Sixth International Congress

Drug Therapy in HIV Infection


17-21 November, 2002
Glasgow, UK

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Feedback from Forum for Collaborative HIV Research (FCHR) Workshop on long-term toxicity monitoring

Alec Walker1
Int Cong Drug Therapy HIV 2002 Nov 17-21;6:Abstract No. PL13.3

[ABSTRACT:] Experts in drug safety monitoring from the academic, government, and industry sectors held a workshop with research clinicians specializing in HIV in April of this year to review the relevance of ‘standard’ monitoring procedures for long-term drug safety to HIV. Clinical trials may not be generally useful for detecting late and infrequent adverse effects of therapy. The observations of clinicians and patients have long been key to the discovery of drug adverse effects in other fields, and have been systematized in databases maintained by regulators in all countries, with by far the greatest numbers coming from Europe and North America. Formal pattern recognition algorithms are being developed for these, but the most important insights still come from informed reading of well-described events. Large automated medical databases now exist, some as computerized medical records, others as administrative files, and can provide extended follow-up on substantial numbers of patients, but the limitations of data content limit their applicability to quantifying entities that have already been well described. Ad hoc prospective observational cohorts provide a potent tool for both quantification and ongoing discovery. The future of long-term safety monitoring in HIV rests on the judicious use of each of these resources, balancing opportunity, cost, and time.

Presenting author: Alec Walker

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1 Ingenix Epidemiology, Newton, and Harvard School of Public Health, Boston, MA, USA

2002-11-17
PL13-3

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