CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with John Moore, formerly a venture capitalist in the technology space, now executive chairman of Trialogics, a provider of clinical trial software serving biotech and pharma partners.
Q: You’ve been a proponent of virtual clinical trials. What’s the most innovative development you’ve seen in that space lately?
A: The most interesting thing happening in virtual clinical trials right now is what’s being done at the Michael J. Fox Foundation. They’ve given wearables to almost 7,000 volunteers with Parkinson’s disease. The volunteers have them on all the time, and every 90 days they report about what’s happening with their symptoms. The foundation has a huge amount of data and the question researchers there are asking themselves is, “Why do patients sometimes respond well and sometimes not respond to the medicines they’re on?” It’s the opposite of a conventional clinical trial, where you have a thesis that you’re trying to prove. What they’re looking for is, “What in this huge data set can give us clues about what’s not being asked in clinical trials that we need to be asking?” It’s about pattern recognition.
Also exciting is a study at the New Jersey Cancer Institute, where they equipped breast cancer survivors with Garmin fitness trackers, and are coaching them through Livestrong and via the YMCA to encourage the patients to overcome the natural lethargy that occurs with post-treatment survivors. The study was published in the Clinical Journal of Oncology Nursing.
It’s fascinating how these wearables are being used to encourage and track, where in the recent past, studies looked at endpoints far more like, “What is the impact of exercise on recovery times?” It was more subjective data. Patients now have a much closer relationship with their cellphone than they do a doctor or nurse. They are much more frank with their phone.
Q: Where does the industry and the FDA stand on wearable technology in trials?
A: Industry acceptance is slow. We think only 25% of the industry is using IRT and electronic patient reported outcomes solutions (ePRO), and 75% is still using paper-based diaries.
The FDA, though, is doing their part to move this forward. We’ve been hearing in the last few months, as companies have been submitting protocols, that the FDA has been requiring time-stamped outcomes. I think this will force companies to adopt ePRO. It’s a very simple thing but very profound because even getting patients to comment and reveal their symptoms in real time can be powerful.
Excel is the enemy of real technological advance. It allows you to collect information and submit it in what seems like an accurate data collection mode, but if you have time-stamped data it’s so much better than just transposing somebody’s handwritten notes that were filled out in the parking lot of the clinical trial site.
I think the FDA is excited about new technologies—wearables and particularly for the data that will come out of it for secondary endpoints. At the end of the day, the outcome will be further adoption of electronic work tools over paper. It’s more adoption of technology we already have as opposed to the shiny objects that might take years to get integrated.
But the industry is always looking to economize. I’ve learned that if the industry is able to push costs onto the sites, they will. It’s an externality that they don’t understand has a big impact on the sites’ ability to recruit. There’s a group called Clinical Score that scores clinical trials in price for big phrama, and they found that the number one factor that correlated with high recruitment at the site is how easy the software is to use. It has huge impact on how the sites do their job. Sponsors need to realize this.
Q: How do the sites feel about adoption of the new technologies that the FDA seems to be getting onboard with?
A: Sites hate paper data, and they hate ePRO because it involves more work. What the sites don’t want is difficult-to-use technology. I think sites’ acceptance of ePRO will come after pharma refocuses the clinical operations teams so they don’t think in terms of their own perspective, but rather in terms of the perspective of the site. They need to ask the site, “What do I have to do to make your life easier?”
If asked, a lot of times they’ll say, “Give me software that’s easy to use, with a single password.” A lot of clinical operations people think the only trial going on at that site is their trial. We, as an industry, have to do a better job of explaining why simple systems that don’t require complicated setup at the sites are important. That’s the cross that pharma and the biotech companies have to bear—being more sympathetic about what the sites go through.
This article was reprinted from Volume 21, Issue 29, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »