A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions

Drug Information Journal

Volumn 46, Issue 4, 2012, Pages 455-463

  Desai, Pankaj B ^a   Anderson, Christopher ^a,b   Sietsema, William K ^a,b  

^a UNIVERSITY OF CINCINNATI   (United States)

^b SYNEOS HEALTH   (United States)

Author keywords

CRF pages; data quality; database changes; global clinical trials; query rates

Indexed keywords

ARTICLE; ASSOCIATION OF CLINICAL RESEARCH ORGANIZATION; CASE REPORT FORM; DATA ANALYSIS; DATA BASE; DATA BASE CHANGE; DEVELOPED COUNTRY; DEVELOPING COUNTRY; METHODOLOGY; NONPARAMETRIC TEST; NORTH AMERICA; ORGANIZATION; PARAMETRIC TEST; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUALITY CONTROL; QUERY RATE; STATISTICAL PARAMETERS; WESTERN EUROPE;

EID: 84873830553     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/0092861512446807     Document Type: Article

References (17)

1. Munos B.Lessons from 60 years of pharmaceutical innovation.Nat Rev Drug Discov. 2009;8:959-968.
2. Goodman M.Pharmaceutical financial performance.Drug Discov Rev. 2009;8:927-928.
3. DiMasi JA,Hansen RW,Grabowski HG.The price of innovation: new estimates of drug development costs.J Health Econ. 2003;22:151-185.
4. DiMasi JA,Grabowski HG.The cost of biopharmaceutical R&D.Manage Decis Econ. 2007;28:469-479.
5. Morgan S,Grootendorst P,Lexchin J,Cunningham C,Greyson D.The cost of drug development: a systematic review.Health Policy. 2011;100:4-17.
6. DiMasi JA,Feldman L,Seckler A,Wilson A.Trends in risks associated with new drug development: success rates for investigational drugs.Clin Pharmacol Ther. 2010;87:272-277.
7. Kaitin KI,DiMasi JA.Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.Clin Pharmacol Ther. 2011;89:183-188.
8. Elias T,Gordian M,Singh N,Zemmel R.Why products fail in phase III.In Vivo. 2006;24:49-54.
9. Honig P,Lalonde R.The economics of drug development: a grim reality and a role for clinical pharmacology.Clin Pharmacol Ther. 2010;87:247-251.
10. Orloff JJ,Stanski D.Innovative approaches to clinical development and trial design.Ann Ist Super Sanita. 2011;47:8-13.
11. Thiers FA,Sinskey AJ,Berndt ER.Trends in the globalization of clinical trials.Nat Rev Drug Discov. 2008;7:13-14.
12. Glickman SW,McHutchison JG,Peterson ED, et al.Ethical and scientific implications of the globalization of clinical research.N Engl J Med. 2009;360:816-823.
13. Malakoff D.Clinical trials and tribulations: spiraling costs threaten gridlock.Science. 2008;322:210-213.
14. Ibia E,Binkowitz B,Saillot JL, et al.Ethical considerations in industry-sponsored multiregional clinical trials.Pharm Stat. 2010;9:230-241.
15. Stough WG,Zannad F,Pitt B,Goldstein S.Globalization of cardiovascular clinical research: the balance between meeting medical needs and maintaining scientific standards.Am Heart J. 2007;154:232-238.
16. Altavilla A.Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency.Eur J Health Law. 2011;18:65-75.
17. Valania M.Quality control and assurance in clinical research.Appl Clin Trials. 2006;15:72-78.