|LETTER TO THE EDITOR
|Year : 2018 | Volume
| Issue : 2 | Page : 97
Clinical trials waiver in India-some considerations
Atul Juneja, Tulsi Adhikari
National Institute of Medical Statistics, ICMR, New Delhi, India
|Date of Submission||04-Sep-2017|
|Date of Acceptance||15-May-2018|
|Date of Web Publication||10-Jul-2018|
Dr. Tulsi Adhikari
National Institute of Medical Statistics, ICMR, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Juneja A, Adhikari T. Clinical trials waiver in India-some considerations. Indian J Pharmacol 2018;50:97
“The Clinical Trials for the drugs used in the US/UK may be waived.” This news drew the attention of all clinical researchers in India including clinicians, regulators, epidemiologist, and statisticians too. There is a clear intention of making those drugs available, which have demonstrated their efficacy for the given conditions in other developed countries such as UK, USA, without being subjected to intensified clinical trials in India. Importantly, it had been very rightly mentioned that this does not provide a general waiver and will be considered on case to case basis.
We feel that this is a welcome move from the health-care system in the interest of the patient care in India but needs to be taken upon certain scientific considerations. It would be important to consider the waiver of trials in India if the trial for that drug has been registered in a clinical trial registry of the country and the trial is searchable on the global pool of the WHO's International Clinical Trial Registry Platform. Disclosure of the results on the registry platform could be an added consideration for the waiver. Being registered on a clinical trial register, ensures the quality of the study is good, as the trial registry captures the data set points prescribed by the WHO on the items covering research design, sample size, randomization allocation concealment and ethics committee approval and also the details of regulatory clearances. The waiver may not be only based on it being used in the countries such as UK/USA, but its scientific and research methodology strength should also be looked on too.
The drug may have some adverse effect on the Indian population. If the drug in consideration has any chance of having adverse effects due to genetic or racial difference in the Indian population, it could be reviewed by scientific committee before the waiver is granted.
If there are trials which do not qualify for the waiver but drugs have some evidence for its efficacy in disease conditions such as H1N1, cancer, and HIV, they could be considered for the fast track clinical trials which would require some statistical and epidemiological considerations in addition to clinical considerations. Such type of trials could be conducted considering a very liberal type-I error as against the conventional level of 5%. Even the power of 70% could be considering the desperate need of making the drug available in view of the poor prognosis with the available treatment in the conditions, mentioned above. This would help to conduct a trial, even in a smaller sample. The very intentions of the liberal type-I error are to provide enough opportunity for the patients to have the drug available even if the probability of going wrong is 20% (P = 0.2) as against as low as 5% or 1%. This is in view of the limited availability of the drug for serious disease conditions as mentioned above.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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