As a result of the COVID-19 pandemic, clinical trials have been put in a very complex position. The standard ways that many clinical trials are run are difficult to maintain with strained access to supplies, destabilized schedules, and additional health regulations.
This article, published in Gynecologic Oncology, provides an analysis of best practices for conducting trials during the pandemic in a way that maintains safety while not compromising the accuracy or validity of the trial results.
The article specifically focuses on gynecologic anti-cancer therapy clinical trials. A team of expert researchers in this field aggregated information about the effects of the COVID-19 pandemic on these trials to set up suggestions and best practices during this time.
Among the recommendations provided, they note that some clinical trials will have to be prioritized over others as resources are strained, telemedicine visits are preferred to limit SARS-CoV-2 exposure, and less immunosuppressive regimens and regimens that require less frequent visits are also preferred.
The overall conclusion of the article is that clinical trials should approximate standard conditions as closely as possible while maximizing the safety of all involved and minimizing risks from deviations in cancer care and contraction of COVID-19.
Although this conclusion is quite general, highly detailed instructions are provided for specific situations that trial participants and researchers may face. The need for high-level analysis of ongoing changes and flexibility is suggested throughout .
Source: Pothuri, B., Alvarez Secord, A., Armstrong, D. K., Chan, J., Fader, A. N., Huh, W., Kesterson, J., Liu, J. F., Moore, K., Westin, S. N., & Naumann, R. W. (2020). Anti-cancer therapy and clinical trial considerations for gynecologic oncology patients during the COVID-19 pandemic crisis. Gynecologic Oncology, 158(1), 16–24. https://doi.org/10.1016/j.ygyno.2020.04.694