The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
The agency made the comments in a reflection paper in which it argues that the relevant regulations - ICH GCP Section 5.1 on sponsors’ implementation of quality systems and Article 2 of GCP Directive 2005/28/EC , which sets out the monitoring procedures necessary - are no longer fit for purpose.
“Current practices are not proportionate or well adapted to achieving the desired goals and are generally very costly, resulting either in success at an unnecessarily high cost or failure which is also very costly.”
Instead, the European Medicines Agency (EMA) proposes that academics, pharmas and contract research organisations (CROs) start thinking about new approaches to ensuring quality in clinical trials and suggests that the definition of the word itself may be a good place to start.
“Simply advocating the ‘highest level’ of quality has little meaning in itself,” it says, adding that “the cost associated with incremental improvements in quality becomes ever higher as perfection is approached and becomes disproportionate to any additional benefit achieved.”
The agency suggests instead that data and information quality should be defined in terms of suitability for decision making which, in the research context, effectively means whether or not the drug under assessment continues to be developed.
Risk-based quality management
The EMA goes on to describe what it calls a ‘risk based approach to quality management,’ which involves sponsors and CROs monitoring and identifying risk continuously throughout the development, execution and analysis of a trial.
“The principles of risk management and the overview of the process as outlined in ICH Q9 apply as much to clinical trials as to other areas,” it says, adding that the application of this approach to trials could “facilitate better and more informed decision making and make the most of available resources.”
The EMA is seeking feedback for its proposals from the contract research sector, the closing date for which is February 15, 2012.