Celgene is committed to responsible and transparent sharing of clinical trial data with patients, healthcare practitioners and independent researchers for the purpose of improving scientific and medical knowledge as well as fostering innovative treatment approaches.? Responsible sharing of clinical trial data is an element of Celgene’s commitment to research and development. ?We believe responsible data sharing can help continually enhance the impact our medicines have in changing the course of diseases and providing new treatment options for patients.
Celgene supports an approach to sharing data that responsibly reflects the interests of all parties involved in clinical trials, including protecting patient privacy, as well as the innovator’s intellectual property rights and other incentives for innovation.? In addition to other responsible data-sharing activities, Celgene endorses and is implementing the EFPIA and PhRMA Principles for Responsible Clinical Trial Data Sharing which can be accessed using the following link.
Click here to read Celgene’s Clinical Trial Data Sharing Policy.
Researchers interested in obtaining access to clinical trial documents and/or data can make their requests for Celgene clinical trial data using the Vivli platform: https://www.vivli.org. This site includes all the instructions necessary for researchers to register and submit a research proposal. ?Celgene accepts requests from qualified researchers for access to information from Celgene clinical studies for compounds and indications approved in the United States and European Union on or after 1st January 2014. Data requests outside the scope of this policy will also be considered depending on availability of the data and assessment of the scientific validity of the request.
Additional aspects of Celgene’s commitment to responsible data sharing include providing lay summaries of results from all Celgene-sponsored studies to the patients involved in the studies via their physicians, to inform and educate them about their clinical trial participation. The company will continue to register all Celgene-sponsored clinical studies with patients on the public repository ClinicalTrials.gov, and all trials conducted in the EU are registered on the EU clinical trials registry (EudraCT) and on national registries as required at the country level. Furthermore, Celgene will continue to ensure clinical trial results of all Phase III clinical trials and any trial results of significant importance are submitted for consideration as abstracts during congresses and for publication in peer-reviewed journals, regardless of the results of the study and including studies that were discontinued.
Clinical Study Report (CSR) Synopses
Celgene provides public access to the CSR Synopses for clinical trials. A CSR is a long and detailed document providing information about the trial. A CSR is written to provide information to the regulatory authorities as part of the process of seeking approval of a new medical treatment. A CSR synopsis is a summary of the study including data related to the study results.
Celgene posts CSR synopses for Celgene studies submitted on or after 1st January 2014 and approved by regulatory authorities in both the US (Food and Drug Administration (FDA)) and the European Union (European Medicines Agency (EMA). ?Anyone interested in obtaining access to CSR Synopses can utilize the following?link.
Project Data Sphere
Celgene is a member of the CEO Roundtable on Cancer, a nonprofit organization founded at the request of former President George H. W. Bush and is comprised of chief executives from major American companies that are committed to fighting cancer. Under the banner of the CEO Roundtable’s Life Science Consortium, Project Data Sphere has created a platform to share clinical trial data and research findings across academic and bio-pharmaceutical partners.
Project Data Sphere provides an easy to use database that allows companies, institutions, and researchers to responsibly share, access, and analyze cancer clinical trial data sets to accelerate oncology research. Project Data Sphere engages the efforts of all stakeholders in the cancer community to advance science by transforming “big data” into solutions for cancer patients around the world. By enabling the cancer community to tap into the value of clinical trial data, the initiative may lead to faster, more efficient research, reduced duplication, and greater transparency.
The goals of this project are to create more efficient research and corroboration with clinical trial data. Several challenges involving privacy concerns, data security, international law, intellectual property and corporate policies have hampered opportunities in the past. The Roundtable has stated that by employing advanced data security and anonymization strategies, and by pooling multiple studies associated with the same diagnosis, Project Data Sphere addresses both the legal and technical issues associated with sharing clinical trial data.
More information for Project Data Sphere can be found at www.projectdatasphere.org.