feel free to share

1. An introduction of:
Investigator initiated research (IIR)
DR NOR HIDAYAH ZAINOOL ABIDIN
Department of Anaesthesiology and Critical care
HRPZ 2, Kota Bharu

2. What is research?
• A systematic investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalize knowledge

3. Research is best learnt by actually conducting
the research project rather than reading or
attending lecture

5. Simple study base on questionnaire
• KNOWLEDGE, ATTITUDE, AND PRACTICE (KAP)
STUDY OF DENGUE AND CHIKUNGUNYA
DISEASE AMONGST ADULT POPULATION OF
KAMPUNG TANJUNG API, KUANTAN, PAHANG,
2009

6. Why research? – The right mindset!
•
•
•
•
•
•
•
•
Untuk mengambil hati boss.
Untuk mendapat markah SKT yang tinggi.
Untuk naik pangkat.
Untuk orang ramai kenal saya.
Untuk menang dalam pertandingan.
Untuk mengisi masa lapang.
Dipaksa/ Dipaksarela.
Saya nak belajar lebih

8. Data is power……
• Vital to the understanding of problems
•
•
•
•
•
•
•
•
Translate basic sciences to human studies, and subsequently to clinical practices.
New drug/ technology development
New diagnostic techniques
To compare effectiveness
To compare safety profile
To study the healthcare systems
Economic evaluation
Applied research

9. Research impact
• Build the scientific foundation for clinical
practice
• Prevent disease and disability
• Manage and eliminate symptoms caused by
illness
• Enhance end-of-life and palliative care
• To help the decision making processes

10. Examples of Clinical Research Types
• Clinical trials or therapeutic research Clinical
epidemiology: disease diagnosis and
prognosis, clinical decision making
• Clinical Economics; cost-effectiveness of
healthcare
• Disease epidemiology: incidence, prevalence,
distribution of and risk factors for disease X

11. What is Clinical trial/clinical study?
• It is any investigation in human subject
intended to discover or verify the clinical,
pharmacological and/or other
pharmacodynamic effects of an investigational
product(s), and/or to study absorption,
distribution, metabolism, and excretion of an
investigation product(s), with the object
ascertaining its safety and/or efficacy

12. General type of research
• Commercialized (ISR – industry sponsored
research)
– Pharmaceutical companies provide protocol and
funds for the researcher to recruit patients and
implement the study
• Non-commercialized (IIR – investigator
initiated reasearch)
– Investigator initiates clinical trials with or without
the involvement of the drug companies

13. Why should we be involve in clinical
trials?
• Reinforcement or our clinical practice
– Clinical trial does not differ much with daily
practice apart from following protocols stringently
– Application of research findings
• Continuous medical education (CME)
– Well verse with the topic/areas involve in the trial
• A lot more readings, literiture search and discussion
with expert of the area

14. • Advantages to
clinician/
investigators
• Benefits to patients
• Advantages to the
institutions
• Advantages to
pharmaceutical
companies
• Benefits to the
country
Advantages
of doing
clinical trials

15. Advantages to the
clinician/investigator
•
•
•
•
•
•
Extra money
Travel overseas
Academic achievement
Experience in well planned clinical trial
Practice better medicine
Experience working with experienced clinician
and peer recognition
• Experience with pre release drugs

16. Benefits to the patient
• Better monitoring of patient’s medical
problems
• Managed by most experienced and dedicated
people
• Better relationship with physician resulting in
better outcome of medical problem

17. Disadvantages in clinical trials
• Clinician/investigators
– Time consuming
– Extended commitment
• Patient
– Risk of developing side effects
– Sereious Adverse event & adverse reaction
• Pharmaceutical companies
– Risk of great financial loss if outcome of trial not
favour them

18. Requirement to become investigators
• Clinician
• GCP certified
• Ready to give full commitment to
make it successful

19. What is Good clinical
practice (GCP)?
• A standard for the design,
conduct, performance,
monitoring, auditing,
recording, analyses and
reporting of the clinical
trials that provide
assurance that the data and
the reported results are
credible, and accurate, and
the rights, integrity and
confidentiality of the trial
subjects are protected

20. GCP- provisions and prerequisites for a
clinical trial
•
•
•
•
•
Ethical principle
Declaration of Helsinki
Justice
Respect for person
Beneficience (maximize benefits and minimize
harms and wrongs)
• Non maleficence (do no harm)
• Fully informed

21. Ethical principles & requirements
• Safeguards the rights, safety and well being of
all trial subjects
– Trial protocol/ amendments
– Written informed consent
– Subject recruitment procedures
– Written informations to be provided to subject

