The prevalence and economic impact of low-enrolling clinical studies at an academic medical center

Academic Medicine

Volumn 86, Issue 11, 2011, Pages 1360-1366

  Kitterman, Darlene R ^a   Cheng, Steven K ^a   Dilts, David M ^a,b   Orwoll, Eric S ^a  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^b OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 80255123795     PISSN: 10402446     EISSN: None     Source Type: Journal    
DOI: 10.1097/ACM.0b013e3182306440     Document Type: Article

References (17)

1. Kassirer JP. Academic medical centers under siege. N Engl J Med. 1994;331:1370-1371.
2. Reis SE, Berglund L, Bernard GR, Califf RM, Fitzgerald GA, Johnson PC. Reengineering the national clinical and translational research enterprise: The strategic plan of the National Clinical and Translational Science Awards Consortium. Acad Med. 2010;85: 463-469. http://journals.lww.com/academic medicine/Fulltext/2010/03000/Reengineering-the-National-Clinical-and.20.aspx. Accessed July 13, 2011.
3. Pober JS, Neuhauser CS, Pober JM. Obstacles facing translational research in academic medical centers. FASEB J. 2001;15:2303-2313.
4. Charlson ME, Horwitz RI. Applying results of randomised trials to clinical practice: Impact of losses before randomisation. Br Med J (Clin Res Ed). 1984;289:1281-1284.
5. Shea S, Bigger JT Jr, Campion J, et al. Enrollment in clinical trials: Institutional factors affecting enrollment in the cardiac arrhythmia suppression trial (CAST). Control Clin Trials. 1992;13:466-486.
6. Cheng SK, Dietrich MS, Dilts DM. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies. Clin Cancer Res. 2010;16:5557-5563.
7. Go R, Meyer C, Mathiason M, et al. Nature and outcome of clinical trials conducted by the Eastern Cooperative Group (ECOG) from 1977 to 2006. Poster presented at: American Society of Clinical Oncology; 2010; Chicago, Ill. Abstract 6069.
8. Schroen AT, Petroni GR. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Clin Trials. 2010;7:312.
9. Cheng SK, Dietrich MS, Dilts DM. Predicting accrual achievement: Monitoring accrual milestones of NCI-CTEP-sponsored clinical trials. Clin Cancer Res. 2011;17:1947.
10. U.S. Department of Health and Human Services. Protection of human subjects. 45 CFR 46.108. http://edocket.access.gpo.gov/cfr-2003/octqtr/45cfr46. 108.htm. Accessed July 27, 2011.
11. Durivage H, Bridges K. Clinical trial metrics: Protocol performance and resource utilization from 14 cancer centers. J Clin Oncol. 2009;27(15 suppl):6557.
12. C-Change. Executive summary. In: A Guidance Document for Implementing Effective Cancer Clinical Trials. Version 1.2. Washington, DC: C-Change; 2005.
13. Califf RM, Berglund L. Linking scientific discovery and better health for the nation: The first three years of the NIH's Clinical and Translational Science Awards. Acad Med. 2010;85:457-462. http://journals.lww.com/ academicmedicine/Fulltext/2010/03000/Linking-Scientific-Discovery-and-Better- Health-for.19.aspx. Accessed July 13, 2011.
14. Dilts D. US cancer trials may go the way of the Oldsmobile. Nat Med. 2010;16:632.
15. Dilts DM, Cheng SK, Crites JS, Sandler AB, Doroshow JH. Phase III clinical trial development: A process of chutes and ladders. Clin Cancer Res. 2010;16:5381.
16. Cooper RG, Edgett SJ, Kleinschmidt EJ. Portfolio Management for New Products. 2nd ed. Cambridge, Mass: Perseus Pub; 2001.
17. Staw B. Knee deep in the big muddy. Organ Behav Hum Decis Process. 1976;35:124-140.