Bayer HealthCare extends access to clinical trial data

- Bayer HealthCare joins internet portal www.clinicalstudydatarequest.com

- Access to clinical trial data for qualified researchers fosters scientific innovation and development of future treatments

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Bayer HealthCare

May 14, 2014, 08:56 ET

LEVERKUSEN, Germany, May 14, 2014 /PRNewswire/ -- Bayer HealthCare announced today that it will start sharing data from its clinical studies through the internet portal www.clinicalstudydatarequest.com. From now on, qualified researchers can request anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the website.

By joining the portal, Bayer HealthCare is supporting efforts of the European Medicines Agency (EMA) to increase the transparency of data from clinical studies. As a member company of the pharmaceutical trade associations EFPIA and PhRMA, Bayer is following their declared principles on responsible clinical trial data sharing.

"Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health," said Dr Joerg Moeller, member of the Bayer HealthCare Executive Committee and Head of Global Development. "Joining the electronic platform and providing access to anonymized patient-level data, protocols and clinical study reports is a further step towards increased transparency while maintaining patient privacy."

Secured data access will be granted after approval of the research proposal 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 1, 2014. Bayer HealthCare is not involved in the decisions made by the independent scientific review panel. Bayer HealthCare will take all necessary measures to ensure that patient privacy is safeguarded, in accordance with applicable laws and regulations.

In addition to the data provided via www.clinicalstudydatarequest.com, Bayer HealthCare provides through its 'Bayer Trial Finder' available at www.bayerpharma.com information about Bayer HealthCare sponsored trials dating back to 2005. This public information first becomes available at the beginning of a clinical study and is updated throughout the conduct of the study. Generally, summaries of trials will be published within a year of study completion.

The joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing are available at:
http://www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Responsible-Clinical-Trial-Data-Sharing-Become-Effective-Today

Click here for more information on Ethics in Research & Development at Bayer:
http://www.bayerpharma.com/en/research-and-development/ethics_in_r_and_d/index.php

About the internet portal www.clinicalstudydatarequest.com
The portal www.clinicalstudydatarequest.com provides a secure system for researchers to request access to anonymized, patient-level clinical trial data provided by sponsor organizations. After creating an account on this website, researchers can submit a single research proposal which is then reviewed by an independent review panel who decides whether access should be provided. The panel reviews the proposed science, publication plans, conflicts of interest and the qualifications of the research team.

Following approval by the independent review panel, researchers are asked to sign a data sharing agreement. The portal allows industry, academic and non-profit sponsors to join and include their studies and is owned by IdeaPoint, Incorporated.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information at www.healthcare.bayer.com

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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