Adult cancer clinical trials that fail to complete: An epidemic?

Journal of the National Cancer Institute

Volumn 106, Issue 9, 2014, Pages

  Stensland, Kristian D ^a   McBride, Russell B ^a,b   Latif, Asma ^a   Wisnivesky, Juan ^b   Hendricks, Ryan ^a   Roper, Nitin ^a   Boffetta, Paolo ^a,b   Hall, Simon J ^a   Oh, William K ^a   Galsky, Matthew D ^a  

^a Tisch Cancer Institute   (United States)

^b MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG; ANTINEOPLASTIC AGENT;

ADULT DISEASE; CLINICAL EVALUATION; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); EPIDEMIC; HUMAN; INCIDENCE; KNOWLEDGE BASE; NATIONAL HEALTH ORGANIZATION; NEOPLASM; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REVIEW; ADULT; ARTICLE; DRUG DEVELOPMENT; EARLY TERMINATION OF CLINICAL TRIAL; ECONOMICS; RESEARCH SUBJECT; STATISTICS; UNITED STATES;

ADULT; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; EARLY TERMINATION OF CLINICAL TRIALS; HUMANS; NATIONAL CANCER INSTITUTE (U.S.); NEOPLASMS; RESEARCH SUBJECTS; UNITED STATES;

EID: 84909606213     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/dju229     Document Type: Review

References (25)

1. Institute of Medicine (U. S.). Committee on Cancer Clinical Trials National Academic Press (U. S.), Institute of Medicine (U. S.). Board on Health Care Services. NCI Cooperative Group Program (National Cancer Institute). A national cancer clinical trials system for the 21st century: reinvigorating the NCI Cooperative Group Program.. National Academies Press. 2010.
2. Faltering cancer trials. The New York Times. April 24, 2010.
3. Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of Oncology Clinical Trials. JAMA Intern Med. 2013:173(11):972-979.
4. Ramsey S, Scoggins J. Commentary: practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist. 2008;13(9):925-929.
5. 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(22):5557-5563.
6. Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007. J Clin Oncol. 2010;28(35):5197-5201.
7. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials. gov results database-update and key issues. New Engl J Med. 2011;364(9):852-860.
8. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA. 2012;307(17):1838-1847.
9. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ. 2012;344:d7292-d7292.
10. Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. New Engl J Med. 2005;353(26):2779-2787.
11. Zarin DA. Factual Errors about ClinicalTrials.gov and other federal mandates in special report by Shuster. Clin Transl Sci. 2012;5(2):217 - author reply 217.
12. Dickersin K, Rennie D. The evolution of trial registries and their use to assess the clinical trial enterprise. JAMA. 2012;307(17):1861-1864.
13. DiMasi JA, Grabowski HG. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics. 2007;28(4-5):469-479.
14. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22(2):151-185.
15. Murthy VH, Krumholz HM, Gross C P. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291(22):2720-2726.
16. Lara PN, Paterniti DA, Chiechi C, et al. Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol. 2005;23(36):9282-9289.
17. Lara PN, Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728-1733.
18. Denicoff AM, McCaskill-Stevens W, Grubbs SS, et al. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations. J Oncol Pract. 2013;9(6):267-276.
19. Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011;86(11):1360-1366.
20. Schroen AT, Petroni GR, Wang H, et al. Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from U. S. Cooperative Oncology Groups. Clini Cancer Res. 2012;18(1):256-262.
21. Meyers FJ, Begg MD, Fleming M, Merchant C. Strengthening the career development of clinical translational scientist trainees: a consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees. Clin Transl Sci. 2012;5(2):132-137.
22. Morris MJ, Basch EM, Wilding G, et al. Department of Defense prostate cancer clinical trials consortium: a new instrument for prostate cancer clinical research. Clin Genitourin Cancer. 2009;7(1):51-57.
23. Perkins LM, Young AQ, Giusti K. One foundation's strategy to accelerate drug discovery through genomics. Sci Transl Med. 2011;3(78):78cm11.
24. Burstein HJ. Beaten at the Alamo by the Europeans. J Natl Compr Canc Netw. 2011;9(1):1.
25. Bach PB. Visions of Hope in Cancer: Focus on InfrastructureComment on "Characteristics of Oncology Clinical Trials" and 'Toward Accountable Cancer Care'Visions of Hope in Cancer. JAMA Intern Med. 2013;173(11):979-980.