The revision of the ICH Good Clinical Practice guidelines: a missed opportunity?

Raffaella Ravinetto

DOI: 10.20529/IJME.2017.057


The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries. A recent process of revision of the ICH GCP, which focused mainly on improving the use of technology and quality systems in clinical trials, did not remedy the pre-existing divide between the guideline, ethics and the challenges of globalised clinical research. It is not clear whether another, newly announced “renovation” of the ICHGCP (a “reflection paper” was open for public comment until March 11, 2017) will succeed in addressing this divide.

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