Clinical Trial Registration Enhanced By Default Eligibility

A new approach that has been created at the Medical University of South Carolina that specifically aims at enhancing clinical trial eligibility has shown positive results.

The patient outreach recruitment team that has been floated by the South Carolina Clinical and Translational Research Institute has made potential patients eligible by default. This has helped them learn about clinical trials in which they can participate. Patients were signaled by default pertaining to the research opportunities and also had the provision to opt out.

The team went on to discuss the new approach in the Clinical and Translational Sciences Journal. They learned from many of their patients that they would like to have a better opportunity when it comes to participating in the research; however, they had no knowledge of the said opportunities, said Associate Vice President, Clinical Research at MUSC, Dr.Patrick Flume.

They believe that the opt-out option in all possibilities grants individuals the autonomy to choose if they want to be a part of the research, according to recruitment manager Tara Pittman. By way of this new approach, to enhance eligibility in clinical trials, individuals within the MUSC Health System are registered across the research participant pool. This primarily increased the number of potential participants to 1.7 million. As per Pittman, patient burnout decreased, and it was highly unlikely that he or she would be contacted more than once or twice. That’s because the same patients who were a part of the trial before the change were no longer subject to receiving repeated requests from the research teams. Initially, the POR team had reservations about whether patients might not like being contacted multiple times pertaining to the studies, and therefore safeguards were put in place to take care of it. That said, all this was found to be unnecessary since the repeat contact went on to be well received by the patients.

To gauge whether the POR approach decidedly elevates the enrolment as well as diversity, more information needs to be looked into, and that information can arise from the recently implemented clinical trial management system by MUSC.

Apparently, if the individuals’ participation as well as diversity see an increase, the POR approach can very well become a vital new tool when it comes to research recruitment toolkits.