Implementation of investigator-led drug clinical trial recruitment

Objective Taking the implementation of recruitment for a drug clinical trial as an example, to discuss the implementation method of investigator-led recruitment for drug clinical trials from the perspective of the investigator’s organization, with a view to providing a reference for optimizing the recruitment for clinical trials as well as strengthening the construction of the research team. Methods From April 14, 2020 to July 4, 2022, General Hospital of Eastern Theater Command conducted an international multicenter phase Ⅲ clinical trial for the EMPA-KIDNEY study, with no third-party involvement in the recruitment process, which was led by the investigator. The study recruited subjects from the Chronic Kidney Disease Patient Registry Study patient pool, on-site recruitment, physician referral, and database screening, and took measures such as developing a recruitment system, clarifying personnel responsibilities to improve team efficiency, and strengthening quality control to manage recruitment. Results A total of 356 subjects were screened and 305 subjects were enrolled in the study, successfully completing the recruitment plan. Among them, 196 subjects were recruited through the “registration study”, accounting for two-thirds of the EMPA enrolment, while the rest of the patients were recruited on-site, referred by the clinic and screened by the database. “The enrolment study” achieved good recruitment results, but the number of outpatient referrals and the success rate of enrolment were lower than expected. Conclusion Compared to the third-party recruitment team, the investigators are more professional in their understanding of the protocol and in their control of the enrolment criteria, and are also more likely to gain the trust of the patients and be more familiar with the hospital environment, and therefore, have an advantage in the implementation of recruitment in hospitals. Researchers should not transfer their functions to recruiting companies or clinical research assistants, but should be more involved in the recruitment process. Recruitment for clinical trials is affected by a variety of factors such as protocol design, team organization and recruitment strategy, so it is important to establish an efficient research team, choose an appropriate recruitment strategy, and strengthen recruitment management for the implementation of recruitment.