Tag Archives: EMA

EMA launches consultation on transparency & Clinical Trials Regulation

The European Medicines Agency has announced a public consultation on how its new transparency rules should be applied to the clinical trial database specified in the 2014 EU Clinical Trial Regulation. Stakeholders are invited to send their comments before 18 February 2015.

The European Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants. The Regulation ensures that the rules for conducting clinical trials are consistent throughout the EU. It also transforms the level of information publicly available for each clinical trial carried out in the EU by requiring transparency on the authorisation, conduct, and results of the trial. The Regulation will apply to clinical trials that are registered once the Regulation is in operation (not before 28 May 2016).

EMA clinical data publication policy comes into force

On 1 January 2015 the new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorisation applications for human medicines. Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.

The policy will apply to clinical reports contained in all marketing-authorisation applications submitted after that date. The reports will be released as soon as a decision on the application has been taken.

The Agency embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.

EMA workshop on development pathways for Advanced Therapy Medicinal Products

The EMA has published a report on its workshop “Development Pathways for Advanced
Therapy Medicinal Products”, which took place in London on December 15, 2014.  The meeting was the 3rd in a series of annual workshops, with more than 130 participants from a broad range of public and private stakeholders in attendance.

Workshop participants engaged in discussions on the adequacy of business development models for such products, the implementation of the ATMP legislative framework and the legal and regulatory provisions available, such as the ATMP certification scheme, guidance on the risk-based approach and hospital exemptions. Other topics raised included the recent regulatory initiatives to support early access e.g. parallel EMA scientific Advice with Health Technology Assessment bodies (HTAs) (link) and adaptive pathways.

EMA begins final steps on clinical trial data transparency policy

The European Medicines Agency (EMA) has announced that it will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May. This will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s Management Board for endorsement in June 2014.

This consultation is meant to clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the policy. The targeted discussions will focus on the presentation by the EMA of the principles set for the possible redaction of the clinical study reports to be published. If applied, the redactions will be based on the criteria identified by the Agency for those parts ofclinical trial data that exceptionally contain commercially confidential information. They will also aim to clarify how the concerned data-owners (e.g. marketing authorisation holders) will be consulted before publication of their clinical study reports, and user-friendly technical measures to make the data accessible under the new policy including their terms of use.

EMA launches adaptive licensing pilot

The European Medicines Agency (EMA) is inviting companies to participate in its adaptive licensing pilot project. Companies who are interested in participating in the pilot are requested to submit ongoing medicine development programmes for consideration as prospective pilot cases.

The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines. It is a prospectively planned process, starting with the early authorisation of a medicine in a restricted patient population, followed by iterative phases of evidence gathering and adaptations of the marketing authorisation to expand access to the medicine to broader patient populations.

“With the adaptive licensing pilot project we intend to explore with real medicines in development a progressive licensing approach that would allow timely access for patients to new medicines that address serious conditions with unmet medical needs,” explains Hans-Georg Eichler, the Agency’s Senior Medical Officer. “The approach seeks to maximize the positive impact of new medicines on public health by balancing timely access for patients with the need to provide adequate evolving information on their benefits and risks.”

EMA restates commitment to publishing trial data

The European Medicines Agency (EMA) has announced that it has now reviewed all comments received on its draft policy on publication and access to clinical trial data. It has also updated its policy statements on “Release of data from clinical trials” and “Publication and access to clinical-trial data: an inclusive development process”.

While the comments received showed that there is large support for the Agency’s plans to allow access to clinical trial data submitted as part of marketing authorisation applications, they also highlighted that there is a need for further analysis and clarification of certain aspects.

The Agency will continue to work with stakeholders, including industry, academia and civil society organisations, to further clarify and fine-tune the proposed rules to achieve the broadest possible consensus. This work will be guided by a set of key principles that were agreed with the Agency’s Management Board on 12 December 2013. The policy on publication of and access to clinical-trial data and an implementation plan will be discussed at the March 2014 Management Board meeting.

The key principles include a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate, the development of a methodology for de-identification of patients, and the definition of a standard format for the submission of data. The principles also foresee the introduction of preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data while ensuring proactive and non-selective access (‘use control’ not ‘access control’).

The Agency reiterates its firm commitment to pursuing the objective of full transparency regarding clinical trial data. The Agency will continue to monitor progress in the Court cases brought by two pharmaceutical companies against the Agency and the on-going discussions on the new European clinical trials legislation. It recognises the need for consistency in the general approach to access to documents by EU institutions and bodies, while recognising the specificity of documents in the possession of the EMA and the Agency’s primary duty to protect and foster public health.

