What are Clinical Trials?
Clinical trials (also known as clinical research or clinical studies) are conducted to determine if investigational drug is effective and safe.
There are four phases of clinical trials in cancer treatment:
- Phase I: An investigational drug is tested in a small group of people to determine a safe dose range and identify side effects.
- Phase II: The investigational drug is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The investigational drug is given to large groups of people to compare its effectiveness to commonly used therapies and monitor side effects.
- Phase IV: After the investigational drug has been approved for marketing, Phase IVclinical trials investigate the agent’s effectiveness in various patient populations and determine side effects associated with long-term treatment.
Quality control of the clinical trials in which the Burzynski Clinic participates is maintained by strict adherence to written study protocols that are FDA reviewed and Institutional Review Board (IRB) approved prior to patient enrollment. Study protocols describe the number of patients that will participate in the clinical trial, the treatment plan, the type and frequency of medical testing, other monitoring requirements, financial considerations, and a detailed patient informed consent document.
Enrollment in Clinical Trials
Since 1993, patients with a variety of advanced cancers have been enrolled in Phase II clinical trials of Antineoplastons. Currently, new FDA-reviewed Phase II and III clinical trials utilizing Antineoplastons are undergoing Institutional Review Board (IRB) approval.