Baxalta designs and conducts clinical studies in accordance with ethical principles included in the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines as well as national and international regulatory requirements and applicable laws.
As a patient-centric company, Baxalta believes that it is important for researchers, clinical study participants, regulators, and the general public to have access to clinical trial information. This supports the advance of medical understanding in disease areas, progress in scientific research, patient care development and public health improvement. We have taken a thoughtful approach that strikes a balance between our commitment to sharing data, while safeguarding patient confidentiality and the regulatory process.
Baxalta adheres to the principles of responsible data sharing laid out by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Baxalta also complies with requirements from the International Committee of Medical Journal Editors (ICMJE), and with the positions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on disclosure of clinical study information and results.
Baxalta publicly shares summarized clinical study results (CSR synopses and lay summaries) for medicines and indications approved in the U.S. and E.U. since January 1, 2014. Researchers are able to request access to patient-level data from clinical trials sponsored by Baxalta for compounds and indications approved in the United States and European Union on or after January 1, 2014. Data Requests outside the scope of this policy may be considered in appropriate circumstances.
Learn more about Baxalta's position on public access to clinical trials information.
Access available summarized clinical study results (CSR synopses and lay summaries).