Data sharing and open publication: the Takeda example

Valérie Philippon

The commitments of pharmaceutical companies to the principles of open science and discoverability of research are enabling an increasing number of researchers, clinicians, patients and caregivers to freely access and learn from research findings. However, awareness about these commitments across academia, the health services and the broader society is still uneven, and better communication is needed. In November 2021, Valérie Philippon, who represents Takeda in Open Pharma, participated in the UK Health Research Authority #MakeItPublic annual conference. At this meeting, she discussed how transparency in medical research and scientific publishing benefits everyone and how Takeda is putting its commitment to open science into practice.

I was invited by the Health Research Authority, a non-departmental public body within the UK’s National Health Service, to speak at their inaugural #MakeItPublic annual conference on 4 November 2021. The conference was focused on transparency in research, and I was delighted to present progress at Takeda, and discuss wider issues and opportunities in transparency in the pharmaceutical industry.

Since 2002, Takeda has been registering and disclosing clinical trial protocol information for company-sponsored research on and other public registries and websites. Takeda also posts clinical trial result summaries on all applicable public registries and websites in compliance with applicable regulations and industry standards.

Takeda supplements the trial summary information posted on public registries with redacted synopses of clinical study reports on a dedicated website, making the information available to patients, medical professionals, researchers and other stakeholders interested in learning about past and ongoing clinical trials. In addition, alongside its clinical study report synopses, Takeda posts easy-to-read plain language summaries, which provide a brief description of the trials in clear language that is understandable to people without medical training. The website also provides information about Takeda’s policies, values and its commitment to integrity and transparency, and describes how academic researchers can request anonymized patient-level data for secondary research purposes. These data are shared via a global data-sharing and analytics platform that gives researchers access to clinical research studies across numerous disease areas. While Takeda recognizes its collective obligation to share data responsibly with the broader scientific community to advance research and knowledge, it also recognizes the legal and ethical obligation to share data in a way that protects trial participants’ privacy.

Takeda’s commitment to transparent data sharing and timely publication of its research is grounded in its corporate philosophy that integrates Patient–Trust–Reputation–Business, in that order. Takeda was the first of the 20 largest pharmaceutical companies in the world to implement an open access publication mandate that requires the submission of all Takeda-supported research manuscripts to journals that make their articles publicly available via open access. This decision enables the public to obtain free, unrestricted online access to Takeda’s research promptly following publication. The open access mandate underscores our commitment to transparency and to serving patients with integrity by prioritizing research dissemination.

What’s next for open science at pharmaceutical and biotech organizations? Achieving full open access of research outputs still presents several challenges for most of these organizations. Internal factors can create barriers: research data generated by pharmaceutical companies come from many different Research & Development groups, who may not all be aware of the importance of open access publishing. In a large company, it takes a lot of communication for such information to reach every group. There are external challenges as well; for example, not all publishers of medical and scientific research offer open access options to for-profit organizations such as biopharmaceutical companies. In addition, some journals only grant open access after a 6–12-month embargo period during which the results are only accessible via a subscription to the journal or by paying a fee to access the content of an individual article.

Both types of challenges can be overcome. Tackling internal barriers is the easiest task, and it can be done by creating open access policies within each company and communicating them very broadly across all internal research groups. On the external side, the past 4–5 years have seen several publishers and societies, such as the American Society of Clinical Oncology, change their policies and start offering open access publishing to biopharma. Hopefully, this trend will carry on, and Open Pharma will continue to have a key role in supporting this positive change. Let’s be hopeful that within a short couple of years, all medical journals and publishers will offer open access publishing regardless of the research funding source.

The panel discussion during then #MakeItPublic conference organized by the Health Research Authority in the UK was an opportunity to discuss transparency and openness in health and social care research with key stakeholders across academia, the pharmaceutical industry and the public. These conversations are essential as they encourage best practices in research transparency and allow for researchers to hear first-hand how transparent, safe and ethical research benefits patients, caregivers and communities.

Valérie Philippon is Head of Global Publications at Takeda, a founding Member of Open Pharma.

This article represents the view of its author and Takeda.