By Carrie Guglielmo, eConsent Initiative lead, TransCelerate, and Laura Comer, innovation lead, Global Clinical Sciences and Operations, UCB
Technological innovation is ongoing and is impacting all aspects of clinical studies, from study start-up through close out. While the shift to digital technologies is pervasive, the informed consent process remains paper based in many clinical trials around the world. Given its inherent inefficiencies and the increasing complexity of clinical studies, the current approach can raise challenges with respect to quality, compliance, and participant understanding. Considering this, sponsors must find new ways to ensure that potential study participants are fully informed, despite the complicated information provided.
Electronic informed consent (eConsent) is an enabling technology that may help address these issues. Using multimedia components (e.g., audio, video, pictures/diagrams), eConsent provides an interactive experience for participants that aligns with their unique preferences, needs, and learning styles. Importantly, informed consent is often also the first interaction an individual has with the clinical trial process. Thus, electronic, patient-guided technologies have the potential to help provide a tailored trial experience to patients, enhance enrollment and retention rates, and ultimately empower participants to make more informed, knowledgeable decisions about their care.
Though the concept of eConsent is not new in the pharmaceutical realm, it has an opportunity to grow tremendously today. To understand more about the global experience with eConsent and where the technology can continue to evolve, TransCelerate launched the eConsent Global Landscape Assessment. The survey was distributed to pharmaceutical companies, clinical research organizations (CROs), and eConsent vendors in December 2016. Despite the industry’s limited experience with eConsent, the survey garnered responses from 17 organizations, showing that eConsent was either submitted to Institutional Review Boards (IRBs) or Independent Ethics Committees (IECs) or was used to consent patients in 29 countries. It also provided insight into the multimedia components submitted, operational considerations, and methods of signature capture. An updated version of the survey was run in 2018, adding three more respondents to those who participated in 2016.
To continue to keep the pulse of eConsent adoption, TransCelerate launched the third eConsent Global Landscape Assessment Survey this August (2019). Building upon the previous landscape assessments, it is intended to collect data on worldwide eConsent submissions and consented patients, as well as guide the development of future solutions to further address any barriers organizations are facing. Participation is voluntary, but TransCelerate encourages organizations to share experiences that will support better understanding of eConsent globally. (Click here to participate.) The 2019 survey will close on September 15, 2019, and feedback will be aggregated and blinded by a neutral third party.
While use of eConsent is on the rise, more concerted grassroots education efforts with all stakeholders would help speed implementation globally. The U.S. Food and Drug Administration (FDA), as well as the UK’s Medicines & Healthcare products Regulatory Agency (MHRA), and Health Research Authority (HRA), have issued guidances on the use of eConsent, and as a result, the industry has a roadmap for compliant implementation of eConsent in countries covered by these regulators. However, companies may still face added ambiguities with local regulations, such as concerns about the use of electronic signatures to document the informed consent vs. capturing consent using a wet-ink signature.
Without broad adoption of eConsent, regulators and IRBs/IECs may not be familiar with the technology and its use may not expand — thereby limiting the opportunity for patients to receive an enhanced informed consent experience. Thus, we must have informational conversations with these stakeholders to outline the benefits of eConsent and share the lessons learned with implementation, while providing additional education to help encourage organizations to use the technology. We must also challenge their existing, outdated paper-based processes and point them toward adopting novel technologies that will provide many benefits to both their organizations and the people that they aim to serve.
Though foundational efforts to get eConsent off the ground are still underway, clear progress is being made in terms of implementation. TransCelerate’s eConsent Initiative has specifically developed tools to support adoption, including the eConsent Implementation Guidance. This document provides information on how to determine whether eConsent is a feasible approach, which eConsent multimedia components are a reasonably good fit for a specific study, and the external and internal processes to consider for implementation. As eConsent becomes more widely used — and as industry adoption practices and/or new regulatory requirements are updated — the Implementation Guidance will continue to evolve.
Looking toward the future, eConsent may offer the opportunity to further simplify data sharing and more efficiently bring disparate data sources together to facilitate decision-making. By tracking consent electronically and bringing in dynamic consenting functionality, we may help give patients control of and access rights to their own medical data, so they may share it with whomever they want to, or not at all. For this reason there may be a greater focus on enhancing the technology through integrations (with electronic data capture, lab sample management, etc.), remote consenting capabilities (where patients can view and document consent outside of the study site), and maximizing self-authoring applications — moving the industry away from a disconnected, paper-based process.
By doing so, we aspire to help the patient more easily navigate the consent process and enter studies sooner, allowing sponsors to save time, boost patient retention rates, and (hopefully) deliver innovative therapies to patients sooner. eConsent technology also benefits sites by reducing paperwork burden and enhancing version control tracking.
Additionally, remote consenting for decentralized trials allows patients to use their own devices during the consenting process, which can improve access and autonomy and minimize patient travel to and from sites. For example, remote re-consenting is an effective way to present new consent information to patients who may have initially signed the consent at a physician’s office. Moving forward, the industry is expected to continue its progress toward broader remote consent adoption.
All stakeholders in the research and development ecosystem have a responsibility to keep eConsent momentum going for the benefit of all patients. Successful implementation of eConsent will not only help provide patients and their families with clear, easy-to-understand clinical trial-related information, but will also empower them to make better, informed decisions.
When all is said and done, patients are waiting for these kinds of technologies to make their lives as trial participants easier. The more eConsent is implemented in global studies, the greater the chances we as an industry have of moving the needle on broader adoption and inspiring the future of participant-centric clinical trials.
It’s truly up to us to make that change happen.
About The Authors:
Carrie Guglielmo is the eConsent Initiative lead at TransCelerate, spearheading the global implementation of eConsent. She has been in the pharmaceutical industry for over 20 years and has held various roles in clinical operations, including trial management, resource and performance management, and process and training. She earned a B.S. in nutrition from Penn State University.
Laura Comer is the innovation lead in Global Clinical Sciences and Operations at UCB. She is also a co-leader of the TransCelerate eConsent Initiative, aiming to help facilitate broad, voluntary adoption and implementation of electronic consent. She earned an MBA/MSW in business administration and management from the University of North Carolina at Chapel Hill.