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.

Enhancing Data Sharing with Researchers

Providing independent researchers access to clinical study data may help advance medical science or ensure creation of further knowledge and understanding. In 2014, Shire began accepting requests from researchers for patient-level data for Shire-sponsored studies. Researchers are able to request access to patient-level data from Shire clinical studies for compounds and indications approved in the United States and European Union on or after January 1, 2014. Data Requests outside the scope of this policy may be considered in appropriate circumstances. For data from clinical trials involving patients with rare diseases, Shire will continue to protect patient privacy by retaining its current approach that balances data utility while mitigating the risk of personal data identification.

Read our Scope of Policy.

Data Request Process Overview

DataRequestProcessOverview

Researchers may submit request for de-identified patient-level data from Shire sponsored clinical studies for compounds and indications approved in the United States and European Union on or after January 1, 2014.

Once Shire assesses the validity of the researcher's data request and determines appropriate consent(s) exists for requested product(s) and indication(s), an internal team will review the request and render a decision. In cases where the validity of the researcher or proposed request is in question, Shire will defer the request to an external Independent Review Panel (IRP) to deliver a final opinion.

For approved requests, the Researchers will be provided access to the approved data on a password protected website after Shire receives a signed Data Sharing Agreement.

Note: Withdrawn marketing applications and those that received a negative opinion from the regulatory authorities will be considered confidential unless or until development of the product is terminated. 

Submission Process

All research proposals must be submitted by completing a Data Request Form which requires the following basic information:

  • Detailed research proposal includes:
    • Background and rationale
    • Research design and objectives
    • Scientific hypothesis
    • References supporting the research proposal
    • The data, information, studies and study populations requested for research
    • Consideration for Ethical Committee or Institutional Review Board approval
    • Statistical analysis plan
    • Publication plan
    • Source of the resource funding
  • Curricula Vitae of all researchers including the biostatistician
  • Assessment of potential conflicts of interest outside the funding of the proposed research

Data Request Review Process

Once Shire assesses the validity of the researcher's data request and determines appropriate consent(s) exists for requested product(s) and indication(s), an internal team made of subject matter experts will review the eligibility of the proposed research against the criteria below and render a decision. In cases where the validity of the researcher or proposed request is in question, Shire will defer the request to an external Independent Review Panel (IRP) for a final, objective opinion.

Eligibility

In response to legitimate, verified scientific requests from researchers qualified to perform the proposed analyses, Shire will request that a Data Sharing Agreement is signed prior to receiving access to clinical trial data. The request will be reviewed on the following criteria:

  • The scientific rationale, statistical validity, and relevance of the proposed research to medical science or patient care
  • The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives
  • The publication plan for the research
  • Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research, and proposals to manage these conflicts of interest
  • The qualifications, experience, and resources of the research team to conduct the proposed research

Independent Review Panel

The IRP membership consists of non-Shire healthcare professionals and clinical biostatisticians.

Access to Data

For approved requests, the Resarchers will sign a Data Sharing Agreement and will be provided access to the approved data on a password protected website.

Due to the complexity of the process to de-identify data, it may take up to 9 – 12 months to provide requestor access to data after obtaining a signed Data Sharing Agreement.

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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