While the Covid-19 pandemic spurred the rise of decentralised clinical trials (DCT), the patient-centric elements of this trial model are still promising and here to stay.
Three experts deliberated the applicability of DCTs in a post-pandemic environment at the 15th Annual Outsourcing in Clinical Trials East Coast conference, which was held 21 – 22 May in King of Prussia, US.
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While the cost of DCTs is higher upon trial initiation, some elements of decentralisation—such as more frequent and accurate data collection, better subject retention and engagement, and faster recruitment—can result in cost savings that benefits the trial in the long run, said Kristen Olszyk, acting Head of Clinical Operations at Chesterbrook, Pennsylvania-based biotech Neuraptive Therapeutics.
Ram Raju, former senior Vice President and Community Health Investment Officer at Northwell Health agreed that DCTs are not currently cost saving. But Raju noted the impact that technology associated with DCTs may have on the job market. “In this country [US], the cost of human service always goes up while the cost of technology is always coming down. Eventually, intuitively, the cost will be lower in the long run,” said Raju. The benefit of DCTs is that this model is more accommodating of patients and allows sponsors to reach patients that would otherwise be unreachable, said Rosanne Petros, PMP, associate director, Clinical Research at Merck Research Laboratories. There is less burden on the patients, but with decentralised trial procedures, studies must employ “very intuitive” devices that are available in multiple languages and facilitate the trial process for patients, Petros added. Technology is the main hurdle to overcome to drive success in DCTs, Raju elaborated, but this is an easily addressable challenge.
In order to reap the most benefits from DCTs, the industry needs to learn from DCT implementation during Covid-19 and build a hybrid study design that combines decentralisation and conventional trials going forward, said Olszyk. DCTs are particularly advantageous for patients with long-term chronic conditions and for patients who experience barriers to accessing clinical studies, agreed Olszyk and Raju.
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