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Landscape Of Surgical Clinical Trials: An Analysis Of Surgical Subspecialties With A Focus On Plastic Surgery
Christian N. Arcelona, BS
1,
Narainsai Reddy, MD1, Kayla Haydon, BS
1, Chelsia Melendez, BS
1, Gabrielle Rodriguez, MD
1, Emily George, MD
1, Kathryn Reisner, BS
1, Giselle Alrachid, BS
2, Vladimira Cechova, BS, MS
3, Arun Gosain, MD
1.
1Ann & Robert H. Lurie Children's Hospital of Chicago Foundation, Chicago, MO, USA,
2Loyola University of Chicago Stritch School of Medicine, Chicago, MO, USA,
3Marian University Wood College of Osteopathic Medicine, Chicago, MO, USA.
PURPOSE: Clinical trial activity varies across surgical specialties and cross-specialty comparisons are limited by a lack of specialty-level classifications. In this work we sort surgical trials and benchmark plastic surgery (PRS) against other American College of Surgeons (ACS) specialties for clinical trial features.
METHODS: We gathered all historical ClinicalTrials.gov/AACT snapshots to collect all involved investigators and sponsors by NCT. Trials were mapped to 14 ACS specialties by name-matching investigators to the ACS roster and the National Provider Identifier Registry. We collected all available trial data points including study type, phase (for interventional trials), interventional models/randomization, and funding. PRS was compared with all other surgical specialties at α=0.05.
RESULTS: 28,956 clinical trials were classified between surgical specialties. When comparing the 1,350 PRS trials with most other surgical sub-specialties, PRS had a higher share of industry-funded studies (31.9%, p<0.001) and significantly fewer NIH-funded trials (p<0.001). PRS trials were more often interventional (84.5%, p<0.001) and enrolled fewer participants (median n=36, p<0.001). Temporal trends showed sustained growth in active PRS trials since 2007 with recent plateauing. Common PRS conditions included breast cancer and burns.
CONCLUSION: PRS trials rely more on industry sponsorship, have fewer NIH-funded studies and smaller enrollments, yet report results at higher rates than peer surgical specialties. Our complete analysis comparing the surgical sub-specialties reveals opportunities to diversify funding, monitor progress, and inform funding policy.
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