Regulatory Focus™ > News Articles > Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

Study Claims German Dossier Requirements Could Improve Open Access to Trial Data

Posted 03 March 2015 | By Michael Mezher 

Study Claims German  Dossier Requirements Could Improve Open Access to Trial Data

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

The researchers, led by Beate Wieseler, head of the department of drug assessment at the Institute for Quality and Efficiency in Health Care (IQWiG), wanted to determine if the reporting requirements for early benefit assessment in Germany yielded more complete clinical trial data than other publicly available sources.

HTA in Germany

In Germany, an early benefit assessment is a review of a product after it is approved to determine if the product offers improved outcomes for patients over existing treatments.

Germany has required newly approved products to undergo an early benefit assessment since 2011, when it passed the Act on the Reform of the Market for Medical Products (AMNOG). IQWiG, which carries out the early benefit assessment, calls for “all relevant study information, including data from unpublished clinical study reports” to be included in the dossiers.

The goal of the early benefits assessments in AMNOG is to link pharmaceutical pricing to patient relevant outcomes. Depending on the outcome of its benefit assessment, a product’s price is either indexed to comparator products, or negotiated with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband).

Incomplete Information

In the study, the researchers compared the documents comprising AMNOG dossiers with documents available from other sources. These sources include European public assessment reports (EPARs), clinical trial registry reports and journal publications.

The study looked at the dossiers for 15 drugs submitted between January 2011 and February 2013, which contained information from 22 different clinical trials. The researchers looked at the availability of results and methods contained within the studies, based on where the documents were available. Their analysis showed AMNOG documents contained more complete information, with 90% of the dossiers containing information on the results and methods of the studies cited.

When looking at non-AMNOG sources for the same 15 drugs, the researchers found less complete information. Overall, the non-AMNOG sources had information on study methods in 75% of cases, and full study results for only 52%.

Of the non-AMNOG sources, the study found journal publications to be the most complete, with 67% containing methods and 41% containing full study results. The study found EPARs to contain methods information only about half the time, and full study results in less than one-third of cases. Clinical trial registry reports were found to be the most lacking–finding methods information for less than half of the trials looked at, and full study results only one-fifth of the time.

Germany as an International Model

The researchers found the clinical trial data found in publicly available sources to be lacking, and argue for making full methods and study results more widely available.

While AMNOG documents are made public, they are not fully translated into English, which makes them less useful on an international level. The researchers suggest a model similar to the one in Germany, where all relevant study information, whether published or not, be made available. This, the researchers contend, would improve the ability of health care providers to make informed decisions, especially for patient subpopulations where relevant clinical information can be harder to find.

Clinical Trial Transparency in the EU

As of 1 January 2015, The European Medicines Agency (EMA) is implementing its new policy on how it will release new clinical trial data to the public.

In April 2014, the European Parliament overwhelmingly passed its new Clinical Trial Regulation, which specifies the creation of an EU-wide clinical trials database and portal. The agency now requires clinical trial data to be publicly available, but allows companies to propose their own redactions for commercially confidential information, which the agency then reviews.

Despite the new measures to increase clinical trial transparency, certain data, such as secondary outcome reporting, are not required for European Public Assessment Reports (EPARs).

IQWiG’s Comments on EU Clinical Trial Database

EMA recently asked for feedback on its plan to implement the new EU clinical trial database and portal. IQWiG found the provisions for commercially confidential information to be too lenient. In an official comment submitted to EMA, IQWiG said:

“The suggested definition of commercially confidential information does not consider the general ethical requirements for research in humans and the requirements laid down in the EU Clinical Trial Regulation. To meet the basic requirements of research in humans and to allow for clinical trials to improve patient care (which is an overriding public interest) the methods and results of a clinical trial generally cannot be considered commercially confidential.”


Information on new drugs at market entry: retrospective analysis of health technology assessment reports versus regulatory reports, journal publications, and registry reports

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