Challenges faced by investigators in conduct of oncology trials during COVID-19 pandemic at Tata Memorial Centre: a cross-sectional survey


  • Devanshi Kalra Clinical Research Secretariat, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India
  • Abhidnya Desai Institutional Review Board, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India
  • Amit Joshi Medical Oncology, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India
  • Gouri Pantvaidya Surgical Oncology, Tata Memorial Hospital and Homi Bhabha National Institute, Mumbai, Maharashtra, India



COVID-19, Pandemic, Clinical trial, Oncology


Background: Novel corona virus disease 2019 (COVID-19) pandemic has impacted health care sector adversely and its major impact is seen especially in the field of oncology. One of the areas of cancer care that has been affected is the conduct of clinical trials. Various challenges have emerged in front of the investigators in providing proper treatment and care to the research participants and moreover in safeguarding the rights, safety and well-being of the research participants.

Methods: A questionnaire survey was conducted among the oncologists from the major specialties (medical, surgical and radiation) during the lockdown period to assess the challenges faced in conduct of clinical trials during this pandemic.

Results: A total of 110 questionnaires were circulated. Of the 110 questionnaires distributed at the Tata Memorial Centre, 50 responded. The overall response rate was 45.45% (50 responses). Majority of investigators (96%) reported that the pandemic affected the initiation of new trials in oncology. 86% investigators reported that COVID-19 situation has resulted in more protocol deviations than usual for ongoing trials also 62% investigators expressed that the quality of the trial data may get affected due to pandemic.

Conclusion: Our survey reports that the majority of the researchers are encountering major challenges in conducting clinical trials in an oncology setting during this pandemic. Despite these challenges in trial conduct, efforts are being made by the investigators and their team to adapt to the new methods for effective management of patients in clinical trials.


Indini A, Aschele C, Cavanna L, Mario C, Bruno D, Giammaria F et al. Reorganisation of medical oncology departments during the novel coronavirus disease-19 pandemic: a nationwide Italian survey. Eur J Cancer. 2020;132:17-23.

Lee LYW, Cazier JB, Starkey T, Turnbull CD, Kerr R, Middleton G. COVID-19 mortality in patients with cancer on chemotherapy or other anticancer treatments: a prospective cohort study. Lancet. 2020;395(10241):1919-26.

Studies highlight COVID-19 impact on cancer patients. CIDRAP. Accessed June 25, 2020.

Waterhouse DM, Harvey RD, Hurley P, Levit LA, Kim ES, Klepin HD et al. Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey. JCO Oncol Pract. 2020:OP.20.00275.

CDSCO initiative to reduce impact of COVID-19 on clinical trials. Accessed June 25, 2020.

ASCO Survey on Early Impact of COVID-19 on Performance of Oncology Clinical Trials - The ASCO Post. Accessed September 8, 2020.

Upadhaya S, Yu JX, Oliva C, Hooton M, Hodge J, Hubbard-Lucey VM. Impact of COVID-19 on oncology clinical trials. Nat Rev Drug Discov. 2020;19(6):376-7.

Parikh P, Mehta P, Kumar MVT K, Govind Babu K. Clinical trials facing “Serious Adverse Events” during the ongoing COVID-19 pandemic. Indian J Med Paediatr Oncol. 2020;41(3):295.






Original Research Articles