Clinical Trial Endpoints Using Mobile Phones: Still a Lot of Ways to Go
[Posted on: Thursday, June 29, 2017]
Can you use a mobile phone to capture endpoints in clinical trials? A study by Clinical Trials Transformation Initiative (CTTI) and FDA found that it could be very hard to develop such endpoints. This week CTTI release detailed recommendations on the process for creating endpoints using mobile phones. Mobile phones can capture a variety of mobility, vital signs and other health related information about an individual allowing real-time data capture providing, in theory, better quality data with convenience potentially increasing patient participation. The process for developing mobile phone endpoints would require a detailed analysis of patient need, patient involvement, and potential for reduced participation burden. Additionally the mobile phone-based endpoints need to be convenient, easy, advanced, and unbiased. Researchers applied the process to four diseases to understand the feasibility of developing such endpoints. In two cases, diabetes and heart failure, the researchers concluded that collecting data to support mobile endpoints in a large-scale clinical trial would be expensive and that it may not improve sufficiently upon evidence gathered from traditional PRO assessments to justify its use. In one case, Dchenne muscular dystrophy, it was concluded that significant additional work will be needed to further develop the endpoints but it may be a very useful tool over time in clinical trials for DMD. In the fourth case, Parkinson’s disease, a novel endpoint could increase the likelihood of an investigational therapy to progress to phase III clinical studies. The overall conclusion of the exercise was that significant work is involved in developing new endpoints based on data captured using mobile phones. The guidance though detailed and well organized, requires a really motivated sponsor who can put the extra effort into developing new endpoints over using conventional endpoints. Patient support groups and non-profits would probably be much more motivated to develop mobile phone based clinical endpoints than a commercial entity. Also, independent development of clinical endpoints will assure a wider spread of the knowledge. There is also an opportunity for software developers to partner with patient groups to develop tools that can then be monetized by having drug developers use such tools. It is still a very nascent field with diverse opportunities.