United States: Clinical Trial Consent: There Is An App For That

We have previously published a post on the potential uses of mobile apps in clinical trials, and the accompanying advantages and limitations. Recent research published in The New England Journal of Medicine (NEJM) confirms the increasing number of innovative studies being conducted through the internet, and discusses the bioethical considerations and technical complexities arising from this use.

Apps used in clinical research

The vast majority of the population, including patients and healthcare professionals, have mobile phones. They are using them in a growing number of ways, and increasingly expect the organizations they interact with to do the same. Clinical research is no exception. As we discussed previously, smartphones are becoming increasingly important as a means of facilitating patient recruitment, reducing costs, disseminating and collecting a wide-range of health data, and improving the informed consent process.

A major development in relation to app-based studies occurred in early 2015 with the launch of Apple's ResearchKit, an open-source software toolkit for the iOS platform that can be used to build apps for smartphone-based medical research. Since then, similar toolkits, such as ResearchStack, have been launched to facilitate app development on the Android operating system.

Several Institutional Review Board-approved study apps were launched shortly after the creation of ResearchKit, including MyHeart Counts (cardiovascular disease), mPower (Parkinson's disease), Gluco-Success (type 2 diabetes), Asthma Health (asthma) and Share the Journey (breast cancer).

The NEJM publication refers to data from MyHeart Counts to emphasize particular features of app-based studies. The MyHeart Counts study enrolled more than 10,000 participants in the first 24 hours: a recruitment figure that many traditional study sponsors would regard with envy. While this figure appears, at least in part, to result from expanded access to would-be participants who are not within easy reach of a study site, it may carry with it a degree of selection bias. For example, the consenting study population in MyHeart Counts was predominantly young (median age, 36) and male (82 per cent), reflecting the uneven distribution of smartphone usage and familiarity across the population in the demographics of app-based study participants. The MyHeart Counts completer population (i.e. those who completed a 6-minute "walk test" at the end of seven days) represented only 10 per cent of participants who provided consent. The reasons for low completer rates in app-based studies are not mapped out, but may relate to participants' commitment to partake in and contribute to the study in the absence of face-to-face interactions.

Regulatory and legal challenges for digital consent

Conduct of clinical trials is guided by good clinical practice (GCP) principles, which seek to ensure that:

  • trials are ethically conducted to protect the dignity, privacy and safety of trial subjects; and
  • there exists an adequate procedure to ensure the quality and integrity of the data generated from the trial.

Informed consent is one of the most important ethical principles, and an essential condition both for therapy and research. It is a voluntary agreement to participate in research, but is more than a form that is signed; it is a process during which the subject acquires an understanding of the research and its risks.

The challenges of conducting clinical research using digital technology are, to name a few:

  1. how to ensure that the language used in the informed consent is engaging and user-friendly to promote greater understanding of the nature of the study and the risks relating to participation in the trial;
  2. how to assess capacity and understanding of trial subjects remotely;
  3. how to assess voluntary choice without the benefit of body language and tone; and
  4. how to verify the identity of the person consenting (although this risk may be mitigated in the future through biometric or identity verification tools).

Moreover, there are practical challenges with using these technologies. For example, relating to the assessment of patient eligibility, and monitoring of trial subjects to ensure clinically meaningful data of an acceptable quality are collected and collated during the trial to comply with the GCP principles and support regulatory submissions.

Because of some of these challenges, the NEJM publication suggests that app-based research may be most suitable for low-risk studies. However, it is likely that these risks will be mitigated in the future as the technology develops and researchers and patients become more familiar with its use.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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