Takeda's Commitment

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 are now referred to as Takeda-ism.

For more than 230 years, the Takeda brand has embodied the values of fairness, honesty, and most importantly, integrity. Known as “Takeda-ism,” these core values serve as guiding principles in our pursuit to promote better health and brighter futures for our patients through innovative medicines.

Today, Takeda continues our tradition of integrity by prioritizing clinical research transparency and making clinical research information and results available to the public.

“Greater transparency and responsible data sharing during development of new medicines and throughout their life cycles are core topics for the pharmaceutical industry. At Takeda, we recognize that responsible sharing of clinical trial data with patients, healthcare providers, researchers, and the public is critical to delivering innovative medicines. Increased transparency improves public trust in our products and treatments and helps all our stakeholders make better healthcare decisions.”

Jeremy G Chadwick, Ph.D., Head of Global Development Office, Takeda R&D

Takeda is committed to compliance with clinical trial transparency laws and regulations as well as an objective, unbiased clinical trial results reporting, regardless of outcome. This includes 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.

Our policies meet or exceed the 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).

Takeda adheres to and seeks to exceed requirements laid out by the Principles for Responsible Clinical Trial Data Sharing, which were issued by the EFPIA and PhRMA in July 2013. Takeda will do this by:

To further promote transparency, Takeda developed a Find a Trial search tool to identify Takeda sponsored interventional and non-interventional clinical trials and provide easy searchability for information on a particular condition/disease; available trials near a defined location; trial entry criteria and design elements, as well as a summary of study results, all written in plain language.

Diversity in clinical trial participation leads to better research, treatment and health outcomes for individuals from a diverse range of backgrounds according, but not limited to age, gender, race and ethnicity. Because some groups have been underrepresented in clinical research in the past, there is an urgent need to ensure appropriate representation in clinical trials and to gain information about treatment outcomes in diverse populations. This is particularly important for clinical trials studying diseases that disproportionately affect specific ethnic minorities.

Takeda is therefore focused on enhancing the diversity of clinical trial populations and promoting participants’ enrollment practices to provide clinical trial results that better reflect the populations most likely to use medical products once they are approved. Takeda is establishing concrete policies and practices to address diversity in clinical trials, as outlined in the PhRMA Principles on the Conduct of Clinical Trials.

Clinical Trial Registration

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

As per Takeda’s policy, all regulations and industry guidelines are met or exceeded through the registration of interventional Phase 1 - 4, and further surpassed by registering applicable non-interventional trials, regardless of trial outcome or where the trial is or was conducted.

Clinical trial protocol information is available on this website.

Clinical Trial Results Disclosure

Takeda posts clinical trial result summaries on all applicable public registries and websites in compliance with applicable regulations and industry standards.

This includes results of Takeda-sponsored trials for unapproved treatments, unapproved uses of approved treatments, and interventional phase 2-4 trials, regardless of trial outcome or where the trial is or was conducted. Takeda also exceeds regulations and industry guidelines by disclosing results from phase 1 interventional and applicable non-interventional trials. For innovative medicines commercially available since 2005, Takeda retrospectively posts historical summary information from phase 1–4 interventional trials that was not previously disclosed (including phase 1 trials in healthy participants, which is not required by law). For clinical trials completed after January 1, 2014, Takeda will post summary results on public registries and websites within one year after trial completion for trials in adults, and within 6 months of trial completion for pediatric trials with an EU nexus, regardless of product approval status.

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.

Clinical trial summary results are available on this website.

Sharing of Clinical Trial Results with Participants

As of January 1, 2014, Takeda has been working with regulators and pharmaceutical trade organizations to adopt mechanisms for creating easy-to-understand plain language summaries. A plain language summary provides a brief description of the trial design, objective and results written in clear language that is understandable to people without medical training.

Takeda voluntarily exceeds current disclosure requirements by continuing development of plain language summaries for certain pivotal studies and making them available not only for patients, but also for the general public on this website.

Clinical Trial Results Publication

Takeda supports scientific research by providing clinical trial investigators with patient-level data from their investigational sites upon trial completion. Appropriately qualified investigators who serve as authors of clinical trial publications are further supported by giving them full access to trial data, results and analyses.

Takeda is committed to making every effort to submit manuscripts describing results of Takeda-sponsored phase 2–3 interventional drug development trials and phase 4 interventional trials using approved compounds, and clinical studies evaluating Takeda’s medical devices, within 18 months after trial completion (for marketed products), after regulatory approval, or after the decision to discontinue clinical development of investigational medicines.

As a demonstration of Takeda’s commitment to Open Science, transparency and the discoverability of Takeda research, all manuscripts resulting from Takeda-sponsored research, regardless of research type, audience, and language, are submitted to journals that offer public availability via Open Access, allowing researchers, clinicians, patients and their caregivers to freely access and learn from our research.

Data Sharing with Researchers

Providing researchers with access to clinical trial data may help advance medical science or facilitate the advancement of knowledge and understanding. Takeda’s commitment includes responsible sharing of 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 trials for which the clinical development program has been terminated.

Patient-level data refers to detailed but anonymized information collected about individual participants during a clinical trial. 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 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). For phase 2 and 3 interventional studies that are part of an approved Takeda compound, Takeda is committed to sharing patient level data within 18 months following completion of the trial or 6 months following EU/US approval or Japanese approval (when EU or US approval was not sought), whichever is the later date.

We recognize our collective obligation to share data responsibly and contribute to the broader scientific community to enable innovative new treatments for patients, but equally Takeda recognizes the need to utilize and share data in a way that protects privacy, where Takeda acts as an ethical steward of patient data. 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.

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

Qualified researchers can 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 using 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.

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

" 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 Global Development Support, Takeda R&D