By Mary Elmer, executive director, Patient, Caregiver, and Consumer Experience, Merck & Co., Inc.
Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development. Patients now understand and expect more from the clinical trial process. What’s more, health regulators have begun to emphasize the need for patient-centered drug development and are driving many initiatives concentrated on patient engagement, placing even further pressure on sponsors to elevate patient involvement in clinical trial processes.
Improved patient involvement is beneficial to the entire clinical trial process: Better patient experiences lead to increased study participation and reduced dropout rates, which can, in turn, speed up the delivery of medicines to market. The issue is that, to date, sponsors lack the tools to improve the patient experience in protocols.
According to a study in Therapeutic Innovation & Regulatory Science, many sponsors don’t have regular processes for engaging patients in study design and conduct. Of 14 companies surveyed, none responded as having a consistent, company-wide process for soliciting feedback from clinical study participants. There is a disconnect between the recognized need for elevated patient engagement and the steps being taken to implement the necessary processes for improving it.
One reason for this is that a great deal of internal development must take place in order for a sponsor to build a framework that can support an engagement process. Increasing the level of patient engagement in clinical design involves steps such as considering budgetary needs, conducting institutional review board (IRB)/ethics committee reviews, establishing teams to lead patient experience and engagement activities, and much more. That is to say, in order to properly engage patients in the design and execution of clinical studies, a great deal of cross-stakeholder collaboration must take place. This can be a time-consuming and exhaustive process, and it can be difficult for sponsors to know where to begin.
To help provide guidance to sponsors looking to improve partnerships with patients, TransCelerate BioPharma launched a Patient Experience Initiative. The initiative seeks to develop ways to engage with patients in the design and execution of clinical studies, and one way of doing so is with the utilization of the initiative’s tools: the Patient Protocol Engagement Toolkit and the Study Participant Feedback Questionnaire. The tools may be used by sites, sponsors, regulators, and others to elevate the understanding of patient experiences during clinical trials through a variety of means, such as questionnaires, resource guides, and user guides.
However, the development of this initiative was also beneficial in that it enabled the team to work side by side with patients, sponsors, regulators, and all other major stakeholders in the drug development process and really think about how the patient experience can be improved. In doing so, we garnered a few takeaways on how sponsors can kick-start their own collaborative efforts with patients.
These are three key learnings sponsors can use to engage with patients as they continue to integrate the patient’s voice into the design and execution of clinical trials:
1. Integrate With Patients And Patient Advocates
It goes without saying that it’s important to gather information directly from patients when drafting a patient engagement plan. There are several ways to go about doing this. Sponsors can engage via patient platforms and networks, hold patient focus groups, conduct one-on-one interviews with patients, or work with patient advisory boards to gather real-time feedback. In the development of the Patient Experience Initiative toolkits specifically, TransCelerate included a patient advisor on the development team so patient input would be integrated throughout the entire process.
Sponsors can take the relationship a step further by connecting with other stakeholders such as site advisory boards and clinical research organizations. The patient has touchpoints with these groups throughout the drug development processes, and therefore collaboration and input from them is beneficial to improving the patient experience and journey.
2. Take Time To Understand The Current Landscape And Regulations
As with any major project, it is helpful to start with primary research. We began with an extensive literature review that considered the current landscape surrounding patient involvement in clinical trials. This included gathering information from every corner of the industry, including materials that outline the current regulatory landscape, resources for engaging patients as partners, and even guidance for patients on how they can become partnership ready. We cite several of the most helpful resources in our Patient Protocol Engagement Toolkit User Guide.
Furthermore, we spent time engaging with regulators, which included face-to-face meetings with the FDA. Current regulation, such as the 21st Century Cures Act, which was designed to accelerate innovation and advances to patients who need them, makes it clear that patients are also on the forefront of regulators’ minds. Regulators have also begun to recognize a need for guidance documents on how to include patient voices in trials, and as sponsors develop engagement plans, it’s beneficial to ensure their goals align with regulations such as the Cures Act or the European Union’s General Data Protection Regulation (GDPR).
3. Build Long-Term Trust
To be successful in producing meaningful tools for patients, there must be a level of shared alignment, clarity, and respect between invested groups. Sponsors must take great care to assert each stakeholder is united with a common goal: elevating the patient experience. Once the goal is agreed upon, sponsors can take steps to elevate transparency by assigning specific roles and responsibilities among stakeholders. Internal processes can be aligned, and points of contact can be established. It’s our hope that throughout this process greater levels of trust and mutual respect are developed. This can then lead to long-term continuity of relationships and greater levels of responsiveness across stakeholders.
While it is true that sponsors may benefit from better patient engagement and its potential to increase patient participation, decrease attrition rates, and ultimately advance the delivery of medicines to market, we must keep the ultimate end goal in sight: to decrease patient burden, incorporate their perspective into medicine development, and increase their satisfaction. With this clear objective in mind, we can continue to make strides in incorporating the patient voice into the design and implementation of clinical trials.
About The Author:
Mary Elmer is the executive director of Patient, Caregiver, and Consumer Experience at Merck, which seeks to create an experience that engages consumers and patients in optimizing their health, well-being, and healthcare outcomes. Elmer also leads a team for global patient engagement in the office for the Chief Patient Officer, helping bring the voice of the patient into the drug development process through collaborative partnerships with patients and organizations serving patients. A nurse practioner with over 20 years’ experience at Merck, she is a member of the company’s Global Diversity and Inclusion Council and co-leads the diversity in U.S. clinical trials initiative. Elmer is a member of TransCelerate BioPharma and leads a work stream on patient engagement.