Disclosure Policy

Standards for publication of Bayer HealthCare Clinical Trial Information in Clinical Trials Registries and in Clinical Trial Result Databases

Bayer HealthCare is committed to proactively disclose information about its clinical trials in humans and supports the position of the global pharmaceutical industry laid down in the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases”.

Bayer HealthCare will make publicly available information on its trials by the use of Clinical Trial Registries and Clinical Trial Result Databases. Whereas in Clinical Trial Registries summaries about trial design will be disclosed at the time a trial is started, Clinical Trial Result Databases inform the public about the outcome of trials, independent whether the results are favorable or unfavorable to a Bayer HealthCare product.

Clinical Trial Registry:

Bayer HealthCare submits information on clinical trials to the publicly funded website ‘www.ClinicalTrials.gov’. Trials sponsored by Bayer HealthCare of drug development phases II, III, and IV, and relevant trials concerning Bayer HealthCare’s Medical Devices are registered. Covered are interventional clinical trials related to Bayer HealthCare’s drug development which started after July 1st, 2005. Additionally, trials in patients of drug development phase I which started after January 1st, 2010 will be registered.

Bayer HealthCare also provides registry information on their drug development trials on its own website ‘www.BayerHealthCare.com’.

Clinical Trial Result Databases:

Trial Result Summaries of Bayer HealthCare sponsored clinical trials in drug development phases II, III and IV are posted on ‘www.ClinicalStudyResults.org’ as well as the Bayer HealthCare website ‘www.BayerHealthCare.com’, if such trials have been conducted on Bayer HealthCare’s drugs which are approved for marketing and are commercially available.

Bayer HealthCare posts results of interventional drug clinical trials in this scope that have been completed after July 1st, 2005. Additionally, results of trials in patients of drug development phase I which started after January 1st, 2010 will be published. The information should be available within 12 months of the trial completion date.

The content of the published Trial Result Summaries conforms to the principles required by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Industry: Structure and Content of Clinical Study Reports (ICH E3 Guidance).

In addition results of relevant drug development trials, and results of trials with Bayer HealthCare’s Medical Devices cleared for marketing will be provided on the publicly funded website ‘www.ClinicalTrials.gov’ in line with the rules set up for this Clinical Trial Result Database.

Access to the mentioned databases including the Bayer HealthCare clinical trials website is unrestricted and free-of-charge.

Though information on Bayer HealthCare’s trials may be found in other public databases as well, the above mentioned databases provide the most comprehensive overview on Bayer HealthCare’s clinical trials. The search engines offered by the WHO (http://www.who.int/trialsearch) and IFPMA (http://clinicaltrials.ifpma.org) collect registry information from multiple databases and thus provide an overview on information about worldwide pharmaceutical research published in leading Clinical Trial Registries.

Questions concerning Bayer’s registry and result disclosure activities should be directed to
clinical-trials-contact@bayerhealthcare.com.

Last update / Valid from: January 2010