Pooling in integrated safety databases

Drug Information Journal

Volumn 34, Issue 2, 2000, Pages 495-499

  Mcentegart, Damian J ^a  

^a BASF Pharma   (United Kingdom)

Author keywords

Integrated safety summary; Meta analysis; Pooling

Indexed keywords

ARTICLE; DATA ANALYSIS; DATA BASE; DRUG APPROVAL; DRUG SAFETY; INFORMATION PROCESSING; META ANALYSIS; PRIORITY JOURNAL;

EID: 0034080455     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400218     Document Type: Article

References (19)

1. ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. Stat Med. 1999;18: 1905-1942.
2. Temple RJ. The regulatory evolution of the integrated safety summary. Drug Inf J. 1991;25:485-492.
3. FDA. Guideline for the format and content of the clinical and statistical sections of an application. Rockville, MD: US Food and Drug Administration; May 1988.
4. CDER draft reviewer guidance. Conducting a clinical safety review of a new product application and preparing a report on the review. Rockville, MD: US Food and Drug Administration, CDER; November 1996.
5. Chuang-Stein C. Safety analysis: Too much? Not enough? And How? ASA Biopharmaceutical Report. 1992;1(3):1-11.
6. Chuang-Stein C. Points for consideration in the collection and analysis of safety data. Drug Inf J. 1995; 29:37-44.
7. Short N. The development of an integrated safety database for a multi-market, over-the-counter medicine. Assoc Clin Data Manage Newsletter. 1999;30: 12-13.
8. Garvey TQ. Can there really be an integrated safety summary? Drug Inf J. 1991;25:501-511.
9. Enas GG, Goldstein DJ. Defining, monitoring and combining safety information in clinical trials. Stat Med. 1995;14:1099-1111.
10. Koch GG, Schmid JE, Begun JM, Maier WC. Meta-analysis of drug safety data. In: Sogliero-Gilbert G, ed. Drug Safety Assessment in Clinical Trials. New York: Marcel Dekker; 1993.
11. Landsman P, Alemayehu D. Meta-analysis of adverse drug events: examples with real data. ASA Proceedings of Biopharmaceutical Section. 1996: 252-256.
12. Von Frenckell R, Copp J, Essers H, Theeuwes A. Format/content of overviews (integrated efficacy and safety report). Drug Inf J. 1995;29:503-505.
13. Webster A. The ISS - integrated safety summary or inherent statistical shortcomings? PSI Annual Conference Report. 1996: 38-39.
14. Anello C, O'Neill RT. Does research synthesis have a place in drug regulatory policy? Synopsis of issues: assessment of safety and postmarketing surveillance. Clin Res Reg Aff. 1996;13:13-21.
15. Wardrop RL. Simpson's paradox and the hot hand in basketball. Am Statistician. 1995:49;24-28.
16. Huster WJ. Clinical trial adverse events: the case for descriptive techniques. Drug Inf J. 1991;25: 447-456.
17. Lineberry C. Approaches to describing common adverse events in the integrated safety summary. Drug Inf J. 1991;25:493-500.
18. Boissel JP, Blanchard J, Panak E, Peyrieux JC, Sacks H. Considerations for the meta-analysis of randomized clinical trials. Control Clin Trials. 1989;10: 254-281.
19. Chuang-Stein C. An application of the beta-binomial model to combine and monitor medical event rates in clinical trials. Drug Inf J. 1993;27:515-523.