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

CC BY-NC-ND 4.0 · Indian J Med Paediatr Oncol 2020; 41(03): 295-298

DOI: DOI: 10.4103/ijmpo.ijmpo_173_20

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.

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.

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 alCreating a framework for conducting randomized clinical trials during disease outbreaks. N Engl J Med 2020; 382: 1366-9