Tracking adverse events in RCTs: Lack of agreement among regulatory institutions

Quality and Safety in Health Care

Volumn 12, Issue 3, 2003, Pages 234-235

  Santiago, L M ^a   Debanne, S M ^a   Neuhauser, D ^a  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM CHANNEL BLOCKING AGENT;

BIOSAFETY; CALCULATION; CLINICAL TRIAL; DRUG USE; FOOD AND DRUG ADMINISTRATION; GENERAL PRACTITIONER; HEALTH CARE; HEALTH PROGRAM; HUMAN; HYPERTENSION; INSTITUTIONAL CARE; LETTER; MEDICAL PRACTICE; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PREDICTION; PROSPECTIVE STUDY; RANDOMIZATION; SIDE EFFECT; UNITED STATES; WORLD HEALTH ORGANIZATION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; GOVERNMENT AGENCIES; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); RANDOMIZED CONTROLLED TRIALS; UNITED STATES;

EID: 0037974570     PISSN: 09638172     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Letter

References (4)

1. Deyo RA. Bruce Psaty and the risks of calcium channel blockers. Qual Saf Health Care 2002;11:294-6.
2. World Health Organisation. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva: World Health Organisation, 1995: Annex 3.
3. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276:637-9.
4. Tramer MR, et al. Quantitative estimation of rare adverse events which follow a biological progression: a new model applied to chronic NSAID use. Pain 2000;85:169-82.