DCTs’ Broader and Multifaceted Implications

Applied Clinical Trials, Applied Clinical Trials-04-01-2022, Volume 31, Issue 4

Moving forward in a DCT world.

The decentralized clinical trial (DCT) movement has become the “it” word in the post-pandemic clinical trials world. In cases of enormous hype, where a term is used over and over, as well as used as an umbrella term to mean multiple things, it becomes less descriptive and, therefore, more confusing.

Now when decentralized clinical trial articles are submitted to our editors, they must begin with what the core article topic is…not decentralized trials, not a historical restating of the facts of how DCTs came to be…not a reairing of all the possible benefits DCTs could bring to the industry. No. What we need now are specifics. Directions. Best practices. Or even things that were tried and didn’t work well.

But what I will concede is that DCTs have brought a whole new cast of characters into the clinical trials mix. And old characters proving that adaptability makes competitive sense.

For a complete and thorough explanation of an example of the new cast of characters, please read our main feature. Here we learn about the challenges of the digital therapeutics industry and how it has grabbed on to DCTs as a way to more easily, and hopefully less expensively, acquire the needed quality data to ensure, at the minimum, outcomes evidence, and, at the maximum, FDA approval. With digital therapeutics, decentralized clinical trials providers such as Curavit Clinical Research or Curebase see a natural kinship or extension of those products with their digitally optimized clinical trials processes. While not the same pathway as a CDER- or CBER-based clinical trial, the needs for patient safety and scientific rigor are no less for a digital therapeutic that is going to make a claim to prevent, manage, or treat a medical disease or disorder.

As for traditional CRO providers, including Rho and PPD, their contributions to advancing DCTs can be found online. Rho has developed its RBQM strategies around a whole new host of key risk indicators that can arise in a DCTs. And PPD’s example of using a mobile RV, a literal DCT on wheels, to ensure the continued participation of a rare disease participant. And again in an oncology trial, designing the protocol so that both investigator and participant could customize their trial to fit the patient’s needs.

We look forward to sharing the use cases, examples, best practices, and more for the hybridization of clinical trials. “Decentralized” may have worn out its welcome, but the term sticks.

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