While feedback from clinical trial participants that they would like their personal study data and overall trial results to be shared with them has been loud and clear for many years now, effective follow-through from sponsors and sites on such sentiments has historically been more muddled. However, recent advances in patient portal capabilities available through “middlemen” technology providers hold promise for breaking down the communication barriers and increasing transparency along the way.
For example, Advarra, a provider of regulatory review solutions and clinical research technology for sites, sponsors, and contract research organizations (CROs), has announced that its platform for research team collaboration across stakeholders now features an online patient portal enabling patients to access their individual clinical trial data and documents.
“The delivered functionality closely follows TransCelerate’s patient engagement framework,” Elisa Cascade, Chief Product Officer at Advarra, told ACRP. “A connected system with site, sponsor, CRO, and patient access provides visibility to all while preserving the site-patient relationship,” she added in a press release about the portal. “This transparent collaboration in real time is a win for everyone involved in the study.”
Among the nonprofit TransCelerate BioPharma Inc.’s initiatives is one focused on patient data return in recognition of how clinical trial participants “would like more data returned to them during and after participation in clinical trials; however, the frequency, timing, and type of data returned to participants today is varied and not widespread,” according to information on TransCelerate’s website.
Advarra notes that its patient portal enables sites to share important documents such as signed informed consent forms and lab results with patients. Further, patients can access educational videos, study information from sponsors and CROs, key study contacts, and quick links to other study tools.
“We’ve been listening to sites who are…feeling out of the loop with direct communication between the sponsor and patient,” Cascade said in the press release. “Sites have control over the information they choose to share with any individual patient,” she added in information shared with ACRP. “The functionality was designed to preserve the relationship between the site and the patient.”
Edited by Gary Cramer