Regulatory confusion, vendor management challenges and a lack of budget flexibility are holding back decentralized clinical trials (DCTs) according to research group, the ACRP.
The assertion followed a meeting in October at which 42 representatives from clinical research organization’s (CROs) discussed how decentralized clinical study models are impacting drug research and sought to identify areas that could be improved.
The key finding, according to the ACRP, was that at present there is a lack of clarity around regulatory requirements that is hindering the adopting of DCTs at the site level.
Other barriers identified by the group include a lack of budget flexibility and the challenges of managing third-party vendors.
And the findings are important because they are based on professional experience according to Susan Landis, ACRP Executive Director.
“DCT approaches rely on principal investigators and study teams being able to incorporate decentralized approaches without impacting safety or quality.
“Therefore, the clinical research industry must consider the real-world experience of clinical research professionals at the site level for DCTs to be successful.”
Challenges
The conclusions are in keeping with the findings of a member survey conducted in August which showed that there is a need for harmonized global expectations and clarity about who accepts oversight liability for remote elements, how data should flow, and where new methods and technologies fit.
The survey also suggested sites need the flexibility to choose their own vendors for DCT-related elements, rather than having these imposed on them by sponsors.
Similarly, a lack of budget flexibility was also identified as a hurdle. According to the survey authors traditional visit-based budget modules do not account for remote visits that take place in hybrid trials, and do not reflect time required for training and change management.
Landis said, “with our combined survey and think tank approach, ACRP has crystallized the realities of implementing DCTs and identified areas where pragmatic solutions can accelerate this promising way of conducting trials.”
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