The ARCAD clinical trials program: An update and invitation

Oncologist

Volumn 17, Issue 2, 2012, Pages 188-191

  Sargent, Daniel J ^a   Buyse, Marc ^b   Matheson, Alastair ^c   Goldberg, Richard M ^d   de Gramont, Aimery ^e  

^a MAYO CLINIC   (United States)

^b INTERNATIONAL DRUG DEVELOPMENT INSTITUTE   (Belgium)

^c Fondation ARCAD   (France)

^d OHIO STATE UNIVERSITY   (United States)

^e HÔPITAL SAINT ANTOINE   (France)

Author keywords

Clinical trials; Data interpretation; Database; Drugs; Gastrointestinal neoplasms; Investigational; Statistical

Indexed keywords

BIOLOGICAL MARKER;

ARCAD CLINICAL TRIALS PROGRAM; ARTICLE; CLINICAL STUDY; COLORECTAL CANCER; DATA BASE; DIGESTIVE SYSTEM CANCER; HUMAN; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PANCREAS CANCER; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; STUDY DESIGN;

CLINICAL TRIALS AS TOPIC; COLORECTAL NEOPLASMS; COOPERATIVE BEHAVIOR; DISEASE-FREE SURVIVAL; HUMANS;

EID: 84857407870     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2011-0332     Document Type: Article

References (16)

1. United States Food and Drug Administration. Critical Path Initiative. Available at http://www. fda.gov/ScienceResearch/SpecialTopics/Critical PathInitiative/default.htm. Accessed August 22, 2011.
2. Office of the Chief Scientist. U.S. Food and Drug Administration. Advancing Regulatory Science for Public Health: A Framework for FDA's Regulatory Science Initiative. October 2010. Available at http://www.fda.gov/ScienceResearch/ SpecialTopics/RegulatoryScience/ucm228131.htm. Accessed August 22, 2011.
3. United States National Institutes of Health. The NIH Common Fund. Regulatory Science. Available at http://commonfund.nih.gov/regulatoryscience. Accessed August 22, 2011.
4. American Society for Clinical Oncology. Research Activities. Available at http://www.asco.org/ ASCOv2/Research+Resources/Research+Activities. Accessed December 12, 2011.
5. The Biomarkers Consortium. Available at http:// biomarkersconsortium.org. Accessed August 22, 2011.
6. Fondation ARCAD (Aide et Recherche en Cance ́rologie Digestive). Available at http:// www.fondationarcad.org. Accessed August 22, 2011.
7. de Gramont A, Haller DG, Sargent DJ et al. Toward efficient trials in colorectal cancer: The ARCAD Clinical Trials Program. J Clin Oncol 2010;28:527-530.
8. Buyse M, Sargent DJ, Grothey A et al. Biomarkers and surrogate end points-The challenge of statistical validation. Nat Rev Clin Oncol 2010;7: 309-317.
9. Buyse M, Michiels S, Sargent DJ et al. Integrating biomarkers in clinical trials. Expert Rev Mol Diagn 2011;11:171-182.
10. Chibaudel B, Bonnetain F, Shi Q et al. Alternative end points to evaluate a therapeutic strategy in advanced colorectal cancer: evaluation of progression-free survival, duration of disease control, and time to failure of strategy-An Aide et Recherche en Cancerologie Digestive Group Study. J Clin Oncol 2011;29:4199-4204.
11. Paoletti X, Oba K, Burzykowski T et al.; GASTRIC Group. Benefit of adjuvant chemotherapy for resectable gastric cancer: A meta-analysis. JAMA 2010;303:1729-1737.
12. Sargent DJ, Patiyil S, Yothers G et al.; ACCENT Group. End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group. J Clin Oncol 2007;25:4569-4574.
13. Buyse M. Contributions of meta-analyses based on individual patient data to therapeutic progress in colorectal cancer. Int J Clin Oncol 2009; 14:95-101.
14. Buyse M. Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials. Cancer J 2009;15:421-425.
15. Gill S, Sargent DJ. Individual data pooled analyses to improve understanding of adjuvant therapy in colon cancer: review of the ACCENT collaborative group. Curr Colorectal Cancer Rep 2008;4:155-159.
16. Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247.