To look at the ethical and good clinical practice (GCP) aspects of clinical trials the European Medicines Agency (EMA) held a workshop for global stakeholders and has published an overview of their comments. Topics discussed included the punishment for non-compliance.
“Serious non-compliance with ethical guidelines should have serious consequences. This should be made clear and a range of regulatory options established to enable proportionate action to be taken”, says the EMA report detailing comments made by workshop participants.
Refusal to consider data from trials when there are serious concerns about the design or conduct of the study is one option. The report describes rejection of a trial as “a very serious step” that should only be taken after considering the violations and the consequence of taking action.
Knock on effects of rejecting a trial include the possible need to rerun the study. More subjects are then exposed to risks inherent in clinical trials and research progress is delayed. However, when ethical standards have been seriously violated these actions may be deemed necessary.
Assessments of applications must be supported by previously conducted good clinical practice (GCP) inspections. By increasing the number of inspections of clinical trials performed outside the EU the EMA will have the information needed to verify the ethical aspects of drug applications.
GCP cooperation
Globalisation of clinical trials means individual regulatory agencies lack the resources to assess ethical and scientific practices at all study sites. In response international regulatory cooperation is intensifying but greater coordination is needed.
“There are existing areas of cooperation between some regulatory authorities, but that these have limitations such as the absence of formal process or agreement for sharing of information, limited resources, or purely local regional effect”, said the EMA.
Existing initiatives should be encouraged and linked to each other to reduce duplication of effort. Workshop participants suggested the EMA take a leading role in coordinating international efforts.
Coordinated cooperation initiatives, such as performing joint reviews and inspections, also create a platform for building the capacity and capabilities of local regulators. The EMA said such cooperation and capacity building was “a key element of the workshop”.
Next steps
Based on discussions held at the workshop the EMA is now revising its draft reflection paper and plans to publish the new version this year. The EMA’s conclusion to the workshop summary gives an idea of the areas of focus.
“Greater international cooperation, mutual support and assistance between regulators, more involvement of patients in the process of drug development and greater overall transparency throughout the process were key themes”, says the EMA report.