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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 an oncology trial. The announcement comes at a time when sponsors, Clinical Research Organizations (CROs)and academic institutions continue to focus on improving the patient experience in clinical trials.
The partnership will see Signant Health collect direct feedback from patients and sites on the impact of its TrialConsent platform during a prostate cancer study. The research seeks to understand how eConsent can improve patient comprehension and reduce site burden. It also seeks to identify areas of opportunities and challenges for sites and patients in future clinical trials.
Bristol BRC selected Signant Health in order to gain insights on ideal study workflows while understanding the strengths and efficacy of eConsent over traditional consenting processes. The BRC team believes that obtaining direct feedback about users’ experiences is critical to improving clinical practice in the future due to the rising costs and complexities of today’s trials.
Signant Health was selected to run qualitative interviews, engage patients and sites, and analyze the findings of the impact of eConsent on sites and patients due to the company’s strong pedigree in clinical oncology. The BRC research team needed a solution that would meet the unique requirements of the study’s mostly aged 65+ patient population characteristics and specific needs. TrialConsent is tailored to meet these needs based on its additional features over paper-based consent. This support comes in the form of customizable features such as larger 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.
Athene Lane, Professor in Trials Research at the University of Bristol and Deputy Lead of the Bristol BRC (Nutrition Theme) Cancer Work Stream, commented, “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 commented, “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 forefront of technological innovation.”