Sponsor Specific Details: ONO

ONO is no longer accepting data sharing requests via this Clinical Study Data Request Consortium. For future data requests, please contact ONO at the following email address: ono-johokokai@ono-pharma.com

• Studies listed

  This listing reflects the clinical study data provided by UCB on the Multi-Sponsor Analysis Hosting System and that are being prepared for data sharing. This list includes clinical studies that were considered 'pivotal studies' for purposes of regulatory approval of certolizumab pegol, lacosamide, rotigotine and levetiracetam.

  Requests for access to additional clinical study data will be considered on a case-by-case basis.

• Exceptions

  Clinical studies of rare diseases, small number of subjects or small number of investigative sites; where there is reasonable likelihood that the individual participants could be re-identified.

  Access to data is determined by the Independent Review Panel based on the scientific merit of the research proposal.

• When studies are listed

  Studies are considered for inclusion after the medicine studied has been approved by the regulatory authorities (first approval in the respective indication) or terminated from development (all indications) and the primary manuscript describing the results has been accepted for publication.

• Additional conditions for data access

  When patients agreed to take part in UCB clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease UCB were researching. Further research must therefore study the medicine or disease that was researched in the original studies.

  For studies starting January 2014, patients will be asked if they agree to give permission for data usage in analyses by UCB or outside academic researchers to answer additional scientific questions related to the study drug/condition. UCB will take appropriate measures to protect this information and will only use and share coded data for this additional research.

  In exceptional circumstances, access to data may be declined by UCB, for example, where there is a potential conflict of interest or an actual or potential competitive risk.

  A condition of providing the data to an external researcher is that the external researcher seeks publication of his/her research results in a peer-reviewed journal. UCB is to be provided with a copy of the manuscript for review prior to journal submission to prevent the unintended disclosure of UCB's confidential information.

  UCB will not seek to influence the content of a publication or the opinion of the external researcher through the review of the publication. UCB supports publications that contain scientifically and/or clinically meaningful results. Other than identification of UCB's confidential information, the final decision whether to accept any comments made by UCB remains with the external researcher.

• Datasets and documents provided

  Where available, the following anonymised patient level data and information is provided in English only for each clinical study.

  Raw dataset. This is the data collected for each patient in the clinical study.
  
  Analysis-ready dataset. This is the dataset used for UCB's analysis.
  
  Protocols with any amendments. This describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
  
  Annotated case report form. This is a blank case report form with descriptions of the data collected and how they are described in the dataset.
  
  Statistical analysis plan with any amendments. This describes methods of analysis and procedures for data handling UCB used for the study.
  
  Dataset specifications. This is the meta-data which describes the datasets e.g., variable labels, variable descriptions, code lists, formats.
  
  Clinical study report. This is the report of efficacy and safety data from the study. It forms the basis of submissions to regulatory authorities such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Appendices which include patient level data, confidential information, or investigator specific information are not included. To protect research participants' privacy and confidentiality, case narratives are not included. The clinical study report has been redacted by UCB with respect to the commercially confidential information and anonymised to protect patient privacy.
• Enquiries

  Researchers can enquire about the availability of data from UCB clinical studies that are not listed on the site before they submit a research proposal.

  In addition, UCB accepts enquiries for clinical document-only access (consistent with the above data sharing policies) via the Enquiry Facility.

• Access to study documents without patient-level data

  UCB also accepts enquiries for clinical study report document-only access (consistent with the above data sharing policies) via the Enquiry Facility.

• Review criteria for enquiries

  Whether the studies have been published or accepted for publication and whether the studies researched terminated or authorised medicines (for approved uses).

  Whether UCB are able to provide the requested data. For example, the majority of non-interventional (or observational) studies use data from third party databases under license agreements which prevent UCB from providing access to the data. Researchers can access data directly from these third party databases under similar agreements.

  Whether UCB has the legal authority to provide the data. For example, UCB may not have the legal authority because the medicine has been out-licensed to another company.

  Whether UCB considers it feasible to anonymise the data without compromising the privacy and confidentiality of research participants. For example, anonymisation of data from studies of rare diseases is more difficult to achieve.

  Whether UCB considers that there are any practical or technical constraints on providing access to the data. For example, imaging data will not be provided.

  Whether it is feasible for UCB to retrieve data and documents from repositories and archives, anonymize data, and redact personally identifiable information from relevant documents. In some cases, particularly for older studies, it may not be feasible to adequately anonymise datasets, and UCB may turn down requests on this basis.

• Anonymisation standards

  
• Clinical study register

  http://www.ucb.com/rd/data-transparency.