22. PATIENT INFORMATION SHEET AND
INFORMED CONSENT FORM
1.
2.
3.
4.
Title of study:
Name of investigator and institution:
Name of sponsor:
Introduction:
1.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
You are invited to participate in a research study (brief introduction why they are selected and what the
study is all about)
What is the purpose of the study
What kind of study products will I receive
What will happen if I decide to take part? (need to fill up medical history data, or
questionnaire, or follow the treatment schedule (just a give a brief what patient need to do,
can be in numbering or phrases form.)
What are my responsibilities when taking part in this study?
What kind of treatment will I receive after my participation in the trial?
What are the potential risks and side effects of being in this study?
What are the benefits of being in this study?
Who is funding the research
Can the research or my participation be terminated early
Will my medical information be kept private
Who should I call if I have questions

23. Protocol
• A document that prescribes the
–
–
–
–
–
–
objectives
design
methodology
statistical considerations
organisation of trial
background and rationale for the trial
• Throughout the ICH-GCP guideline the term
protocol refers to protocol and protocol
amendments (a written description of changes to
or formal clarification of a protocol

24. •
•
•
•
•
•
•
Generate ideas
Review related literatures
Formulate research questions/ objectives
Design research & study proposal Conduct study
Analyse data
Interpret results
Determine implications of research (conclusion
and recommendations)
• Publication/ presentation

26. Complicated????

27. CRC Malaysia

28. • Perkhidmatan
• Pengenalpastian pesakit
• Pemilihan subjek
• Pegurusan projek
– Registry pesakit
– Menjalinkan usahasama dalam kajian
• Kursus dan latihan
– Program bimbingan
•
•
•
•
•
•
Pendaftaran dan permohonan geran penyelidikan
Pembentukan protocol kajian
Analisa statistik
Pembentangan hasil kajian
Penulisan saintifik hasil penyelidikan
Analisa statistik
– Pembentangan GCP
• Khidmat rundingan
– Pendaftaran penyelidikan
– Rekabentuk dan metodology kajian

31. CRM

32. Research in Ministry of health (MOH)
Current MOH policy on research, as specified in
the guideline, requirement

33. Policy statement 1
• All research require prior registration with the
approval by MOH
• National medical research registry (NMRR)
• To upload
– Agreement from investigators
– Agreement of HOD
– Agreement of director of institutions/hospital
• NIH review and approval

34. Policy statement 2
• Research involving human subjects require
prior review and approval by the medical
research @ ethical committee (MREC)

35. Policy statement 3
• All research publications and presentations
must have DG of health approval
• Submit cover letter + form + draft to NIH
secreteriats
• Prior review by NIH panels
• NIH sec  DDG (P&ST)  DG

36. National Medical Research Register
(NMRR)
The NMRR is thus specifically designed to enable:
• Online registration of research. to be registered in publicly accessible research registers.
• This is to ensure transparency and to increase public trust in the conduct of medical research; as
well as to inform physicians and prospective volunteers about ongoing research in which they may
wish to enroll.
• Online submission to an appropriate authority for approval, as well as online review of the
submitted research by relevant appointed reviewers. The online system ought to reduce the
research review time as well as to enable investigators to track the status of their research online
• Online submission of research publication to the NIH for approval
• Finally, the NMRR also enable MOH management to document the level of research activity in the
MOH, and also to track the progress of the research it has approved and/or provided support such
as funding.
• The title of all registered research and its associated publications where available will be published
in the Directory of Medical Research on the NMRR website.
• In the process of registering a research, participating investigators are required to be registered on
NMRR too. All such registered investigators shall also be published in a Directory of Clinical
Investigator & Medical Researchers on the NMRR website. The Directory should be of help to
investigators to locate other potential collaborators, and to sponsor of clinical trial to identify
suitably qualified clinical investigators to participate in their multi-centre trials.

40. Documents for submission
• Research documents
–
–
–
–
Protocol synopsis
Protocols/ amendments
Investigator broshure
Patient informed consent
• Investigators documents
–
–
–
–
CVs
GCP certificate
Investigator’s agreement and HOD approval
Professional indemnities

41. Research tools
• to create dataset and data analysis
– SPSS
– Epi-info
• Endnote
– Search, organize and share research. And
automatically format bibliographies with
the only patented bibliography technology.
• Epical 2000 software
– statistical calculator that works with pretabulated data

42. Because bunches
and guesswork is
not enough