The Clinical Research Access & Information Exchange Initiative targets TransCelerate’s strategic priority of improving the patient experience by better informing patients.
The links between available information about clinical trials and the potential trial participants are often missing or broken, and this is further complicated by the fact that available clinical trial information often lacks utility for the average patient. Existing infrastructure used to host and disseminate clinical trial information can be very complex and difficult to navigate and to understand. Furthermore, when patients do enroll in clinical trials, they do not always have access to valuable information about their experience during or after clinical trial participation.
Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.
We ultimately expect to facilitate:
- Simpler, user-friendly clinical trial information search and navigation on clinical trial registries
- More meaningful information (and data) exchanges between clinical researchers and trial participants before, during, and after trial participation
- Better engaged and educated public (including patients and health care professionals) with respect to clinical trials
The following assets have been delivered by this initiative:
- Position paper examining the value and potential options for making it easier for potential clinical trial participants to contact individual site locations through government clinical trial registry listings
- Published proposal and proof of concept illustrating patient-focused improvements for adoption by government clinical trial registries (Clinical Trial Registry of the Future)
- Position paper examining the value and key principles associated with improved information exchange between researchers and trial participants
- Templates to support clinical trial sponsors exchange information with patients before, during and after clinical trial participation (Sample letters and Trial information templates)
Moreover, in response to the National Institute of Health’s request to the industry to resolve quality issues regarding data submitted to public registries as a precursor to addressing issues with public registry platforms, such as ClinicalTrials.gov, the initiative will look at authoring procedural best practices for sponsors to help facilitate the availability of complete, accurate, timely, and lay audience-friendly information, as well as improve data re-usability. In addition, the initiative will assess current-state registry reporting practices and explore developing a sponsor “Self- Evaluation” Template and the first release of a Common Registry Data Packet. These guidance materials can encourage greater engagement with and understanding of trials and enrollment opportunities by patients, caregivers and healthcare professionals.