Access to Our Clinical Trial Data

The Company is fully committed to providing qualified scientific researchers access to anonymized patient level data and full clinical study reports (CSRs) from our clinical trials. Qualified researchers with appropriate competencies, engaged in rigorous, independent scientific research can submit a data request for patient-level data or a full CSR.

Scope of Data
The Company will provide access to patient-level data and CSRs for clinical trials performed by the Company for which results are posted on the clinicaltrials.gov registry (dating back to September 2007) for products or indications that have been approved by regulators in the US and EU. In general, data will be made available for request approximately 18 months after clinical trial completion. Data from Phase I trials in healthy volunteers and consumer health care studies are out of scope.

Genetic or exploratory biomarker data requires a detailed, hypothesis-driven statistical analysis plan that is collaboratively developed by the requestor and Company subject matter experts.

View our procedure on access to Clinical Trial Data

Start a Proposal
To start the request proposal, you can search for any of our Clinical Trials using the search form below. Once you locate a trial you are interested in you can request a proposal by clicking on the Trial Data link, then the Request Data button.

 

Visual Overview

Read More About Our Data Sharing Program

 

Data Sharing Agreement

Prior to access to clinical trial data, the researcher must enter into a standard data sharing agreement with us. The data sharing agreement commits the researcher to use the data only for the stated research purposes and not to disclose the data to third parties. This is in line with data privacy legislation. In addition, researchers are expected to commit to transparency in the publication of their work.

There are additional circumstances that may prevent the Company from sharing the requested data.

• The Company may not have the legal authority because the product was co-developed with a partner or obtained from an external partner under a contract that does not permit the disclosure.
• It may be difficult to ensure protection of the privacy and confidentiality of research participants. For example, small trials (e.g., with less than 50 participants) or studies of rare diseases may have too few participants to prevent re-identification of individuals.
• The informed consent may not allow for data sharing.
• There may be substantial practical constraints to providing access to the data (for example, size and complexity of databases or resources required to retrieve data from repositories and redact personally identifiable information from relevant documents).

 

Submission Process

Research proposals for studies found on the site must be submitted through Engage Zone and must adhere to the requirements for the submission process. The following basic information will be required:

1. Detailed Research proposal which includes:
   • Background and rationale
   • Objectives of the research
   • Scientific Hypothesis
   • Statistical analysis plan
   • Publication plan
2. Curricula Vitae of all researchers including the biostatistician