European Union: New European Clinical Trials Regulation - Are You Ready?

Last Updated: 3 September 2015
Article by Fiona Maini and Sarah Chan

Most Read Contributor in UK, August 2017

The new clinical trial regulation (EU Regulation No. 536/2014), adopted in April 2014 is scheduled to come into force from the end of May 2016. Its aim is to harmonise the requirements for clinical trials across the EU while ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated. It also seeks to increase transparency with regard to clinical trials results, data and their outcomes.1 Indeed, the availability of internet access, mobile devices and the proliferation of social media have fuelled a growing demand for access to clinical trial information and results from researchers, patients and consumers alike. For life science companies, however, disclosing clinical trial information requires a huge cultural change given they operate in a very competitive environment, with high risk and high rewards. This week's blog considers the challenges and benefits of implementing this new regulation with respect to strengthening transparency for clinical trials data. 

Safety first

The new regulation replaces the EU Clinical Trial Directive 2001/20/EC, which the European Commission acknowledges contributed to a significant fall in the number of clinical trials conducted across Europe, and increased the administrative burden and the time taken to launch new trials by 90 per cent. As the new EU regulation applies across all EU member states, it ensures a level of consistency that has been lacking over the past decade. The intention is to create a favourable environment for conducting clinical trials, while maintaining the highest standards of patient safety, across the EU. Intrinsic to this is the simplification of current rules including:

  • Streamlining the procedures for assessing and authorising clinical trials, removing duplication and reducing delays in launching new clinical studies
  • Introducing a lighter regulatory regime for trials conducted with medicines that are already authorised and which pose only minimal risk compared to normal clinical practice 
  • Simplifying reporting requirements, sparing researchers from submitting largely identical information on the conduct of the study to various bodies
  • Recognising that a trial can be led by more than one organisation, by formally introducing the concept of co-sponsorship

Improving transparency, by publishing clinical trial results, whether positive or negative, so that both researchers and patients can be made aware of past trials and their outcomes, and avoid the same studies being repeated unnecessarily.2

In the open 

Over the last few years, increasing numbers of life science companies have adopted a more open and transparent policy with respect to the outcome of their clinical trials irrespective of whether the results are positive or negative.3 This more open policy has required strong leadership and significant investment from finance and human resources. The benefits have included stronger analyses, better explanations of treatment outcomes and help in identifying additional uses for products.

Clinical trials are an essential part of the development of new medicines and also have a role in the improvement of medical care more generally. The traditional method of developing a drug consists of five key study phases: preclinical, clinical trial phases I, II and III, and post-marketing phase IV. During the first three clinical trial phases, where the study participants are most at risk, disclosure of clinical trial results helps reduce risks and avoid repetition or duplication of efforts by other companies planning to conduct similar studies. This could then free up research resources to be allocated to other clinical trials. In addition, the results of these publications should in the future enable physicians to better match products and Importantly, the new regulation introduces requirements for sponsors to submit a publicly available summary of the results of the trial within one year of its end irrespective of the outcome (positive or negative) . Furthermore, for clinical trials which have led to a request for marketing authorisation, a full clinical study report will have to be submitted for publication in the EU database.

In order to discourage unfair commercial use of the data, the European Medicines Agency has defined a process for publication of clinical reports with reports available on-screen for any user, with a simple registration process; and downloadable clinical reports available only to identified users. Both situations will be governed by dedicated terms of use. This will allow researchers, patients and the public to be aware of both the past trials and their outcomes. If registered for general information purposes, the users can view results but cannot download or save them. If registered for academic and non-commercial research purposes, the identified users can download clinical study reports, transcribe, cut and paste the data.4

A moral duty 

A 2014 survey by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, found that an overwhelming majority of doctors supported the principle of "Clinical Trial Data Transparency" and that such information should be disclosed and accessible. Eighty–one per cent of respondents agreed that a "moral duty" exists for drug manufacturers to make completed data available to trial participants, the general public and the research community; and 87 per cent agreed that increased scrutiny of data will lead to better science and research.5

There are a number of steps that pharma companies might want to consider when planning to make their clinical trial data publicly available. These include:

  • Setting up a Clinical Trial Disclosure Governance Committee
  • Devising a disclosure strategy and policy for the company
  • Developing a process for handling clinical trial result requests
  • Adopting a technology for redaction particularly to protect study subjects' private information and commercially sensitive information
  • Developing a process for preparing a study summary and clinical study report
  • Selecting an IT solution for publication and submission of data to regulatory authorities
  • Allocating resources to monitor the clinical trial transparency land scape including regulatory requirements and industry trends.

A key benefit from the growing demand for clinical trial transparency and disclosure is that patients should be able to benefit from better prescribed products with improved quality of life. Disclosing clinical trials results by life science companies will utilise resources better and avoid duplication of effort. In general, the more information available, the more innovation is possible.







The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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