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IIS's are clinical studies initiated and managed by a non-pharmaceutical company researchers who could be an individual investigator, an institution or a group of institutions, and a collaborative study group or a cooperative group.

Purpose of IIS - Investigator Initiated Studies

Clinical trials are not, and cannot be, designed to determine all the potential uses for a medication. IITs expand product knowledge, including safety.

Physician researchers often identify new ways of using existing treatments, thus improving the health of numerous other patients. And there is always greater weight attached to non-industry sources of data. Even large pivotal randomized clinical trials are done by academic research organizations, e.g., Public Health Research Institute (PHRI) or Duke Clinical Research Institute (DCRI).

On the face of it, we must have more investigator initiated trials. The usual practice is to design global clinical development programs (with the help of researcher-clinicians) and then place studies in countries where carefully selected investigators execute the study under the oversight of clinical operations. The principal investigator is sometimes reduced to being a pure implementer. At least those clinicians who participate in protocol development meetings get the satisfaction of being a part of cutting edge research and not merely being the executors.

Guidelines for IIS - Investigator Initiated Studies

FDA’s May 2015 Guidelines for Investigator Initiated Trials, Studies ... s-studies/

ICMR: National Ethical Guidelines -IIS ... elines.pdf

NCBI – Investigator Initiated guidelines

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