Pfizer ($PFE) wants a contractor to handle recruitment/setup for the European phase of its first-ever "virtual" clinical trial. A key requirement here: The CRO must learn from the delays and snafus Pfizer has faced in the ongoing U.S. portion of the study.
Outsourcing-Pharma reported the news, noting that organizers are still ironing out the kinks for the domestic portion of the REMOTE trial testing the overactive bladder treatment Detrol LA. Announced in June, REMOTE is designed to recruit 600 patients in the U.S. who could participate regardless of their location, checking in through mobile phone or a web address rather than at specific trial sites.
An ongoing struggle to recruit the number of patients for the trial has amounted to a pretty significant stumbling block so far. As the story explains, recruitment is behind schedule, in part because patients are skittish about posting large amounts of health information online. Pfizer organizers also focused more on regulatory issues than patient needs, leading to a sign-up and participatory process that became "quite complicated and tedious," Pfizer's senior director of clinical sciences, Miguel Orri, admitted to Outsourcing-Pharma.
In other words, you can't run a trial in which you expect subjects to participate autonomously when you make it bureaucratically and emotionally challenging to the point at which they hesitate to get involved. It's like throwing a party and then making it as hard as possible for people to decide to attend.
Some improvements have helped, according to the story, including a call center that helps patients through the initial process. And in planning on a contractor to handle the European trial expansion (REMOTE 2.0), Outsourcing-Pharma reports that Pfizer will add another innovation: a mobile device similar to a simplified iPad, which will make it easier for patients who don't spend much time online to check in and follow their trial protocol.
- read the Outsourcing-Pharma story