The Wellcome Trust, the Bill and Melinda Gates Foundation and the African Academy of Sciences want to reshape international guidance for clinical trials of treatments that are not aimed at registering a new drug.
The three organisations announced on 14 February that they have established the Joint Initiative on Good Practice in Clinical Research to develop new clinical practice guidelines for trials of health interventions that are not seeking a drug licence and therefore do not fit within the current guidelines for clinical trials.
The existing Guideline for Good Clinical Practice—published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)—was developed in 1996 by international regulatory councils and the pharmaceutical industry. In 2016 it was updated, but only with further guidance on new trial methodologies.
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