In June 2013, the NINDS hosted a workshop on Improving Neurological Subject (and Provider) Participation In the Research Enterprise (INSPIRE). The purpose of the workshop was to address the growing challenge of engaging patients in clinical research and to develop tools to enhance recruitment and retention to neurological clinical studies. The workshop brought together more than 125 investigators, clinicians, clinical coordinators, project and data managers, biostatisticians, communications specialists, patients and patient advocates, as well as NIH and FDA staff.
Over the course of two days, attendees heard from leading experts on patient-centered research, the state of the clinical research enterprise and changing attitudes towards public engagement. They also participated in working sessions focused on a wide range of issues that can impact patient recruitment including protocol design and data collection; communication and outreach; recruitment and retention planning and study management. During interactive session, participants shared model plans, resources, training programs and experiences (both positive and negative), and developed recommendations that could serve as action plans for future researchers, clinicians, patients and patient advocates.
Attendees challenged each other’s assumptions, focused on key principles underlying a wide range of studies (from epidemiologic to intervention, studies in children to older adults, studies of acute and chronic diseases), and highlighted solutions to the barriers that are frequently cited as the reasons for failure in clinical research. Common themes in each of the groups included the need to build trust, test assumptions, develop training programs, incorporate a variety of communications tools to meet audience needs and interests, and to plan early and often.
In the area of patient engagement, a key recommendation was to acknowledge that patients share an intense desire to find answers to their medical problems, but also answers to problems that can slow the pace of clinical research. The enterprise would benefit from opportunities for patients to learn about the overall goals of clinical research to prepare them for the important roles that they play.
With regard to clinical trial design, attendees recommended the design of studies that answer questions that are relevant for patients and for clinical practice, and to make efforts to involve both patients and practitioners in this process.
Overall, meeting attendees recommended making better use of the expertise of investigators, clinical coordinators and patients, with the notion that the expertise of the latter two groups is often not recognized or underutilized. They also recommended raising the bar for investigators, coordinators, and patients so that academic clinical research can mirror the sophistication of industry-run studies and to ensure that everyone, including patients, understands and is committed to their role in clinical research.
A holistic approach to clinical research will require future investigators to build trust (among the many stakeholders in the enterprise), to build expertise (through specialized training programs as well as collaborations with people who have expertise in education and communications), and to adopt continuous quality improvement measures to plan, design and adapt clinical research studies using organized, data-driven models.
Watch this page for additional information as well as links to tools and resources in the coming months. In the meantime, to access the meeting agenda and list of attendees, click here.
Last updated September 3, 2013