Why India?   Clinical Research Industry      Europe      Asia      Latin America      United States   Clinical Trials   Clinical Data Management   Central Reference Lab     WHY INDIA - FAQ'S   05) Please describe the study site infrastructure(e.g., pharmacy, study coordinators)   The study site depending on the type of study would have the following personnel - Principal Investigator, Co Investigators, Specialty Physician (depending on type of study like Radiologist etc), Study Coordinator, Study Nurse and a Pharmacist.   06) What is the FDA's policy regarding patient populations from India? What is acceptable regarding a more homogenous population that may not fully reflect the US?   (FDA tends to be biased toward US and Northern European data due to applicability and similarities in practice patterns). Many global sponsors have carried out their own audits of clinical trials conducted in India. Numerous audits in India are a testimony to the level of quality. Data from clinical studies in India have been successfully filed with international regulatory agencies. The overall impression is that the data quality in India is usually excellent. Many studies in which Indian sites were part of the global study team, the data have been accepted in FDA.   07) What import issues/limitations are there regarding US drugs coming into india for study? How are these handled?   Import license has to be obtained from the Drugs Controller General of India for import of drugs to India. An application will be forwarded to regulatory agency along with the Clinical Trial application with justification to the number of drugs to be imported. The import license would be awarded along with the approval to conduct of clinical study.   08) In oncology, what subspecialties are covered in clinical studies (e.g., leukemia, lymphoma, solid tumors, etc.)?   There are premiere oncology institutes in India where all subspecialties investigators are present. There are medical oncologist, surgical oncologist, radiologist, pediatric oncologist, head & neck cancer specialist, breast cancer specialist who are involved in various studies. Thus most of the subspecialties studies have been conducted in India.   09) How is cancer care different/similar in India to that in the US?   The medical care to cancer is similar to US, but due to genetic variation, there might be difference in the response to therapies in India as compared to US.   > next

Privacy Policy     Disclaimer