Everyone over the age of ten knows there’s an app for everything. Healthcare is no exception. There are over 150,000 health-related (mHealth) apps; most focus on overall health, managing chronic conditions, diagnostics, medication management, or recordkeeping.
However, only a very small percentage of mHealth apps are dedicated to clinical trials. And most clinical trials apps are quite simplistic---only designed to allow patients and their caregivers to search for a trial in a specific geographic area for a specific disease.
The reason for the lack of broad-functioning clinical trial apps is understandable, as each element of clinical trials---from recruitment to onboarding to participation to data collection---is complex, and designing apps that meet the needs of all (or even some) of those elements can be challenging and costly from both a development and regulatory perspective (regulatory issues include those related to privacy, accuracy, and quality).
The federal government appears to be an advocate of mHealth technology to streamline and improve the clinical trial process. In October 2015, the Food and Drug Administration (FDA), under the auspices of the Department of Health and Human Services (HHS), established an online "Public Docket" titled Using Technologies and Innovative Methods to Conduct FDA-Regulated Clinical Investigations of Investigational Drugs. Forty organizations and individuals shared opinions; however, the FDA has yet to issue a summary or any public guidance related to this initiative.
Educational institutions and non-profit organizations seem to be taking the lead in the research and development of clinical trial smart technology. A couple of examples:
- The National Institutes for Health (NIH) awarded a grant of $9.75 million over five years to the University of California San Francisco (UCSF) for the creation of Health ePeople, a platform that will enable investigators to conduct mobile and wireless health research in a less costly, more streamlined manner.
- Using Apple’s ResearchKit, Sage Bionetworks, a non-profit biomedical research organization, developed mPower, using Apple’s clinical observational study about Parkinson disease conducted purely through an iPhone app interface.
We are confident about the future role of mHealth technologies in clinical trials, to better engage patients, help them understand their clinical trial options, and make it easier for them to participate. The pairing of a knowledgeable technology team and forward thinking organizations will play an active and innovative role in healthcare’s digital evolution.