2021 Promises for Clinical Trials

I could promise that I’m not going to write another editor’s letter this year about decentralized trials, but I don’t make promises I can’t keep. While so many issues related to COVID’s impact on clinical trials rise to the top of the news stream, it has pulled decentralized trials along its wake since the pandemic’s start. I can promise, however, that we are encouraging contributors to rise above the urge to blanket everything under the decentralized trials-per-COVID umbrella. We are much happier to offer the readers of Applied Clinical Trials actual, concrete solutions or dialogue that furthers the conversation. We can keep pointing to the past, but not learning from that past and putting lessons into future practice, the industry runs the risk of falling back into reactive clinical trial habits.

Because of recent sponsored projects, the editors are privy to information we can’t attribute yet on decentralized trials, but safe to say, many industry stakeholders are open to change and to further the cause. Observations include:

• The pandemic has truly accelerated the adoption of patient-centric technologies, as well as expectations for accelerated timelines.
• Leaders that believe in taking action and who enable adoption of technologies or practices is essential for the industry—or at least their organizations—to thrive.
• When the regulatory decisions on submissions during the COVID timeframe are made, many will look to those as signals for FDA readiness.

At press time, we are putting the final touches on Applied Clinical Trials’ first ever virtual Symposium titled “Clinical Trials Operational Successes Post COVID-19”. The event is live on February 11 and 12. If you can’t make it, however, the symposium will be available on-demand, and we encourage you to watch at your leisure. You can also submit questions on-demand, and they will be forwarded along to the respective presenters for their response.

For the rest of the year, any topic we write to will include a component of COVID. For example, site feasibility will include aspects of ensuring sites can recruit participants from a diverse population, as indicated by the need borne out of COVID vaccine trials. Patient centricity and diversity again would not be complete without including the natural outcome of patient-centric solutions expected to take deeper roots post-COVID.

2021 has just begun, but thankfully, it looks like a promising year.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mjhlifesciences.com.