A national cancer clinical trials network: Recommendations from the Institute of Medicine

American Journal of Therapeutics

Volumn 18, Issue 5, 2011, Pages 382-391

  Nass, Sharyl J ^a   Balogh, Erin ^a   Mendelsohn, John ^b  

^a NATIONAL ACADEMIES OF SCIENCES   (United States)

^b UNIVERSITY OF TEXAS   (United States)

Author keywords

cancer clinical trials; Cooperative Group Program; drug development; oncology; patient accrual

Indexed keywords

ARTICLE; CANCER THERAPY; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); EVIDENCE BASED MEDICINE; HEALTH CARE QUALITY; HUMAN; MEDICAL SOCIETY; NATIONAL HEALTH ORGANIZATION; ORGANIZATION AND MANAGEMENT; PATIENT ADVOCACY; PATIENT CARE; PRIORITY JOURNAL;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; DRUG APPROVAL; DRUG DESIGN; HUMANS; INSTITUTE OF MEDICINE (U.S.); NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; UNITED STATES;

EID: 80052773751     PISSN: 10752765     EISSN: 15363686     Source Type: Journal    
DOI: 10.1097/MJT.0b013e3181ff7e23     Document Type: Article

References (30)

1. C-Change. A Guidance Document for Implementing Effective Cancer Clinical Trials: Version 1.2. Washington, DC: C-Change; 2005.
2. Cheng S, Dietrich M, Finnigan S, et al. A sense of urgency: evaluating the link between clinical trial development time and the accrual performance of CTEP-sponsored studies. J Clin Oncol. 2009:CRA6509.
3. Ramsey S, Scoggins J. Practicing on the tip of an information iceberg? Evidence of under publication of registered clinical trials in oncology. Oncologist. 2008;13: 925-929.
4. Baer AR, Kelly CA, Bruinooge SS, et al. Challenges to National Cancer Institute-supported Cooperative Group Clinical Trial participation: An ASCO Survey of Cooperative Group sites. J Oncol Pract. 2010;6:114-117.
5. Levinson D. Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials. Washington, DC: Department of Health and Human Services Office of Inspector General; 2010.
6. IOM (Institute of Medicine). A National Cancer Clinical Trials System for the 21st Century. Washington, DC: The National Academies Press, 2010.
7. Chase RB, Tansik DA. The customer contact model for organizational design. Manag Sci. 1983;29:1037-1050.
8. NCI (National Cancer Institute). Report of the Operational Efficiency Working Group of the Clinical Trials and Translational Research Advisory Committee: Compressing the Timeline for Cancer Clinical Trial Activation. Bethesda, MD: National Cancer Institute; 2010.
9. IOM. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: The National Academies Press; 2009.
10. IOM. Cancer Biomarkers: The Promises and Challenges of Improving Detection and Treatment. Washington, DC: The National Academies Press, 2007.
11. CEO Roundtable on Cancer and NCI. Proposed Standardized Harmonized Clauses for Clinical Trial Agreements. Rockville, MD: CEO Roundtable on Cancer and NCI; 2008.
12. PCAST (President's Council of Advisors on Science and Technology). University-Private Sector Research Partnerships in the Innovation Ecosystem. Washington, DC: Office of Science and Technology Policy; 2008.
13. IOM. Extending the Spectrum of Precompetitive Collaboration in Oncology Research: Workshop Summary. Washington, DC: The National Academies Press; 2010.
14. PCAST. Priorities for Personalized Medicine. Washington, DC: Office of Science and Technology Policy; 2008.
15. IOM. Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary. Washington, DC: Institute of Medicine; 2009.
16. EDICT (Eliminating Disparities in Clinical Trials). The EDICT Project: Policy Recommendations to Eliminate Disparities in Clinical Trials. Houston, TX: EDICT Project; 2008.
17. Comis RL, Miller JD, Aldige CR, et al. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21:830-835. (Pubitemid 46606442)
18. Comis RL, Miller JD, Colaizzi DD, et al. Physician-related factors involved in patient decisions to enroll onto cancer clinical trials. J Oncol Pract. 2009;5:50-56.
19. Harris Interactive. Misconceptions and lack of awareness greatly reduce recruitment for cancer clinical trials. Health Care News. 2001;1:1-3.
20. Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomized control trials. JAMA. 2009;9:977-984.
21. ACS CAN (American Cancer Society Cancer Action Network). Barriers to Provider Participation in Clinical Cancer Trials: Potential Policy Solutions. Washington, DC: American Cancer Society Cancer Action Network; 2009.
22. Zon R, Meropol NJ, Catalano RB, et al. American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol. 2008;26:2562-2567.
23. ENACCT (Education Network to Advance Cancer Clinical Trials) and CCPH (Community-Campus Partnerships for Health). Communities as Partners in Cancer Clinical Trials: Changing Research, Practice, and Policy. Bethesda, MD: Education Network to Advance Cancer Clinical Trials. Seattle, WA: Community-Campus Partnerships for Health; 2008.
24. Getz KA, Wenger J, Campo RA, et al. Assessing the impact of protocol design changes on clinical trial performance. Am J Ther. 2008;15:450-457.
25. George SL. Reducing patient eligibility criteria in cancer clinical trials. J Clin Oncol. 1996;14:1364-1370. (Pubitemid 26105547)
26. AHRQ (Agency for Healthcare Research and Quality). Horizon Scan: To What Extent Do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base? Rockville, MD: Agency for Healthcare Research and Quality, 2009.
27. IOM. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: National Academy Press, 2000.
28. NCSL (National Conference of State Legislatures). Clinical trials: What are states doing? August 2009 update. Available at: http://www.ncsl.org/default. aspx? tabid=14331. Accessed October 22, 2009.
29. HHS (US Department ofHealth andHuman Services). Fact sheet: Keeping the health plan you have: The affordable care act and "grandfathered" health plans. Available at: http://www.healthreform.gov/newsroom/keeping-the- health-plan-you-have.html. Accessed August 2, 2010.
30. Robinson B. Harold Varmus becomes fourteenth director of the National Cancer Institute. NCI Cancer Bull. 2010;7:2.