The shy embrace by clinical researchers of all things digital warmed by a few degrees as the old year ended. Mark, if you haven’t yet, publication by the US regulators of guidelines on the use of digital tools to obtain patients’ consent in clinical trials; and, as if in lock step, a parallel surge of interest among sponsors and CROs in eConsent-style services.
The advantages of media-rich eConsent tools over the traditional, paper-based approach are numerous, notably: improved patient understanding (leading to higher compliance and retention rates), control and consistency in the consenting process, a more secure audit trail and, ultimately, significant cost savings for the sponsor from a more timely and efficiently-run trial.
The more forward-thinking players in the industry have long supported eConsenting.
The joint publication in the US in December 2016 by the Office for Human Research Protections (OHRP) and the FDA, was a final version of a long-awaited draft first published in 2015. Compiled as a Q&A document, it answers many commonly-asked questions from the clinical research industry on how eConsent can be implemented.
How should information be presented in an electronic informed consent (eIC) tool? What can be done to ensure the candidate has understood the content? How can their identity be verified and their privacy assured? And what special considerations apply to paediatric studies?
The shy embrace by clinical researchers of all things digital warmed by a few degrees as the old year ended.
These questions and more are explored in what is largely a dry and technical document. The answers, though, give much encouragement to sponsors and suppliers to get on, if they haven’t already, with developing eIC offerings; and they rightly recognise the potential of digital media – including graphics, video, podcasts and interactive websites – and the facility for trial candidates to review (and re-review) the content in the comfort of their own homes, and at a time of their choosing, to enhance the consenting process.
The more forward-thinking players in the industry have long supported eConsenting. As Pierre Corin (ex-Genentech, now a clinical operations executive at Karyopharm Therapeutics) said: “Common sense tells us that approaching a technical explanation from several angles with mixed media has more chance of success.”
The Association of American Medical Colleges was also an early backer, warmly endorsing the draft version of the guidelines, though calling for the research community “to develop an evidence base for the circumstances and types of research for which such a format is most effective”.
“Common sense tells us that approaching a technical explanation from several angles with mixed media has more chance of success.”
- Pierre Corin
A final caveat, though, is that even the latest guidance is only that. The document is clearly flagged as containing “non-binding recommendations”, many of them top-line with little clarifying detail; and the authors leave it up to the review boards (ethics committees ex-US) to judge whether a particular eIC tool has met all the requirements for effective and compliant consent. So, it seems likely there will be a further period of experimentation, while the industry and the ethicists converge on a consensus on what an acceptable eIC tool should look like.
By Peter Coë
Image by Kaboompics // Karolina on Pexels