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Summary

Apple’s ResearchKit aims to simplify the challenging process of recruiting patients for clinical studies by enabling researchers to use iPhone apps to recruit patients. It is seen as a boon for medical research communities and the life sciences industry, because the number and profile of patients recruited for clinical studies are major factors influencing study outcomes. Apple is likely to target medical device manufacturers and pharmaceutical companies, as many of these spend a year or even more recruiting patients for clinical studies.

The first iteration of ResearchKit will require more work on aspects such as security and privacy, tackling the problems of recruiting patients who do not meet the eligibility criteria and enrolling patients who are not fully informed of the risks. More importantly, it will need to be efficient in collating disparate content from third-party apps if it is intended to be a part of the larger health application ecosystem that Apple is developing.

Apple’s ResearchKit could help transform the way patients are recruited for clinical studies

The initial focus for Apple’s open source software framework has been on applications for asthma, Parkinson’s, breast cancer, diabetes, and cardiovascular diseases. The open source software enables developers to build more apps in the future, which will increase public participation in clinical studies.

One of the advantages of ResearchKit is that it enables users to share data directly with researchers, which is something that many patients are keen to do. This was evident in the early response to the platform’s launch: thousands of volunteers signed up within a day of the launch, including 11,000 patients who enrolled themselves on the Stanford University cardiovascular trial. To put this into context, healthcare organizations need almost a year to achieve a similar scale. The application framework and templates reduce both paperwork and the time required to recruit patients, and this will enable researchers to spend more time on clinical studies to produce more reliable outcomes.

Poorly designed applications will pose challenges for Apple

Clinical studies have a broad range of requirements, which is why Apple has made ResearchKit flexible, with clear guidelines for developers to build applications. However, poorly designed applications could defeat the purpose of ResearchKit in a number of ways: an application may not have a robust verification process to ensure patients do not enter the wrong data to participate in a clinical study; an application may ask patients a set of questions that are not the same as those asked by physicians; the number of users signing up for a study may not represent a given region, which could lead to population bias; and patients could participate in clinical studies without being fully aware of the risks involved.

As the number of users and applications increases, further work must be done around security and privacy. Addressing these complex challenges is a tall order, but Apple has made a good start by working closely with multiple healthcare experts. If it continues with this approach, it stands a good chance of building on this first iteration successfully.

Appendix

Further reading

“Wearables: Apple’s smartwatch faces key obstacles to joining mass market,” TE0004-001019 (March 2015)

“Google Wallet pips Apple into Europe, but needs to up its game,” IT0059-000002 (February 2015)

Author

Srikanth Venkataraman, Analyst, Healthcare Technology

srikanth.venkataraman@ovum.com

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