UNDERSTANDING PERSPECTIVES, BARRIERS AND ENABLERS FOR CLINICAL TRIAL PARTICIPATION IN REPRESENTATIVE PATIENT POPULATIONS
Author(s)
Keila Meginnis, PhD1, Harrison Clarke, MSc2, Evie Webb, MSc1, Anne M. Skalicky, MPH3, Olufemi Babalola, PhD4, Tracy L. Gray, MBA, MS, RN4, David J. Gebben, PhD4, Lexie Perreras, MPH4, Misti Malone, PhD4, Robert Wright, PhD4, Cynthia Grossman, PhD5, Jennifer Whitty, PhD1.
1Thermo Fisher Scientific, London, United Kingdom, 2Thermo Fisher Scientific, Bethesda, MD, USA, 3Thermo Fisher Scientific, Wilmington, NC, USA, 4FDA, Silver Spring, MD, USA, 5FDA, Boston, MA, USA.
1Thermo Fisher Scientific, London, United Kingdom, 2Thermo Fisher Scientific, Bethesda, MD, USA, 3Thermo Fisher Scientific, Wilmington, NC, USA, 4FDA, Silver Spring, MD, USA, 5FDA, Boston, MA, USA.
OBJECTIVES: Clinical trials or studies (CTs) have historically struggled with participant enrollment. This study aimed to explore perspectives, barriers and enablers to participation in CTs and medical device CTs, through patient interviews.
METHODS: Forty interviews were conducted between June-October 2025 with adult (≥18 years) peripheral vascular and/or cardiovascular disease patients in the US. Participants answered open-ended questions about CTs and ranked features influencing their CTs participation, from three lists: logistical, informational and treatment related. Descriptive statistics and qualitative content analysis were used to understand common themes.
RESULTS: Participants had a mean age of 52.4 (SD 16.6) years with slightly more female (72.5%) than male (27.5%). The sample comprised 42.5% White, 42.5% Black/African American, 2.5% Asian, 12.5% American Indian/Alaska Native, 2.5% Middle Eastern/North African, and 17.5% Hispanic/Latino participants. Approximately half had CT experience (57.5%). Health benefits (67.5%) and a willingness to help science (47.5%) were mentioned as reasons for wanting to participate in CTs. Individuals discussed possible side effects (55%), time commitment (22.5%) and the unclear benefit (20%) as reason for CTs hesitancy. Most (45%) were open to participate in a hypothetical medical device CT, but many (37.5%) stated that the need for a surgically implanted device was burdensome. Almost all participants ranked their doctor’s advice as an important informational CTs feature and the location or time commitment as important logistical CTs features. Chance of side effects or the need for an invasive treatment were ranked as important treatment-related features for CTs participation.
CONCLUSIONS: Among the participating US patients with cardiovascular disease, many were open to participating in future CTs research. Experience in CTs research did not appear to predict future CTs participation. Clear information on the study duration, side effects, and types of procedures required for medical device CTs, were identified by the participants as information that could inform participation.
METHODS: Forty interviews were conducted between June-October 2025 with adult (≥18 years) peripheral vascular and/or cardiovascular disease patients in the US. Participants answered open-ended questions about CTs and ranked features influencing their CTs participation, from three lists: logistical, informational and treatment related. Descriptive statistics and qualitative content analysis were used to understand common themes.
RESULTS: Participants had a mean age of 52.4 (SD 16.6) years with slightly more female (72.5%) than male (27.5%). The sample comprised 42.5% White, 42.5% Black/African American, 2.5% Asian, 12.5% American Indian/Alaska Native, 2.5% Middle Eastern/North African, and 17.5% Hispanic/Latino participants. Approximately half had CT experience (57.5%). Health benefits (67.5%) and a willingness to help science (47.5%) were mentioned as reasons for wanting to participate in CTs. Individuals discussed possible side effects (55%), time commitment (22.5%) and the unclear benefit (20%) as reason for CTs hesitancy. Most (45%) were open to participate in a hypothetical medical device CT, but many (37.5%) stated that the need for a surgically implanted device was burdensome. Almost all participants ranked their doctor’s advice as an important informational CTs feature and the location or time commitment as important logistical CTs features. Chance of side effects or the need for an invasive treatment were ranked as important treatment-related features for CTs participation.
CONCLUSIONS: Among the participating US patients with cardiovascular disease, many were open to participating in future CTs research. Experience in CTs research did not appear to predict future CTs participation. Clear information on the study duration, side effects, and types of procedures required for medical device CTs, were identified by the participants as information that could inform participation.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR81
Topic
Patient-Centered Research
Topic Subcategory
Patient Behavior and Incentives
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)