PM+: EU’s clinical trials regulation ‘a step in right direction’

Written by Ancel•la Santos Quintano on 9 April 2014 in Opinion Plus
Opinion Plus

But threats to clinical trial data transparency remain on the horizon, warns Ancel•la Santos Quintano.

Last week, the European parliament voted by an overwhelming majority in favour of a new clinical trials regulation. From mid-2016, when the new rules are expected to come into force, all trials conducted in the European Union must be registered on a publicly accessible database, along with a summary of their results, within a year from the end of the trial.

Clinical study reports, which offer the most comprehensive information on each trial, must also be published once a decision on the marketing authorisation of the drug has been made, or the application has been withdrawn.
Certainly, this is good news. The regulation will help to improve the status quo, where data secrecy is the rule rather than the exception.

It is estimated, after all, that only half of all clinical trials have been published in academic journals. And when results are published, they often give an overly-optimistic assessment of a medicine.

These common practices of publication and reporting bias in biomedical research have long put people at greater risk of adverse drug reactions, which are estimated to be the fifth leading cause of hospital deaths. These biases have also, no doubt, contributed to wasteful spending on ineffective therapies.

"Over the coming months and years, the ongoing issue of commercial confidentiality may continue to threaten clinical trials transparency in Europe"

While the regulation will significantly advance transparency of clinical trial data, its full potential has been somewhat diminished. Unfortunately, data disclosure requirements will not apply to retrospective trials. The general public will therefore continue to be deprived from all information about medicines that are currently in use.

Additionally, clinical trial data that is not submitted for marketing authorisation will not need to be published in full. This is unfortunate because the disclosure of information about trials that do not achieve the expected results can help to avoid the repeating of unnecessary - and potentially dangerous - studies.

Furthermore, although the regulation states that clinical trial data cannot be considered commercially confidential, this provision is not legally binding. Some clinical trial data - maybe even unfavourable information about a drug, such as its harms or lack of efficacy - could therefore be redacted before being published.

In fact, a redaction of information on the grounds of commercial confidentiality was the basis of last week’s agreement between the European medicines agency (EMA) and AbbVie regarding the disclosure of trial data on Humira (adalimumab).

Over the coming months and years, the ongoing issue of commercial confidentiality may continue to threaten clinical trials transparency in Europe. For instance, the European Federation of Pharmaceutical Industries and Associations (EFPIA) is continuing to push for clinical trial data to fall under the definition of a ‘trade secret’ within the EU’s upcoming directive on the protection of trade secrets.

In addition, the industry is lobbying the EU and US government for a harmonised, restrictive approach on clinical trial data disclosure -again to protect commercial interests -in the ongoing transatlantic trade and investment partnership (TTIP) negotiations.

Meanwhile, the EU is currently reviewing its framework on the protection of personal data, which could hinder the ability for anonymised clinical trial data to be disclosed. Given that the de-identification of personal data is common practice in medical research and good standards exist, access to health data should not be restricted due to unfounded concerns.

The new regulation is, most definitely, a step forward for clinical trials transparency in the EU, but there is a need to continue working towards full disclosure of all trial data.

Unfounded concerns about commercial and patient confidentiality do not justify data secrecy. Public health should always come first. The EMA’s future policy on publication and access to clinical trials data should reflect this.

About the author

Ancel•la Santos Quintano is a policy advisor at Health Action International (HAI) Europe

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