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.

Scope of Policy

Data sharing principles and processes are evolving. Our policy is another step on our journey to strengthen our commitment to our patients. It is subject to updates as appropriate based on our experience and recommendations from advisory and regulatory groups.

Beginning January 2015, our disclosure policy applies to the registration of all interventional and non-interventional Phase 1-4 Shire-sponsored clinical studies conducted in patients regardless of study outcome or where the study is conducted on applicable public registries, with the exception of clinical pharmacology studies in healthy volunteers. Shire will only register clinical pharmacology studies in healthy volunteers that the protocol review committee has determined should be registered.

Shire-sponsored studies are those in which our company is fully responsible for every aspect of the study. We will take the responsibility of meeting our obligations under our public disclosure policy to the extent permitted by law and other legal obligations. Shire promotes an open and transparent way of accessing and disseminating patient-level data. There are circumstances when patient-level data cannot reliably be de-identified (e.g. in small studies of rare diseases), which may pose challenges, as patient privacy or confidentiality must universally be safeguarded. In such cases, Shire will continue to protect patients’ privacy by retaining its current approach that balances data utility while mitigating the risk of personal data identification. In addition this may also include clinical study report sections that contain certain commercially confidential information (CCI) and intellectual property (IP). It may also apply to circumstances where legal, contractual or consent provisions prohibit data transfer to a third party (i.e. co-developed or out-licensed projects or the limitations of the informed consent of study participants might not allow data sharing).

Shire lists clinical studies for approved and investigational drugs, devices and biologics. We will not list studies of our products or investigational therapies that are sponsored by physicians or academic investigators or partner companies, but encourage them to do so.

Search our List of Studies.