Strategies adopted in conduct of clinical trials amidst coronavirus disease-2019 (COVID-19)
| Autor: | Kannikan Viswanathan, Kulasegaran Karkuzhali, Ramasamy Aarthy, Balasundaram Bhavani Sundari, Ravi Pavitha, Abdul Ali Tameem Nisha, Mohamed Althab Begum, Jagannathan Ramesh, Ranjit Mohan Anjana, Rajkumar Marappan, Subramani Poongothai, Boopathi Hemalatha, Selvam Kasthuri, Mahalakshmi Ravisankar |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
clinical trials
medicine.medical_specialty lcsh:RC648-665 Coronavirus disease 2019 (COVID-19) Approved Protocol business.industry challenges lcsh:Diseases of the endocrine glands. Clinical endocrinology Clinical trial Food and drug administration Investigational product covid-19 Family medicine Pandemic Agency (sociology) medicine General Earth and Planetary Sciences Adverse effect business General Environmental Science |
| Zdroj: | Journal of Diabetology, Vol 11, Iss 2, Pp 81-85 (2020) |
| ISSN: | 2078-7685 |
| DOI: | 10.4103/jod.jod_32_20 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|