Drug development study designs have reached the danger zone

Expert Review of Clinical Pharmacology

Volumn 6, Issue 6, 2013, Pages 589-591

  Getz, Kenneth ^a   Campo, Rafael ^b  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Medidata Solutions Worldwide   (United States)

Author keywords

clinical study designs; clinical trial protocols; drug development objectives; protocol; protocol design; protocol end points; study design

Indexed keywords

CLINICAL RESEARCH; COMPARATIVE EFFECTIVENESS; DRUG DEVELOPMENT; DRUG SAFETY; FOLLOW UP; HUMAN; META ANALYSIS (TOPIC); PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; STUDY DESIGN;

CLINICAL PROTOCOLS; DATA COLLECTION; DRUG APPROVAL; MEDICAL ERRORS; RESEARCH DESIGN; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84887283998     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2013.841539     Document Type: Review

References (15)

1. Koreith K, Anderson A. Sites rate the best sponsors of 2013. The CenterWath Monthly. 20(3), 9-13 (2013).
2. Getz K, Campo R, Kaitin K. Variability in protocol design complexity by phase and therapeutic area. Drug Inf. J. 45, 413-420 (2011).
3. Friedman L, Furberg C, DeMets D. Data Collection and Quality Control in the Fundamentals of Clinical Trials. Springer Science and Business Media, New York, NY, USA, chapter 11, 199-214 (2010).
4. Nahm ML, Pieper CF, Cunningham MM. Quantifying data quality for clinical trials using electronic data capture. PLoS ONE 3(8), e3049 (2008).
5. Barrett J. What's Behind Clinical Trial Data. Appl. Clin. Trials 18(1), 22 (2009).
6. Abrams J, Erwin R, Fyfe G, Schilsky L, Temple R. Data submission standards and evidence requirements. Presented at: The Conference on Clinical Cancer Research, Panel 1. Engelberg Center for Health Care Reform, Washington, DC, 14 September 2009.
7. Clark T. Data is King. International Clinical Trials. Samedan LTD Pharmaceutical Publishers (Spring 2012), London, UK, 173, 32-42 (2012).
8. DiMasi JA, Grabowski HG. R&D Costs and returns to new drug development: a review of the evidence. In: The Oxford Handbook of The Economics of the Biopharmaceutical Industry. Danzon PM, Nicholson S (Eds). Oxford University Press, Oxford, UK, chapter 2, 21-46 (2012).
9. Getz K, Stergiopoulos S, Marlborough M, Whitehall J, Curran, M, Kaitin K. Quantifying the Magnitude and Cost of Collecting Extraneous Protocol Data. Am. J. Ther. doi:10.1097/MJT.0b013e31826 fc4aa (2013) (Epub ahead of print): http://dx.doi.org/10.1097/MJT.0b013e318 26fc4aa (Accessed 28 June 2013).
10. Getz K, Zuckerman R, Cropp A, Hindle A, Krauss R, Kaitin K. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Inf. J. 45, 265-275 (2011).
11. Getz K, Wenger J, Campo R, Seguine E, Kaitin K. Assessing the impact of protocol design change on clinical trial performance. Am. J. Ther. 15, 449-456 (2008).
12. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomized controlled trials - a systematic review. J. Clin. Epidemiol. 52(12), 1143-1156 (1999).
13. Madsen S, Holm S, Riis P. Ethical aspects of clinical trials. Attitudes of public and out-patients. J. Intern. Med. 245(6), 571-579 (1999).
14. Andersen J, Fass R, van der Horst C. Factors associated with early study discontinuation in AACTG studies, DACS 200. Contemp. Clin. Trials 28, 583-592 (2007).
15. Getz K, Wenger J, Campo R, Seguine E, Kaitin K. Assessing the impact of protocol design change on clinical trial performance. Am. J. Ther. 15, 449-456 (2008).