After pressure from citizens and scientists the European Medicines Agency has agreed to scrap restrictions on clinical trial data sharing that would have made independent scrutiny of the data impossible.

Hundreds of citizens and organisations representing thousands of people across Europe have been asking the EMA to overturn a rule that would have allowed researchers to view Clinical Study Reports (CSRs) on screen only. CSRs are documents produced for regulatory purposes and often contain thousands of pages of complex information. Researchers would not have been able to print, download, save or share these, making their work analysing benefits and harms of medicines virtually impossible. At a Management Board Meeting today the EMA agreed to remove this restriction from its final data sharing policy.

However, other parts of the policy remain a concern for researchers:

The policy puts primary responsibility for redacting information into the hands of trial sponsors. This means that they get to suggest which information submitted to the EMA should be kept hidden. The EMA has a policy that the information in clinical trial reports should not generally be considered commercially confidential (this is echoed in the EU Clinical Trials Regulation) but it may never become clear which information is being kept hidden.

The Terms of Use contract researchers must sign allows trial sponsors to take direct legal action against researchers for possible violation of the Terms of Use. Individual researchers are therefore being made vulnerable to protracted legal battles with large companies which will introduce a new and unpredictable risk of high legal costs into routine academic work, effectively chilling researchers’ ability to use information relevant to patient care.

Tracey Brown, Managing Director, Sense about Science:

“Over recent weeks hundreds of European citizens and patient groups have pressed the EMA to end secrecy around clinical trial results. The EMA has responded by reversing the ridiculous proposal that researchers would only be able to see information from clinical trials on-screen in a sealed room. That restriction would have stopped the reviews and computation of multiple studies that are necessary to work out which medicines have the best and worst effects. However, it is still the case that trial sponsors might be able to cut out any information they don’t want others to see. Companies and other bodies that have embraced an open approach to their trials have made it clear that the need for redaction is very limited. The EMA should ensure that its rules on redaction reflect this approach. In this respect it is disappointing that the European regulator’s commitment to transparency is actually lagging behind the more progressive companies.”

Dr Ben Goldacre, author, Bad Pharma:

“Firstly, the EMA records are woefully incomplete for informed decision making: EMA only holds CSRs for a small proportion of all the trials done on all the medicines we use today. We need a radical overhaul giving retrospective transparency on all CSRs from industry, and clear transparency on methods and results for all trials done by academics. Secondly, this policy does nothing to move forward on the safe sharing of individual patient data – whilst respecting patient privacy – which was promised by EMA in 2012. Lastly, there are serious concerns around the redactions process. For this, we can only go on recent performance, which is not encouraging. EMA reached an agreement this year with AbbVie to censor information on protocol changes from the public release of a CSR. Protocol changes in a trial are precisely the kind of information that researchers need, to make an informed decision about whether that trial was a “fair test” of the treatment. It is hard to see how it is justifiable to hide protocol changes, in a trial from eight years ago, on over-riding grounds of commercial confidentiality.”

Professor Carl Heneghan, Director, Centre for Evidence Based Medicine, Oxford University:

The EMA’s announcement on the publication of clinical reports is a major step forward and represents a real shift in favour of ensuring research data is shared routinely and re-used effectively in the public interest. The EMA’s plan is to start making clinical study reports available from January 2015, and by recognizing the importance of this data, it sets a standard for data transparency now and in the future. However, what it also clearly demonstrates is the need to ensure clinical study reports are made available for all of those drugs that are in use today and predate this ruling. In terms of providing access to individual patient data, the EMA’s consultation should ensure the substantial benefits and impact on global health of individual data are communicated clearly to patients, healthcare professionals, academia and industry.  Finally, the EMA’s attitude to redactions should be independently audited to ensure overzealous approaches do not hinder access to important information on benefits and harms contained within clinical study.”

Ilaria Passarani, Head of the Food and Health Department, BEUC, the European Consumers Organisation made some preliminary comments on the policy:

“We are glad that following public pressure, EMA will now allow users to search on screen, save and print the information. However we regret that the industry will have the opportunity to remove information it considers commercially confidential. This contradicts the principle that clinical study reports do not contain commercially confidential information. Should Drug Regulatory Authorities in EU member states and beyond apply EMA’s policy, it would further boost trials transparency. But today’s policy is not set in stone and might face further undermining. Cases by pharmaceutical companies like the ones by AbbVie and Intermune against EMA’s previous policy on data disclosure could happen again. The ongoing discussions on commercial confidentiality in the context of the Transatlantic Trade Investment Partnership could also reverse today’s move forward. The planned transfer of pharma policy from the European Commission’s health affairs to industry also augurs badly.”

Read the EU Ombudsman’s reaction

Read BEUC’s press statement


EU adopts plan to cut trial secrecy Reuters

What drug-data ruling means for pharma firms and you New Scientist

EMA remains under fire for its policy on disclosing clinical trial data Wall Street Journal Pharmalot

European Medicines Agency reduces clinical trial secrecy Pharmaceutical Journal

EU medicines agency hands victory to advocates of trial data sharing Science

Mixed response to EMA data transparency plans Pharmafile

EMA extends clinical data access but questions remain PharmaTimes

EMA draws fire on new clinical reports policy PMLive