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Takeda Clinical Trials

Quick Trial Finder

Takeda is committed to transparency and integrity in fulfilling our core mission of developing innovative new medicines that promote better health and brighter futures for our patients.

The Nori. Written in 1940 by Chobei Takeda V, the Nori (shown here) is a list of 5 principles that guide all Takeda employees’ actions. The Nori principles have become the spirit of Takeda and are now referred to as Takeda-ism. The Takeda-ism principles are centered upon integrity and guide the actions of all Takeda employees.

» Read more about Takeda’s history
and corporate philosophy

Takeda Clinical Trial Transparency Overview

Takeda’s commitment to transparency reflects our strong support for sharing clinical trial information to benefit patients and to foster scientific discovery in a way that maintains patient privacy and preserves the integrity of our research.

Specifically, Takeda is committed to complying with clinical trial transparency laws and regulations applicable to our company-sponsored clinical research, regardless of outcome. Furthermore, our transparency policies meet or exceed pharmaceutical industry’s guidelines and best practices relating to clinical trial registration and results disclosure, including guidelines issued by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA); the European Federation of Pharmaceutical Industries and Associations (EFPIA); the Japan Pharmaceutical Manufacturers Association (JPMA); and the Pharmaceutical Research and Manufacturers of America (PhRMA). Learn more about Takeda’s expanded commitments to clinical trial transparency outlined in the sections below.

Additionally, Takeda’s policies meet or exceed the transparency principles set out in the Principles for Responsible Clinical Trial Data Sharing that were issued by EFPIA and PhRMA in July 2013. These 5 principles call for a broader sharing of clinical trial data in ways that safeguard patient privacy, respect regulatory processes and oversight, and maintain incentives to invest in biomedical research.

As a testament to our commitment to integrity and Takeda-ism, our transparency policies have recently been broadened to provide expanded access to clinical trial information.

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Clinical Trial Registration

Since 2002, Takeda has registered and disclosed information for company-sponsored clinical research on clinicaltrials.gov and other websites in compliance with industry standards and applicable regulations.

Takeda’s expanded clinical trial data transparency policy seeks to go beyond compliance. To achieve this, Takeda will register all Takeda-sponsored interventional trials or non-interventional trials designed to assess the effects of our medicines. Takeda commits to register these trials on www.clinicaltrials.gov (at a minimum) prior to the start of each trial. Our trial registration policies meet or exceed all regulations and industry guidelines (for example, by including more types of trials, such as phase 1 healthy-participant trials).

To further demonstrate our commitment to transparency and in a continued effort to support our patients’ access to medical information and to clinical trials, Takeda also seeks to consolidate publically disclosed clinical trials summary protocol registration information on this website.

Takeda will not list studies of products or investigational therapies that are sponsored by physicians or academic investigators or partner companies, but encourage them to do so.

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Clinical Trial Summary Results Disclosure

Find more information about Takeda clinical trials in English here:

Takeda’s approach to posting clinical trial result summaries on public registries (such as clinicaltrials.gov and the EU Clinical Trials Register for studies in scope with EU requirements set forth by EMA) and posting trial result synopses on Takeda’s website demonstrates our commitment to enhancing public access to clinical trial information.

Specifically, summary results for completed Takeda-sponsored interventional trials, non-interventional trials designed to assess the effects of our medicines, and other clinical trials that convey significant medically important information about the benefit/risk profile of our medicines, are disclosed by Takeda on all applicable public registry databases (at a minimum on clinicaltrials.gov). Takeda supplements the summary information posted on these tabular public registries by making clinical trial result synopses available to patients, researchers, and healthcare providers.

Redacted and anonymized full Clinical Study Reports (CSRs) for Takeda-sponsored and Shire (now part of Takeda)-sponsored clinical trials on products covered in a Clinical Trials Application and approved in the EU are accessible on the EMA Clinical Data Website.

For new clinical trials completed after January 01, 2014, Takeda will post tabular and synoptic summary results no more than one year after trial completion on public registries (or sooner as required by law) and on TakedaClinicalTrials.com, respectively, regardless of product approval status.

In addition, Takeda is broadening results disclosures for innovative medicines approved and commercially available since 2005 to include retrospective posting on TakedaClinicalTrials.com of historical summary information from Takeda-sponsored phase 1–4 interventional trials that had previously not been disclosed (for example, because they were not required by law, such as phase 1 trials in healthy participants).

To further demonstrate our commitment to transparency and in a continued effort to support our patients’ access to medical information and to clinical trials, Takeda also seeks to consolidate publically disclosed clinical trials summary protocol registration information on this website.

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Our Commitment to Sharing Results With Patients Who Participate in Clinical Trials

As of January 1, 2014, Takeda is working with regulators and pharmaceutical trade organizations to adopt mechanisms for creating easy-to-understand factual summaries (“lay summaries”) of clinical trial results and making these summaries publically available to research participants.

