On 3 April 2014 your MEP will have the chance to vote in favour of greatly increasing the transparency of data obtained in clinical trials. Once the regulation is in force all pharmaceutical companies and non-commercial sponsors of clinical trials in the European Union will have to:
Submit a summary of results to a publicly accessible database, within a year of completing the research
Submit a summary understandable to a layperson
Submit the full Clinical Study Reports of trials when applying to put a medicine on the market
Register or publish old trials, if they want to use them to back up applications for new trials
Face financial penalties if transparency requirements are not met
These rules will apply regardless of whether the trial was successful, unsuccessful or inconclusive.
If you want to sign the petition or write to your MEP follow the link below. The vote should be tomorrow so not a lot of time.
Thanks myrddin for raising this. As we know in CLL clinical trials are often the most viable option for some people as their disease progresses. Whilst we have good links to trial data worldwide it is critical that we have all information available to enable us to make informed treatment choices. All the information good, bad and sad, knowledge is power and most people I know fully informed would still participate as the alternative is not always a viable treatment option.
This legislation is important going forwards to ensure that the new medicines, we all are likely to need, can be obtained quickly and most economically. This will affect all of us.
Once it becomes law we hopefully will see more open research with faster drug development.
‘’ A well known example from the recent past involved pharmaceutical giant Merck and their drug Vioxx – in a well reported case, the drug maker was accused of failing to report cardiovascular related deaths, burying negative data and hiding risks to patients in order to gain approval and profit — ultimately they withdrew the drug in 2004 and have suffered significant legal consequences since then.’’
The proposed new law:-
‘’Most drug companies conduct numerous trials in an effort to develop new (and profitable) drugs to treat disease. The process of drug development is tedious and can take many years to go from concept, to bench to clinical trials — and eventually to market in the US via FDA approval. Now, for the first time, European legislators are working to approve a measure that would require all studies to be publicly reported within a year of completion — irrespective of the outcome.’’
Why it matters:-
‘’ Many doctors are concerned that the motivation for profit may ultimately do patients harm. Withholding negative results related to a drug in development may result in incomplete data being presented to regulatory agencies. For example if a drug has one positive trial and two others that showed less benefit statistically, the drug could be approved without examining all of the evidence. This approval may lead physicians to believe the drug is more effective than it actually is.’’
Some good progress on this was achieved yesterday.
Snip…..
Last night EU MEPs voted overwhelmingly in favour of a new law that will require all drug clinical trials in Europe to be registered and their results reported in a public database.
This new law comes into effect in 2016.
This vote is already having a ripple effect as we have just learned that drug maker AbbVie has dropped its lawsuit against the European Medicines Agency. They had sued the authorities in an effort to keep trial data confidential.
There remain some problems in that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future.
We need all trials – on all uses of all currently prescribed treatments – to be made available, and urgently. There is no excuse for industry inflicting ongoing harm on patients, and on their own reputation, by continuing to campaign against this position.’’
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I have TP53
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