eConsent is a key vehicle for change, and not simply to improve trial efficiency

Which would you prefer?

Which would you prefer?

Which do you think patients prefer: the excerpt below from a 23-page, informed consent document or the same information presented in visual format in the following video?

Unsurprisingly research has shown that patients prefer to learn about the trial through the more accessible medium of video. Not only do patients favour the video, but the information provided in this format is more easily understood which leads to better trust in the process and most importantly facilitates a trusted relationship with the investigator. This instilled trust has the potential to be transformative in clinical trials.

I have drawn inspiration for an innovative informed consent process from my time working alongside Charles Spinosa, a business consultant known for transforming trust between a company, its customers, and its employees. Spinosa studied how relationships change based on trust, built from everyday interactions and implicit expectations. Based on this knowledge, Spinosa has turned around businesses such as ADP, Hospital for Special Surgery, and CEMEX. (The latter case won fame from its description by Chan Kim and Renée Mauborgne the Blue Ocean Strategy.)

Are we missing an opportunity to build trust in the consent process that can substantially improve recruitment, retention, and compliance rates? eConsent is a key vehicle for change, and not simply to improve trial efficiency (e.g., time savings from biometric signature capture and validation), the true potential of eConsent lies in the opportunity to improve patient comprehension about the trial’s procedures and educate patients in a more personal and comfortable way. Through an eConsent platform, patients can learn about a trial by watching informative videos at their own pace, rather than reading a long document. Patients who are empowered by information that they can understand are more likely to ask personally relevant questions of clinicians, feel confident in getting answers and having generally more transparency throughout the trial.

Infusing this crucial conversation with trust prevents patients from entering a trial blindly — which can have implications for retention. Thus, the transformative potential of eConsent stems not just from efficiency in administration, but from improving how patients understand the treatment they will receive, what their participation involves and how they are protected within the framework of the clinical trial consent.

At ICON we have designed videos, similar to the clip at the top of this blog, for our Firecrest Patient Portal that provide patients with more easily comprehensible (and retainable) information. This enables what we term “truly informed consent.”

Empirical research on multimedia consent assets, performed by Baruch Fischhoff, Ph.D. at Carnegie Mellon University (and sponsored by ICON), is revealing insights that make for better patient centric trials. Fischhoff’s research is continuing and a full report will be available later this year upon study completion.