“Bayer is committed to reporting on its clinical trials in order to foster innovation in medicine.”
- Dr. Johannes Bruening, Head of Clinical Trial Transparency, Bayer
Transparency Policy at Bayer on sharing clinical trial data
The Bayer Transparency Policy reflects our commitment to increasing transparency and sharing of clinical trial information.
Patients, their relatives, healthcare professionals and the public can find in clinical trials registration databases such as the ‘Bayer Trial Finder’ and www.clinicaltrials.gov summary information about Bayer sponsored clinical trials and learn for example which active pharmaceutical ingredients or diseases are being tested. Additionally, information about requirements for participation (eligibility criteria) is offered, as well as locations where the study is being conducted and contact information for the study locations.
As a further step towards increased transparency, Bayer joined the online platform www.clinicalstudydatarequest.com. In this way, Bayer helps to share research findings among scientists and drive forward medical progress.
The portal www.clinicalstudydatarequest.com was created in 2014 and enables researchers to gain secured access to anonymized patient-level data, protocols and clinical study reports. With this membership, Bayer underlines its support for the European Medicines Agency (EMA) in its efforts to increase the transparency of data from clinical studies. As a member company of EFPIA and PhRMA, Bayer is fully committed to their declared principles on responsible clinical trial data sharing, which aim to benefit patients and foster scientific discovery.
The joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing are available here.
How to access anonymized patient-level data
Any scientist or research team who wishes to obtain anonymized patient-level data in order to conduct further research must use the portal www.clinicalstudydatarequest.com to request access to this kind of data and supporting documents from clinical studies. After creating an account on this website, researchers can submit a single research proposal which is then reviewed by an independent scientific review panel which decides whether access should be granted. The panel reviews especially the scientific rationale and relevance of the proposed research to medical science or patient care.
Following approval by the independent scientific review panel, researchers are asked to sign a data-sharing agreement which allows them access to the requested documents via a secured data access system.
Qualified researchers can request access to data on new Bayer medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014.
www.clinicalstudydatarequest.com is owned by IdeaPoint, Incorporated.
Access to publicly available information about clinical trials
Public information about Bayer-sponsored clinical trials is available on the company website in the specific section ‘Bayer Trial Finder’ to provide the public with easy access to information about ongoing or completed clinical trials. Since 2005, Bayer-sponsored studies are registered on both websites as soon as they begin, and the information on the websites is updated throughout the study. Summaries of trials are usually published within a year of study completion.
Patient privacy is of paramount importance for all Bayer activities. All clinical data made available via the portal www.clinicalstudydatarequest.com undergo a comprehensive data anonymization process, in accordance with applicable laws and regulations.
The data anonymization includes the removal of location identifiers as well as of personally identifiable information and the replacement of original dates by random dates. Moreover, the original subject identification numbers used in clinical studies are replaced by new numbers and the code key that was used to generate the new identification numbers is destroyed, to prevent any re-identification.