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Navigating the new Clinical Trial Regulation with DIA

Published on 14/11/17 at 12:07pm

For those stakeholders involved with clinical trials in Europe, the new Clinical Trial Regulation to be introduced in 2019 will have a dramatic impact. The aim of the change in regulation is to increase the efficiency of all trials in Europe, as well as promoting research while avoiding the duplication of clinical trials.

This will mean increased transparency of trial information and the introduction of consistent rules for conducting clinical trials. The benefits are plain to see but the implementation, for those involved, will be complicated – especially as the deadline rapidly approaches.

DIA’s Clinical Trial Regulation event, held on the 5-6 December in London, will see leaders from the pharmaceutical industry, representatives from CROs and regulatory affairs professionals convening to plot a path through the incoming changes to the regulatory environment.

The workshop aims to give stakeholders the chance to exchange information, providing practical solutions to any issues that may have arisen and allowing for collaborative discussions across lectures, panel discussions and interactive sessions.

In particular, the objectives of the workshop are to:

  • Understand the new requirements along with the practical and operational considerations for implementation by authorities and clinical trial sponsors
  • Identify the key challenges and opportunities of the new requirements and policies
  • Leverage insights on how companies and research institutions are fine-tuning and optimising processes to meet the requirements of the Clinical Trials Regulation
  • Exchange views between regulators, clinical trial sponsors, patients, and other stakeholders

The key topics that will be covered will be:

  • Member States preparedness for the regulation, including plans for co-operation between agencies and ethics committees and coordinated assessment
  • Development of the EU clinical trials portal and database
  • Considerations for the preparation of applications and notifications by sponsors
  • Impact of new requirements for disclosure and transparency of data from clinical trials

To gain a better handle on what to expect from the event, Pharmafile.com spoke to Elke Stahl, CTFG co-chair, Clinical Trial Unit, Federal Institute for Drugs and Medical Devices (BfArM), Germany, as well as sitting on the Programme Committee for DIA’s workshop.

Stahl will be speaking at the event and began by giving an overview of what she would be discussing:

“I will cover the preparedness of the EU member states. For instance, how ready are the member states for certain key topics, like the reorganisation of the cooperation between NCAs and ethics committees; if you need a national IT system; and if your national laws have to be revised and updated.

“We have been tracking this for a couple of years already and two-thirds of the member states are going to have pilots, or have already been running them for a year or so; those currently organising them have quite a lot of experience with these pilots, meaning they have experience of cooperation between NCA and ethics committees for mono-national decision-making.”

In terms of the wider discussions that will occur at the event, Stahl noted:

“There are other sessions concerned about the status of the EU portal and database. There will be some experiences from stakeholders on the current trials of this, and we will also discuss how to build a user-friendly system to work with it when it goes live. We have an audit next year and then, after, there’s still half a year for co-development. I think this topic will bring up some interesting discussions and we can work to together to identify what will be the impact.

“A major discussion will be the challenges of the implementation from the different stakeholders and this will be coupled with some pre-defined questions, sure, but will also provide an opportunity to take up questions from the audience. This will be more like an exchange, to discover what the areas of interest are for the stakeholders”.

When asked about what topics or presentations Stahl was looking forward to personally, she replied:

“As a regulator, I am always interested in how the sponsors are getting on – what their impressions of the guidelines are and what the challenges are for them, in order to learn from each other. In regards to the portal, we are not so far apart, such as in safety. As well as this, the joint session on transparency and how the sponsors have addressed these issues – since we have it in the regulation that everything will go public on a certain timeframe – I think that will raise topics that will be interesting and bring up new discussions.”

Stahl ended on what the benefits of attending events, like DIA’s Clinical Trial Regulation workshop, are:

“You can learn from how the others presenting are tackling the issues and going to implement the guidelines – it’s a great way to get new ideas. I think everyone involved can gain something of value from the workshop because, really, it’s an exchange between all stakeholders; you can ask questions directly and get an immediate answer. The workshop is really an all-over view on the clinical trials environment.”