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Our Commitment to Publish Clinical Trial Results

Takeda is committed to the accurate, balanced, and timely publication of its research. Takeda submits for publication to peer-reviewed venues the results from all clinical trials in patients, regardless of trial outcomes, and all other research for which the results are considered scientifically or medically important.

Takeda’s publication policy and practices are aligned with the following guidelines: The International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, the IFPMA Joint Position on the Publication of Clinical Trial Results; the Consolidated Standards of Reporting Trials (CONSORT) group (Schulz et al, BMC Medicine; 2010); and Good Publication Practice for Communicating Company-Sponsored Medical Research (Graf et al, BMJ;2009).

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Our Commitment to Enhance Data Sharing With Researchers

Takeda has expanded our transparency commitment to include responsible sharing patient-level clinical trial data and clinical trial documents, such as clinical study reports, protocols, and statistical analysis plans, for approved medicines with qualified researchers. We also share data from studies for which the clinical development program has been terminated.

Patient-level data refers to detailed information collected about each individual participant during a clinical trial. Takeda’s sharing of patient-level data with researchers may help to further scientific understanding of our medicines and demonstrates our commitment to transparency and the wider research community.

Takeda primarily shares patient-level data via Vivli. Vivli is a global data-sharing and analytics platform providing researchers access to clinical research studies across numerous disease areas. Vivli has the potential to create a more connected and interoperable data sharing landscape and in so doing positively impact the health of our patients. Takeda supported the development of Vivli from its inception and is proud to be a founding member and data contributor.

Qualified researchers are able to make requests for anonymized clinical trial data relating to in-scope approved or terminated Takeda products through the Vivli data sharing platform. Requests are initially reviewed for completeness and undergo sponsor checks prior to being reviewed by a fully independent review panel (managed by the Wellcome Trust). Once a research proposal is approved and a data sharing agreement is signed, the data are provided to researchers through the secure Vivli cloud-based research environment. Prior to being shared, the data and documents are anonymized/protected to maintain the privacy of participants and Takeda confidential information. In agreement with good scientific practices, researchers are required to submit a research plan and commit to transparency by publishing or otherwise making public the results of their research.

For data requests for Shire (now part of Takeda) clinical trials, please visit Data Sharing with Researchers.

Takeda’s patient-level data-sharing policy seeks to provide qualified researchers access to data and supporting clinical trial documentation from Takeda-sponsored phase 1–4 interventional trials for commercially available medicines and vaccines that received initial marketing approval since 2005 (or products whose clinical development has been completely terminated since 2014) in applicable regions (generally in US and/or EU, and Japan-only).

This policy exceeds the minimum requirements set out in the joint position principles for responsible data sharing published by the International Federation of Pharmaceutical Manufacturers & Associates (IFPMA) and consistent with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Japanese Pharmaceutical Manufacturers Association (JPMA).

» Find more details about the scope of Takeda’s data sharing policy here

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Expanded Access to Investigational Drugs

New medicines are only approved by regulators, such as the Food and Drug Administration (FDA) for the United States, the European Medicines Agency (EMA) for the European Union, and the Pharmaceuticals and Medical Devices Agency (PMDA) for Japan, once they have been thoroughly evaluated in clinical trials and are safe and effective for their intended use. Before approval, new medicines are often called “investigational drugs.” Clinical trials are the most common route for patient access to investigational drugs. Participation in clinical trials is vital to the development of new medicines. Takeda encourages patients to discuss with their licensed healthcare professional whether participating in a clinical trial could be a potential option for them. Information about Takeda’s open clinical trials is available on this website or on www.clinicaltrials.gov.

Takeda is committed to serving patients by providing safe, fair, and sustainable patient access to its medicines. In some cases, Takeda may be able to provide patients access to its investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of investigational drugs outside of a clinical trial is known as Expanded Access (sometimes referred to as compassionate use). Expanded Access may not always be available and requires the individual patient meet certain eligibility conditions:

  • Has a diagnosis of a serious, life-threatening or debilitating disease
  • Has no alternative treatment options available
  • Is unable to participate in a clinical trial due to eligibility criteria or other reasons

In addition, Takeda will consider providing Expanded Access only if the risk/benefit profile of the investigational drug is favorable in light of the available safety and effectiveness information and the treating physician’s assessment of the patient’s medical condition.

To request Expanded Access, your licensed healthcare professional should contact Takeda on your behalf by emailing ExpandedAccess@Takeda.com. Takeda will make every effort to respond within three business days.

In addition, you or your licensed healthcare professional can find more information on existing Expanded Access Programs in the U.S. by searching for Expanded Access records on www.clinicaltrials.gov.

» Our Commitment to Enhance Data Sharing With Researchers

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Independently Sponsored Research Collaborations

Takeda provides support for unsolicited, independent clinical and basic science research that addresses important medical and scientific questions related to our compounds and therapeutic areas of interest through its Investigator Initiated Sponsored Research (IISR) program.

» Learn about Takeda’s IISR Program.