mHealth and Pharma: Bridging the Regulatory Gap

mHealth and Clinical Trials

The often daunting challenges of pharmaceutical development are no secret: throughout the industry, stakeholders experience hefty price tags, lengthy timelines, and difficulties with patient recruitment and retention. According to Pharmaceutical Research and Manufacturers, it takes an average of ten years and $2.6 billion to develop a new drug – and there is typically just a 12% chance of achieving FDA approval.

In recent years, researchers and regulatory bodies have placed greater emphasis on innovations to overcome these persistent research hurdles — and increasingly view mHealth as an answer. Devices including Fitbits, Apple Watches, and smartphone apps hold the potential to expedite data collection while enhancing patient engagement. Due to an industry-wide shift toward patient-centricity, and since each time a patient misses a monitoring visit or drops out of a trial, timelines get backed up and costs increase, these tools hold tremendous potential value. That’s why ninety-four percent of pharmaceutical companies, CROs, and service providers plan to expand their use of mHealth.

When mHealth Innovation Meets Regulation

While there’s no denying mHealth’s immense potential, regulatory and practical concerns need to be reckoned with before its full capacity can be unlocked. Since smartphones and wearables are not official eClinical tools, they lack the edit checks, audit trails, and other regulatory requirements necessary to meet FDA standards. Unlike an EDC tool, for example, they aren’t designed to validate protocol changes and likely lack CFR Part 11 compliance.

It’s incumbent upon the clinical research industry to bridge this regulatory gap to transform the revolutionary potential of mHealth into widespread use. Until that happens, the enthusiasm around the innovative use of these technologies in clinical trials will amount to little more than hype.

There are, however, potential solutions – and chief among them is integration. If mHealth data had a seamless way to be fed into an eClinical system, it could be subjected to the regulatory mechanisms of eClinical technology. Integrating with a cloud-based solution also offers the benefit of of providing all stakeholders with real-time access to vital participant information and potentially match more patients to trials. Beyond integration, pioneers in the use of mHealth in clinical trials can do more to make the potential of these tools known – especially to regulators. The FDA wants evidence of the efficacy of these devices. The industry should work to provide this evidence, whether by implementing version control, showing that data collected via smartphone app is aligned with data collected in an EDC, or through other measures.

Determining the safety and efficacy of new drugs is a process that will always take time and careful research. However, mHealth, combined with a cloud-based infrastructure, would give pharmaceutical researchers new opportunities to gather data, meet enrollment targets, and reduce the burden of trial participation on the patient. Bridging mHealth’s regulatory gap is a necessary step that can save valuable resources, increase trial participation, and heighten researchers’ power to bring more life-improving therapies to market faster.