15/11/04

Standards of care in research ‘need local context’

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Standards of care — the treatment received by participants in medical research — have been a source of controversy in some clinical trials. Tests of a drug known to prevent mother-to-child transmission of HIV in Africa, for instance, meant a control population received nothing. This was viewed by many as an inadequate standard of care, and unethical.


In this editorial in the British Medical Journal, Zulfiqar Bhutta, a professor of paediatrics and child health at the Aga Khan University in Karachi, Pakistan, argues that in such research, standards of care need to reflect the state of the test country’s own healthcare system — not the “best current” methods as suggested by updated international guidelines.


Aspiring to best standards of care may be irrelevant, unsustainable and even unethical in developing countries, and low-cost feasible alternatives many be more appropriate than “gold standards”. The best way forward, says Bhutta, is to adopt a flexible, pragmatic approach in research that allows existing guidelines to be interpreted in the context of local standards of care. Better yet, he suggests, international guidelines could adopt this approach.

Link to full article in British Medical Journal