Raffaella is Head of the Clinical Trials Unit at the Institute of Tropical Medicine Antwerp and the University of Leuven (KU Leuven). She points out the many problems with the international GCP guidelines (both the WHO and ICH), which were issued 20 years ago, when trials were mainly conducted in Western contexts by commercial sponsors. She contrasts the polar opposites of the original ICH-GCP guideline, to harmonise the conduct of trials conducted by industry to support the registration of new drugs and which was created at a time when almost all trials were taking place in developed countries, with the work of her own unit, which undertakes non-commercial collaborative trials in low-income countries. An example of this would be her unit’s work supporting a recently published Ebola study in Guinea.
What Ravinetto finds surprising is the recent failure of ICH in its proposed update to ICH-GCP to take account take of the many different types of trials conducted in vastly different settings, and related challenges. This means that the ICH-GCP fails to give adequate guidance for the conduct in low-income settings of randomised trials of public health importance to develop and evaluate effective treatments for diseases, such as malaria, Ebola, TB and leishmaniasis.
Ravinetto sums it like this, “The 1996 failure of ICH to give adequate consideration for the challenges of non-commercial research in low and middle income countries might have been argued to be acceptable, but in 2016 the features and needs of globalised clinical research cannot be ignored anymore”.
The full work can be read here.