Why Clinical Trials Fail before They Get even Started: The 'Frontloading' Process

Quality Assurance Journal

Volumn 8, Issue 1, 2004, Pages 21-32

  Beck, Jürgen ^a   Esser, Peter J ^b   Herschel, Michael B ^c  

^a Monitoring Force GmBH   (Germany)

^b Repr of German Industry and Trade   (United States)

^c GLAXOSMITHKLINE   (Germany)

Author keywords

Clinical trial failure; Feasibility; Frontloading process; Legal aspects

Indexed keywords

BEHAVIOR; CLINICAL TRIAL; DECISION MAKING; FEASIBILITY STUDY; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; STANDARDIZATION; TEAMWORK; TRAINING;

EID: 1442314347     PISSN: 10878378     EISSN: None     Source Type: Journal    
DOI: 10.1002/qaj.261     Document Type: Review

References (11)

1. Holt P. The art of the practical? It's in purpose and processes. GCPj 2003; 10(6): 3-4.
2. ICH Guideline for Good Clinical Practice (E6). http://www.ich.org.
3. Warlow C. How to do it. Organise a multicentre trial. Br Med J 1990; 300(6718): 180-183.
4. Farrell B. Efficient management of randomised controlled trials; nature or nurture. Br Med J 1998; 317: 1236-1239.
5. 21 Code of Federal Regulations. http://www.fda.gov.
6. Declaration of Helsinki. http://www.wma.net/e/ethicsunit/helsinki.htm.
7. Directive 2001/20/EC on the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. http://europa.eu.int/eur-lex/pri/en/oj/dat/2001/1_121/1_12120010501en00340044. pdf.
8. Foubister V. Lawsuits over clinical trials have doctors wary, but not quitting research yet. American Medical News, 2001; April.
9. Health Insurance Portability and Accountability Act (HIPAA). http://www.hipaa.org.
10. An 'official guidance' document issued by the U.S. Food and Drug Administration on Patent Term Restoration. http://www. fda.gov/cder/about/smallbiz/patent_term.htm.
11. Goldratt E. Das Ziel. Campus, 2002.