Factors Associated With Clinical Trial Discontinuation in Aesthetic and Reconstructive Breast Surgery

Background: Randomized controlled trials are the gold standard for investigating the safety and efficacy of a new intervention. In particular, clinical trials in aesthetic and reconstructive breast surgery are critical for the advancement of treatment modalities and device development. This study evaluates the factors associated with early discontinuation of breast reconstruction and aesthetic breast surgery-related studies. Methods: A cross-sectional analysis of all breast surgery-related clinical trials on the ClinicalTrials.gov registry was performed. Trials were categorized as aesthetic, reconstructive, or both. Clinical trials related to breast cancer surgery only, without reconstruction, were excluded. Trials listed as “suspended,” “terminated,” or “withdrawn” were defined as discontinued trials. Trials were then further subdivided into 7 study topics, which included: (1) anesthesia/pain management, (2) infection control/wound healing, (3) breast implant/tissue expanders, (4) general breast reconstruction, (5) fat grafting, (6) microsurgery, and (7) patient/surgical education. Additional factors examined included intervention type, funding source, enrollment size, subject gender, subject age, trial start date, and location. Results: A total of 3658 clinical trials were identified with start dates between January 1994 and July 2024. Of these, 565 trials were included in the final analysis. Seventy-eight percent of studies were reconstructive, 8% were aesthetic, and 14% were both. A total of 76 trials were prematurely discontinued, most commonly secondary to low patient accrual (24%), institutional/principal investigator decision (17%), and inadequate staffing (12%). Thirty-nine percent of discontinued trials were device-related, followed by drug/pharmaceutical (33%) and surgical technique (21%). Study category, topic, and study location were not associated with early discontinuation. Observational studies had a significantly lower likelihood of early discontinuation compared with randomized controlled trials [OR=0.23 (0.10-0.48), P <0.001]. Industry-funded studies had a higher likelihood of early discontinuation compared with nonindustry funded studies [OR=2.07 (1.17-3.59), P <0.001]. Conclusion: Successful completion of clinical trials in aesthetic and reconstructive breast surgery is essential for improving patient outcomes. Our study demonstrates that 13.5% of clinical trials did not reach fruition, largely secondary to poor patient recruitment and staffing issues. Targeted efforts to help support trial completion are necessary to help improve evidence-based practice within breast surgery.