The National Institute for Health Research Bristol Biomedical Research Centre (NIHR Bristol BRC) at the University of Bristol has selected Signant Health, formerly CRF Health and Bracket, as its partner to provide electronic informed consent (eConsent) support for a prostate cancer study.
The partnership will see Signant Health collect direct feedback from patients and sites on the impact of its TrialConsent® platform during the study. The research seeks to understand how eConsent can improve patients’ understanding of trials and reduce the administrative burden on trial sites. It also seeks to identify opportunities and challenges of using eConsent for sites and patients in future clinical trials.
Bristol BRC selected Signant Health to gain insights on ideal study eConsent workflows while understanding the strengths and efficacy of the approach over traditional consenting processes. With the complexities and costs of modern trials, direct feedback about users’ experiences is essential to improving the trial management process.
The eConsent project is nested in a small feasibility study. It will investigate whether exercise before surgery for prostate cancer can help people recover sooner and has longer term benefits. The study will explore if men are willing to be randomised to having exercise testing measurements done before surgery, alongside some samples being taken for further research.
Signant Health have a track record in clinical oncology research. In the eConsent project, they will run qualitative interviews, engage patients and sites, and analyze the impact of eConsent on sites and patients.
The BRC research team needed a solution that would meet the needs of the study participants, who are mostly aged 65 and over. TrialConsent has customisable features such as larger font size, alongside 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.
Athene Lane, Professor in Trials Research at the University of Bristol and Deputy Lead of the Bristol BRC (Nutrition Theme) Cancer Work Stream, said:
“Understanding how patients and sites experience and use eConsent is fundamental to our work. We know that data privacy is a big issue so we’re happy that TrialConsent’s password-controls, role-based access rights, and encrypted patient data allows us to offer users increased reassurance around this. The complete findings of the research study will be published jointly with Signant Health in due course.”
Mike Nolte, CEO of Signant Health, said,
“We are honored to be selected by such a prestigious academic institution in the UK for such a valuable collaboration. Our expertise in managing oncology studies is second to none and we are always seeking to understand how we can make eConsent more effective. We’re excited to see what we can learn from this study and how it helps us improve our patient-centric engagement. These opportunities to support and collaborate with academia for new and novel approaches help us remain at the vanguard of technological innovation.”
To learn more about Signant Health’s solutions for eConsent, visit signanthealth.com.