The Agency’s draft policy has prompted broad debate among an unprecedented range of stakeholders, including the important focus on the benefits to patients, and more generally to society of giving access to clinical trial data and on the best approach to achieve this. It has been the catalyst for various initiatives from the pharmaceutical industry, funding bodies and academia centres in this direction.

The Agency has embarked on developing its plans for the proactive publication and access to clinical-trial data because it believes that the release of data is about establishing trust and confidence. The Agency is also firmly of the opinion that wider availability of data broadens the scientific knowledge base, fosters innovation and encourages investment in the development of medicines and ultimately benefits public health.

EMA publishes highlights from workshop on studies in everyday practice

The European Medicines Agency has published a summary of a “Workshop on methods for efficacy studies in everyday practice”, which was held in October. The meeting took place as a preparatory step to the development of scientific guidance on post-authorisation efficacy studies (PAES), which the Agency will develop according to a mandate set out in the new pharmacovigilance legislation and subsequent to any outputs of the European Commission on the situations in which such studies may be required.

The objectives of the workshop were to understand strengths and weaknesses of different design options to study efficacy in the conditions of the everyday medical practice, to issue recommendations on best use of methods to account for bias and confounding and to identify needs for the improvement of methods in the field of efficacy studies.

Five main topics were addressed by invited experts in working groups:

  • pragmatic trials
  • observational studies
  • registries
  • the use of electronic health records for pragmatic trials, and
  • methods to control for confounding.

Public consultation on EMA transparency proposals closes

The European Medicines Agency’s (EMA) three-month public consultation on its draft policy on publication and access to clinical-trial data has ended on September 30th.

The draft policy outlines rules for publication and access to clinical-trial data submitted to the EMA as part of a marketing-authorisation application, once the decision-making process has ended.

More than 150 individuals and organisations submitted over 1,000 comments during this consultation. Healthcare professionals, academics and the pharmaceutical industry responded in broadly similar numbers and together represented almost half of all contributors. There was also significant input from patient organisations, regulatory authorities and health-technology assessment bodies and payers. A large proportion of respondents were individual citizens expressing their support for the EMA’s initiative to increase clinical-trial data transparency.

Pending an endorsement by the EMA Management Board at its 12 December meeting, once the policy is finalised it will be published on the EMA website together with an overview of comments received. The Agency expects this policy to come into force on 1 January 2014. An implementation plan is under preparation.

Consumer lobby group supports EMA in transparency battle

In a statement, the European Consumer Organisation (BEUC) has said that it will intervene to support the European Medicines Agency (EMA) in the pending proceedings before the European Court of Justice (ECJ).

EMA was sued in February 2013 by pharmaceutical companies AbbVie and InterMune for releasing the clinical trial data for some of their products. After an interim judgement, the EMA halted release on any further data relating to the proceedings, but is continuing to treat other applications on a case-by-case basis. The EMA published proposals for new policies and processes around clinical trial data transparency earlier this year, with a public consultation to close later this month.

BEUC had lodged a request to intervene a few months ago. The news about the application being officially accepted have been freshly delivered.

Monique Goyens, BEUC Director General commented: “This is great news for consumers. Our participation in the Court case will show that the public at large is interested in test results, be they good or bad. The European Medicines Agency chose to stand for transparency, and this is where we stand too.

“Consumers, as patients, carers and potential users of medicines, increasingly want to be involved in the decisions regarding their health. They have the right to access information on clinical trials. Therefore keeping such results confidential boils down to denying this right. We hope our intervention will contribute to make headway towards more open data and serve as a precedent for future cases.

“While waiting for the court ruling, we are concerned about the various delays imposed to the revision of the clinical trials’ legislation. We urge Member States to support the Parliament’s position advocating for more transparent clinical trials results. The ball is now in the European Council’s court. It is time consumers’ concerns were listened to and their safety put on the forefront of negotiations.”

Updated webinar on clinical trial transparency running through September

I’ve updated my 60-minute webinar to reflect the latest changes to policy around clinical trial transparency. Running on multiple dates through September, ClinDev subscribers and ICR members can save £20 on the standard delegate rate.

To find out more, and to book your place, visit https://clinicaltrialtransparency.eventbrite.co.uk/