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.

Public Access to Clinical Study Information and Results

Study registration

Shire registers all interventional and non-interventional Phase 1-4 Shire-sponsored clinical studies conducted in patients regardless of trial outcome or where the study is conducted on applicable public registries (i.e. www.clinicaltrials.gov and national registries as required by local regulations), 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 will also register all Shire-sponsored studies conducted in Europe in their relevant registry, EudraCT, which the EMA makes publically available via the clinical trial registry (www.clinicaltrialsregister.eu).

Study results

In a timely manner and in accordance with all applicable laws and regulations, Shire will post results from all Shire-sponsored products involving Shire products completed after September 27, 2007 or initiated on or before that date, and were still ongoing as of December 26, 2007 on www.clinicaltrials.gov and other registries as required, including Shiretrials.com, regardless of geographical location or trial outcome. Learn more about FDA Amendments Act and Final Rule.

Shire will post results of all Shire-sponsored studies on EudraCT in scope with EU requirements in accordance with timing and modality set forth by EMA. Learn more about EMA Directive 2001/20/EC.

Redacted and anonymized full Clinical Study Reports (CSRs) for Shire-sponsored clinical trials on products covered in a Clinical Trials Application and approved in the EU are accessible on the EMA Clinical Data Website. In addition, Shire is in the process of making redacted synopses of CSRs for Shire-sponsored clinical studies in patients available on www.shiretrials.com.

Furthermore, as of January 1, 2018, Shire-supported research manuscripts will be submitted to journals that are visible to the public via Open Access

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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