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Euro'vision blog

A look at the key issues for pharma across Europe

Safeguarding European research

How changes to EU clinical trials legislation will help 
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As the global market for clinical trials become increasingly competitive, Europe has risked losing its status as an attractive environment for clinical trials research. The Clinical Trials Regulation, which comes into effect at the end of 2018, will, from an industry perspective, facilitate a more harmonised approach to clinical trials in the EU, with a single submission and overall streamlined assessment process. It also encompasses a laudable approach to transparency, which respects the need to protect personal patient data and commercially confidential information.

One of the major aims of the Regulation has been to streamline the clinical trial application and supervision process - enabling research and underpinning the EU as a have for clinical trials at global level.

With this in mind, it has sought to simplify the applications process by, in the first instance, allowing for a single set of documents to be prepared and submitted for the application.

Moreover, in contrast with the former Directive, the EU Clinical Trials Regulation will see the introduction of a streamlined application procedure via a single entry point, the EU portal. While this is a welcome development, establishing a technically advanced and user-friendly CT Portal will require collaborative effort, including input from trial sponsors, in order to overcome the inherent complexities and to avoid technical duplications. All this will have to be achieved while adhering to a strict timeline. It will be vital that the EU Portal is developed in a way that fully supports the aims of the Regulation. This means it must be technically advanced and user-friendly.

The Regulation also introduces a harmonised procedure for the assessment of applications for clinical trials, which is divided in two parts. Part I will be assessed jointly by all concerned Member States - this refers solely to those countries in which the trial is intended to be conducted. There is only a single set of data requirements for all Member States for Part I assessment and no additional national requirements. Part II is assessed by each concerned Member State, separately. It is therefore essential that clear/consistent requirements are available from all Member States for this and that they will be available from a single source.

Ethics committees will be involved in the assessment of parts I and II as applicable and in accordance with the decision made about the assessment responsibilities of the individual concerned Member State. This is also new in Regulation compared to the Directive. This does not, though, permit aderogation from the pre-stipulated timelines.

Greater cooperation between ethics committees would improve the pace of approval of a trial as well as provide the potential for networking and increased collaboration, while promoting a convergence of standards in the field. From an industry perspective, collaboration between ethics committees, such as through the creation of ethics committee networks, should be encouraged during the implementation phase of the Clinical Trials Regulation.

Streamlined safety reporting procedures have been introduced through the Regulation. This should allow sponsors the opportunity to avoid submitting broadly identical information, separately each of the players involved and even to individual Member States. What the new reporting provisions provide is the clarity to ensure a harmonised approach, applying specifically to the type of information that goes to investigators and ethics committees, annual reporting and the presentation of data. Furthermore, safety reporting must be fully aligned with existing pharmacovigilance rules.

Increased transparency with regard to clinical trials and their outcomes is also one of the mainstays of the new Regulation. Industry supports the provisions related to disclosure of information on clinical trials under the Regulation.

The pharmaceutical industry has already moved quickly in this direction, with the EFPIA/PhRMA Joint Principles for Responsible Clinical Trial Data Sharing implemented on 1 January 2014, underscoring the commitment of the pharmaceutical industry to disclosing clinical trial data.  EFPIA members have made significant progress in developing processes for clinical trial data access schemes, translating principles into practice.

Also, the European Medicines Agency's Policy 0070 on the publication of clinical data is still being implemented and industry believes that consistent and integrated processes under the policy should be developed. It is essential that there is close convergence and integration that will reduce complexity and allow a comprehensive system for sharing and access to clinical trial data that is operable and cost-efficient. A simple and easy system can greatly facilitate stakeholder compliance and increase trust in clinical research.

Finally, it is clear that in the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. It is critical that European partners in research to develop systems to maximise the potential of big data while protecting confidentiality of patient data, to further biomedical research.

Article by
Sini Eskola

EFPIA director of regulatory affairs, has a degree in pharmaceutical sciences (M.Sc) and is a member of the Executive Committee of Industrial Pharmacy Section of the International Pharmaceutical Federation.

20th May 2016

From: Regulatory



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