While receiving cancer treatment at Shaw Regional Cancer Center, patients may have the opportunity to participate in our clinical trials program, which is conducted in cooperation with the University of Colorado. Clinical trials are the studies that allow patients access to new methods of treating cancer with chemotherapy, biotherapy or radiation.
Clinical Trial Guidelines
Clinical trials follow strict guidelines to provide scientifically sound results, and to ensure the safety of all participants. Every trial has a specific treatment plan known as a "protocol." Each protocol typically includes the following components:
- Rationale for the study
- Objectives of the study
- Number of participants to be included
- Specific eligibility criteria
- Intervention/treatment being studied
- Duration and schedule of the trial
- Possible side effects
- Required medical tests and follow-ups
Endpoints of the Study
There are many safeguards in place to ensure the protection of clinical trial participants, including federal oversight by the Office of Human Research Protections (OHRP), as well as the Food and Drug Administration (FDA) and Institutional Review Board (IRB). These agencies provide approval, monitoring and the informed consent process to ensure that all participants understand their rights and responsibilities and what they can expect for the duration of the trial.
Before any drug is tested on humans in a clinical trial, it must undergo rigorous laboratory and animal testing. The FDA uses the results from these tests to determine first whether a drug is safe and then to evaluate its potential efficacy in human clinical trials.
For more information, call Clinical Trials Coordinator, Amanda Nokes, at (970) 275-1488, or refer to the recommended resources below.