all aboard…

Posted on Friday 13 September 2013

Dear Friends

Support for AllTrials around the world is growing and we need to keep it that way as we reach some crucial debates.

The European Medicines Agency’s proposed policy on publishing and sharing information from clinical trials is open for comment until 30th September. Many of you have been involved in getting your organisations to sign up in support of AllTrials for all trials registered and all results reported. The EMA’s proposals will help to make that happen. But organisations that want to slow or restrict transparency are already making their views known. Please send comments to the EMA before the deadline. Even if you can only comment briefly, please do. It is vital that they hear from the range of bodies and individuals who want an end to hidden trials. We will publish our response next week and share it with you in case that helps.

Last month we published the AllTrials manifesto, which sets out challenges that regulators, companies, researchers, professional bodies, journals and others are addressing (or should be) to make sure that all trials are registered and results reported. There have already been meetings, discussions and documents enlarging on some of the points in there, such as how registries can work together to cross reference registered trials and what journals, funders and ethics committees can do to check up on registration.

We’re going to link these into the document and map out progress in different parts of the medical research system. Meantime, here is some of the news:
  • In the UK, the Health Research Authority is about to implement its new policy to ensure all UK clinical trials are registered in a publicly accessible database. From 30th September it will be a breach of good research practice to fail to register a clinical trial.
  • PLOS Medicine announced that it will now consider retrospectively registered trials for publication.
  • The British Pharmacological Society and the American Society for Pharmacology and Experimental Therapeutics have announced their support for the publication of negative findings from early clinical trials.
  • A new paper in the BMJ shows that only 28% of medical journals require a clinical trial reported in their pages to be registered.
  • Trial registries around the world are going to work together to identify practicable ways to complete missing trial information.
We put campaign news onto our website at www.alltrials.net every day. We are just about to move on making the website, which we put up in a rush at the start, a more rapid and comprehensive way to keep up with the campaign developments across the world. If you have been visiting it and have suggestions please email in the next few days.

 

Best wishes

Síle

If  you signed the AllTrials petition, you probably got the above email. If you haven’t signed it, there’s a link right here [upper left] to make it easy. I reproduced the email here to clarify a point. The important action right now is to write the European Medicines Agency [EMA] before September 30th. Here are the operative pieces of information:
  • The EMA Proposal:
    It gives PHARMA beyond ample protection, but read it if you need proof.
  • The reason to write the EMA:
    I’ve tried to outline the attempts by PHARMA to undermine the EMA [a deal-breaker?…, an aside…].
  • How to write the EMA:
    Their email address is ctdatapolicy@ema.europa.eu, but they suggest that you use a Submission Form [here]. It’s a Word File asking for details and I found it ponderous. Torn with indecision, rather than obsess about which to use, I did both. When you look at the Submission Form, you’ll understand the confusion.
And as long as you have pen in hand, quickly sign David Healy’s petition to AbbVie and Intermune to withdraw their suit against the EMA:
  • How to sign Dr. Healy’s petition:
    It’s easy. Just click here
If you agree that the pharmaceutical industry has abused its place in healthcare beyond endurance, jump on this train headed for data transparency. It’s the train that’s finally going to take us where we’ve been needing to go for a very long time…

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