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Joint Position on the Disclosure of Clinical Trial Information (2008)

Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases[1]

Updated November 2008

efpia European Federation of Pharmaceutical Industries and Associations

IFPMA International Federation of Pharmaceutical Manufacturers & Associations

[1] A number of different terms are in current usage to describe electronic repositories for various types of clinical trial information. This position uses the term ‘registry’ for information on ongoing clinical trials, and ‘database’ for the results of completed clinical trials. However, the term ‘database’ has been applied elsewhere for information on ongoing clinical trials, and the term ‘register’ for the results of completed clinical trials.

The innovative pharmaceutical industry[2] is committed to the transparency of clinical trials that are sponsored by our member companies.

[2] The Joint Position sets forth the views of the innovative pharmaceutical industry, as represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).

We recognize that there are important public health benefits associated with making clinical trial information more widely available to healthcare practitioners, patients, and others. Such disclosure, however, must maintain protections for individual privacy, intellectual property and contract rights, as well as conform to legislation and current national practices in patent law.

We therefore commit to the following principles regarding the disclosure of information relating to clinical trials we sponsored and appeal to all sponsors of clinical trials to commit to keeping these registries accurate and up to date.

Clinical Trial Registries

A clinical trial registry serves as a repository for information on new or ongoing clinical trials. The innovative pharmaceutical industry commits to make the following information available on new or ongoing clinical trials of medicinal products it sponsors. For convenience, these are organized by “Which Trials”, “When posted”, “Where Posted” and “What information”.

WHICH TRIALS:
All confirmatory clinical trials[3] and all exploratory efficacy trials[4] at a minimum should be submitted for listing.


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