EMA’s data publication policy a year in review: ‘Positive outcomes’ achieved via industry collaboration

By Melissa Fassbender contact

- Last updated on GMT

(Image: iStock/Pinkypills)
(Image: iStock/Pinkypills)

Related tags: Clinical data, Contract research organization, Pharmaceutical industry, Pharmacology

A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.

Last year​, the European Medicines Agency (EMA) opened up access to clinical reports through its clinical data publication (CDP) website​.

In a recent survey of those using the site, three-quarters of respondents agreed that the proactive publication of clinical data helps the agency “build public trust and confidence in its scientific and decision-making processes​,” according to the EMA. Additionally, two-thirds of respondents agreed that the data helps researchers to re-assess the clinical data.

The EMA “is pleased with the experience to date" ​and "has received positive feedback on this initiative," ​an EMA spokesperson told us. "In particular, we are pleased with the variety of stakeholders who responded to the survey and hence can be assumed to be accessing the CDP website​.”

Respondents included pharma companies, academics, regulatory consultants, and contract research organization (CROs), as well as patients, healthcare professionals, and regulators, among others.

According to the spokesperson, respondents cited a range of reasons for accessing the website, such as for regulatory intelligence purposes and benchmarking, as well as supplementing journal information for research purposes and accessing information relevant to an individual’s disease or area of clinical practice.

The survey aimed to garner feedback on the EMA’s reasons for developing the policy, including to build public trust, encourage innovation, and avoid clinical trial duplication. The majority of respondents agreed with four out of five of the agency's stated intentions​, the spokesperson said.

This is all the more satisfying as it is clearly too early to draw conclusions on some of our expectations e.g. the publication of clinical data will encourage the development of new medicines​,” the spokesperson added.

Thesepositive outcomeshave been achieved through a strong commitment from the Agency and the collaboration from industry​.”

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