Principles of Medical Research
Clinical Trial Registry
Eli Lilly and Company is committed to principles of medical
research that define the ethical conduct, funding, and communication of
clinical research. Lilly conducts clinical research with the highest standards
of scientific integrity and respect for patients. Lilly discloses publicly all
medical research results that are significant to patients, health care
providers or payers – whether favorable or unfavorable to a Lilly product - in
an accurate, objective and balanced manner in order for our customers to make
more informed decisions about our products.
The standards described below represent our commitment to serve patients
through transparent and comprehensive disclosure of clinical research results
of all our marketed products.
Disclosure of Lilly Clinical Trial Results:
Regardless of outcome, Lilly commits to disclose publicly
the results of all trials on marketed products for which Lilly is the sponsor.
This includes the results of all Phase I (early exploratory), Phase II (proof
of concept), Phase III (registration), and Phase IV (post-marketing) trials
conducted anywhere in the world.
- What we disclose: Lilly commits to disclose the clinical
trial results of the primary and secondary outcome measures that are
specified in the study protocol, as well as additional safety and efficacy
results that impact patient care and the use of our products. Also, Lilly discloses a comprehensive
description of the trial design and methodology for each study. Results which do not support the
hypothesis being tested, or which are contrary to the intended outcome,
will be disclosed. A listing of all phase III and phase IV trials will be
posted on the registry at the initiation of each study using a unique
study identifier. When the trial
is completed and the drug is commercially available, the results of these
trials will be appended to its identifier.
- When we disclose: For phase I, II, and III clinical
trials, Lilly discloses results when a drug’s indication is approved and
it is commercially available.
Phase III trial results for secondary indications of marketed drugs
that fail to achieve approval will also be posted. For phase IV clinical
trials, Lilly discloses the results as soon as possible after the data
analysis is completed but no later than one year after the trial has
completed. For studies that are
under review by peer-reviewed journals that prohibit pre-publication
results disclosure, the results will be posted on the registry at the time
of the publication.
- How we disclose: In all cases, Lilly discloses clinical trial results on a publicly
available clinical trial registry.
Lilly also discloses clinical trial results through peer-reviewed
medical journals, subject to the discretion of the journal editors. In addition, clinical trial results are
disclosed through presentations and abstract submissions at professional
scientific meetings. A reference
will be provided in the clinical trial registry for study results disclosed
in a peer-reviewed journal.
- Effective date: Implementation of these standards will
begin with all clinical trials of marketed products that are completed
after July 1, 2004. In addition,
the registry will be populated retrospectively with results of core
efficacy and safety registration trials of marketed compounds with first
approval after July 1, 1994.
- Verification of disclosure: An independent third party will audit
and verify adherence by Lilly to these standards on results disclosure.