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-  2019 

New clinical trial rules: Academic trials and tribulations

DOI: 10.4103/picr.PICR_103_19

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Abstract:

Academic trials or investigator-initiated studies (IIS) are clinical studies conceived, planned, and managed by individual physician–researchers or an institution or a group of collaborative clinical researchers or institutions.[1,2] IIS include a wide range of studies – clinical trials of new drugs and real-world prospective or retrospective studies. IIS can help physicians in repurposing of drugs and in investigating health research questions relevant to their practice.[1] Data from real-world setting, which are applicable to population studied, can help in developing hospital/state/country-specific health guidelines and policies.[1

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