Journal of Diabetology (Jan 2020)

Strategies adopted in conduct of clinical trials amidst coronavirus disease-2019 (COVID-19)

  • Subramani Poongothai,
  • Ranjit Mohan Anjana,
  • Ramasamy Aarthy,
  • Selvam Kasthuri,
  • Mohamed Althab Begum,
  • Kulasegaran Karkuzhali,
  • Kannikan Viswanathan,
  • Balasundaram Bhavani Sundari,
  • Ravi Pavitha,
  • Boopathi Hemalatha,
  • Abdul Ali Tameem Nisha,
  • Mahalakshmi Ravisankar,
  • Rajkumar Marappan,
  • Jagannathan Ramesh

DOI
https://doi.org/10.4103/JOD.JOD_32_20
Journal volume & issue
Vol. 11, no. 2
pp. 81 – 85

Abstract

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The conduct of clinical trials is crucial to all research stakeholders and very challenging to the investigators, study teams, and participants during (coronavirus disease-2019) COVID-19 pandemic. The main challenges include difficulties in maintaining complete adherence to approved protocol, regulatory provisions applicable guidelines, recruitment of subjects, protection of rights, safety and well-being of trial subjects (participants), is of paramount importance. The CDSCO (Central Drugs Standard Control Organization), EMA (European Medicines Agency), and FDA (Food and Drug Administration) have come out with the guidelines on the management of clinical trials during the COVID-19. This article describes the process of conducting clinical trials at Department of Clinical Trials at Madras Diabetes Research Foundation (MDRF), Chennai, during the COVID-19 pandemic. Effective strategies taken at our site include compliance with scheduled visits of subjects, laboratory testing (investigations), administration of investigational product(s), assessment of safety and efficacy parameters, reporting of SAEs (serious adverse event). These strategies could be a useful reference to investigators, doctors, and research staff across hospital sites in India and elsewhere.

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