Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
News, developments and strategies related to eClinical, data management, data collection, ePRO, and more information technology used in the drug development chain. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
(This blog is part 2 of my interview with Tomasz Sablinski, MD, PhD, Founder and CEO of Transparency Life Sciences.
As noted in my first blog, Sablinski’s company announced it was the first company to have an IND cleared using a crowdsourced protocol. As part of the protocol, extensive use of telemonitoring in place of regular site visits is achieved through its partner AMC Health. In this protocol, specifically a Phase II trial to assess lisinopril as an adjunctive therapy for multiple sclerosis (MS), the only patient visits are at day 0, and on the last visit in month 12. And by virtue of these visits, the trial is not wholly virtual--not in the way the Pfizer REMOTE trial was virtual.
“The biggest similarity with REMOTE is the desire to change the paradigm,” stated Sablinski of TLS. He is very supportive and appreciative of the efforts of Pfizer for trailblazing the concept, and to Craig Lipset, Head of Clinical Innovation, Development Operations within Worldwide Research & Development at Pfizer, for pushing the innovation forward internally.
Sablinski’s main observation of the REMOTE trial was that it was engineered around the online patient recruitment aspect. But he believes that online patient recruitment is not essential to the success of the TLS model, and the extent to which its clinical trials are enrolled online will vary from trial to trial. This reflects the fact that a very large volume of potential subjects typically needs to get through a rigorous screening process in order to find the required number of participants.
The other issue that has been stated as a potential recruitment problem of REMOTE was the need for security in recruitment and screening. The ways in which the screening process establishes identity, and the questions and passwords required as part of the process, could turn potential participants off, especially if they aren’t comfortable with technology in the first place.
What many subject recruitment experts note is that any kind of recruitment activity needs to be customized for the population of interest. That could also be said for the protocol design. Thus crowdsourcing the protocol gets to the heart of that issue: will this population participate and what will make it easier for them to do so?
The Protocol Builder for the specific clinical trial is developed using input from registered users. Anyone can go in and view the Protocol Builder report generated from the data, but only registered patients, medical researchers, and physicians can provide input to the protocol design. The conversion rate, that is the number of people who register and then contribute is currently at 30% to 40%. Patient input to the Protocol Builder also helps the company identify what is important to patients who are potential participants in the trial.
The patient/participant comfort zone is something Lipset himself alluded to in a Q&A we had with him in February 2012, prior to the trial terminating in June 2012. That is “Make sure the subjects feel supported and the process is as simple as possible. Participants in this model do not have that in-person physical engagement, which helps to make subjects feel comfortable.”
That in-person physical engagement is part of what Sablinski noted the TLS trial will offer, at visit 0 and 12, which was deemed doable by the crowd. The interaction with study site personnel initially, and then the ability to communicate through Skype, or via cell phone or online chat during the trial, should be adequate contact for these participants.
“[REMOTE] was a spectacular idea that is not going to be achieved right away. There needs to be many steps taken before it can be successful,” said Sablinski. “It needs to be preceded by steps that makes people more comfortable.”