Study sponsor: Lilly
||Lilly will list Lilly-sponsored interventional clinical studies from approved medicines
and indications in the United States (US) and European Union (EU) in the following
Additional studies outside of this scope may be proactively listed by Lilly.
- Phase 2, 3 or 4 studies used as part of a regulatory approval submitted to the US
Food and Drug Administration (US FDA) on or after 1999.
- Phase 2, 3, or 4 global studies in indications approved in both the US and EU with
a first patient visit after 1 January 2007.
- Phase 2, 3, or 4 regional/local studies in indications approved in both the US and
EU with a first patient visit after 1 January 2014.
||Interventional clinical studies of rare diseases or single site studies may be excluded
from proactive listing on this site. This is because anonymisation of these data
is more difficult to achieve. For these studies Lilly will assess the feasibility
of anonymisation as part of the review of enquiries described below.
Interventional clinical studies where Lilly is the sponsor but does not have the
legal authority because the medicine has been out-licensed to another company or
the data are the property of an academic organization.
|When studies are listed
||Studies are listed after the studied medicine and indication have been approved
by regulators in the US and EU and after the primary manuscript describing the results
has been accepted for publication.
|Additional conditions for data access system
||In exceptional circumstances, access to data may be declined by the sponsor, for
example, where there is a potential conflict of interest or an actual or potential
|Datasets and documents provided
||When available, the following anonymised patient level data and information is
provided for each clinical study.
Raw dataset. This is the data collected for each patient in the clinical
study. PK data is not routinely provided.
Analysis-ready dataset. This is the dataset used for Lilly’s analysis. PK data is not routinely provided.
Protocols with any amendments or addenda. This describes the objectives,
design, methodology, statistical considerations, and organisation of a clinical
Annotated case report form. This is a blank case report form with descriptions
of the data collected, metadata and how they are described in the dataset. If an
annotated case report form is unavailable, a blank case report form may be provided.
Reporting and analysis plan. This describes methods of analysis, procedures
for data handling and data displays (figures and tables) Lilly used for the study.
Dataset specifications. This is the meta-data which describes the datasets
e.g., variable labels, variable descriptions, 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
US FDA and the European Medicines Agency (EMA). Appendices which include patient
level data are not included as these data are provided in the datasets Lilly provides.
To protect research participants’ privacy and confidentiality, case narratives are
not routinely included. They may be provided where they are needed for a specific
research proposal, provided research participants’ privacy can be protected.
||Researchers can enquire about the availability of data from Lilly clinical studies that are not listed on the site before they submit a research proposal.
|Access to study documents
without patient-level data
||Researchers can enquire about access to clinical study documents only (without patient-level data, such as the Clinical Study Report) by completing the online enquiry form.
|Review criteria for enquiries
||Whether the studies have been published or accepted for publication and whether
they researched authorised medicines. It is Lilly policy to provide access to patient
level data only after authorisation of the medicine and acceptance of the study
for publication in the scientific literature.
Whether Lilly 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 Lilly from providing access to the data.
Researchers may seek to access data directly from these third party databases under
Whether Lilly have the legal authority to provide the data. For example, Lilly may
not have the legal authority because the medicine has been out-licensed to another
company or the data are the property of an academic organization.
Whether Lilly 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 the trial data are available in electronic format.
The resources (costs) for Lilly 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 Lilly may turn down requests on this basis.
|Clinical study register
||Lilly currently registers all its local and global interventional clinical studies