The use of mobile health technologies in clinical trials is on the rise. In recent years, mobile health (mHealth) – the practice of medicine and public health supported by mobile devices – has been embraced and adopted by those within the industry. With the advent of mHealth in clinical trials, processes can potentially be streamlined, reducing the number of clerical errors, improving trial results, and ultimately increasing access to healthcare.

Using mobile technology in clinical trials also fosters greater engagement between researchers and patients, with clinical research now making the most out of 21st century resources. Research indicates that by 2018, roughly 1.7 billion smartphone and tablet users will have downloaded mobile health applications. This supersedes the FDA's previous estimate of 500 million smartphone users by the end of 2015. A majority of these users, it is claimed, are a combination of health care professionals, consumers, and patients.

Recent efforts by big pharma to integrate mHealth into clinical trials indicate a willingness to move away from age-old processes in favour of new paradigms. Already, the likes of GSK and Purdue Pharma are both exploring the potential of mHealth devices in their clinical trials. The use of Apple's highly regarded ResearchKit is testament to that.

But for all the advantages of mHealth, the use of it does present somewhat of an ethical grey area. The issue has been raised within industry over what happens in the event researchers inadvertently access personal data from a patient. Within the current framework of clinical trial guidelines – be it FDA or EMA regulations – there aren't clear rules on how to regulate the use of mHealth tools.

With that said, will the use of mHealth tech in clinical trials require a new code of ethics? The short answer for that – possibly.

In 2014, the EMA's Innovation Task Force (ITF), widened its scope to assess the regulatory implications of mHealth in clinical trials. The ITF aims to provide a platform for dialogue with stakeholders to identify any scientific and legal issues that may arise from the use of emerging technologies. (Source: EMA)

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In turn, last summer, the FDA sought public input on the potential impact of using innovative technologies to conduct clinical research. What's more, the FDA was keen to identify any challenges that could serve as a deterrent of its use.

In effect, the FDA is said to be looking at:

  1. What challenges do stakeholders anticipate in the adoption mHealth technologies?
  2. Are there challenges in complying with regulatory requirements surrounding the conduct of clinical investigations that use such technologies or methods?
  3. What are the perceived barriers or challenges to obtaining and documenting informed consent or obtaining institutional review board review, approval, and oversight for clinical investigations utilizing these technologies or methods? (Source: FDA)

As it stands, the FDA is yet to reveal any feedback it has received from the industry. Certainly, whatever the outcome, experts say any use of mHealth technologies must fall within Good Clinical Practice (GCP) rules and regulations. However, on the matter of developing a code of ethics, there has been movement. The creation of the Connected and Open Research Ethics (CORE) project – developed by experts at the University of California, San Diego – is a significant step. CORE aims to facilitate researchers in conducting mHealth-related studies that are ethically sound.

With the EMA's recent efforts and the FDA following suit, there's a clear desire by regulatory bodies to define mHealth's place within clinical research. But the question on how best to utilise mobile technology remains up in the air.



mHealth Intelligence –
mHealth News –
Federal Register –
GSK working to build Apple's ResearchKit into its clinical trials –
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