Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

COMMUNITY PERSPECTIVES ON EXPANDED ACCESS TO DRUGS

Edward King
NAM Publications, 16a Clapham Common Southside, London SW4 7A8 Tel: 0171-627 3200 Fax: 0171-627 3101 E-mail: eking@nam.org.uk WWW: http://www.nam.org.uk/nom/

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. 3.3
AIDS 1996, Vol. 10 (Suppl. 2);S2

The development of potent new anti-retroviral therapies has resulted in rapid changes in perceptions of the standard of care in HIV therapy.

In the USA and on a pan-European level, steps have been taken to expedite the formal licensing of new drugs. Nevertheless, there remains demand among clinicians and people with HIV for access to experimental drugs outside clinical trials while Phase II/III studies are underway, and during the period between the successful conclusion of studies and licensing.

Some researchers have expressed concern that early access to experimental treatments will hamper recruitment to controlled studies, although community advocates counter that expanded access schemes are designed for people who are genuinely unable to participate in trials, or who are excluded by the protocol, or whose medical situation justifies immediate intervention.

Debate continues over several issues:

• How much evidence of safety and efficacy is required before a drug should be made available through expanded access?

• Should pharmaceutical companies be required to institute expanded access arrangements once an application for drug approval has been submitted to the regulators?

• Should expanded access schemes have inclusion and exclusion criteria, or should enrollment be left at the physician's discretion?

• What safety and/or efficacy data con and should be collected?

• Which patients should be prioritised when expanded access supplies of drug are limited – extensively pre-treated people in pressing need of new therapies, or those with less advanced disease or less prior treatment who may better tolerate and respond to the drug?

Presenting author: Edward King

1996-11-03
3.3

Originally published in AIDS Volume 10, Supplement 2 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701

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