Our Commitment to Transparency

Transparency is inherent in our commitment to serve the patient by creating a vibrant, inventive and ethical culture that will help people lead better, fuller lives today, tomorrow and well into the future. Shire is committed to responsible sharing of clinical study data.

The value of Shire's clinical trial transparency efforts

Our efforts toward proactively exceeding clinical trials transparency regulations aim to provide valuable support to our stakeholders. We want to give them consistent access to information on clinical trials throughout the product life cycle: from discovery to licensure to post-marketing activities. At Shire, we firmly believe that greater transparency creates value and is critical to advancing patient, public and global health.

Jeremy Chadwick

“Greater transparency and responsible data sharing are increasingly important topics for the pharmaceutical industry. At Shire, we recognize that sharing 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, Head Clinical Development Operations)

The patient and public relationship

Providing the highest possible level of transparency for our patients and the public supports visibility of clinical trials, and facilitates their potential to contribute to future therapies. We do this by providing public access to redacted Clinical Study Report (CSR) synopses and plain language summaries (PLSs). Access to this information is intended to facilitate patients’ roles in decision-making, and to increase their confidence in product development and their understanding of authorities’ decisions.

We also provide access to patient level data (PLD) for researchers (in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization). This access supports additional investigations - for example, comparisons with other products - and prevents redundant research. In doing this, the number of clinical trials can be reduced, and, in the longer term, we hope to facilitate lower costs of medicines for our patients. All of this is tied to the ultimate goal of improving patient care and making it affordable.

Still, we are mindful of our ethical responsibility to ensure that the privacy of research participants and patients is protected. Our focus on rare diseases increases the urgency of our prioritization of patient data protection and we are careful to mitigate the risk of data identification.

Our scientific publications help to facilitate exchange between patients and the scientific community by increasing understanding of how clinical trials contribute to the development of new products and therapies, while also expanding knowledge in the public sphere.

The research and medical community relationship

Shire’s endeavors to enhance clinical trial transparency for the research and medical communities by enabling access to PLD, CSRs and their synopses, clinical trial protocols, and other supportive study documents for legitimate scientific investigations help to increase understanding of our product development pipeline and expand researchers’ scope for further exploration. In keeping with our engagement to provide patients and the public with PLS, we anticipate indirectly supporting the scientific community by empowering patients and driving their decisions to participate in clinical research (by enrolling in clinical trials) to serve their interests.

Shire’s commitment to “open access” for all scientific publications facilitates academic dialogue and can pinpoint common foci of research and future opportunities for synergies with research/medical communities.

Our Studies

Shire sponsors many clinical research studies to develop innovative treatments for a variety of conditions and unmet medical needs. Click below to see a list of studies.

Frequently Asked Questions

What is a clinical trial?

A research study is the name given to a scientific study used to find out if and how a new or existing drug/treatment works. These can also be called clinical trials, clinical studies, or clinical research studies.

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Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate.

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