Fergus Sweeney on GCP inspections & quality

In his address at ICR’s European conference, Fergus Sweeney of the EMEA discussed the coordination and findings of GCP inspections in member states, and discussed some key findings and their implications for the future. The role underpinning this is the protection of participants in clinical trials and patients who might take the medicines in the future. In the EU and EEA, this equates to 500 people. At a recent stakeholder meeting, patient groups stated that the EU must remain at the forefront of good clinical trials practice.
Fergus highlighted the virtuous circle of commercial trials providing revenue to investigational teams, funding academic studies that keep those teams at the cutting edge. It is also vital to have pools of investigators and patients who are available and willing to take part in clinical studies. As a community, we must be vigilant to ensure that we play an active part in the development of the medicines that we will depend upon in the future.
The EMEA has a GCP Inspectors’ Working Group, reporting to the EMEA and the Heads of all national Medicines Agencies and to the European Commission. This helps to coordinate inspections by the 130 or so inspectors, which mostly involve representatives of several national agencies. The group is also developing core guidelines on inspections, some of which are already available from the EMEA website. Draft reflection papers are available on bioequivalence studies and electronic source documents. A series of commonly-asked questions are discussed on the website.
Fergus discussed the processes of routine inspections (selected early in the submission process on internal criteria) and triggered inspections (eg, for a single pivotal trial), which are generally decided on day 120 of the CHMP centralised evaluation procedure. The routine inspections are designed to ensure surveillance of different sponsors, work in different geographical areas and different types of studies (eg, biosimilars). At present, routine inspections are around 40%, and Fergus expects them to exceed 50% soon.
Looking at data from 2005 to 2007, Fergus showed that nearly half of patients in EU pivotal studies came from the US, with 30% from the EU. The proportion coming from Latin America and Asia are increasing and Fergus noted that this data lags around 4 years behind patients entering trials.
Looking at key findings, Fergus stated that he had not seen a geographical difference in study quality between USA EU and elsewhere, but more variation between individual sites, sponsors etc. Finding types related to study design (eg, of protocols, CRFs, informed consent and other forms), source data, medical records and drug and patient accountability. He suggested that data should be recorded a minimum number of times, rather than asking the investigator to record the same data several times. Other findings related to investigator infratructure and delegations, laboratories, labelling and blinding of IMP, monitoring, safety, contacting, data collection and analysis.
Putting all these activities in place, we can assure the continued excellence of European clinical research.