What Biotech and Pharma need to consider about decentralized trials
Monday, June 13, 2022
Source: BIOPHARMADIVE
A decentralized clinical trial (DCT) is where some or all patient visits occur outside the traditional clinic or hospital setting. It can employ wearables and sensors, telehealth, smartphone-based apps, in-home visits or other methods to make the trial more patient-centric and remote from the site. Before COVID-19, DCTs were becoming more common, however, the pandemic shifted the paradigm and motivated sponsors to look at decentralized and hybrid trials in a different light and realize the benefits these new models will deliver.
Although not all therapeutic areas or indications are appropriate for a decentralized approach, when they can be used, they can increase patient recruitment, retention and diversity and deliver high-quality data, all while making it easier for patients to participate. This can be particularly important for rare disease studies, where a relatively low number of appropriate patients may be more geographically spread across the country or indeed the globe.