Study sponsor: Roche
||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 is in the process of compiling a list of studies in scope. 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.
||Clinical studies with a sample size of less than 50 patients or in rare diseases.
This is because anonymisation of these data is more difficult to achieve. For these
studies Roche will assess the feasibility of anonymisation as part of the review
Phase 4 clinical studies conducted for non-registrational purposes or local affiliate
|When studies are listed
||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 data 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 are to be provided with a copy of the manuscript
after journal submission for information. Roche may chose 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.
|Datasets and documents provided
||Where available, the following anonymised patient level data and information is
provided for each clinical study.
Raw dataset. This is the dataset collected for each patient in
Analysis-ready dataset. This is the dataset used for Roche’s analysis.
The number of datasets (raw and derived) for each study will be limited to the minimum
reasonably achieve the scientific objectives of the research proposal (e.g. if the
research is focusing on efficacy, adverse event datasets would not be provided).
Protocol 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.
Reporting and analysis plan. This describes methods of analysis,
procedures for data handling and data displays (figures and tables) Roche used
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.
||Researchers can enquire about the availability of data from Roche clinical studies that are not listed on the site before they submit a research proposal.
|Access to study documents
||Researchers requesting clinical study documents only can do so via the following link: http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing/clinical_study_documents_request_form.htm
|Review criteria for enquiries
||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 have 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
Whether Roche consider 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 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
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, anonymise 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.
|Clinical study register