Why clinical trials need mobile health tools
I have previously written why mobile technologies need clinical trials. I would now like to discuss why clinical trials need mobile technology.
For readers not familiar with clinical research, a CRO (clinical research organization) is “an organization that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management andpharmacovigilance. (Wiki)”
CROs 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.
In an excellent paper Transforming the Economics of Clinical Trials, the authors discuss the introduction of technology in clinical trials: “Over the last decade, electronic data capture (EDC) has made some progress in transforming this (business) model. In an EDC-enabled environment, paper forms are replaced by electronic forms, whereby sites enter their data into an electronic database. This technology has produced some efficiency gains as edit-checks reduce the cost of the manual data-query process. However, the EDC platform was largely embedded in the traditional clinical research business model, with legacy concepts around site monitoring and validation. New opportunities for central statistical monitoring of data in these systems were not widely embraced)… Patient screening and recruitment costs remained largely unchanged.” They then suggest the mining of EHRs for data for the screening and recruitment of patient research subjects, and mobile technologies for direct data collection. What is also keenly pointed out is the current absence for a technology-based business model.
The report goes on to discuss monitoring of trial sites. Both the European Medicines Agency and the FDA have endorsed centralized monitoring of trials via technology on a real-time basis.
One company providing mobile tools for clinical trials is exco intouch. InVentiv Health is a CRO that has recently become active in the mobile side of clinical trials. InVentiv bought a stake in Mytrus, a company that has mobile technology that facilitates obtaining informed consent for clinical trials.
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.
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, a practicing cardiac electrphysiologist with more than 25 years in patient care and founder and director at DLS Healthcare Consulting, LLC (digitalhealthconsultants.com). A pioneer adopter of remote patient monitoring and data integration with electronic health records, he lectures worldwide promoting the benefits of digital health technologies. He is board certified in internal medicine, cardiovascular diseases and clinical cardiac electrphysiology, serves on the mHIMSS Advisory Council and is chairman of its Roadmap task Force,Twitter: @dlschermd, He also blogs at http://davidleescher.com. He was cited as one of the 10 cardiologists to follow on Twitter and one of the top ten blogs on healthcare technology.