Is the New EU Clinical Trial Regulation 536/2014 Merely a Missed Opportunity?

June 22, 2015
Martin Robinson

The EU has announced a new regulation - number 536/2014 - for clinical trials, which is planned to come into force not before 28th May 2016. It is an important step because it sets out the requirements for a single clinical trial approval portal and the content of clinical trial applications to be standardized.

 

Clinical research is becoming ever more complex and demanding meaning the need for quality, competent and well-trained staff is more important than ever. The EU has announced a new regulation - number 536/2014 - for clinical trials, which is planned to come into force not before 28th May 2016. It is an important step because it sets out the requirements for a single clinical trial approval portal and the content of clinical trial applications to be standardized. The regulation also is designed to facilitate increased public openness about trials and the results produced. This will be achieved through an EU portal allowing the EU database on clinical trials to be publicly accessible, with the data presented in an easily searchable format. The regulation will be applied in full in all member states, with no need for separate national legislation, which will result in consistent and uniform application throughout the EU. Having a regulation enables the European Commission to conduct controls in Member States making sure that rules are properly supervised and enforced.

The EU Regulation has been brought in to remedy some of the difficulties caused by the current EU Directive 2001/20/EC, one of which requires submission of separate applications for each of the countries involved in a trial. This has caused delays in the start of clinical trials and a disproportionate administrative burden, despite the use of the Voluntary Harmonization Procedure which took a more centralized approach to Competent Authority approvals. The Regulation provides specific timelines for the different steps in the authorization process and confirms the concept of tacit authorization to ensure that timelines are adhered to.

However is this a missed opportunity? With clinical research becoming increasingly more challenging the danger is that, unless a competence-based approach is used instead of relying solely on education training and experience, incompetent people can still be hired, employed or promoted with the potential risk to the safety and wellbeing of patients and the integrity of clinical trial data. Competence through accreditation, for example, would help to ensure that Good Clinical Practice (GCP) is adhered to and that patients’ rights and wellbeing are upheld. Nowhere in the new regulation is there a mention of competence in terms of the ability of individuals to conduct clinical trials. Having internationally recognized and ideally accredited professionals whose competence has been independently assessed would give both the industry and the general public further reassurance that those in clinical research are competent to fulfil their roles. Unfortunately, neither education, training nor experience can guarantee competence. Clinical research staff need to have the skills and abilities that reflect the contemporary setting in which they work to ensure that out of date and substandard practice is eliminated.

The new EU Clinical Trial Regulation may need further detail and clarification in some areas in order to be able to implement the new requirements. However there may well be some guidance documents already in preparation by the European Commission. Perhaps the solution to the problem of a lack of competence standards in the sector is to have a guidance document which sets out the requirements for training and experience centered on a competence–based approach.  

Martin Robinson, PhD, is Executive VP & IAOCR Ambassador, where he leads a team providing independently accredited training courses for clinical research professionals, including project management, CRA and GCP training. He can be reached at mrobinson@iaocr.com

 

Looking for insight to put the new regulation into practice? 

This October, CBI is hosting a prep forum for the New EU Clinical Trial Regulation. Join industry thought leaders and early adopters to develop an implementation roadmap and evaluate the impact of the new directive on global programs. To learn more and register visit www.cbinet.com/NewEURegulation.

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