There are important health benefits in making clinical trial data and
information available to health care providers, researchers, patients
and the general public. Thus, we have adopted national and
international principles and standards regarding the sharing and
publication of clinical trials data and information. In addition,
AbbVie conducts audits of compliance to ensure we are meeting those
principles and standards.
Our commitment to the disclosure of clinical trial information
adheres to the existing legislative requirements at national and
international levels. We register all clinical trials on publicly
accessible clinical trial registries in the United States and in
the European Union. Regardless of outcomes, we
disclose the results of our clinical trials on the US Government’s
publicly accessible clinical trial registry.
- Informed consent given by study
- Commercially confidential information and
- The role of regulatory authorities in
making risk-benefit decisions that determine access to our
- The rights of scientists to undertake scientifically
valid research that will advance public health interests
We honor science-based requests from researchers to access
subject-level data, study-level data and protocols from our clinical
trials. We also provide access to synopses of clinical study reports
(CSRs) following the approval of new medicines by US and EU
regulators. Information about the efficacy and safety of our products
also are available through patient-directed and professional labeling
as well as summary documents made available through regulatory authorities.
We will review and, where appropriate, update our approach to data
and information sharing in response to feedback received and changing
principles and standards governing this topic in the future.
For a summary of how our commitment aligns to the PhRMA-EFPIA Principles for Responsible Clinical
Trial Data Sharing, see this table.
AbbVie has certified that we have established policies and
procedures to implement our data sharing commitments with PhRMA and EFPIA.
For more information on particular elements of our clinical trials
data and information sharing activities, please see the following links: