When Apple released ResearchKit, an open source software framework making it easier to create apps for medical studies, comments ranged from “Not for serious research’ to ‘This is going to change clinical trials forever?”
We had two reactions: 1) It will likely be good for research and medicine. 2) Rather than competing with Clinpal, it will probably help drive more interest in our suite of solutions. So for both reasons, early on we announced our strong support for the initiative.
From our point of view, we believe Apple’s kit will help bridge the often-significant gap between biometric capture technologies and the recording of relevant information for clinical trials. Initially this may only be for Apple devices, but the successful release of the kit can only spur on equivalent initiatives from Google and Microsoft. But ResearchKit is incomplete. The one missing piece in the Apple solution is the server side. Where does all the information go? Is it safe? Is it private? Is it secure?
We know a few things about security in this business. In 2012 when we launched our company we placed data safety, patient privacy and security at the top of our list of mandatory features together with scalability, cost effectiveness and simplicity for patients and sites.
ResearchKit demands – but fails to provide – a solid back-end that can act as a ‘big data repository’ while also serving as a repository feeding the metadata (questionnaires & tasks for example) required to drive the apps. Fortunately Clinpal is for a number of reasons a perfect ‘Apple ResearchKit server.’ It provides all of the functional elements required to provide server support for ResearchKit based apps.
1). Forms– One of the 3 major building blocks of the Clinpal platform is the ability to prepare multi-media, multi-use forms. These forms may be for electronic data capture (EDC), patient reported outcomes, electronic Informed consent or a variety of other purposes. Again, quite fortunately for the marketplace and for Apple, one of Clinpal’s deployment scenarios is to prepare forms for deployment to mobile devices – in this case – Apple ResearchKit. Once defined in Clinpal, these forms can be replicated in Clinpal app built on ResearchKit.The forms then capture data directly from patients before sending it securely back to the Clinpal server. This data (and form) is available online for the patient, and any approved user such as the patients GP, or clinical trial researchers.
2). Messaging– Clinpal provides a secure messaging platform optimized specifically for clinical trials. The platform protects patient privacy by assuring messages can only be exchanged between appropriate stakeholders. Messages can be sent between patients and physicians with assurance that they won’t be shared with sponsor companies. This can help drive patient trust and participation and also help with clinical trial compliance.
3). Electronic Informed Consent– Clinpal provides full support for patient consent. Typically this would be via a browser / tablet where the larger form factor makes the sharing of videos and textual information most appropriate. However, situations exist where consent is relatively straightforward or short – in this scenario, an app-based approach is best. The Clinpal App, based on ResearchKit, provides this capability.
4). Satisfaction surveys– It can take weeks or even months for sponsors to determine whether patients in their clinical trial are satisfied. This is important because if the protocol, study drug or procedures are poorly received, compliance may suffer and the trial may experience a high proportion of dropouts. The Clinpal ResearchKit app provides a means for patients to easily log their involvement satisfaction. This information is automatically feedback to the Clinpal Cloud Server and consolidated into anonymous information, and thus sponsors and sites can take action earlier to “save” their trial if they sense trouble.
5). Any Trial / Any Device– With mobile devices, it has never been easier to capture data directly from patients. However, that does not close the door on more traditional methods. Clinpal provides end-to-end trial support for Researchkit as an additional method to capture data and engage with patients during trials.
6). Patient Privacy Why? Sponsors cannot control who can, and who cannot see patient private data. They cannot capture information that is required for the effective execution of the trial if they are in direct control of it. If they could, they could inadvertently capture a patients name, or other contact details before the patient has provided their privacy or clinical trial consent. Clinpal’s unique architecture with patient privacy awareness built in assures that information presented to sponsors redacts any patient private data.
We anticipate that the availability of the Apple ResearchKit together with Clinpal as the server will be very attractive to a wide range of organizations look towards better outreach to patients both before, during and after a clinical trial.
eClinicalHealth looks forward to demonstrating the Clinpal / Researchkit integration at the Annual DIA in Washington June 14-18th 2015.
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Doug Bain | Co-Founder, CEO | eClinicalHealth Limited