Getting Transparent about Clinical Trials
Program keeps everybody in the loop
Information about clinical trials is often not available for potential subjects, or else is irrelevant to their particular cases or their level of education.
Now TransCelerate has created a Clinical Research Access and Information Exchange Initiative, according to Moe Alsumidaie writing in Applied Clinical Trials. Its purpose is to improve communication between trial organizers and potential participants and between patients and doctors. The initiative seeks to create more and better information, to create a better clinical trial experience for subjects including clearer and less complicated information for online trial registry pages.
Julie Dietrich, director of clinical development at Amgen, is associated with the project and spoke about it at length. Asked which party in the clinical trial process has the greatest need for improved communication, Dietrich said, “…one of the most under-appreciated communication gaps is between sponsor companies and patients. Patients want direct communication with sponsors that goes beyond the informed consent form and includes updates on the study, their data and study results. Another critical relationship is between the sponsor and the investigational site. We can’t do clinical research without sites, and receiving sites’ feedback about the experience is very important.”
Since most patients and caregivers have no experience with clinical trials, Dietrich said, “Patients without study experience might have unclear or unrealistic expectations of clinical research, so we need to clarify expectations, enhance conversations between patients and providers, anticipate patient challenges and optimize trial information exchange based on those needs. We want to improve patients’ experiences at all steps of the clinical trial.”
Attending physicians are a potentially important element in the clinical trial information process. Dietrich said, “The majority of providers would want to know if the patients they referred for a clinical trial were eligible for it and, if not, why. They also want access to their patients’ data and to know the results at the end of the study.” Surveys have found that many doctors are interested in clinical trials but need more information about upcoming trials and also need to find the time to talk with patients.
TransCelerate’s information initiative aims to create uniform modes of feedback from participants. “Each sponsor company will need to assess what is right for it and can adapt TransCelerate’s suggestions wholly, in part or not at all,” Dietrich said.
Dietrich offered specific advice for trial organizers: “We recommend five principles for effective information exchange. Understand and consider patients’ needs, establish clear objectives and expectations, ensure that the information is as timely as reasonable and complete the feedback loop by sharing with patients what we heard. The fifth principle is to always maintain the scientific integrity of the study, because without scientific rigor, we are not honoring the time and effort of clinical trial participants.’
Other efforts for improved communication include the Clinical Research Awareness Initiative, which focuses on public education and doctor-patient discussions about clinical trials, and the eConsent Initiative, which seeks to produce a uniform electronic patient consent form.