Takeda is committed to transparency and integrity in its clinical research in keeping with our corporate philosophy of Takeda-ism. Takeda has been and continues to be committed to complying with all laws and regulations related to the registration and disclosure of Takeda-sponsored clinical study information.
Takeda is dedicated to the timely registration of clinical studies, communication of clinical study result summaries, and publication of our company sponsored clinical research. Following a change in the Association of the British Pharmaceutical Industry's (ABPI) Code of Practice, companies are now obliged to publish all clinical trial results within one year of marketing authorisation and publically register new trials within 21 days of the first patient being enrolled. Takeda is pleased to meet these requirements.
In addition, Takeda supports pharmaceutical industry's joint initiatives relating to increased clinical trial transparency, including the principles and joint positions of IFPMA, EFPIA, JPMA, and PhRMA relative to the disclosure and publication of results from clinical studies for approved medicines. Takeda is committed to complying with the PhRMA/EFPIA principles and to sharing, upon request from qualified scientific and medical researchers for legitimate research purposes, anonymised patient-level clinical study data, study-level results summaries, and protocols from clinical studies for approved medicines and indications. Takeda is actively working to establish processes to accept and review data sharing requests consistent with this commitment, while also safeguarding patient privacy and confidentiality.
Takeda makes all reasonable efforts to provide current protocol information and study result summaries for Takeda-sponsored clinical studies. These study results pertain to the main objectives and key safety information in the form of summary data based on a single study population. These data do not include patient-level data.
Although these single study result summaries may be helpful to patients, physicians, and researchers, they may not reflect the overall benefits and risks associated with Takeda's medicines, which are based on the entirety of the information available for a given medicine. So while patients are welcome to view the study result summaries provided via the below link, only qualified healthcare professionals can determine if a specific medicine is appropriate for a particular patient. If you are a patient and have questions regarding any information available, or a particular medical condition, you should consult a qualified healthcare professional.
When making prescribing decisions, healthcare professionals should always refer to the specific labelling information approved in the patient's country or region rather than information provided by Takeda. The information provided by Takeda is not intended to promote or otherwise commercialise (directly or indirectly) Takeda medicines or any off-label or unapproved uses.
As we are in the process of combining information relating to Shire clinical trials and aligning Takeda and Shire clinical trial approaches, please visit www.ShireTrials.com?to learn more about Shire clinical research and, if an academic researcher, to request access to clinical trial patient-level data through the Shire legacy data sharing process.?
Date of Preparation: March 2020