ArticleClinical cancer research : an official journal of the American Association for Cancer Research2012
Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U.S. Cooperative Oncology Groups.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
44 citing papers in PubMed.
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- What drives cancer clinical trial accrual? An empirical analysis of studies leading to FDA authorisation (2015-2020).BMJ open · 2022Trial
- Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.JCO oncology practice · 2021Trial
- Trial
- Language Barriers Limit Clinical Trial Accessibility for Patients With Gastrointestinal Cancer.Gastroenterology · 2026Article
- Development and Preliminary Validation of a Tool to Assess Barriers and Facilitators to Participation in Adjuvant Endocrine Therapy Switch Trials.Current oncology (Toronto, Ont.) · 2026Article
- Evaluating the impact of delayed study startup on accrual in cancer studies.Contemporary clinical trials communications · 2025Article
- Article
- Patient Enrollment per Month (Accrual) in Clinical Trials Leading to the FDA Approval of New Cancer Drugs.Targeted oncology · 2024Article
- Enrollment Success, Factors, and Prediction Models in Cancer Trials (2008-2019).JCO oncology practice · 2023Article
- Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial.JMIR formative research · 2023Article
- Evolving a national clinical trials learning health system.Learning health systems · 2023Article
- Article
- Clinical trial recruitment in primary care: exploratory factor analysis of a questionnaire to measure barriers and facilitators to primary care providers' involvement.BMC primary care · 2022Article
- Challenges to Randomized Trials in Adult and Congenital Cardiac and Thoracic Surgery.The Annals of thoracic surgery · 2022Review
- Non-oncology clinical trial engagement in a nationally representative sample: Identification of motivators and barriers.Contemporary clinical trials · 2022Article
- Article
- Establishment of a Nationwide Patient Database for Clinical Trial Recruitment in Dermatology: Concept and Patient Characteristics.Acta dermato-venereologica · 2021Article
- Effectiveness of Flexible Ureterorenoscopy Versus Extracorporeal Shock Wave Lithotripsy for Renal Calculi of 5-15 mm: Results of a Randomized Controlled Trial.European urology open science · 2021Article
- Estimating the rate and reasons of clinical trial failure in urologic oncology.Urologic oncology · 2021Article
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12 authors.
Funding
Abstract
purposeAssessing impact of poor accrual on premature trial closure requires a relevant metric. We propose defining accrual sufficiency on apparent ability to address primary endpoints (PE) rather than attaining accrual targets. EXPERIMENTAL
designAll phase III trials open January 1, 1993, to December 31, 2002, by five U.S. oncology Clinical Trials Cooperative Groups (CTCG) were evaluated for accrual sufficiency and scientific results. Sufficient accrual included meeting accrual target, CTCGs documentation attesting adequate accrual, or conclusive results at interim analysis; insufficient accrual included poor accrual as cited closure reason or other reasons rendering a trial unable to address its primary endpoints. Closure rates based on our accrual sufficiency definition are compared with rates of meeting accrual targets and addressing the primary endpoints. A percentage of target accrual above which trials commonly answer the intended scientific question was identified to serve as an alternative to meeting full target accrual in designating accrual success.
resultsOf 238 eligible trials, 158 (66%) closed with sufficient accrual. Among 80 trials with insufficient accrual, 70 (29%) closed specifically because of poor accrual. Inadequate accrual rates are overemphasized when defining accrual success solely by meeting accrual targets. Nearly 75% of trials conclusively addressed the primary endpoints with positive results in 39% of trials. Exceeding 80% of target accrual serves as a reliable proxy for answering the intended scientific question.
conclusionsApproximately one third of phase III trials closed with insufficient accrual to address the primary endpoints, primarily due to poor accrual. Defining accrual sufficiency broader than meeting accrual targets represents a fairer account of trial closures.
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