifier alone would point to individual,
but dataset with several indirect identifiers could
• dataset including at least 3 indirect identifiers should
be assessed by independent researcher or ethics
committee to evaluate risk to privacy
Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG.
Preparing raw clinical data for publication: guidance for journal editors, authors,
and peer reviewers BMJ 2010; 340:c181

8. Clinical study identifiers Indirect
Place of treatment, name of doctor
Sex, ethnicity
Year of birth or age
Place of birth
Socioeconomic data eg occupation, income
Household & family composition
Sensitive data eg illicit drug use
Rare disease or unusual treatment
Anthropometry eg height, weight, BMI
Number of pregnancies
Small denominators—population size of
<100
Very small numerators—event counts of <3
Verbatim quotes, transcripts of interviews
Direct
Name/initials
Address with full/partial postcode
Phone/fax/email
Unique ID eg study participant number
Vehicle registration number
Medical device ID (eg hip implant serial no.)
Website URL
Biometric data
Photo of face or other unique image eg tattoo
Audio- or videotaped interview
Relatives’ names
Personal dates eg D.O.B.

9. • For all new centralised drug marketing authorisations
submitted after 1 January 2015 the European
Medicines Agency (EMA) will provide public access to
the core content of clinical study reports and will allow
researchers to use the reports for further analyses
• After further debate on the ethical and technical
challenges, the agency intends to also provide access to
anonymised individual patient data

10. https://www.clinicalstudydatarequest.com/

11. AllTrials campaign
THE PROBLEM
Thousands of clinical trials
have not reported results.
Information on what was
done and what was found
in these trials could be lost
forever to doctors and
researchers, leading to bad
treatment decisions, missed
opportunities for good
medicine, and trials
needlessly repeated.
All Trials Registered | All Results Reported
#AllTrials www.alltrials.net
WHAT CAN YOU DO?
• Join the >81,000 individuals who have signed the petition
for all clinical trials to be registered and the results
reported.
• Ask your organisation to join the campaign (520+
organisations have joined so far)
• Write a feature, blog post, editorial, or tell your members
in your organisation’s newsletter
• Ask your friends, family, and colleagues to sign up
• Donate to the campaign
• Get involved in other ways via www.alltrials.net

12. 2007
2013
2014

13. @trished tgroves@bmj.com