Abstract
Under-recruitment in clinical trials is an issue worldwide. If the number of patients enrolled is lower than expected, based on the required sample size, then the reliability of the study results and their validation tend to be impaired. The current study therefore evaluated factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective cohort study. The researchers encouraged research institutions to accelerate patient enrollment via e-mail, newsletters, telephone calls, and site visits. We analyzed the relationship between several potential factors associated with acceleration of patient enrollment including site visits and patient enrollment in a real clinical study. Data were collected from 106 research institutions that participated in a multicenter prospective cohort study. Results showed that the following parameters differed in terms of patient enrollment and non-enrollment: urban area (47.2 vs. 67.6%, p = 0.04), clinical research coordinator (CRC) participation in data input to electronic data capture (EDC) (41.7 vs. 11.8%, p < 0.01), and site visit (38.9 vs. 11.8%, p < 0.01). A multivariate analysis revealed that patient enrollment was significantly associated with urban area (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.12–0.86, p = 0.02), CRC participation in data input to EDC (OR 5.02; 95% CI 1.49–16.8; p < 0.01), and site visit (OR 4.54, 95% CI 1.31–15.7, p = 0.01). In conclusion, site visits and CRC participation in data input to EDC had a significant effect on patient enrollment promotion. Moreover, hospitals in rural areas were more effective in promoting patient enrollment than those in urban areas.
Highlights
Completing patient enrollment within the enrollment period is vital for successful clinical research
If selection criteria are directly stated upon visiting the centers, the researchers are more likely to determine whether the patients are eligible, will more likely be knowledgeable about STAR-ACS participation, and will seriously consider patient enrollment
We believe that an important factor in facilitating patient enrollment is balance between abundant support provided by clinical research supporters and the busyness of physicians who are in a position to recruit patients
Summary
Completing patient enrollment within the enrollment period is vital for successful clinical research. To identify barriers to patient recruitment in clinical trials, Stein et al conducted focus groups and key informant interviews with investigators, coordinators, and other stakeholders in clinical and translational research. They reported that the main barrier was a lack of support from clinical staff. The Juntendo Clinical Research and Trial Center (JCRTC) fully supported the multicenter cohort study “Real World Anticoagulation and Antiplatelet Practice in Patients with Acute Coronary Syndrome Complicated with Atrial Fibrillation” (STAR-ACS) (University Hospital medical information network (UMIN), 2017), an ongoing, nationwide prospective cohort study involving 144 institutions (7.6% in Hokkaido, 2.8% in Tohoku, 36.1% in Kanto, 13.2% in Chubu, 17.4% in Kinki, 4.9% in Chugoku, 4.2% in Shikoku, and 13.9% in Kyushu). The current study aimed to investigate factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective study
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