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It has been a long time coming, but there is light at the end of the COVID tunnel. Fortunately, it is not a train coming head on.
Over the last two years, like other industries, companies involved in the pharmaceutical and medical device industries had to adapt quickly. While challenging for all, it was a matter of survival for small sponsors, CRO’s, and clinical research sites, some of which did not make it. Operational changes that might have been uncomfortable to adopt pre-COVID became easier when faced with the realities of the need to change in order to survive.
For those that survived, the journey was tortuous, yet, in many ways, the industry and the individual businesses that survived are stronger for it. While not new, decentralized clinical trial (DCT) design was incorporated into some study designs, and remote study visits and electronic data capture via a variety of devices was added to some studies. While the industry still has a long way to go to fully leverage the power of DCT, and use of artificial intelligence (AI) and other advanced technologies getting momentum, the progress made during a time of “must adapt quickly to survive” has been impressive and might not have occurred at all if not for the COVID-19 pandemic.
The future is bright, as a variety of companies emerged to facilitate new methodologies, while the door is opening to others as the industry continues to seek better ways to find and access patients to participate in studies. Full commercialization of the systems and platforms to make remote participation in studies easy for patients and referring physicians cannot come too soon. Together with more effective ways to identify patients for studies (particularly rare disease studies), some form of DCT will be incorporated into most studies within the next few years.
Sponsors and CRO’s: Are you already utilizing DCT design in your studies? If not now, when?
Sites: Have you participated in studies that involve remote visits by patients? If not, would you like to?