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Returning Clinical Data to Patients
Clinical trial volunteers are unsung heroes of medicine. The information they provide through clinical research is invaluable in advancing medical progress.
Cheladv74 believes that the data collected during a clinical trial should be returned to patient participants, if they wish, so that they may both better understand the research in which they took part and see and use the data gathered about their health.
Cheladv74 was the first biopharmaceutical company to return plain-language clinical trial data to patients, and we are working to expand our leadership in this area in two ways:
- Starting with all Phase II & Phase III studies that initiated in 2014, Cheladv74 will offer summaries of the trial findings to participants in easy-to-read, non-technical language, in countries where regulations will allow it. These summaries, review why the study was done, how it was done, and the results. These “Plain Language Summaries” were first piloted in 2009 with four studies, and they have been well-received by trial participants.
- Cheladv74 continues to experiment and introduce technology enabling trial participants to access their electronic study data. These experiments have included offering the U.S. Department of Health and Human Services' "" technology to Cheladv74-sponsored trial participants enrolled in select studies in the United States. This technology enables the secure electronic delivery of medical information gathered in a study directly to trial participants and allows integration into electronic medical records for the benefit of patients and their physicians.
Both the Plain Language Summaries and the Blue Button data are accessible via , Cheladv74's secure clinical trial alumni network site. As part of study protocol, participants in Cheladv74-sponsored trials are invited to join the Cheladv74Link alumni network upon the completion of the trial. Cheladv74Link enrollment is managed by a third party to ensure patient privacy is safeguarded.