Nature and outcome of clinical trials conducted by the Eastern Cooperative Group (ECOG) from 1977 to 2006.

Go, R. S.; Meyer, Christine; Mathiason, Michelle A.; Emmel, Ann E.; Frisby, Kathleen A.; Meyer, Lori A.; Schroeder, Josh E.; Sieber, Debbie L.; Crampton, K. L.; Pingali, Sai Ravi

doi:10.1200/jco.2010.28.15_suppl.6069

Cited by 5 publications

(5 citation statements)

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“…Additional evidence of the problem can be seen in three additional studies. Go et al 15, investigating a total of 495 ECOG phase II and III trials from 1977-2006, found that 27% of trials failed to complete accrual. Schroen et al 16 in a study of 248 phase III trials open in 1993-2002 from five cooperative groups discovered that 35% were closed due to inadequate accrual.…”

Section: Discussionmentioning

confidence: 99%

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Dilts

Cheng

Crites

et al. 2010

Clinical Cancer Research

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Purpose: The Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual.Methods: The Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program. Accrual data were also collected.Results: Opening a phase III cooperative group therapeutic trial requires 769 steps, 36 approvals, and a median of approximately 2.5 years from formal concept review to study opening. Time to activation at one group ranged from 435 to 1,604 days, and time to open at one cancer center ranged from 21 to 836 days. At centers, group trials are significantly more likely to have zero accruals (38.8%) than nongroup trials (20.6%; P < 0.0001). Of the closed NCI Cancer Therapy Evaluation Program-approved phase III clinical trials from 2000 to 2007, 39.1% resulted in <21 accruals.Conclusions: The length, variability, and low accrual results demonstrate the need for the NCI clinical trials system to be reengineered. Improvements will be of only limited effectiveness if done in isolation; there is a need to return to the collaborative spirit with all parties creating an efficient and effective system. Recommendations put forth by the Institute of Medicine and Operational Efficiency Working Group reports, if implemented, will aid this renewal.

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Section: Discussionmentioning

confidence: 99%

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Dilts

Cheng

Crites

et al. 2010

Clinical Cancer Research

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“…3 More than 80% of clinical trials are delayed as a result of low participant recruitment, and some studies are prematurely terminated. [4][5][6][7][8] The consequences of low study participant accrual range from substantial financial costs to missed opportunities. Continuing such studies could be considered unethical as they promote undue risk to enrolled participants while not yielding the scientific benefit on which they had been premised.…”

Section: Problemmentioning

confidence: 99%

“…This dilemma is not unique to any one study-type, nor is it confined to academic institutions and/or health centers 3. More than 80% of clinical trials are delayed as a result of low participant recruitment, and some studies are prematurely terminated 4–8…”

Section: Problemmentioning

confidence: 99%

Studysearch: A Web-Based Application for Posting and Searching Clinical Research Studies

Gonsenhauser

Hallarn

Carpenter

et al. 2016

Journal of Investigative Medicine

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Participant accrual into research studies is critical to advancing clinical and translational research to clinical care. Without sufficient recruitment, the purpose of any research study cannot be realized; yet, low recruitment and enrollment of participants persist. StudySearch is a web-based application designed to provide an easily readable, publicly accessible, and searchable listing of IRB-approved protocols that are accruing study participants. The Regulatory, Recruitment and Biomedical Informatics Cores of the Center for Clinical and Translational Science (CCTS) at The Ohio State University developed this research study posting platform. Postings include basic descriptive information: study title, purpose of the study, eligibility criteria and study personnel contact information. Language concerning benefits and/or inducements is not included; therefore, while IRB approval for a study to be listed on StudySearch is required, IRB approval of the posted language is not. Studies are listed by one of two methods; one automated and one manual: (1). Studies registered on ClinicalTrials.gov are automatically downloaded once a month; or (2). Studies are submitted directly by researchers to the CCTS Regulatory Core staff. In either case, final language is a result of an iterative process between researchers and CCTS staff. Deployed in January 2011 at OSU, this application has grown to approximately 200 studies currently posted and 1500 unique visitors per month. Locally, StudySearch is part of the CCTS recruitment toolkit. Features continue to be modified to better accommodate user behaviors. Nationally, this open source application is available for use.

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“…[1][2] Yet low accrual to trials persists, [3][4][5] with an unacceptable percentage of National Cancer Institute (NCI)-sponsored trials failing to achieve minimum accrual goals. [6][7][8][9] NCI's Office of Communications and Education (OCE) has researched factors related to accrual and recruitment best practices for clinical trials, including structured interviews with health association leaders, in-depth studies of five comprehensive cancer centers, and more than 15 community clinical oncology programs (CCOPs). Four specific themes arose from this research: (1) despite numerous published articles and strategies developed at the local level, clinicians require assistance identifying best practices and strategies to improve accruals to clinical trials; (2) existing tools and resources are scattered across multiple media and require extensive work to retrieve and render them useful for local conditions; (3) efforts to improve enrollment to trials are generally point solutions, that is, they are developed to solve a particular problem at a single site; and (4) there are limited opportunities to share best practices and collaborate among the community of oncology trialists.…”

Section: Introductionmentioning

confidence: 99%

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform

Massett

Parreco

Padberg

et al. 2011

JOP

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Purpose: Present the design and initial evaluation of a unique, Web-enabled platform for the development of a community of practice around issues of oncology clinical trial accrual. Methods:The National Cancer Institute (NCI) conducted research with oncology professionals to identify unmet clinical trial accrual needs in the field. In response, a comprehensive platform for accrual resources, AccrualNet, was created by using an agile development process, storyboarding, and user testing. Literature and resource searches identified relevant content to populate the site. Descriptive statistics were tracked for resource and site usage. Use cases were defined to support implementation.

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Nature and outcome of clinical trials conducted by the Eastern Cooperative Group (ECOG) from 1977 to 2006.

Cited by 5 publications

References 0 publications

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Phase III Clinical Trial Development: A Process of Chutes and Ladders

Studysearch: A Web-Based Application for Posting and Searching Clinical Research Studies

AccrualNet: Addressing Low Accrual Via a Knowledge-Based, Community of Practice Platform

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