Standards for disclosure of Bayer clinical trial information
Bayer is fully committed to publicly disclose information about its clinical trials in humans. Public disclosure of clinical trial information is done in line with the position of the global pharmaceutical industry associations laid down in the “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases”.
As a member company of EFPIA and PhRMA, Bayer complies with their declared principles on responsible clinical trial data sharing, which aim to benefit patients and foster scientific discovery. Increased transparency while maintaining patient privacy will ultimately encourage innovation and benefit patients.
Bayer is supporting efforts by the European Medicines Agency (EMA) and the EU Parliament to further increase the transparency of data from clinical studies as laid down in the new EMA policy on publication of clinical data for medicinal products for human use and the new EU Clinical Trials Regulation EU No 536/2014.
Bayer has implemented a thorough monitoring and quality control process to ensure that high standards for transparency of clinical trial information for Bayer medicines are fully met and that information on clinical trials as outlined in this policy is publicly disclosed in time and is of high quality.
Sharing of clinical trial data with qualified researchers
Bayer commits to sharing upon request from qualified scientific and medical researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the United States (US) and European Union (EU) as necessary for conducting legitimate research.
To process related scientific research requests Bayer joined the clinical trial data request portal www.clinicalstudydatarequest.com. Researchers can use this site to request access to anonymized patient-level data and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Data access will be granted to anonymized patient-level data, protocols and clinical study reports after approval by an independent scientific review panel. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
Public disclosure of clinical trial information
Bayer publicly discloses 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 usually be disclosed before the trials will start, Clinical Trial Result Databases inform the public about the outcome of trials, independent whether the results are favorable or unfavorable to a Bayer product.
Disclosure of clinical trial registry information
Bayer submits information on its clinical trials to the publicly funded website www.ClinicalTrials.gov. Trials sponsored by Bayer of drug development phases II, III, and IV, and trials concerning Bayer’s Medical Devices are registered. Covered are interventional clinical trials related to Bayer’s drug development which started after July 01, 2005. Additionally, trials in patients of drug development phase I which started after January 01, 2010 are registered.
Observational studies based on primary data collection evaluating the effects of Bayer drugs and initiated and funded by Bayer are registered on www.ClinicalTrials.gov if started after May 1, 2007. This registration commitment is extended from May 01, 2014 onwards to include observational studies initiated and funded by Bayer based on secondary data collection focusing on the evaluation of efficacy and safety of Bayer drugs.
Clinical Trial Registry information on Bayer trials are also provided in the Bayer Trial Finder application on the Bayer website.
Disclosure of clinical trial results information
Trial Result Summaries of Bayer’s sponsored clinical trials in drug development phases II, III and IV are provided in the Bayer Trial Finder application, if such trials have been conducted on Bayer’s drugs approved for marketing and commercially available.
Bayer posts results of interventional clinical drug trials in this scope that have been completed after July 01, 2005, this includes results disclosure for terminated trials. Additionally, results of phase I trials in patients which started after January 01, 2010 are published.
Results summaries of observational studies registered by Bayer are provided in the Bayer Trial Finder application.
The study result information is usually 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 clinical drug trials, and results of trials with Bayer’s Medical Devices cleared for marketing will be provided on the publicly funded website www.ClinicalTrials.gov in line with the rules defined in the FDA Amendment Act. Trial Results will also be accessible from www.ClinicalTrials.gov as link to the Trial Finder application that provides result summaries in a retrievable database.
Access to the above mentioned databases including the Bayer Trial Finder is unrestricted and free-of-charge.
In order to help inform patients about the clinical trials in which they participate, Bayer will work as member of EFPIA and PhRMA with regulators to adopt mechanisms for providing a factual summary of clinical trial results in lay language.
All Bayer-sponsored clinical trials are considered for publication in the scientific literature irrespective of whether the results of the clinical trials are positive or negative. At minimum results from all phase III studies should be submitted for publication in scientific journals.
Though information on Bayer’s trials may be found in other public databases as well, the above mentioned databases provide the most comprehensive overview on Bayer’s clinical trials. The search engine offered by the WHO (http://www.who.int/trialsearch) collects registry information from multiple databases and thus provides an overview on information about worldwide pharmaceutical research published in leading Clinical Trial Registries.
If you have questions concerning Bayer’s clinical trial disclosure activities and this policy please contact us via email.