The National Institute for Health Research Bristol Biomedical Research Centre (NIHR Bristol BRC) at the University of Bristol selected Signant Health, formally CRF Health and Bracket, as its vendor to offer electronic informed consent (eConsent) support for an oncology trial. Does eConsent represent a more patient-centric experience for collecting informed consent for a clinical trial?
This is the position Signet Health and NIHR Bristol BRC at the University of Bristol position in a recent joint press release. Throughout sponsor, CRO and investigator site operations patient-centricity is the buzz. And why shouldn’t it? Patient experience as a concept in clinical trials traditionally is not top of mind at all.
An eConsent Trial
The deal focuses on the use of TrialConsent® for one oncology study. However, Bristol BRC seeks to understand how eConsent can improve patient comprehension and reduce site burden. In addition, it seeks to identify areas or opportunities and challenges for sites and patients in future clinical trials.
Prominent Research Center Seeks to Understand eConsent
Bristol BRC, wisely, seeks to understand eConsent in the context of its’ study workflows while also gaining a better understanding of the strengths and efficacy of eConsent over traditional consenting processes. The Bristol BRC team will utilize this partnership to elicit feedback and analyze eConsent’s impact on site and patient experience. An important exercise as rising costs and complexities of clinical trials necessitate careful selection, calibration, and orchestration of processes and systems to work towards greater site and patient experience while also gaining efficiencies.
Signant Health was perhaps selected due to 1) its depth and experience in the oncology field 2) eConsent product maturity 3) vendor’s willingness to roll up sleeves and structure partnership relationship dynamic (e.g. run interviews, engage sites and patients and analyze findings) and 4) flexible solution that could deal with the unique requirements of the study’s mostly aged 65+ patient population characteristics and thus, specific needs.
The partnership notes in the press release that TrialConsent can be tailored and configured to meet unique patient needs–via customizable features such as font size, friendly multimedia elements, quizzes, the ability to flag sections for investigator review, and the ability to track, provide and report on data in real-time. Moreover, for the potential site and patient concerns for data protection and privacy, TrialConsent features password controls, role-based access rights as well as encrypted patient data.
The Bristol BRC and Signet Health will track results and publish for the world to consume—or at least those fascinated with clinical trial technology such as these authors. We will surely be monitoring and awaiting to share.
Informed consent is arguably one of the most important steps in patient engagement. A fundamental ethical principle out of the Declaration of Helsinki, it is sought that moving from paper-based approaches to digital models can add flexibility and dynamism to patent engagement—not to mention efficiencies for all as ultimately clinical research paper-shuffling must be fully transformed into a seamless, data-driven, AI-augmented reality.
Transcelerate, the consortium of large pharma companies, initiated an eConsent program for industry consideration. They noted a couple of years ago that due to the ever-increasing complexity of stakeholders participating in clinical research not to mention full globalization of the process, eConsent would need to usher economical and efficient means of bringing information together to augment decision making. Once all consents are digital, this data will be utilized not only in analytics but also in data sharing for superior collaboration and to improve patient experience and ultimately money savings.
Key trends Transcelerate published included: A) Integration with study operational systems as the industry needs fewer technology interfaces to simplify work; B) Flexibility with device approach to allow participants to bring their own devices (e.g. smartphone); C) Mutual-training recognition (e.g. standardized training tools reduce redundancies); D) more efficient authoring and approvals (software supports collaborative engagement between sponsor and IRB/ECs during consent authoring and approval lifecycle; and E) Approve data sharing like connecting the eConsent system with IVRS (randomization) and clinical laboratory databases to reduce data transcription efforts.
Why Hasn’t eConsent become the Norm?
At the start of the year, a group of experts hosted a roundtable at the Summit for Clinical Ops Executives, SCOPE in Orlando to discuss what’s standing in the way of eConsent adoption. One of the presenters, Thorsten Ruppert, Senior Manager, Research, Development and Innovation, Association of German Research-Based Pharmaceutical Companies, noted in a Clinical Informatics News article that not only is the eConsent field challenging “as it is fraught with regulatory uncertainties and industry ambiguity. Tearing apart this tangle will be necessary for eConsent to do what the technology is meant to do: inform trial participants and speed enrollment.”
Back to Signant Health
Signant Health has been around since 2000 in one form or another. It offers a suite of products and services to support clinical research organizations from sponsors, to CROs to sites including eConsent, eCOA (electronic Clinical Outcome Assessments), Patient Engagement, IRT, Clinical Supply Management and Endpoint Quality scientific and data support services.
Formerly called CRF Health and then Bracket, they offer solutions that they claim will simplify every step of the patient journey to make it easier to participate in (and for sites and study teams to run) clinical trials. They declare that by uniting eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite, infused with 20 years of experience, they can differentiate from competitors.
A private equity-backed venture, Genstar seeks to take middle-market companies and help them grow significantly and secure returns typically several years ahead.
The Signant Health Bristol BRC deal clearly seeks to address at least some of the issues and challenges raised by experts in this field—a careful, methodical study of how the technology can modify or shape workflow for efficiency (without compromising compliance) is the task at hand. If the results go well, we suspect there will be more purchases of software.
Call to Action: Interested in eConsent trends? Transcelerate initiated a program on this topic. Check out their materials, including an eConsent implementation guide. Seeking to understand the competitive vendor space, we can publish a competitive analysis if we receive enough requests.