CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2020; 41(03): 295-298
DOI: 10.4103/ijmpo.ijmpo_173_20
Original Article

Clinical Trials Facing “Serious Adverse Events” during the Ongoing COVID-19 Pandemic

Purvish M Parikh
Department of Oncology, Shalby Cancer and Research Institute, Mumbai, Maharashtra, India
,
Prashant Mehta
Department of Medical Oncology/BMT, Asian Institute of Medical Sciences, Faridabad, Haryana, India
,
Krishna Kumar MVT
Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital, Hyderabad, Telangana, India
,
K Govind Babu
Department of Medical Oncology, HCG Hospitals, Bengaluru, Karnataka, India
› Author Affiliations
Financial support and sponsorship Nil.

Abstract

Aims and Objectives: The ongoing COVID-19 pandemic is having a profound impact on the current clinical trials. We wanted to document the extent of the disruption amongst Indian clinical trial sites. Materials and Methods: We conducted an online survey among oncologists in India with active trials to document their experience with challenges and novel solutions. Results: A total of 60 oncologists replied of which 40 had ongoing trials with open recruitment. Majority of them had stopped screening (55%) and recruitment (62.5%). Almost half of the sites did not have adequate infrastructure (47.5%). Almost all the sites had enrolled patients worried about the impact of COVID-19 on their health outcome (up to 87.5%). The majority of sites had problems with adherence to study schedule of events (87.5%) and administration of study medication (42.5%). A total of 55% of the sites had provided the option of virtual visits. Both investigators (75%) and sponsors/contract research organizations (67.5%) had reached out to each other to maintain study integrity. More than half the centers had difficulty related to adverse events and serious adverse events (documentation and reporting; up to 75%). Discussion: Regulatory authorities in several countries have announced guidelines on the conduct of clinical trials during the COVID-19 pandemic. Whether the disruption lasts for a short or long time, its impact on clinical trials is going to be irreparable.



Publication History

Received: 19 April 2020

Accepted: 26 May 2020

Article published online:
28 June 2021

© 2020. Indian Society of Medical and Paediatric Oncology. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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  • References

  • 1 Available from: https://www.worldometers.info/coronavirus/. [Last accessed on 2020 Mar 29].
  • 2 Trends, Charts, and Maps. Available from: https://clinicaltrials.gov/ct2/resources/trends. [Last accessed on 2020 Mar 16].
  • 3 Thornton J. Clinical trials suspended in UK to prioritise covid-19 studies and free up staff. BMJ 2020; 368: m1172
  • 4 Available from: https://www.ncbi.nlm.nih.gov/pubmed/?term= covid-19. [Last accessed on 2020 Mar 28].
  • 5 Available from: https://www.ncbi.nlm.nih.gov/pubmed/?term= covid-19. [Last accessed on 2020 Apr 08].
  • 6 McDermott MM, Newman AB. Preserving clinical trial integrity during the coronavirus pandemic. JAMA. 2020. [Ahead of Print]
  • 7 Available from: https://edition.cnn.com/2020/03/30/us/brooklyn-hospital-coronavirus-patients-deaths/index.html. [Last accessed on 2020 Apr 08].
  • 8 Available from: https://fullfact.org/online/video-supposedly-showing-covid-19-patients-st-marys-hospital-london-was-actually-filmed-madrid/. [Last accessed on 2020 Apr 08].
  • 9 Available from: https://www.dailymail.co.uk/video/news/video- 2133646/Video-COVID-19-patients-lining-corridors-crammed-Italian-hospital.html. [Last accessed on 2020 Apr 08].
  • 10 Zhang L, Zhu F, Xie L, Wang C, Wang J, Chen R. et al. Clinical characteristics of COVID-19-infected cancer patients: A retrospective case study in three hospitals within Wuhan, China. Ann Oncol. 2020. [Ahead of Print]
  • 11 Dabhade S, Pandit P, Tiwari S, Pandit D, Chopra A. Reasons for patient's withdrawal from clinical trials of rheumatoid arthritis in India. J Orthop Allied Sci 2015; 3: 8-11
  • 12 Available from: https://www.mohfw.gov.in/pdf/Telemedicine.pdf. [Last accessed on 2020 Mar 28].
  • 13 Purvish MP, Prashant M, Shweta B, Shyam A, Amol P, Atul B, Ranjit S. Protecting healthcare professionals and workers (other than COVID-19 management facilities) from contamination during COVID-19 pandemic. Indian J Med Sci 2020; 72: 3-4
  • 14 Available from: https://theprint.in/health/modi-govt-allows-pharma-firms-to-tweak-clinical-trial-rules-during-covid-19-lockdown/392437/. [Last accessed on 2020 Apr 08].
  • 15 MHRA. Managing Clinical Trials during Coronavirus (COVID-19); 19 March, 2020. Available from: https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-COVID-19. [Last accessed on 2020 Apr 08].
  • 16 FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic: Guidance for Industry, Investigators, and Institutional Review Boards. US Food and Drug Administration; March, 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-COVID-19-pandemic. [Last accessed on 2020 Apr 08].
  • 17 Available from: https://www.nihr.ac.uk/news/dhsc-issues-guidance-on-the-impact-on-COVID-19-on-research-funded-or-supported-by-nihr/24469. [Last accessed on 2020 Apr 08].
  • 18 Dean NE, Gsell PS, Brookmeyer R, Crawford FW, Donnelly CA, Ellenberg SS. et al. Creating a framework for conducting randomized clinical trials during disease outbreaks. N Engl J Med 2020; 382: 1366-9