Exploring Differences in Screening and Enrollment Metrics in Orthopaedic Clinical Trials

Area of Science:

• Orthopaedic Clinical Trials
• Patient Recruitment and Retention
• Clinical Study Design

Background:

• Clinical trial success is contingent upon effective patient recruitment and retention.
• Orthopaedic clinical trials involve unique challenges in patient selection and enrollment.
• Variations in study design and patient populations can impact recruitment dynamics.

Purpose of the Study:

• To review screening and enrollment metrics for orthopaedic clinical trials.
• To compare patient populations and identify common recruitment challenges.
• To analyze differences in enrollment rates across various study types.

Main Methods:

• Manual review of screening logs and study trackers from four orthopaedic clinical trials at an academic institution.
• Inclusion of randomized controlled trials (RCTs) and an observational study.
• Extraction of data on screened patients, exclusions (with reasons), enrolled patients, and withdrawals (with reasons).

Main Results:

• The point-of-care diagnostic test trial had the highest exclusion numbers but the lowest refusal rate.
• The venous thromboembolism prophylaxis study exhibited the highest patient refusal rates.
• Enrollment rates were lowest in an RCT of drug treatments and highest in the observational study.

Conclusions:

• Patient recruitment success in orthopaedic trials depends on careful consideration of factors like sample size and eligibility criteria.
• Insights into recruitment experiences across different patient populations and study types are valuable for future trial planning.
• Addressing specific challenges, such as high exclusion or refusal rates, is essential for optimizing orthopaedic clinical trial recruitment.