04 Jun Semantics Matter: DCTs And An Industry Decentralized

By Daniel J. Fox, MPH, Ph.D., Clinical Leader

Amidst one of the greatest global health crises in over 100 years, national decentralized clinical trials (DCTs) organizations hit the industry like a storm. Investor-backed giants injected resources into what they thought would be once-in-a-lifetime returns on investments during the desperate times and high demands of the COVID-19 pandemic. They promised all the patients without those pesky local sites getting in the way. They claimed the quadrupled RFP will be worth it in the end when you eliminate the waste of inefficient trials at the local level. And because it was COVID and our world was in a state of crisis, the industry listened. Yet, many of our local community sites interpreted their introduction as an attempt to cut them out of the process or to replace their frontline efforts altogether (Costello and Larrabee 2021).

We remember those social media posts: “DCT is the future! If you don’t adopt it, you will go extinct.” The local community site was not only under attack but also under greater scrutiny as national corporations and pharmacies swooped in to take control of frontline local community activities, physicians’ decisions, and patients.

Fast forward several years. The pandemic has gradually left the world’s priorities, and the allure of “convenience” of national DCT efforts has subsided as hefty price tags (and equally impressive revenue anticipated by investors) are no longer justified. Sponsors instead are falling back into their pre-COVID budgets, standards, and site expectations. One by one, the same organizations promising a site-free future are closing their doors as they realize the finances of clinical trials are nowhere near what they projected during pandemic times. Read more…