Participating in a Clinical Trial

The Decision to Participate is Yours
Before you decide to participate in a clinical study, your doctor will discuss the potential benefits and risks with you. Your doctor's input is very important. His or her insight and knowledge of your medical history and condition are the best basis for treatment selection. The ultimate decision, however, is always yours. Patients who take part in research studies may benefit themselves, as well as future patients.

Control Group Vs. Intervention Group
All the studies may use a 'Control' Group to compare with an 'Intervention' Group: The Control Group receives the best standard treatment or care available. The Intervention Group receives the new drug or therapy approach being tested by the study. In almost all cases, the patient will receive either the best available standard treatment or a new study treatment.

"Blinding" in clinical research
Blinding keeps one or more parties involved in conducting the trial unaware of the treatment assignment. In a "single-blinded clinical trial, the participant is unaware of which treatment she/he is receiving. In a "double-blinded" trial, neither the physician nor the study participant know which group the participant is in. Double-blinded trials are valuable for eliminating the observer's bias in studying the treatment effect. In special medical situations, if a doctor needs to find out which study drug the participating patient is on, this is possible through the study sponsor's office.

Protection of Patient safety
Once an individual becomes a research participant a process begins for protecting the individual as a human subject. Individuals participating in the research have the right to be protected against harmful risks by research interventions of new drugs and/or procedures being tested.

Some of the regulatory patient-protection safeguards that clinical trials must comply to are the following:

• Human Subjects Protection Training. Participating physicians who enroll patients in clinical trials must be approved annually by the National Cancer Institute and are required to have Human Subjects Protection Training. The intent of this training guides the physician in how to protect the rights and welfare of all human participants in research.
  
  
• Informed Consent. Each individual, as a clinical trial participant, must be informed of the potential risks and benefits of the research study they are considering and must give signed consent to participate.
  
  
• Institutional Review Board (IRB).
  
  • Reviews and approves each protocol activated by the Colorado Cancer Research Program.
    
  • Is comprised of scientific and lay members
    
  • Is responsible for evaluating new and ongoing clinical trials on the basis of scientific, legal and ethical merit.
    
  • Assumes the responsibility to assure that no unreasonable risks, compared to potential benefits, are taken.

In protecting each research participant, Colorado Cancer Research Program adheres to the standards for scientific integrity recognized around the world. The Colorado Cancer Research Program respects the dignity of research participants with regard to self-determination and full disclosure of information throughout the research process.

About Prevention Clinical Trials
Prevention trials are a relatively recent addition to clinical research. They provide the potential means to reduce the incidence of cancer, to delay its onset, and to reduce cancer-related death and disability. Some of today's prevention clinical trials are testing dietary and drug approaches that may reduce the risk of developing some cancers. The prevention research seems particularly important to people with special risks for cancer, such as having a history of cancer in the family. These participants elect prevention clinical trials as a way to be a part of the solution and to possibly prevent getting cancer.