Clinical trials are the engine room that powers our ability to deliver new treatment options to patients.
The rigorous testing and resulting data that help us understand how new treatments work are what propels our industry forward.
But the engine room has flipped a switch. Governments have brought in various measures to reduce the number of COVID-19 infections and to help health systems cope with related pressures. The impact of these measures, compounded by pressures on supply chains, coupled with new recommendations from regulators on managing clinical trials, as well as companies’ own internal reprioritisations, have created a perfect storm in R&D. Hundreds of trials have been affected—including delays and disruptions to ongoing trials and cancellations or revisions to planned ones—and more changes are expected.
Furthermore, many healthcare providers have been pulled in to support critical care needs or at-risk patients, leaving less time and resources for clinical trials. This leaves patients with other conditions at risk of being left behind. With many patients unable—or unwilling—to visit clinics, uptake of telemedicine is flourishing, which is a positive step forward, but also creates its own set of challenges in data collection. Nonetheless, increased adoption of telemedicine, real-world evidence practices, and different types of outcomes could help recalibrate perceptions of acceptable—and approvable—trial results.
But in the meantime, delays to data availability—combined with medical conferences postponing and/or moving to virtual formats—is requiring many companies to rewrite their congress and publication strategies. We need to take new approaches in determining how, when and where to share data with target audiences, whilst ensuring timely and transparent communications. In addition to changing the playbook of how we communicate with those approving, prescribing or taking medications, we also need to keep advocacy groups, investors and internal colleagues informed of changing plans, particularly as launch timings may be delayed.
It is apparent the pandemic will have a far-reaching impact on clinical trials, which will ripple out to all areas of our industry.
Our immediate focus should be on protecting the integrity of ongoing trials and ensuring study participants know about changes to trials and how we are protecting their safety. In the medium term, we will have new opportunities to spark greater creativity in communicating results, and hopefully new best practices in trial design and regulatory requirements. In the longer-term, there will be an R&D pipeline that looks quite different from today’s. Amidst all this change, adaptability will be key.