Worker prepares capsules

to be used in a clinical trial

Credit: Esther Dyson

Many in the research community have lauded the European Medicines Agency’s (EMA’s) plans to make clinical trial data available to the public.

But the agency has also drawn criticism for the way it plans to go about increasing transparency.

The EMA has said it plans to make trial data available online in a “read-only” mode. So readers will not be able to save or transfer the data, making scientific analysis difficult, if not impossible.

The EMA also plans to allow drug manufacturers to omit some trial data from its public posts.

In response to this news, the European Ombudsman, Emily O’Reilly, wrote a letter to the EMA expressing concern about their seemingly significant change in policy.

“We were pleased when EMA announced, in 2012, a new pro-active transparency policy, giving the broadest possible public access to clinical trial data,” O’Reilly said.

“I am now concerned about what appears to be a significant change in EMA’s policy, which could undermine the fundamental right of public access to documents established by EU law. European citizens, doctors, and researchers need maximum information about the medicines they take, prescribe, and analyze.”

Beate Wieseler, PhD, and her colleagues from the German Institute for Quality and Efficiency in Health Care, echoed this sentiment in a “rapid response” published in the British Medical Journal.

The authors said the proposed read-only mode of accessing data makes scientific analyses, such as risk-benefit assessments of drugs, impossible.

For these assessments, an enormous amount of data must be viewed, annotated and saved, pooled from different studies, analyzed statistically, and shared among researchers. But the read-only mode would not allow for that.

Dr Wieseler and other critics also take issue with EMA’s decision to allow drug manufacturers to omit some trial data from its public posts.

The EMA has said that, within the context of market approval, drug manufacturers will be able to submit 2 versions of a clinical study report to the EMA: a complete one, by means of which the agency will decide on approval, and an incomplete one for the public.

The EMA previously decided that individual patient data, which could allow patients to be identified, would be deleted from the study reports. Now, this step has been extended to cover study results.

For example, the EMA believes deleting information is acceptable in cases of results on exploratory outcomes that are not supportive for the approval decision. However, Dr Weiseler and her colleagues noted that such study results often contain analyses of patient-relevant outcomes such as health-related quality of life.

“We are talking about studies in people who participated in a clinical study because they hoped that, with the information gained, better treatments would be developed,” Dr Wieseler said. “This information can only be used to improve patient care if it is publicly available to all.”

About the policy change

In June 2013, the EMA released for public consultation a draft policy on “publication and access to clinical trial data.” In that draft, the agency proposed publishing data submitted in support of marketing-authorization applications (only for centrally approved medicines from 2014 onward).

The idea was that interested parties would no longer need to invoke the European Freedom of Information Regulation (Regulation [EC] N°1049/2001), when exercising their right to access documents held by the EMA.

However, according to documents the EMA shared during a stakeholder consultation earlier this month, the EMA now plans to allow systematic censorship by pharmaceutical companies and impose both strict confidentiality requirements and restrictions on the use of data.

For more information on the policy, see the EMA website.

EMA’s transparency plans criticized