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Why clinical trials need mobile health tools
mHealthNews (blog)
Pfizer used social media to recruit patients for a clinical trial of Detrol.
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CROs (clinical research organization, "an organization that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis") as we know them today started in the late 1970s and early 1980s and have grown as a part of Pharma R&D budgets from 4 percent in the 1990s to close to 50 percent in the mid 2000s. In a previous post on why Pharma needs mobile apps, I briefly mention their potential role in clinical trials. I would like to discuss this in more detail now. The cost of performing clinical trials is increasing significantly. Technology including mobile technology and analytics can decrease these costs, but the challenge is for both business models and the research processes to adapt around them. This presupposes that the technologies can perform trials well.
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Both the European Medicines Agency and the FDA have endorsed centralized monitoring of trials via technology on a real-time basis.
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Recruitment of patients is another aspect of digital technology in clinical trials. Pfizer used social media to recruit patients for a clinical trial of Detrol. One company hosting 200,000 patients in online communities which gather data on 150,000 disease states, PatientsLikeMe has signed agreements with pharmaceutical companies to match patients with trials using its clinical trial search tool.
Other advantages of mobile clinical trials, as I see them, include less biased recruitment via crowdsourcing, a dramatic reduction in costs, better medication tracking via pill sensor technology (Proteus Digital Health), and faster reporting of adverse events (which can potentially save lives and stop negative studies earlier via transmission to the Data Safety Monitoring Board), and more timely analytics and trial reporting. In addition, they might lend themselves to more comprehensive or efficient audits, and will strengthen the assistance of caregivers (who can receive and transmit data with/for the patient) in the trial.
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While I do not believe that mobile technology will replace CROs, I do believe that it will significantly reduce costs and improve procedural inefficiencies and accuracy. The digitalization of clinical trial data represented a significant step in improving process and quality of trials. Making it mobile will take it to an even higher level.
David Lee Scher, MD, FACP, FACC, FHRS, is a clinical associate professor of medicine at the Pennsylvania State University College of Medicine,
Via rob halkes
Well, I agree very much with David about the potential and the benefits of using mobile technology in trial studies.
Yet, I think that the very patients are entitled to not just that. I know of cases in which patients have been supported and guided on an intensive schedule to their participation in the trial. But, alas, when the trial was over, so the support and guidance disappeared.
Why not continue this in the very support at therapy? My take is that both FDA and EMA should take steps to guarantee that services rendered during trials should be continued, by the participating institutes and business of care and research to the services for the participating patients. Isn't that self evident?
Please endorse this, by your comments!