Our Clinical Trial Transparency Commitments

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Integrity and Transparency

At Takeda, our policies meet or exceed the pharmaceutical industry's guidelines and best practices for transparency. This includes guidelines issued by the International Federation of Pharmaceutical Manufacturers & Associations; the European Federation of Pharmaceutical Industries and Associations; the Japan Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America.

“Takeda-ism”

Our core values and guiding principles of fairness, honesty, and most importantly, integrity, have been embodied by the Takeda brand for more than 230 years. What does this mean for our clinical research?

  • The ongoing pursuit to promote better health and brighter futures for our patients through innovative medicines.
  • Prioritization of clinical research transparency.
  • Availability of research information and results to the public.
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Diversity, Equity and Inclusion

At Takeda, we believe that in order to achieve health equity, everyone must have an equitable opportunity to attain their full health potential.

We are working to achieve greater health equity for all communities regardless of social position, age, gender, race, ethnicity, or any other factors that impact health and access to healthcare.

To achieve greater health equity for all patients:

  • We address health disparities and inequities that disproportionately impact underserved communities, including access to clinical trials.
  • We are committed to creating diverse, equitable, and inclusive culture within Takeda, within our communities, and across our clinical trials

Find more details here about Takeda’s Commitment to Diversity, Equity and Inclusion.

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Takeda Clinical Trial Portal

The TakedaFind a Clinical Trialsearch tool is an easy-to-use method to locate Takeda-sponsored trials and provide searchability for plain language information on:

  • A particular condition/disease
  • Available clinical trials near a defined location
  • Clinical trial entry criteria and design elements
  • Summary of study results

To promote the diversity of clinical trial populations and to demonstrate respect for patients’ multilingual backgrounds and preferences, translation options are available using the translation tool at this website. Translation is also offered on an individual study basis.

For those with disabilities, accessibility adjustments are available using the adjustment tool o icon on the website.

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Clinical Trial Registration

Since 2002, Takeda has been registering and disclosing clinical trial protocol information for company-sponsored research onclinicaltrials.govas well as other public registries and websites in compliance with industry standards and applicable regulations.

Regulations and industry guidelines are met or exceeded through the registration of:

  • Interventional Phase 1 - 4 clinical trials.
  • Applicable non-interventional clinical trials – including real world evidence and studies of health economics and cost effectiveness.

Clinical trial protocol information is available on this website. Detailed information on clinical trials is also available in different languages using the translation tool .

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Clinical Trial Results Disclosure

Takeda posts the results of our clinical trials on all applicable public registries and websites in compliance with applicable regulations and industry standards, regardless of the trial outcome or where it might take place.

This includes results of Takeda-sponsored clinical trials for:

  • Unapproved treatments and unapproved uses of approved treatments.
  • Interventional Phase 2 - 4 clinical trials.
  • Other types of interventional and non-interventional clinical trials (including, eg phase 1, real world evidence, health economic and cost effectiveness studies) even if not required by regulations/requirements.

Clinical trial summary results are available on this website.

Takeda supplements the summary information posted on public registries with redacted synopses of clinical study reports, which are available to patients and the public on this website.

Redacted and anonymized full Clinical Study Reports (CSRs) for clinical trials on products covered in a Clinical Trials Application and approved in the EU are accessible on the EMA Clinical Data Website. For products that received a final regulatory decision by Health Canada, the redacted and anonymized CSRs are accessible on the Health Canada Website.

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Sharing of Clinical Trial Results with Participants and Public

Takeda has created (since 2014) easy-to-understand plain language summaries that describe the design of each study and explain the objectives and results. These are provided in clear language that is intended to be understood by people without medical training.

These are made available not only to patients, but also to the general public on this website.

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Clinical Trial Scientific Publications

Takeda is committed to making every effort to submit manuscripts describing results of Takeda-sponsored phase 2–4 interventional clinical trials within 18 months after clinical trial completion (for marketed products), regulatory approval in a major market (for investigational assets), or the decision to discontinue clinical development of investigational medicines.

All manuscripts resulting from Takeda-sponsored research are submitted to journals that offer public availability via Open Access.

As ethical stewards of patient data, Takeda uses stringent safeguards to minimize the risk of study participant re-identification for all manuscripts, thereby ensuring that the data presented in our scientific publications is secure and untraceable. Find more details here.

Access to scientific publications on Takeda-sponsored clinical trials is possible using this website via clinicaltrials.gov, where links to articles in scientific journals are available.

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Data Sharing with Researchers

Access to clinical trial data is important for the advancement of medical science. Takeda is committed to responsible sharing of information related to approved medicines with qualified researchers. This includes:

  • Patient-level clinical trial data (anonymized information collected about individual participants during a clinical trial).
  • Clinical trial documents, such as clinical study reports, protocols, statistical analysis plans.

Takeda also shares data from clinical trials for which the clinical development program has been terminated.

Takeda’s patient-level data-sharing policy provides qualified researchers access to data and supporting clinical trial documentation from Takeda-sponsored:

  • Phase 1 - 4 interventional clinical trials for commercially available products that received initial marketing approval in 2005 or thereafter (or products whose clinical development was terminated in 2014 or thereafter) in applicable regions (generally in US and/or EU, and Japan-only)
  • Phase 2 and 3 interventional studies for approved Takeda compounds.

Takeda is committed to sharing patient-level data within 18 months following completion of the clinical trial or 6 months following EU/US approval or Japanese approval (when EU or US approval was not sought), whichever is the later date.

As an ethical steward of patient data, Takeda shares the data in a way that protects privacy. Takeda primarily shares patient-level data via Vivli. Vivli is a global data-sharing and analytics platform that provides researchers access to clinical studies across numerous disease areas in an anonymized, protected format.

Find more details about Takeda’s data sharing commitments (Data Sharing Policy)

Requests from qualified researchers through Vivli are rigorously reviewed, and access is provided in a secure, cloud-based environment.

See a figure showing the outcome of researcher requests received on an annual basis since 2014here.

“Sharing clinical trial data with the wider research community and other biopharmaceutical companies represents a significant step forward in improving clinical trials’ transparency. It is also a tremendous enhancement to the clinical research process and a unique opportunity for comparative and exploratory investigations. In turn, this can prevent redundant clinical trials and result in new treatment opportunities, identified through analyses of shared data among broader research entities - all of which will bring meaningful benefit to our patients.”

Penny Carlson, VP, Head of Innovation and Data

Takeda R&D

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Takeda Policies