Wednesday, 28 October 2015

Now we can check what Pharma is up to. Where is the fingo trial?

On 1 January 2015 a new European Medicines Agency 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 Agency is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical-trial data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete.

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.

The main objectives of the policy by making clinical data available proactively, are to enable 

• public scrutiny 
• and application of new knowledge in future research, all this in the interest of public health.
  • Access to clinical data will allow third parties to verify the original analysis and conclusions, to conduct further analyses, and to examine the regulatory authority's positions and challenge them where appropriate.
  • The Agency also takes the view that transparency should be mutually respected. Those who perform secondary analysis of clinical data, published in accordance with this policy, must be held to the same standard of transparency as those who generate clinical data in the first place. Hence, all secondary analyses are expected to also be in the public domain and accessible for further scrutiny by the scientific community. In addition, those who perform secondary analysis of clinical data published in accordance with this policy, are encouraged to provide the Agency with a copy of any article resulting from such secondary analysis before publication, in particular in those circumstances where the secondary analysis might result in the need for regulatory action to protect public health. This is a critical consideration in view of the Agency’s role and responsibilities for a timely review of all available information which might have an impact on the benefit/risk ratio of centrally authorised products.

EMA Gearing up to Publish Clinical Data Ahead of New Clinical Trials Regulation

The European Medicines Agency (EMA) is moving forward with its plan to release the clinical data used in marketing authorization applications.

Background: Clinical Trials Regulation

In April 2014, the European Parliament overwhelmingly passed a new regulation governing clinical trials, Regulation (EU) No 536/2015, repealing Directive 2001/20/EC following a transition period lasting through 28 May 2016.

One of the major changes in the new Clinical Trials Regulation is increased transparency measures, which require clinical trials to be registered in a "publicly accessible and free of charge database which is a primary or partner registry of, or a data provider to, the international clinical trials registry platform of the World Health Organization (WHO ICTRP)."

The regulation also calls for the creation of a new, publicly accessible, clinical trials database and portal. The information submitted to the database will be made publicly available, except where certain exceptions apply:

protection of personal data
protection of commercially confidential information
protection of confidential communication between Member States in the preparation of their assessment
protection of the supervision of clinical trials by Member States

Companies are required to publish a summary of the results of all clinical trials within a year of a trial's completion.

So where is the fingolimod PPMS trial?

For trials used to support a product's marketing authorization, companies are required to publish the "clinical study report within 30 days after the day the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for marketing authorisation has withdrawn the application."

Publication of Clinical Data

Shortly after the passage of the Clinical Trials Regulation, EMA adopted a policy on the proactive publication of clinical data.

The policy requires EMA to publish the clinical reports used in all marketing authorization applications submitted after 1 January 2015 once the agency has made a decision on the application. Because of the lengthy nature of the marketing authorization process, EMA expects the first clinical reports released under the policy to be published in mid-2016.
Clarifying the Policy

EMA also released a questions and answers document intended to inform stakeholders about the policy, its interpretation and implementation. The document also explains EMA's rationale for implementing the new policy less than two years before the Clinical Trials Regulation takes effect. The agency says that because new clinical trials will not have to follow the new regulation's requirements until May 2016, the Clinical Trials Regulation will likely not result in publicly available clinical reports in the next four to five years.

Between November 2010 and April 2013, the Agency released over 1.9 million pages of clinical-trial data.


  1. Does this mean that the data on each clinical trial is open? Even the details not published in the journals? Like what is aimed in the #AllTrials campaign?

    1. yep.

      If you had the data wpuld you go to the company becore you publish as a courtest or publish and be damned


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