COVID-19 challenges in clinical trials

Authors

  • Murugan Panchatcharam Amaris Clinical; Division of Caplin Point Laboratories Limited, Chennai, Tamil Nadu, India
  • Sravanthi Lakshmi Mukku Amaris Clinical; Division of Caplin Point Laboratories Limited, Chennai, Tamil Nadu, India http://orcid.org/0000-0003-0153-4808

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20212092

Keywords:

Antioxidant enzymes, Atherogenicity, Coconut oil, Glucose tolerance

Abstract

Clinical research involves working with human subjects to answer questions relevant to their well-being in an ethical manner. The current scenario from the past one year has drastically changed the face of the clinical trials. The present COVID prevalence and simultaneously conducting the research with all the regulations and the precautions has been the difficult task for the contract research organisations (CRO).

References

Current clinical trials. Available at: https:// clinicaltrials.gov/ct2/resources/trends. Accessed on 20 February 2021.

DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet. 2020;395 (10221):361-9.

FDA guidance on conduct of clinical trials of medical products during COVID-19 public health emergency. Available at: https://www.fda.gov/media/136238/ download. Accessed on 20 February 2021.

Cinical trial reporting. Available at: https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(20)32264-9.pdf. Accessed on 20 February 2021.

Public disclosure of clinical trial results. Available at: http://www.who.int/ictrp/results/WHO_ Statement_results_reporting_clinical_trials.pdf. Accessed on 20 February 2021.

Anderson ML, Chiswell K, Peterson ED, Tasneem A, Topping J, Califf RM. Compliance with results reporting at ClinicalTrials.gov. N Engl J Med. 2015; 372:1031-9.

World medical association. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191-4.

Bagiella E, Bhatt DL, Gaudino M. The consequences of the COVID-19 pandemic on non-COVID-19 clinical trials. J Am Coll Cardiol. 2020;76:342-5.

Coronavirus in the US: latest map and case count. Available at: https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?action=click&pgtype=Article&state=default&module=styln-coronavirus&variant=show&region=TOP_BANNER&context=storylines_menu#states. Accessed on 13 May 2020.

Downloads

Published

2021-05-25

How to Cite

Panchatcharam, M., & Mukku, S. L. (2021). COVID-19 challenges in clinical trials. International Journal of Basic & Clinical Pharmacology, 10(6), 769–769. https://doi.org/10.18203/2319-2003.ijbcp20212092

Issue

Section

Letter to the Editor