December 29, 2022 | Decentralized trials have been on everyone’s lips this past year, with COVID-19 providing a “stick” to motivate change in a way we had not yet accomplished with any of the worthy “carrots.” The first real data coming in on the success and value of new trial formats has also prompted other questions around standardizing vocabulary, prioritizing the incorporation of new pharmacists, and more. In addition, new data science technologies including machine learning and “tokenization” aim to shape clinical research.  

Decentralized Trial Data: Early this year, the Center for Information & Study on Clinical Research Participation (CISCRP) reported from 2021 surveys that interest in decentralized trials is high—provided the participant-study staff relationship remains intact. By mid-2022, the Tufts Center for the Study of Drug Development released the first hard metrics around decentralized clinical trials, reporting a higher “expected net present value” (eNPV) than traditional trials, and presentations at the 2022 Summit for Clinical Ops Executives (SCOPE) conference gave real world examples of how decentralized trials are performing.  

Part of the challenge in decentralized trial adoption has been vocabulary, argues the Decentralized Trials & Research Alliance (DTRA). In September, the group released a decentralized trial lexicon to begin to standardize our conversations, making it easier to find common ground and make progress on our efforts.  

Pharmacies & Trials: As expanded clinical trial designs emerge, the role of pharmacists has gained increasing attention. It is simply too costly and risky to exclude pharmacy professionals from clinical trials, several stakeholders explained. It is odd that the pharmaceutical industry ever excluded pharmacists in the research process to begin with, one said. “It has always been doctors, nurses, and patients, but in the commercial setting in the real world, it’s doctors, pharmacists, and patients.” The big pharmaceutical chains clearly agree. Walgreens envisions a clinical trial future for itself; Walmart and CVS are investing as well. Clinical Research News Senior Writer, Deborah Borfitz, dug deeper in a Scope of Things podcast episode.  

Data Science & Trials: Beyond the big questions of clinical trial design, we explored how AI can add efficiencies to clinical trials. The promise is faster, more efficient clinical trials with less of the bias associated with purely manual evaluations, proponents argue. Data science can also be used for the “tokenization” of clinical research participants to link information from trials to real-world data (RWD) on the same patients. The rationale includes the ability to track individuals more easily over the long haul and contextualize adverse events detected in studies. 

Clinical Trials Marketplace: Finally, 2022 marked the launch of ClinEco, the world’s first clinical trials ecosystem and marketplace. ClinEco is a sister company to Clinical Research News, so have been lucky enough to get a first peek at the launch news and then an updated conversation for the Scope of Things podcast this summer.