Clinical Trials
Clinical trials play an essential role in the development of new medical products and are a required part of the research process for many Baxter products. 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. It defines the minimum requirements for clinical trials, studies and investigations involving human subjects that are sponsored by Baxter (including but not limited to businesses, regions and functions) that use investigational and/or marketed medicinal products and/or medical devices. The policy applies to all Baxter-sponsored studies worldwide.
The standards to which Baxter adheres are found in, but 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 or assessments, the respective study subject must provide informed consent. Studies follow privacy rules as required, such as U.S. Health Insurance Portability and Accountability Act regulations or other applicable country-specific requirements.
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, the trial will be registered at www.clinicaltrials.gov within three weeks after the first subject has been recruited. As of June 1, 2008, this site included 98 Baxter-sponsored studies.
