Publication of clinical trial data: IQWiG supports EMA policy

The European Medicines Agency (EMA) receives comprehensive clinical trial data from pharmaceutical companies; these data provide the basis for decisions on the approval of new drugs (“marketing authorization”). In order to make this information available to researchers and decision-makers, EMA presented its draft policy “Publication and access to clinical trial data“ in June 2013. In a comment issued on 30 September, the German Institute for Quality and Efficiency in Health Care (IQWiG) welcomed the EMA draft as a major step forward.

In the interest of patients

In the assessment of the benefits and harms of drugs, scientific institutions such as IQWiG depend on clinical trials. However, these trials are often not fully published or not published at all. In contrast, pharmaceutical companies regularly submit comprehensive clinical trial data to EMA on the basis of which marketing authorization decisions are made. EMA would now also like to make this information available to researchers outside of regulatory agencies.

IQWiG considers this plan to be a major step forward, as it supports informed, patient-orientated and practical benefit assessments of drugs. Whereas often only selected results of clinical trials – if at all – are published in scientific journals, the EMA documents also contain detailed information on methods, all outcomes investigated, and characteristics of populations included in clinical trials.

Complete data are indispensable

“In our work we have repeatedly discovered that neither scientific publications nor other public documents achieve the information content of complete clinical trial data as are available at EMA,” says Beate Wieseler, Head of IQWiG’s Drug Assessment Department. “We therefore regard the EMA draft to be a major step in the right direction. We hope that EMA will not deviate from its course because of the alarmist comments made by the pharmaceutical industry. The alternative proposals by industry are insufficient to solve the existing problems caused by the lack of transparency of trial results. Some people preferably would like to declare all trial results as commercially confidential information.

However, we are talking about trials in human beings who participated in the hope that better treatments will be developed using the information gained. In addition, the claim by industry that the EMA draft insufficiently considers the protection of patient data seems to be a pretext: patient-level data are required to answer many important questions; however, according to EMA’s proposals these data are strictly only used in an anonymized form.”

EMA’s archives should be opened to allow access to further clinical trial data

However, the currently planned access to EMA data is not enough. As the Head of IQWiG, Jürgen Windeler, explains: “EMA can only provide access for IQWiG and other researchers to clinical trial data submitted by pharmaceutical companies during the marketing authorization process. However, data from trials not used in a marketing authorization application are just as important. In addition, EMA is only planning to publish clinical trial data submitted from 2014 onwards. Most of the drugs in use today will not be covered by the new policy.” IQWiG therefore suggests that EMA should open its archives to allow access to clinical trial data submitted before 2014 or not connected to a marketing authorization application.

To close further gaps in the evidence, for example, in the reporting of trials on non-drug interventions, IQWiG is pinning its hopes on the further development of the legislation on clinical research. For drug research, the draft of the EU regulation “Clinical trials on medicinal products for human use“, which, among other things, provides for greater transparency of trial data, will be submitted to the European Parliament for first reading in the near future. Similar legislation should also be introduced for trials with non-drug interventions.