... BUT it was from a piece about the magnificent Aaron Swartz, who was already on the case.https://t.co/oLl4vw5EoE… Please watch this heart-rending documentary on Aaron. The enemies of open data and open knowledge really are a shoddy bunch.https://t.co/iR1XKp793c

Politicians in all countries manage to be idiots about cycling. And in so many different, interesting ways.https://t.co/QcFBQianXa

So basically Brexit has been cancelled but we're still going to spend loads of money lose all influence over eu law lose lots of business through uncertainty lose the EMA and EBA create vast new UK-only bureaucracies foment social division and lose status. Well done Brexiteers.

Following months of extensive debate and numerous delays, the European Parliament overwhelmingly adopted a political agreement on the new Clinical Trials Regulation on 2 April. The new Regulation, aims to improve the EU’s competitiveness in clinical research and the development of new and innovative treatments by reducing bureaucracy and streamlining procedures for the management and control of clinical trials. More specifically, the new legislation introduces four main changes: 

Clinical studies to be made publicly available

The Regulation requires that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be made available within a year once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on trial sponsors who do not comply with these requirements. 

Glenis Wilmott, rapporteur to the European Parliament on the proposal was quoted as saying "It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe." However, Ben Goldacre, co-founder of the transparency campaign AllTrials, whilst recognising the Regulation as "an excellent small step forward," still wishes for the Regulation to extend to cover all trials, not just new ones done after the Regulation comes into effect.

A more straightforward authorisation procedure

The new law provides for a faster and more thorough assessment of the application by all Member States concerned, that allows for a centralised - rather than country-by-country- requirement and a single assessment outcome.

  Simplified reporting procedures 

Researchers would no longer have to submit largely identical information on the clinical trial separately to various bodies and Member States.

Increased cross-border cooperation 

The Regulation would make it easier to carry out cross-border clinical trials (i.e. conducted in more than one Member State) which could in turn foster rare disease clinical trials by reducing costs.

A move towards greater transparency

The day after the landmark vote in the European Parliament, pharmaceutical company AbbVie announced they were dropping their court case against the European Medicines Agency for seeking to release clinical trial data for one of its medicines, following concerns over its safety and efficacy. Meanwhile the European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the decision reached by the European Parliament, but has warned that further work is needed to maintain incentives for companies to make long-term investments in biomedical research.

Ben Goldacre