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

Abstract

<p class="abstract"><strong>Background: </strong>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.</p><p class="abstract"><strong>Methods: </strong>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.</p><p class="abstract"><strong>Results:</strong> 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.</p><p class="abstract"><strong>Conclusion: </strong>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.</p>