Reimagining digital clinical trials

Our growing reliance on digital devices and communications has turned us into digital consumers who expect every product or service interaction to be a seamless, omnichannel experience. New digital health products and services that originated in the consumer market, such as wearables, smartphone apps, and social media-based disease support groups, have started to alter what patients expect from the health care industry.

As a result, we're witnessing the rise of the digital patient—and discovering that health care isn't on equal footing with more digitally savvy industries. This disparity is acutely evident in clinical trials, where there are significant digital gaps in the way processes are performed versus how similar consumer services are provided.

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In addition to current trends giving rise to the digital patient, two others are emerging that may further alter patient expectations for the health care industry, potentially disrupting established players.

• The electronic life record. The convergence of different types of data (health, socioeconomic, behavioral, and financial) is already starting to take shape. New health and wellness mobile applications allow consumers to input personal information (nutrition, exercise, financial) to create a more holistic profile of their life.

This trend, albeit in its infancy, could give rise to an electronic life record (ELR) that expands the boundaries of a traditional electronic health records. If ELRs come to fruition, patients may require that clinical trials accept their version of the ELR as both the repository of their life history and the de-facto platform that will track their medical activity during and after a trial.

• Monetizing patient data. Connected health devices are generating increasing amounts of relevant health data that provides patients with new opportunities to take a leading role in consolidating their data and, ultimately, be compensated for its use.

The rise of the ELR may further empower patients with richer and more diverse data sets that they can donate or sell to clinical research organizations. Recognition of data’s value may result in patients demanding that they receive access, ownership, and control over their clinical trial data.

•Reimagining how digital technologies can improve the patient experience in a clinical trial. In general, the patient experience should be consistent across the trial continuum (pre-trial, mid-trial, post-trial), and trial sponsors and operators should identify ways to make trials more patient-friendly.

•Enabling processes, ecosystems, and technologies. Redefining the patient journey requires reimagining clinical trial processes to support patient interactions; developing new ecosystems and partnerships to better collaborate; and employing innovative technologies to better share and analyze data.

The health care industry has incrementally moved toward realizing our vision for digital clinical trials. If this future is fully realized, it could significantly and positively impact both the health care industry and the digital patient. Increased collaboration among commercial companies, government regulators, and patients may hold the key to making clinical trial innovation and execution a reality, sooner rather than later.