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How We Operate

Position on Public Access to Clinical Trials Information

Baxalta demands transparency in clinical study results with the aim of empowering patients and healthcare professionals to make informed decisions about treatment.

Current commitments:

Clinical study registration

Baxalta believes that public registration of clinical trials is a scientific and ethical obligation, facilitating physicians’ decisions, enabling patient access to new therapies and potential participation in clinical studies.

Baxalta meets existing authority requirements regarding the disclosure of clinical trial information and results. Upon initiation of a clinical trial, protocol information is posted on publicly accessible online registries, including www.clinicaltrials.gov, www.clinicaltrialsregister.eu, www.encepp.eu, and country-specific/national trial registers, as applicable.

Clinical study results disclosure

After completion or termination of a clinical trial, results are posted, regardless of the outcome, according to laws and regulations, on publicly accessible online registers including www.clinicaltrials.gov, www.clinicaltrialsregister.eu, www.encepp.eu, and country-specific/national trial registries, as applicable.

Clinical study results publication

The results of Baxalta clinical trials are published in peer-reviewed medical journals in order to disseminate clinical study results to the scientific community.

Clinical study report synopses and lay summaries

Clinical Study Report (CSR) synopses and factual lay summaries of clinical trials using medicines/indications approved in the US and EU from January 1, 2014 will gradually be made available on this website.

Access available summarized clinical study results (CSR synopses) and lay summaries here.

Protection of patient privacy

Baxalta has made a commitment to protect patient privacy by safeguarding personal data and restricting the use of data from clinical trials so that the scope of patients’ informed consent is respected.

Therefore, personal data and certain commercially confidential information contained in clinical study synopses and summaries is redacted prior to posting.

Anonymized patient-level data

Anonymized patient-level data from clinical trials sponsored by Baxalta for medicines/indications approved in the U.S. and E.U. from January 1, 2014 can be made available for legitimate academic and non-commercial research upon request from qualified external researchers.

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