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1.Is IEC Approval required for PMS Studies-(Observational studies) and if yes, is it required from all the sites where the study is taking place. If it is non-interventional study, EC approval is not required See the ICMR 2006 guidance Phase IV studies or post marketing surveillance is undertaken to obtain additional information about the risks and benefits resulting from long term usage of drug. It is an important aspect of drug trial on the long-term effects of the drugs and the adverse reactions induced by drugs, if any, should be brought to the notice of the Ethics Committee. In addition there are Phase IV studies that are designed to evaluate the marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. The drug is used for the labeled indication in these studies. Therefore Licensing Authority permission is not needed. However, EC permission is needed. A third type of post-marketing study involves evaluation of the drug for a new indication of a marketed drug, eg. studies with letrazole. Here, DCGI permission and EC approval are needed which really makes the trial a Phase III study. 2.Is Insurance required for PMS Studies as many sponsors say they don't require as the drug is in the market. Most sponsors have a product liability insurance which covers marketed drugs 3.In Phase 2/3,the clinical report is called as CSR,but what is the term used for preparation of PMS study report.Is it also a CSR or different terminology is used. CSR includes all phases of development including Phase IV PMS study.
4.If a sponsor wants do a study(PMS) to assess the safety on and efficacy on more patients, is DCGI permission required.
If number is more than DCGI approved, the sponsor needs DCGI permission to include additional patients.
5.In Phase 4 study, if the sponsor has come out with combination drug, then DCGI approval required
Yes if the combination falls in category of new drug as per 122 E.
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