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 the national and international levels. We register all clinical trials on publicly accessible clinical trials 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 trials 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.
For a summary of how our commitment aligns to the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing, see this table.
For more information on particular elements of our clinical trials data and information sharing activities, please see the following links:
Updating Our Approach to Data and Information Sharing
We will review and, where appropriate, update our approach to data and information sharing in response to feedback received in the future and changing principles and standards governing this topic.