TransCelerate Focuses on Improving Information Exchange Along the Entirety of the Patient’s Clinical Trial Journey

Jan 12, 2018

TransCelerate has launched the Clinical Research Access & Information Exchange Initiative, which focuses on enhancing information exchange with patients. This initiative seeks to provide a better window into information about clinical research and trial options while also contributing towards a more rewarding clinical trial experience via better exchange of information with trial participants. In this interview, Julie Dietrich, a Director in Clinical Development at Amgen, will provide more information regarding this initiative and how it is expected to benefit patients and the industry.

Moe Alsumidaie: Across which stakeholder areas is there a lack of clinical trial information exchange?

Julie DietrichJulie Dietrich: First, bidirectional communication is important between all stakeholder groups—patients, caregivers, advocacy groups, healthcare providers, investigators, site staff, regulatory agencies, ethics committees, sponsor companies—but, one of the most underdeveloped and under-appreciated communication gaps is between sponsor companies and patients. Patients want direct communication with sponsors; they want information that goes beyond the informed consent form, including updates on the study, their data and study results. Sponsors also want to know about patients’ experiences, so sponsors can improve the design and logistics for current and future studies. However, we’ve seen that sponsors can be hesitant to communicate directly with patients, as there is a heightened sensitivity about needing to avoid the perception of using promotional speech and compromising the scientific rigor of the study by introducing systematic bias or increasing placebo response rates.

Another critical relationship is between the sponsor and the investigational site—we cannot do most clinical research without sites, and receiving sites’ feedback about their experiences is very important. TransCelerate is trying to improve sites’ clinical trial experiences through the introduction of its Shared Investigator Platform and other initiatives.

MA: Your study has shown that 74% of neither patients, nor their caregivers had experience in clinical trials. What impact does this have on study compliance and data quality? What do patients want?

JD: We found that preferences for clinical trial information were largely similar between patients who had and patients who had not previously participated in a clinical trial. Patients without study experience might have unclear or unrealistic expectations of clinical research, so we need to clarify expectations, enhance clinical trial conversations between the patients and their healthcare providers, anticipate potential patient challenges, and then optimize clinical trial information exchange based on those needs. It is possible that unrealistic or unclear expectations might result in lower adherence to study procedures, which can lead to missing data and poor data quality.

We want to improve patients’ experiences at all stages of the clinical trial—from when patients are first learning about clinical research to when they are participating in the clinical trial to when they complete the study and are transitioning back to usual care, thinking about future clinical trial opportunities and talking to others about their experiences. It might be important for patients to better visualize what it would be like to participate in a trial. Right now, many sponsors are providing patients with supplemental materials, such as handouts about study visit procedures. In the future, we, alongside ethics committees, can examine how new technologies, such as augmented reality or virtual reality, might be incorporated into clinical trials compliantly to help patients better absorb information and enhance discussions between patients and their healthcare providers.

MA: Your survey demonstrated that 75% of sponsors recognize that they can improve current practices with patient information exchange. How could sponsors do a better job on this front, and why is it important?

JD: It is critical that information exchange becomes the default approach for sponsor companies. Accordingly, we recommend five principles for effective information exchange: understand and consider patients’ needs and preferences, 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 from them and what actions will be taken in response. The fifth principle is to always maintain the scientific integrity of the clinical study, because without scientific rigor, we are not honoring the time and effort of clinical trial participants.

When sponsors are designing studies, they need to look at each endpoint and think systematically: can we preserve the scientific integrity of the study and share this data with patients before the end of the study? And if so, how and exactly when and what support would they need to be able to do that. We also encourage sponsors to think about all the data that can be shared, not only lab values but maybe some patient-reported outcomes data that might help patients better understand their condition during trial participation. 

Sponsors can develop and employ different methods in which they can exchange information with patients according to their own standard operating procedures. We want to encourage sponsors to plan early and have a patient information exchange plan before they start a program or study.

MA: What information do healthcare professionals want? Why?

JD: According to our global survey of 462 healthcare providers, the majority of providers would want to know if the patients they referred for a clinical trial were eligible for that trial, and if not, why. They also would want access to their patients’ data that were collected during the study and to know the results at the end of the study. Healthcare providers feel accountable for the quality and continuity of patient care, even when a patient is currently participating, or has participated, in a clinical trial.

We did a focus group, led by the American Academy of Family Physicians, with 8 healthcare providers (all were primary care physicians who had not recently served as investigators). We learned that most of the physicians in the group were interested in helping to raise clinical trial awareness with their patients. They wanted to have discussions with patients about clinical trials, but in order to do that, they need to have more information about available clinical trials and sufficient time to discuss that information with their patients.     

MA: Your research suggests that no sponsors used consistent processes to collect feedback from patients across all studies. How will TransCelerate standardize this process and what are the expected outcomes?

JD: Many of the tools that TransCelerate shares are applicable to all sponsor companies. Each sponsor company will need to assess what is right for them and, based on these needs, can adopt TransCelerate’s suggestions wholly, in part, or not at all. We hope that sponsor companies and other stakeholder groups will understand that TransCelerate’s information exchange initiatives are intended to improve the patients’ experiences with clinical research, which can, subsequently, improve enrollment, retention, adherence to study procedures, data quality, and protocol amendment rates.

Clinical trial participants could have a positive experience and be willing to talk to their friends and family about that experience. At the highest level of outcomes, we might see greater support from the public about participating in clinical research, leading to enhancements in our healthcare systems.

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