Healthy Skepticism Library item: 4444

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Waller PC, Wood SM, Langman MJ, Breckenridge AM, Rawlins MD.
Review of company postmarketing surveillance studies.
BMJ 1992 Jun 6; 304:(6840):1470-2

Abstract:

OBJECTIVES—To review postmarketing surveillance studies sponsored by the pharmaceutical industry since the introduction of voluntary guidelines in 1987 and to evaluate their contribution to monitoring drug safety. DESIGN—Retrospective analysis of the information submitted to the Medicines Control Agency on postmarketing surveillance studies. SETTING—United Kingdom. MAIN OUTCOME MEASURES—Study designs, projected and actual sample sizes, provision of interim and final reports, number of suspected serious adverse reactions reported, identification of new drug safety hazards. RESULTS—31 studies had been conducted under the guidelines, of which 27 were prospective and four retrospective. Nine studies had at least one comparator group, the remainder were uncontrolled. The median projected sample size for the studies was 5600 patients. Only five studies had achieved at least 75% of the projected sample size. 11 studies had been abandoned, predominantly because of difficulties in recruitment, and 15 were ongoing. One study had identified an important new safety hazard. CONCLUSIONS—Company postmarketing surveillance studies have made only a limited contribution to the assessment of drug safety, principally because of weak study designs and difficulties in recruitment. The guidelines require modification to take this experience into account.

Keywords:
Drug Industry Drug Therapy/adverse effects* Great Britain Humans Product Surveillance, Postmarketing/methods* Prospective Studies Research Design Retrospective Studies *analytic survey/United Kingdom/drug company sponsored research/postmarketing research/safety & risk information/EVALUATION OF PROMOTION: DRUG SAFETY/PROMOTION DISGUISED: POSTMARKETING RESEARCH/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/SPONSORSHIP: RESEARCH