Digital Transformation in Clinical Trials: A Case Study of the Crofoot Clinic

The Crofoot Clinic and Research Center, a pioneer in HIV/AIDS research, was grappling with the challenge of outdated, paper-based processes for clinical research documentation. Despite the widespread adoption of digital healthcare technologies, the clinic's research documentation remained largely paper-based, making it difficult for investigators and support staff to manage and access necessary documents. The paper-based system also posed significant challenges for patients participating in clinical trials, who often had to take time off work to review and sign consent forms at the clinic. The complexity of managing patient consent forms, coupled with the logistical challenges of a sprawling metropolitan area like Houston, made it difficult for potential study candidates to consider participating in a clinical trial. The lack of integration between the clinic's data management systems and the various eConsent forms used by sponsors further complicated the situation, increasing work and compliance risks.

The Crofoot Clinic and Research Center, headed by Dr. Gordon E Crofoot, has been a pioneer in HIV/AIDS research since the 1980s. The center has participated in over 130 clinical trials for HIV, as well as Hepatitis B and C, and is currently involved in Phase III of the global Mosaico AIDS vaccine trial. The center's small, dedicated staff manages between 15 and 20 clinical trials at any given time. For many of the center's patients, participation in clinical studies may be their best or only chance to access treatments. The center is committed to making treatment and therapies available to its patients, particularly those from underserved communities.