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While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.
The COVID-19 pandemic has created widespread uncertainty in our industry, which is clearly demonstrated by the number of clinical trials that have stopped, slowed, failed to start or are otherwise impacted. While there has been some hopeful news around the margins from our industry on treatments and vaccines, it is important to consider that COVID-19 related issues are expected to continue into 2021.
Regulators have provided guidance for patient safety and study conduct during COVID-19. A core safety risk mitigation strategy for study sponsors and the industry has been replacing face-to-face clinic visits with remote visits, where telemedicine and other technologies allow a participant to complete study activities from their home or other remote location. Particularly, patients in active trials need support and information as to the status of their trial, risks associated with discontinuing or continuing with scheduled appointments, and the potential impact of COVID-19 on their health due to existing conditions.
Collection of electronic patient-reported outcomes (ePROs) in a decentralized trial model has been widely adopted and accepted across the industry prior to changes brought about by the pandemic. Mobile phone applications for ePROs, eDiaries, and sensors and wearables are among the patient-focused tools that create opportunities to engage not only patients but also their care partners to improve the trial experience. Because of the pervasiveness of technological devices, designing trials around bring-your-own-device (BYOD) strategies is becoming not only accepted but appreciated by participants. Additionally, the remote administration of clinician reported outcomes (ClinRos) in a decentralized model was less established than PROs prior to COVID.
With this in mind, as we look to the future of the clinical trial landscape, with several months of trials run during the COVID-19 pandemic, the question isn’t if, but how, digital technology will contribute to enabling reliable and feasible remote data collection of outcomes, including ClinRos, PROs, sensors and other reliable and feasible for all stakeholders.
Some considerations when navigating this landscape are listed below:
Sponsors and other stakeholders should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies. The considerations described can help sponsors and researchers manage uncertainty and engage with patients effectively as we navigate the pandemic together. As an industry, the opportunity to proactively address patient safety and access to studies can be a silver lining to the pandemic, bringing broader participation to current and future clinical research.
Dan DeBonis is the Principal of Endpoint Solutions at Signant Health