{"doi":"10.1016/j.jss.2024.03.048","title":"Advancing Randomized Clinical Trials in Surgery: Role of Exception From Informed Consent, Central Institutional Review Board, and Bayesian Approaches","abstract":"Designing and completing randomized clinical trials (RCTs) in surgery is especially challenging due to unique barriers in study design, patient recruitment, and the administrative logistics of multicenter collaborative studies. 1 Diener M.K. Simon T. Büchler M.W. Seiler C.M. Surgical evaluation and knowledge transfer--methods of clinical research in surgery. Langenbecks Arch Surg. 2012; 397: 1193-1199 Crossref PubMed Scopus (15) Google Scholar , 2 Macefield R.C. Boulind C.E. Blazeby J.M. Selecting and measuring optimal outcomes for randomised controlled trials in surgery. Langenbecks Arch Surg. 2014; 399: 263-272 Crossref PubMed Scopus (29) Google Scholar , 3 Wartolowska K. Collins G.S. Hopewell S. et al. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open. 2016; 6e010194 Crossref PubMed Scopus (49) Google Scholar , 4 Speich B. Adequate reporting of the sample size calculation in surgical randomized controlled trials. Surgery. 2020; 167: 812-814 Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar , 5 Blencowe N.S. Brown J.M. Cook J.A. et al. Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials. 2015; 16: 392 Crossref PubMed Scopus (47) Google Scholar Surgical interventions are typically more complex to study than pharmacologic interventions, particularly when comparing surgery with a placebo arm and attempting to blind parties to the intervention. 3 Wartolowska K. Collins G.S. Hopewell S. et al. Feasibility of surgical randomised controlled trials with a placebo arm: a systematic review. BMJ Open. 2016; 6e010194 Crossref PubMed Scopus (49) Google Scholar ,5 Blencowe N.S. Brown J.M. Cook J.A. et al. Interventions in randomised controlled trials in surgery: issues to consider during trial design. Trials. 2015; 16: 392 Crossref PubMed Scopus (47) Google Scholar , 6 Probst P. Grummich K. Harnoss J.C. et al. Placebo-Controlled trials in surgery: a systematic review and meta-analysis. Medicine (Baltim). 2016; 95e3516 Crossref Scopus (39) Google Scholar , 7 Speich B. Blinding in surgical randomized clinical trials in 2015. Ann Surg. 2017; 266: 21-22 Crossref Scopus (15) Google Scholar Selecting and assessing patient-centered outcomes for surgical trials also pose challenges, and the risks of bias are high. 1 Diener M.K. Simon T. Büchler M.W. Seiler C.M. Surgical evaluation and knowledge transfer--methods of clinical research in surgery. Langenbecks Arch Surg. 2012; 397: 1193-1199 Crossref PubMed Scopus (15) Google Scholar ,2 Macefield R.C. Boulind C.E. Blazeby J.M. Selecting and measuring optimal outcomes for randomised controlled trials in surgery. Langenbecks Arch Surg. 2014; 399: 263-272 Crossref PubMed Scopus (29) Google Scholar Traditional statistical approaches result in large sample size calculations, which are daunting when intersecting with patient recruitment challenges for surgical clinical trials. 1 Diener M.K. Simon T. Büchler M.W. Seiler C.M. Surgical evaluation and knowledge transfer--methods of clinical research in surgery. Langenbecks Arch Surg. 2012; 397: 1193-1199 Crossref PubMed Scopus (15) Google Scholar Unsurprisingly, many surgical clinical trials are not adequately powered to detect a clinically meaningful difference or yield results that are statistically fragile. 4 Speich B. Adequate reporting of the sample size calculation in surgical randomized controlled trials. Surgery. 2020; 167: 812-814 Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar ,8 Vivekanantha P. Shah A. Hoit G. Ayeni O. Whelan D. Predictors of increased fragility index scores in surgical randomized controlled trials: an umbrella review. World J Surg. 2023; 47: 1163-1173 Crossref Scopus (0) Google Scholar Surgical trials are also frequently not reported in accordance with existing CONSORT guidelines. 9 Adie S. Harris I.A. Naylor J.M. Mittal R. CONSORT compliance in surgical randomized trials: are we there yet? 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Raval","orcid":"0000-0002-1527-2661","position":3,"is_corresponding":false},{"id":519213,"name":"Mayur B. Patel","orcid":"0000-0001-5230-0871","position":4,"is_corresponding":false},{"id":872403,"name":"Martin L. Blakely","orcid":"0009-0004-6441-1834","position":5,"is_corresponding":false},{"id":430709,"name":"Amelia W. Maiga","orcid":"0000-0001-6488-7024","position":0,"is_corresponding":true}],"reference_count":54,"raw_metadata":null,"created_at":"2026-07-19T02:07:22.248464Z","pmid":"38670847","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}