Apple’s ResearchKit: A Disruptive Innovation that could Radically Change How Clinical Trials are Conducted (Part 2 of a 4-part series)

Apple’s ResearchKit: A Disruptive Innovation that could Radically Change How Clinical Trials are Conducted (Part 2 of a 4-part series)

Despite almost all hospitals and physician practices in the United States having digitized their patients’ medical records, recruitment of qualified participants for clinical trials remains an inefficient and expensive effort. Identifying prospective study participants, successfully recruiting them, and obtaining informed consents is a disjointed process, involving multiple steps and coordination between (time-constrained) practitioners and researchers. In this second installment of a four-part series, I’m going to discuss an exciting IT-based initiative with the potential to radically improve how clinical trials are conducted: Apple ResearchKit.

Leading electronic health record (EHR) system vendors offer features to facilitate clinical trial recruitment as part of the clinical workflow (see Greenway’s PrimeResearch for example), but research has shown this technology alone falls short in capabilities for accurately identifying trial candidates, collecting research-quality data,  and directly engaging clinical trial participants on an ongoing basis.

The engagement of clinical trial participants is an area ripe for disruptive innovation and an opportunity to advance the Center for Healthcare Research's Agenda topic, Role of open innovation in clinical trials and drug discovery. What makes this frontier especially intriguing is Apple’s release earlier this month of ResearchKit, an open source software application framework that has the potential to radically change how participants are recruited and data are collected for research studies.

Using the ResearchKit framework, study designers can quickly build mobile applications for use by current and prospective participants on their smartphones and tablets. A recent Modern Healthcare article reveals how academic medical centers are already embracing the ResearchKit. Mount Sinai’s Asthma Health study app quickly recruited 4,000 participants. University of Rochester’s Parkinson study app, called “mPower”, resulted in more than 7,000 downloads within 72 hours of its release.

Mobile apps like these to recruit and engage clinical trial participants could be a positively disruptive technology in healthcare by making clinical trials simpler, more convenient, and accessible to a greater number of people. Furthermore--by digitally connecting participants to trials--a richer, timelier set of data can be collected, and feedback provided to foster more engaged patients in a study.  

Before mobile apps based on ResearchKit are accepted and used by researchers on a large scale, some critical questions need answers. Here are a few on my mind:

  • Can authentication technology be incorporated to ensure that people responding to the clinical trial invitation are truly who they say they are?
  • Will the mobile-based informed consent document and procedure have the rigor as well as checks in place to confirm a prospective participant fully understands the study?
  • Will mobile apps for research widen or narrow the “digital divide?” Although minority populations have widespread use of smartphones and may be easier to reach, many older people do not use smartphones or tablets.  
  • How can mobile apps for research be used to better leverage the data found in EHRs?

These questions reflect broader areas in need of research–and time is of the essence. As more mobile apps are designed using ResearchKit without evidence-based “best practices” to ensure high-quality studies, the risk of disillusionment with this technology grows. This is an area of tremendous opportunity for scholars at the Center for Healthcare Research to develop models for conducting clinical trials more efficiently and even strengthening the study designs – by effectively using mobile apps that are integrated with EHR systems. 

Share with the community your thoughts on the potential of mobile research apps, issues that need to be addressed, and the opportunities for researchers.

What are potential sources of funding for this area of research?    

Comments

James Gillespie's picture James Gillespie | May 9, 2015 6:55 am MST

Michael, Excellent commentary.  You provide a lucid analysis of an interesting and potentially disruptive technology.  Do you know whether the big clinical research organizations (CROs) like Quintiles, Covance, and PAREXEL are embracing Apple ResearchKit yet?

Also do you think the prospects are good for eventually incorporating authentication?  That will be essential if this is to continue spreading in use.

Michael R. Solomon's picture Michael R. Solomon | May 11, 2015 10:11 am MST

Dr. Gillespie, none of the CROs you name are listed as ResearchKit app partners at the Apple ResearchKit website. The overwhelming majority are academic medical centers and health foundations. This is not surprising as the ResearchKit was just announced two months ago (March 9). With respect to support of authentication, it doesn't appear from the ResearchKit technical overview provided by Apple that authentication is an integral module. However, considering how critical authentication is to studies, I believe it's reasonable to anticipate that developers will leverage the iTouch (fingerprint) technology available with the iPhone6 to create authentication APIs that will become available to the ResearchKit open source community.