How useful are unpublished data from the Food and Drug Administration in meta-analysis?

MacLean, Catherine H; Morton, Sally C; Ofman, Joshua J; Roth, Elizabeth A; Shekelle, Paul G; for the Southern California Evidence-Based Practice Center,

« Previous Next »Journal of Clinical Epidemiology
Volume 56, Issue 1 , Pages 44-51, January 2003

How useful are unpublished data from the Food and Drug Administration in meta-analysis?☆

Catherine H MacLean
- Corresponding author. Tel.: 310-393-0411; fax: 310-451-6917. E-mail address:
- RAND, 1700 Main Street, M-23C, Santa Monica, CA 90407-2138, USA
- Department of Medicine, Division of Rheumatology, UCLA School of Medicine, 1000 Veteran Ave., Room 32–48, Los Angeles, CA, USA
Sally C Morton
- RAND, 1700 Main Street, M-23C, Santa Monica, CA 90407-2138, USA
Joshua J Ofman
- Departments of Medicine and Health Services Research, Division of Gastroenterology, Cedars-Sinai Health System, Beverly Blvd., Los Angeles, CA, USA
- Zynx Health Inc, 9100 Wilshire Blvd., East Tower, Suite 655, Los Angeles, CA, USA
Elizabeth A Roth
- RAND, 1700 Main Street, M-23C, Santa Monica, CA 90407-2138, USA
Paul G Shekelle
- RAND, 1700 Main Street, M-23C, Santa Monica, CA 90407-2138, USA
- Department of Medicine, West Los Angeles VAMC, 11301 Wilshire Blvd., #111G, Los Angeles, CA, USA
- Dr. Shekelle is a Senior Research Associate of the Veterans Affairs Health Services Research and Development.
for the Southern California Evidence-Based Practice Center

Received 15 April 2002; received in revised form 14 June 2002; accepted 23 August 2002.

Abstract

The goals of this systematic review and meta-analysis were to ascertain whether studies of nonsteroidal anti-inflammatory drugs (NSAIDs) summarized in the FDA reviews are ultimately published, to compare the methodologic and population characteristics of studies summarized in the FDA reviews with those reported in peer reviewed literature, and to compare the pooled relative risk of dyspepsia from NSAIDs in each data source. Summary measures of risk difference were calculated with a random effects model; meta-regression was used to assess the effect of study covariates. Among 37 studies described in the FDA reviews, one was published. Sample size, gender distribution, indication for drug use, and methodologic quality did not vary significantly between the published and FDA data. The pooled risk ratio for dyspepsia obtained using published data (1.21) or FDA data (1.07) did not differ significantly or practically. Data from FDA reviews may be a viable data source for systematic reviews and meta-analyses but only after being subjected to the same methodologic scrutiny as published data.

Keywords: Unpublished data, Systematic review, Meta-analysis, Non-steroidal anti-inflammatory drugs, Dyspepsia, Gastrointestinal toxicity