French researchers first exposure to decentralised trials

CONTEXT:  Discussion article on one French company’s first experience with the concept of decentralised clinical trials and how they went about solving the operational issues.  Interesting to see a real life example  with the kinds of issues that face researchers all the time.  How long do we think the decentralised trial craze will run for?  I’m not sure we will be talking about it this time next year, but let’s see.

READ TIME:  5 mins

1. “They sold the idea of conducting decentralized trials, but when he dug deeper into their experience, he found they had a technology platform, but it was not an integrated solution; all the components were separate, such as the home nurse service, the telemedicine platform, and the app platform for patients.” 

2. “The standard “brick-and-mortar” approach is difficult in rare disease studies since even a major site in a large city might only see one or two patients.” 

3. “But what we saw from many vendors was still essentially a site-based model with a technology platform that enabled patients to conduct some activities without going to a site.”” 

4. “McCarthy describes PharPoint as a boutique CRO, but one that had knowledge of rare diseases and decentralized trials, and Science 37 as an integrated virtual study platform, combining econsent, ePRO, and telemedicine.” 

5. “McCarthy believes this was the first time the Science 37 model would be applied to patients in a rare disease trial, and he knew there would be challenges — one of which was getting the sites comfortable using the new platform.” 

Source URL: https://www.clinicalleader.com/doc/a-drug-developer-s-first-experience-with-decentralized-trials-0002