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Clinical Trial Data more transparent

Clinical Trial Data more transparent

Publish date: 2014-11-13

After lingering debates and discussions with stakeholders, the European Medicines Agency has finished a policy on the publication of clinical data regarding medical products for human use. The system that will allow future investigation of clinical trial information is not free from controversies.

Tags: EMA , clinical trials , healthcare , data , policy

According to the decision of the European Medicines Agency (EMA), the pharmaceutical companies selling products in the European Union will be obliged to publish all clinical reports for a drug irrespectively of its approval or rejection. Importantly, the data for applications made before January 1, 2015 will not be subjected to the policy.

The whole process started in 2012, when numerous issues associated with making the complex clinical data available for free were discussed during a workshop on clinical-trial data and transparency. The event has gathered much attention of numerous groups, institutions and individuals which proposed solutions that would meet the needs of clinical trial data stakeholders.

The major aim of the EMA’s policy is to provide as much information as possible about used medicaments to physicians, patients and scientists. The Agency believes that improved transparency will lead to increased trust in the whole medical system. Moreover, the policy will enable the reassessment of data sets by academic institutes and researchers. Another expected advantage is associated with avoidance of clinical trial duplication and increase in a number of innovative and novel projects of drug development.

Concerns regarding the new policy has appeared at the early beginning of the whole process that eventually led to the formal adoption of EMA’s decision. A draft of EMA’s plan released in June 2013 encountered strong dissent of pharmaceutical companies. Two of them, AbbVie and Intermune, even decided to sue the Agency, however, they eventually withdrew the lawsuits after EMA had introduced change in the transparency policy. As a matter of fact, those modifications also aroused controversy, this time among EMA’s strong supporters due to barriers that would make the access to clinical trial data more difficult for researchers.

The most controversial aspect of the policy is connected with redacting commercially confidential information. Many commentators claim that the definitions for confidential commercial information are not precise enough.

Up to now, the results of performed clinical trials were usually unveiled in publically available journals, however, they did not contain detailed descriptions concerning the design, efficiency and safety examination of the trials as the information was confidential. The pharmaceutical companies tried to keep commercially confidential data in secret in order to avoid its unfair usage for commercial purposes. The decision of EMA has revolutionized the whole medical area with the aim to make it more transparent. However, the subject of the policy is quiet delicate and controversies around this decision will certainly continue to appear.

 

Sources:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000556.jsp

http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000555.jsp

http://avalere.com/news/ema-posts-final-decision-on-clinical-trial-data-transparency

http://www.raps.org/Regulatory-Focus/News/2014/10/02/20472/In-Landmark-Decision-EMA-Adopts-Clinical-Trials-Transparency-Plan/

http://blogs.wsj.com/pharmalot/2014/10/03/ema-remains-under-fire-for-its-policy-on-disclosing-clinical-trial-data/

Maciej Smolarz

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