1. Vikas Dhikav, PhD Vikasdhikav@hotmail.com
Clinical Trials
Vikas Dhikav, PhD

2. What a clinical trial?
Type of clinical research following a pre-defined plan or protocol

3. Aim of clinical trial?
This is a human experiment, designed to show if one form of treatment is superior to the otherSuperiority trial
If the experimental treatment is shown (not) worse than the standard treatmentnon-inferiority trial
Most equivalence trials are bio-equivalance trials
Bulletin of the NYU Hospital for Joint Diseases 2008;66(2):150-4

4. Clinical research
Clinical research directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue.

5. Importance of clinical trials
Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.
registry

6. Recruitment Inducting patients into clinical trials.
Now, a billion dollar industry.
Done by clinical research organizations (CRO)

7. History
Case series have been historically been most important type of “experiments”
“Crude method”, biases are common.
James LindScurvy trial

8. India & clinical trials
“India has a tradition of founding the basic principles, preparing formulations, selecting the best one of the available lot till the end of medieval period”
Af J Traiditional Med 2007; 4 (3):

10. Phases of clinical trials
Phase-I (pk/pd) study, involving subjects.
Phase-II (efficacy) study, involving patients.
Phase-III (Randomized Control Trial), ideally, double blind, patients.
Phase-IV (Post marketing surveillance), also called as pharmacovigilance or adverse drug reaction monitoring
National Institute of Health, USA

11. Steps… Feasibility Indentify target population Sites selection
Recruitment material: brochures, posters, leaflets etc. including translations in local languages
Advertisements
Informed consent method
Study website
Monitoring & reporting
Auditing
guidelines (Accessed online April 17th 2014)

12. Randomized clinical trials (RCTs)
RandomizationEvery patient is randomized to receive either the active drug or the placebo.
Double blind neither the investigator, nor the patients know what they getting.
Double-dummy designadditionally, patients who are getting the drug get placebo and vice versa
Placebo (psychological medicine). This will ensure that patients who are getting active treatment and showing response can be compared.
guidelines (Accessed online April 17th 2014)

13. Methods of randomization
Coin method
Simple random method
Systemic random method
Stratified random method

14. Modern methods of randomization
Computer generated random numbers
IVRSinteractive voice response system
Indrayan A. Medical Research 2009, 3rd Ed, AITBS Publishers, pp 27

15. Active comparator
Active comparator means, an active drug that will be compared against a new drug undergoing development.
guidelines (Accessed online April 17th 2014)

16. Problems of clinical trials in India
Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. 
registry

17. Way forward
Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data.
registry (Accessed online April 11th 2014)

18. Trial registry in India
Registration of trials will ensure transparency, accountability and accessibility of clinical trials.
This would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry.
registry

19. Trial registrations is MUST in India
Initiated as a voluntary measure, since 15th June 2009,trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) ( Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication
registry

20. Register before you start
Registration is expected to register the trial in the CTRI before enrollment of the first participant.
Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etcbefore the enrollment of the first patient.
registry

21. Registration checklist…
Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. 
Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI.
registry

22. Purpose of trial registration
The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered, i.e. before the enrolment of the first participant.
registry

23. Clinical research costs in drug development
And almost 70% of the total cost of a developing molecule as a drug is due to the clinical research.
Developing countries like India have become the preferred avenues for clinical trials related activities almost 20-30% of the activities of the global share.
It is forecasted to grow at a compound annual growth rate of 30%.
J Pharm Bioallied Sci. 2013; 5(1): 2–9

24. Thank you! 