For all the personal and economic devastation it has wrought, the COVID-19 pandemic has at least brought about one positive change: a growing interest in, and acceptance of, decentralized clinical trials (DCTs) and the technology that supports them. The pandemic has catalyzed advancing the notion that not every clinical-trial visit has to be conducted in-person, on-site. With eClinical innovations, such as eConsent, tele-health, and direct-to-patient (DtP) shipment of drug products, DCTs are finally poised to go mainstream.
Many sponsors who’ve eyed DCTs from afar acknowledge that virtualization is the way of the future, and the industry is on the precipice of a fundamental change in how trials are conducted. There appears to be no reason, or will, to return to the way things used to be, as I’ve observed a general interest in continuing the momentum of the last year and a half.
Yet, sponsors in this risk-averse industry are often reluctant to take the plunge and invest in the technologies that make DCTs possible—in part because, in some cases, the technology is ahead of regulations. How can companies become comfortable in breaking out of the “late majority”, described in Geoffrey Moor’s Crossing the Chasm, to join the “early majority”, let alone the “early adopters” and “innovators”? Or, more to the point, how can sponsors minimize their risk in adopting eClinical technologies? Much of their success depends on their selection of technology partners.
Putting Expertise to the Test
Sponsors concerned about the potential risks of adopting eClinical technologies to enable DCTs should seek out technology partners who are experts and can take the worry out of making the investment and implementing significant changes. But what does expertise look like, particularly with innovations that are still quite new? The following is a short litmus test that can be applied when selecting an eClinical partner:
DCT trials will only catch on in the post-pandemic world if sponsors can adopt the associated technology with minimal risk. After all that the industry and humankind have been through with the pandemic, it would be a great loss if we are unable to turn what we’ve learned about operating remotely into an opportunity to re-invent trial operations. Sponsors, working with expert technology partners. can proceed confidently knowing that they will get the necessary guidance to minimize their risk and conduct a successful DCT trial.