Details
Category: Volume 09 Issue 09 September 2021
Hits: 868

Title: COVID-19 and Clinical Trials: An Aftermath

Authors: Mukthambika B, Rajesh S.Hiray, Jyoti Gadhade, Jain Minal Bharat, Rajesh Mailagire

 DOI: https://dx.doi.org/10.18535/jmscr/v9i9.15

Abstract

In the recent times of the COVID-19 Pandemic crisis, the clinical trial has caught a lot of interest. The whole world is waiting anxiously for a medication or a cure that can cure this dreaded disease or a vaccine that can prevent it. The COVID-19 pandemic has put a huge strain on supporting the clinical trial endeavour and will moreover likely impact key trial results; these impacts should be considered during each and every phase of conducting the trials like the data analysis, investigation and interpretation. All things considered, the reactions to the pandemic have additionally presented innovations and developments that will help the conduct of clinical studies. Our article aims to give an overview of how this dreaded pandemic has had an impact on clinical trials. Trials have confronted numerous vulnerabilities and tremendous challenges including focusing on patient safety in the midst of the pandemic, consenting and selecting participants into trials, data collection and management. Innovation has given numerous answers for these difficulties, and trial managers have adjusted to better approaches for working while proceeding to conduct their clinical trials.

References

  1. The Center for Systems Science and Engineering (CSSE) at Johns Hopkins University. Coronavirus COVID-19 Global Cases. Available at: https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6.
  2. Livingston E, Desai A, Berkwits M. Sourcing personal protective equipment during the COVID-19 pandemic. JAMA.2020;323:1912–1914.
  3. S. Food and Drug Administration. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. 2020. Available at: https://www.fda.gov/media/136238/download.
  4. National Institutes of Health. Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19. 2020. Available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html.
  5. European Medicines Agency. Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic. 2020. Available at: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol10/guidanceclinicaltrials_covid19_en.pdf.
  6. Anker SD, Butler J, Khan MS, et al. Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA)of the European Society of Cardiology (ESC). Eur Heart J 2020;41:2109-17.
  7. Abraham WT, Fiuzat M, PsotkaMA, O’Connor CM. Heart Failure Collaboratory statement on clinical trials in the landscape of COVID-19. J Am Coll Cardiol HF 2020;8:423–5.
  8. van Dorn A. COVID-19 and readjusting clinical trials. Lancet. 2020;396 (10250):523–4.
  9. National Library of Medicine. Clinical Trials. gov. Available at: https://clinical-trials.gov.
  10. Shiely F, Foley J, Stone A, Cobbe E, Browne S, Murphy E, et al. Managing clinical trials during COVID-19: experience from a clinical research facility. Trials. 2021;22(1):62.
  11. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/clinical-trial-conduct-during-covid-19-pandemic
  12. The guidance for institutional review boards, investigators, and sponsors Use of Electronic Informed Consent in Clinical Investigations (December 2016). Available at https://www.fda.gov/regulatory-information/search-fdaguidance-documents
  13. Decentralized clinical trials: A data scientist’s perspective [Internet]. Hcltech.com. [cited 2021 Jun 4]. Available from: https://www.hcltech.com/blogs/decentralized-clinical-trials-data-scientists-perspective.
  14. Nabhan C, Choueiri TK, Mato AR. Rethinking clinical trials reform during the COVID-19 pandemic. JAMA Oncol. 2020;6(9):1327–9.
  15. Nuffield Department of the Population Health University of Oxford. How to setup a trial in nine days. https://www.ndph.ox.ac.uk/longer-reads/how-to-set-up-a-trial-in-nine-days
  16. Altman DG. The scandal of poor medical research. BMJ. 1994;308(6924):283–4.
  17. Chalmers I. Current controlled trials: an opportunity to help improve thequality of clinical research. Trials. 2000;1(1):3
  18. Clinical trials in India: COVID-19 pandemic crisis and beyond [Internet]. Pharmabiz.com. Available from: http://pharmabiz.com/ArticleDetails.aspx?aid=130204&sid=9

Corresponding Author

Dr Rajesh S. Hiray

Professor and HOD, Department of Pharmacology, Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune – 411001, Maharashtra, India