Clinical trials data & information sharing

We are wholly committed to responsible transparency regarding the clinical trials we sponsor.

Our commitment to data and information sharing

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 approach to data and information sharing

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.

Our goal is to share data and information while respecting
and protecting:

  • Patient confidentiality
  • Informed consent given by study participants
  • Commercially confidential information and intellectual property
  • The role of regulatory authorities in making risk-benefit decisions that determine access to
    our products
  • 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: