Project zero delay: A process for accelerating the activation of cancer clinical trials

Journal of Clinical Oncology

Volumn 27, Issue 26, 2009, Pages 4433-4440

  Kurzrock, Razelle ^a   Pilat, Susan ^a   Bartolazzi, Marcel ^a   Sanders, Dwana ^a   Van Wart Hood, Jill ^a   Tucker, Stanley D ^a   Webster, Kevin ^a   Mallamaci, Michael A ^a   Strand, Steven ^a   Babcock, Eileen ^a   Bast Jr , Robert C ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BUDGET; CANCER CENTER; CANCER PATIENT; CLINICAL PRACTICE; CLINICAL PROTOCOL; CLINICAL RESEARCH; CLINICAL TRIAL; DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE MANAGEMENT; HEALTH CARE ORGANIZATION; HEALTH CARE QUALITY; HUMAN; INTERPERSONAL COMMUNICATION; NEOPLASM; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY OF LIFE; UNITED STATES; LEGAL ASPECT; MEDICAL RESEARCH; METHODOLOGY; PHASE 1 CLINICAL TRIAL; TIME;

NEW DRUG;

BIOMEDICAL RESEARCH; CLINICAL TRIALS, PHASE I AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; HUMANS; NEOPLASMS; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70349348941     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.21.6093     Document Type: Article

References (11)

1. Jemal A, Siegel R, Ward E, et al: Cancer Statistics, 2008. CA Cancer J Clin 58:71-96, 2008
2. Cancer Res UK: Cancer worldwide: The global picture. http://info. cancerresearchuk.org/cancer stats/geograhic/world/incidence/
3. Goldberg KB: Cancer trials take 800 days to start on average: NCI vows improvement. Cancer Letter 34:1, 2008
4. Dilts DM, Sandler AB: Invisible barriers to clinical trials: The impact of structural, infrastructural and procedural barriers to opening oncology clinical trials. J Clin Oncol 24:4545-4552, 2006
5. Camacho L, Marubio L, Purdom MA, et al: Improving the institutional submission and approval process for clinical research protocols in oncology. J Clin Oncol 25:1632-1633, 2007
6. Congress of the United States: Research and development in the pharmaceutical industry: A Congress Budget Office Report. October 2006. http://www.cbo .gov/ftdocs/76xx/doc7615/10-02-DrugR-D.pdf
7. DiMasi JA, Hansen RW, Grabowski HG: The price of innovation: New estimates of drug development costs. J Health Economics 222:151-185, 2003
8. Food and Drug Administration: Innovation or stagnation; Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/ oc/initiatives/criticalpath/whitepaper.html
9. Kola I, Landis J: Can the pharmaceutical industry reduce attrition rates? Nature Rev Discovery 3:711-715, 2004
10. 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. J Clin Oncol 24:4553-4557, 2006
11. Dilts DM, Sandler A, Cheng S, et al: Development of clinical trials in a cooperative group setting: The Eastern Cooperative Oncology Group. Clin Cancer Res 14:3427-3433, 2008