Conducting Phase IV clinical studies: A moral imperative?

ecancermedicalscience

Volumn 6, Issue 1, 2012, Pages

  Hill, T P ^a,b  

^a RUTGERS UNIVERSITY   (United States)

^b ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG SAFETY; ETHICS; EXTERNAL VALIDITY; INTERNAL VALIDITY; MARKETING; PATIENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHASE 4 CLINICAL TRIAL (TOPIC); REVIEW; RISK ASSESSMENT;

EID: 84869428542     PISSN: None     EISSN: 17546605     Source Type: Journal    
DOI: 10.3332/ecancer.2012.276     Document Type: Review

References (18)

1. Wells KB (1999) Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research Am J Psychiatry 156 5-10 PMID: 9892291
2. Suvan V (2010) Perspect phase IV of drug development Clin Res 1(2) 57-60. Accessed on September 27, 2012 from www.ncbi.nim.nih.gov
3. Vlahakes GJ (2006) The value of phase iv clinical testing N Engl J Med 354(4). www.nejm.org DOI: 10.1056/NEJMe058272 PMID: 16436775
4. Accessed on August 6, 2012 from www.who.int/iclrp/glossary/en/index.html
5. Accessed on August 6, 2012 from En.wikipedia.org/wiki/Clinical-trial
6. Fritz JM and Cleland JA (2003) Effectiveness versus efficacy: more than a debate over language J Orthop Sports Phys Ther 33(4) 163-165 PMID: 12723672 (Pubitemid 36871437)
7. Van Thiel GJMW and Van Delden JJM (2008) Phase IV research: innovation in need of ethics J Med Ethics 34 415-6 DOI: 10.1136/jme.2007.023911 PMID: 18511610
8. Rizzo M The ethics of phase IV clinical trials www.aan.com/global/axon/ assets/6110.pdf
9. Hill TP (2000) Research and practice: ethics at a muddled middle N J Med 97 39-42 PMID: 10917012 10.
10. Trochim WM (2006) The research methods knowledge base, 2nd edn. http://www.socialresearchmethods.net/kb/quasiexp.php
11. Rajan S (2011) Phase IV studies: a market with a proactive approach for growth of a pharmaceutical firm. Accessed on August 6, 2012 from http://www.biotecharticles.com/
12. Phase IV Trials Conducted Within Clinical Development Often Face Stiff Internal Competition (2011) Accessed on August 6, 2012 from www.cuttingedgeinfo. com/2011/phase-4trials-internal-competition
13. Phase IV Clinical Trial Management Structure Can Overcome Organizational Bias (2011) Accessed on August 6, 2012 from www.cuttingedgeinfo.com/phase-iv- clinical-trials
14. Clinical Trial Costs Are Rising Rapidly//Pharmalot (2011) Accessed on August 6, 2012 from www.pharmalot.com
15. Clinical Continuity: The Commercial Role of Phase IV Studies (2011) Accessed on August 6, 2012 from www.pharmaphorum.com/ September 9
16. Phase IV Clinical Trial Teams Identify Top Challenges for Post-Marketing Studies (2011) http://marketwire.com/press-release/phaseiv- clinical-trial-team
17. Strategies for More Effective Payer Interfaces (2009) www.social.eyeforpharma.com/.../strategies-more-effective-payer-interface
18. Contractarianism (Stanford Encyclopedia of Philosophy) (2007) Accessed on August 7, 2012 from http://plato.stanford.edu/entries/contractarianism/April 4