What Are Clinical Trials?

In the United States, before any new drug or therapy can be made commercially available to the public, they must receive approval from the U.S. Food and Drug Administration (FDA). Each drug or treatment must proceed through a systematic, thorough and comprehensive clinical trials evaluation process. The research results must ensure they have met the FDA’s acceptance levels of safety and have demonstrated a definitive benefit to helping patients with a specific cancer or disease.

A clinical trial is a research study designed to evaluate potential new treatments for cancer. These studies are one of the last stages of research and the result of a long and thorough clinical research process, often taking years. Clinical trials test the safety and effectiveness of new, or improvement on older, cancer drugs and treatments, new or changed dosages, new/unique approaches to surgical and non-surgical therapy, and varied combinations of treatments (such as surgical treatments combined with immunotherapy).

Clinical trials are a vital component in the study of new cancer drugs and treatments. Having the ability to test new drugs and treatments on humans enables us to truly analyze the effects of these new drugs and ultimately improve the treatment of not only cancer, but hundreds of other diseases.

 

Clinical Trials Essentially Fall into Two General Categories:

• The first category of clinical trials is designed to evaluate new drugs, compounds, or biologic agents that have not yet been approved by the (FDA) for administration to patients. All substances must go through several phases of clinical trials documenting their safety and effectiveness before the FDA approves them for routine use to treat cancer patients. Prior to FDA approval, these treatments are only available through clinical trials.
  
• Clinical trials may also evaluate drugs, compounds, or biologic agents already approved by the FDA for the treatment of one type of cancer. These substances have already been demonstrated to be safe by the FDA and are now being tested and evaluated in different doses, schedules, and combinations to find new ways to optimally use them for the treatment of a variety of cancers.

Upon the successful completion, and favorable results, of a clinical trial and all of the required clinical and diagnostic research, the new drug or treatment is submitted to the FDA for review and approval.

As each clinical trial is unique and has its own benefits and risks, each participant should educate himself or herself as much as possible before agreeing to participate in any clinical trial (See Frequently Asked Questions About Clinical Trials). The following is a list of some of the general benefits and risks associated with clinical trials.

 

Some of the Possible Benefits and Risks of Clinical Trials
 

Possible Benefits to the Participants

• Play an active role in ones own health care
• Gain access to new research treatments before they are available to the general public
• Receive expert medical care and treatment at a leading health care facility during the trial
• If the new drug or treatment works, you would be among the first to benefit
• Our participants become directly involved in helping others by contributing to medical research
  
  

Possible Risks to the Participants

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment
• The experimental treatment may not be effective for the individual participant or for any
• Because these are in fact “trials” the various protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements