September 10, 2020

Introduction

The world — even the clinical world — was caught off guard by the COVID-19 pandemic. Fortunately, the clinical development industry had already begun to adopt a variety of innovative practices designed to streamline clinical trials and relieve the burden on patients and clinical trial sites, many of which are well suited to keeping patients and site staff safe while research continues during a pandemic. It’s becoming obvious to most that the pandemic is not likely to end anytime soon. As we find ourselves adjusting to the new reality, it’s time to adopt these practices more widely. The health emergency created by COVID-19 may well usher in a new wave of innovation in trial operations.

For oncology patients who are eligible for, or participating in, clinical trials, the COVID-19 pandemic creates unique safety challenges that affect their emotional state as well as the logistics of trial participation. Oncology patients are immunocompromised and often very ill, so Sponsors and sites must take special care to minimize patients’ risk of exposure to the virus during their participation in any clinical trial. Following is an exploration of the issues that are particularly challenging for oncology patients and trial operations. We also present a practical guide to innovative approaches, many of which could be adopted as best practices on a routine basis.

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