Clinical Trials
Clinical trials play an essential role in the development of new medical products and medical devices and are a required part of the research process for many of the products Baxter develops. Baxter protects the life, safety, privacy and dignity of clinical trial participants, as well as the integrity of data obtained from these studies.
In 2006, Baxter adopted a new Clinical Trials Policy, which defines the minimum requirements for clinical trials, studies and investigations involving human subjects that are sponsored by Baxter (including but not limited to divisions, regions and functions), using investigational and/or marketed medicinal products and/or medical devices.
The standards Baxter adheres to are found in, but are not limited to, the following:
- Guidelines for Good Clinical Practice (GCP), edited by the International Conference on Harmonization (ICH), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP);
- Declaration of Helsinki and the laws and regulations of the applicable country;
- International Ethical Guidelines for Biomedical Research Involving Human Subjects;
- Directive 2001/20/EC and Directive 2005/28/EC on the approximation of the laws, regulations and administrative provision of the Member States relating to the implementation of good clinical practices in the conduct of clinical trials on medicinal products for humans for Europe; and
- Applicable privacy and data protection standards.
Clinical trials are not started until written approval is received by an Independent Ethics Committee/Institutional Review Board. Prior to any study-related activities/assessments, all participating study subjects must provide informed consent. Privacy rules, such as U.S. Health Insurance Portability and Accountability Act regulations, or other applicable country-specific regulations, are followed as required.
For any clinical trial that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome and where Baxter desires to publish the results, the trial will be registered at www.clinicaltrials.gov prior to the enrollment of patients.
