Formation RechercheUniversité d'Eté de Nutrition
EFGCP Workshop on Options and Challenges for Ethical Assessment in the Clinical Trial Regulation Proposal
Les thèmes abordés au cours de ces journées porteront sur :
· Besoins protéiques et aspects sensoriels de la nutrition
· Qualité et tolérance des céréales et des produits laitiers
· Nutrition et maladies dégénératives/cancer
N. Cano, C. Philippe, C. Rémésy, L. Wittrant
Y. Boirie, N. Cano, A. Cirotte, V. Coxam, A. Jordan, L. Mioche, C. Rémésy
EFGCP Interactive Investigator Training for Inspections
In July 201, the European Commission adopted a proposal for a Regulation on Clinical Trials to resolve a number of problems identified with the current legislation. In the legislative process this proposal is now subject to discussions by the European Parliament and the Council representing the 27 Member States and in parallel by all stakeholders affected by it.
One of the key changes proposed concerns the assessment and decision system for clinical trial applications. The Commission defines the objectives to be achieved, which will have implications on the national competent authorities and the review by ethics committees. The workshop is meant to provide a platform for a constructive discussion on the way ethics committees could act and interact in the future.
EFGCP Workshop on 'A Practical Approach to Risk-Based Monitoring'
This one-day course is aimed at clinical trial centre staff such as investigators, co-investigators, study nurses and coordinators and anyone who is involved in the conduct of clinical trials of any phase and design, sponsored by commercial or academic institutions. Inspections are no longer linked to a submission by a sponsor to Health Authorities to obtain a marketing authorization but in the today’s inspection landscape inspections can occur at any time with and without a particular event triggering these. Especially in Europe, Health Authorities conduct inspections as part of their routine oversight activity. For clinical trial centre staff it is, therefore, important to understand what is required during an inspection, how to prepare for and follow-up on an inspection. It is also important to understand and apply new trends such as the concept of a risk based approach that is becoming the reference for inspectors.
This is the first seminar and although being held in London it will address not only UK specificities but also general and EU themes.
The specific role of Educational Working Party at EFGCP is to identify priority needs and primary challenges in the education and training of GCP among the various parties involved in preparing and carrying out clinical trials. As the multi-centre and multi-country clinical trials increase across Europe, there is a need to focus on the co-ordination and harmonisation of educational and training programs in GCP. At the same time, it is becoming more and more evident that different traditions in medical and scientific education across Europe need to be appreciated in developing GCP practices.
Over the last year several key documents have been developed globally by regulatory authorities indicating the universal trend to a risk-based monitoring approach. The regulators recognise there have been considerable advances in technology since the release of ICH GCP back in 1996. Risk management is also an area which is often poorly understood as is the use of risk management tools. Identifying risk and mitigation as well as establishing priorities and quality tolerance limits require a stratified approach. In the UK, during 2011 the MHRA have also started to look at risk-adaptive approaches in the management of clinical trials. More recently, the Commission has adopted a “Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC" ("Clinical Trials Regulation") which also needs to be considered.
The Education Working party is currently developing materials on risk-based monitoring. This potentially flexible approach to monitoring is possible especially with the use of current technologies but many have been reluctant to follow this route. It was recognised early in EFGCP’s process of developing risk-based training that despite all the discussions about adaptive monitoring, how clinical researchers should develop this approach at a practical level is less easy to understand. This new approach needs to ensure that subjects are protected on clinical trials and that data quality is not compromised. The aim of the Workshop is to interact directly with the regulators and other interested groups in order to discuss what can realistically be achieved and to define when researchers still need to follow more traditional approaches.