Role of Digital Health to Support Clinical Trials

  • Nov 11th, 2018
  • Adele Kulyk and Guy Paterson

Role of Digital Health in Clinical Trials

By Guy Paterson and Adele Kulyk

In an October 19, 2018 Blog in Medical Design and Outsourcing  Nancy Crotti discusses the role of Digital Health in improving patient engagement in clinical trials.

She cites some statistics on clinical trials that are disconcerting at a time when many new treatments are in the research pipeline...  She cites NIH data that in clinical trial an estimated 30% of patients enrolled in clinical trials drop out before results can be evaluated and 85% of clinical trials fail to reach completion due to problems with patient retention.

This presents a significant challenge to both researchers and companies requiring validated clinical trials to progress research and product development.

With a goal of improving patient engagement in clinical trials, the article proposes the use of Digital Health as a single integrated point of access, such as a unified smartphone app that combines patient assessment input, sensor connections, trial notifications, communications, gamification, reimbursement, travel management, study information and patient profile management.  It is suggested that Digital Health be combined with more traditional personal contact methods to further increase patient engagement and compliance by providing clinical trial patients with choices that fit their preferences and circumstances, being able to select the right channel fir the right use and marrying the convenience and efficiency of digital technology with the trust of personal contact.

Examples include use of Mobile Health applications to acquire required physiological data remotely and passively using available monitoring devices, and where patient data entry is required that it could be done utilizing the app rather than calling in or visiting the trial site.  Reducing the number of trial site visits reduces travel time and costs decreasing clinical trial overhead and would allow organization of required visits including appointment times, transportation, required lab work to be done within the application with less burden to the patient and clinical trial staff.

Improving the patient experience in clinical trials can help resolve the known problems of patient dropout and lack of usable trial data that can be a cause of trail failure.  Providing direct patient access including data input, timely patient notification of required data input or missing input, and a readily available communications channel with clinical trial staff to address patient concerns, combined with the traditional personal contact can optimize data collection and ultimately avoid costly delays or trial failure.


Adele Kulyk and Guy Paterson The authors are Co-Chairs of the Saskatchewan Chamber of Commerce - Office of Heath Innovation Initiative and represent solely their personal opinions.

In support of Digital Health Week - November12 - 18, 2018    Digital Health Canada

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