Challenges to accrual predictions to phase III cancer clinical trials: A survey of study chairs and lead statisticians of 248 NCI-sponsored trials

Clinical Trials

Volumn 8, Issue 5, 2011, Pages 591-600

  Schroen, Anneke T ^a   Petroni, Gina R ^b   Wang, Hongkun ^b   Thielen, Monika J ^a   Sargent, Daniel ^c   Benedetti, Jacqueline K ^d   Cronin, Walter M ^e   Wickerham, Donald L ^f   Wang, Xiaofei F ^g   Gray, Robert ^h   Cohn, Wendy F ^b   Slingluff, Craig L ^a   Djulbegovic, Benjamin ⁱ  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c MAYO CLINIC   (United States)

^d SOUTHWEST ONCOLOGY GROUP STATISTICAL CENTER   (United States)

^e UNIVERSITY OF PITTSBURGH GRADUATE SCHOOL OF PUBLIC HEALTH   (United States)

^f NSABP Foundation Inc   (United States)

^g DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h DANA FARBER CANCER INSTITUTE   (United States)

ⁱ UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER RESEARCH; EXPERIMENTAL DESIGN; HUMAN; NATIONAL HEALTH ORGANIZATION; PHASE 3 CLINICAL TRIAL (TOPIC); PREDICTION; PRIORITY JOURNAL; REVIEW; STATISTICAL ANALYSIS;

BIOSTATISTICS; CLINICAL TRIALS, PHASE III AS TOPIC; DATA COLLECTION; HUMANS; INTERNET; MEDICAL ONCOLOGY; NATIONAL CANCER INSTITUTE (U.S.); PATIENT PARTICIPATION; PATIENT SELECTION; QUESTIONNAIRES; RESEARCH DESIGN; THERAPEUTIC EQUIPOISE; UNITED STATES;

EID: 80054812741     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511419683     Document Type: Review

References (17)

1. 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: 1728-33 (Pubitemid 32230874)
2. Prescott RJ, Counsell CE, Gillespie WJ, et al. Factors that limit the quality, number and progress of randomized controlled trials. Health Technol Assess. 1999 ; 3: 1-143
3. Grunfeld E, Zitzelsberger L, Coristine M, Aspelund F. Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer. 2002 ; 95: 1577-83
4. Ross S, Grant A, Counsell C, et al. Barriers to participation in randomized controlled trials: a systematic review. J Clin Epidemiol. 1999 ; 52: 1143-56 (Pubitemid 29535414)
5. Ellis PM. Attitudes towards and participation in randomized clinical trials in oncology: a review of the literature. Ann Oncol. 2000 ; 11: 939-45
6. Mapstone J, Elbourne D, Roberts IG. Strategies to improve recruitment to research studies. Cochrane Database Syst Rev. 2007 ; 18: MR000013 - MR000013
7. Mills EJ, Seely D, Rachlis R, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 2006 ; 7: 141-48 (Pubitemid 43159500)
8. Dilts DM, Sandler AB, Baker M, et al. Processes to activate phase III clinical trials in a cooperative oncology group: the case of Cancer and Leukemia Group B. J Clin Oncol. 2006 ; 24: 4553-57 (Pubitemid 46630950)
9. Schroen AT, Petroni GR, Wang H, et al. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials. Clin Trials. 2010 ; 7: 312-21
10. Dillman DA Mail and Internet Surveys: The Tailored Design Method. 2 nd. Wiley & Sons, New York, 2000. New York: Wiley & Sons ; 2000 :
11. Freedman B. Equipoise and the ethics of clinical research. NEJM. 1987 ; 317: 141-45 (Pubitemid 17092151)
12. Mann H, Djulbegovic B. Choosing a control intervention for a randomized clinical trial. BMC Med Res Methodol. 2003 ; 3: 7-12
13. Taylor KM, Feldstein ML, Skeel RT, et al. Fundamental dilemmas of the randomized clinical trial process: resultsof a survey of the 1,737 Eastern Cooperative Oncology Group investigators. J Clin Oncol. 1994 ; 12: 1796-1805 (Pubitemid 24349380)
14. 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: 5557-63
15. Clinical Trials Working Group of the National Cancer Advisory Board. Restructuring the National Cancer Clinical Trials Enterprise. June 2005. Available athttp://integratedtrials.nci.nih.gov/ict/CTWG-report-June2005.pdf. Accessed on August 26, 2009.
16. Demmy TL, Yasko JM, Collyar DE, et al. Managing accrual in cooperative group trials. J Clin Oncol. 2005 ; 22: 2997-3002
17. Asch DA, Jedrziewski MK, Christakis NA. Response rates to mail surveys published in medical journals. J Clin Epidemiol. 1997 ; 50: 1129-36 (Pubitemid 27477990)