At Ultragenyx Pharmaceutical Inc. we support the overall principles of greater clinical trial data transparency as outlined below:
Registration: Ultragenyx Pharmaceutical Inc. registers protocol information for company sponsored clinical trials of investigational and marketed products in accordance with applicable laws and regulations in public websites and registries, such as www.clinicaltrials.gov, www.clinicaltrialsregister.eu or www.encepp.eu
Disclosure of Clinical Trial Results: Ultragenyx Pharmaceutical Inc. discloses the results of company sponsored clinical trials in accordance with applicable laws and regulations in public registries, such as www.clinicaltrials.gov, www.clinicaltrialsregister.eu or www.encepp.eu
Publication of Clinical Trials Results: Ultragenyx Pharmaceutical Inc. commits to submit the results of all company sponsored clinical trials, for publication in peer-reviewed journals or at scientific meetings, regardless of study outcome. Studies that terminate early are included in our commitment to publish, provided they yield scientifically or medically important results.
Sharing of CSRs and Participant Level Data: Ultragenyx Pharmaceutical Inc. will make reasonable efforts to address all clinical data requests for legitimate research purposes from qualified researchers. Requests will be evaluated for approval based on the following key criteria:
- Requestors must submit a complete Submission Form, detailing a methodologically sound proposal for analysis
- Proposals should be for data from clinical studies that are completed and the product/indication is approved at minimum in the US and EU; or development of the product/indication is discontinued
- Researchers must not have any actual or potential conflicts of interest (including funding for the proposed analysis) and have the proper qualifications to execute their proposal
Additionally, proposals may be denied if not consistent with safeguarding patient privacy and informed consent; Ultragenyx did not collect the requested information; Ultragenyx does not have the ability to share based on contracts with a third party (eg, co-developed or divested products); or the proposed analysis is already underway or planned.
The research proposal may include enquiries for clinical data outside of the scope of these criteria. In these instances, Ultragenyx will assess feasibility of sharing the data as part of the review process.
Proposals are reviewed internally by a panel of experts familiar with the data. In response to legitimate, verified, scientific requests from researchers qualified to perform the proposed analyses, Ultragenyx will require that the requestor sign a data access and use agreement before accessing the data.
For information on the process for submitting a scientific or medical research proposal, please contact email@example.com.