Awareness of clinical trial among resident doctors - Survey at a tertiary care teaching hospital in Gujarat

Dr. Rakesh A Malpure, Dr. Chandresh B Dumatar

Abstract


Background: There is an increasing trend to undertake clinical trials in India, but its awareness among the resident doctors remain far from satisfactory. Resident doctors arenot specially trained on clinical trials (CTs) in their postgraduate curriculum.

Aim: This questionnaire survey was designed to assess the level of knowledge, perceived understanding and awareness regarding basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues among resident doctors.

Materials and Methods: A cross sectional, descriptive, questionnaire based survey was conducted among resident doctors of Civil Hospital, Ahmedabad. Study duration: 3 months

Results: Out of the 420residents approached, 217 returned the completed questionnaire (response rate 51.7%). 4% residents had participated inCT as sub investigator.Majority (70%) were unaware about which CTs taking place at their institute. Majority (67%) were undecided about future participation in CTs. Overall good level of knowledge about different phases, types and sites of CTs was observed. Information of documentary requirement of CTs by regulatory bodies was lacking. Knowledge regarding research informed consent and financial compensation (69%) was average. Knowledge regarding role of ethics committee (41%), investigator responsibilities (40%), sponsor responsibilities (60%), safety reporting (30%) and drug regulatorybodies (39%) was low.

Conclusion: The study has revealed specific areas of deficient knowledge, which might be emphasized while designing training on CT methodology.


Keywords


Awareness, Survey, Clinical trial, Resident doctors

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References


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