George Clinical is proud to have been involved in developing the recently announced recommendations by the Clinical Trial Transformation Initiative (CTTI): The Recommendations for Engaging Patients and Sites in Mobile Clinical Trials. The recommendations, to which George Clinical contributed as a member on the expert committee, aim to help research organizations, sponsors, and other stakeholders maximize the opportunities presented by mobile technologies to advance the development of new medical products.
The recommendations will assist trial stakeholders in:
- Engaging patient and site perspectives in planning clinical trials using mobile technologies including protocol design, technology selection, and pilot testing;
- Maximizing value and minimizing burden for study participants including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support; and
- Addressing challenges for investigative sites including contracting, budgeting, and training.
“George Clinical welcomes the recommendations released by the CTTI,” Dr. Maria Ali, Chief Medical Officer of George Clinical, and member of the CTTI expert panel said. “Our business of managing clinical trial programs is highly dependent on engaged investigators, sites and patients. We see the value in these recommendations highlighting the importance of using technology to support clinical trials providing maximum value to the patients and sites involved while also reducing the burden on them.”
These are the fourth set of recommendations generated through CTTI’s Mobile Clinical Trials program. In previous years the organization has announced recommendations for developing novel endpoints generated by mobile technologies and solutions for using mobile technologies for data capture, planning and conducting decentralized clinical trials.
The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration, seeks to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Comprised of more than 80 member organizations—representing academia, clinical investigators, government and regulatory agencies, industry, institutional review boards, patient advocacy groups, and other groups—CTTI is transforming the clinical trials landscape by developing evidence-based solutions to clinical research challenges.