|About||Roche shares clinical data because we understand it helps physicians, patients and healthcare providers to make informed treatment decisions. Data sharing can also enable researchers to more easily build on our research and the research of others, in the hope of advancing scientific progress.
Roche is committed to delivering on the principles of clinical trial transparency as set out in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing including sharing patient level data in compliance with global legal and regulatory requirements.
|How we share on the Vivli Platform||Available studies are listed and searchable on the Vivli Platform. Data requestors should use the Vivli Data request form to request company’s data package(s). If approved, requesters will need to sign a Data Use Agreement and the anonymized data will be shared in the Vivli secure research environment.|
|Studies Listed for Sharing||All phase 2 and 3 clinical studies or phase 4 studies that were used as part of a regulatory approval or where the product was terminated from development (all indications) with a first patient enrolled as of 1 January 1999 onwards.
Roche will regularly update this list to add studies going back to January 1999. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study.
|Exceptions||Clinical studies with a sample size of less than 50 patients or in rare diseases. This is because anonymization of these data is more difficult to achieve. For these studies Roche will assess the feasibility of anonymization as part of the review of enquiries.
Phase 4 clinical studies conducted for non-registrational purposes or local affiliate studies.
Studies where data sharing is prohibited by the consent, legal, regulatory, or contractual constraints on data sharing.
|When Studies are Available for sharing||After the medicine studied has been approved by regulators for the indication in both the US and EU or terminated from development (all indications).
18 months after completion of the study report (to enable a publication to be submitted).
|Additional Conditions for Access||When patients agreed to take part in Roche clinical studies they gave permission (through informed consent) to use their data to study the medicine or disease Roche were researching. Further research must therefore study the medicine or disease that was researched in the original studies.
For future studies (2014 onwards) patients will be asked to give permission for broader research so other research may be possible with data from these studies.
A condition of providing the data is that the external requester seeks publication of their research results. Roche is to be provided with a copy of the manuscript after journal submission for information. Roche may choose to provide the requester with comments on the document as a courtesy, but the external requester is not obliged to incorporate any feedback resulting from this review.
|What information will be provided||Where available, the following anonymized patient level data and information is provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in the clinical study.
Analysis-ready dataset. This is the dataset used for Roche’s analysis.
Please note: only clinical data that underlies the CSR is made available. Therefore some data types may not be routinely provided (eg. Exploratory Biomarker data, Images, Genomic data, PK data).
If individual patient data from the same study is made available outside of Vivli this can not and should not be linked to data on the Vivli platform by researchers external to Roche due to a potential increase in risk of patient re-identification.
Protocol. This describes the objectives, design, methodology, statistical considerations, and organization 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.
Reporting and analysis plan. This describes methods of analysis, procedures for data handling and data displays (figures and tables) Roche 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 are not included as these data are provided in the datasets Roche provide.
|Questions or enquiries||Researchers can enquire about the availability of data from Roche clinical studies that are not listed on the site before they submit a data request. Please use the Vivli Enquiry form.|
|Review Criteria for Data Requests||Whether the studies have been included in a completed regulatory filing (EU and US) or whether the study is from a terminated development program (all indications). It is Roche policy to provide access to patient level data after either criteria has been achieved and it is >18 months after the study report was completed.
Whether Roche has the legal authority to provide the data. For example, Roche may not have the legal authority because the medicine has been out-licensed to another company.
Whether Roche considers it feasible to anonymize the data without compromising the privacy and confidentiality of research participants. For example, anonymization of data from studies of rare diseases is more difficult to achieve and will be reviewed on a case-by-case basis.
Whether Roche consider that there are any practical constraints to providing access to the data. For example, imaging data, notes from patient interviews or genomic data will not be provided unless and until all relevant patients provide explicit consent.
The resources (costs) for Roche 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, the costs could be considerable and Roche may turn down requests on this basis.
|Data Request Review Process||Consistent with expectations of good scientific practice, researchers can request access to our studies by providing a data request with a commitment to publish their findings. The data request is reviewed by an independent review panel. This is a team of external independent experts who were appointed by the Wellcome Trust.
Requests for the LORELEI (GO28888) study may be additionally reviewed by an independent study specific steering committee.
|Access to study documents without participant-level data||Researchers requesting clinical study documents only can do so via the following link:
Roche Clinical study documents request form
|Anonymization Standards||Anonymization of Clinical Trial Datasets|
|Clinical Study Register or Website||www.clinicaltrials.gov|