About Clinical Trials
A clinical trial is one of the final stages of a long and careful research process.
- The search for new treatments begins in a laboratory, where scientists develop and test new ideas.
- If a new drug seems promising, the next step is often testing a treatment in animals to see how it affects certain diseases and biological systems in a living organism, establish effective doses, and whether the drug may have side effects.
- If the treatments are successful in animal models, studies are then done for several years in healthy people and patients to find out if these promising treatments are safe and effective.
- The ultimate goal of clinical research is to cure the disease and/or improve quality of life.
For many patients, the investigational treatments from clinical trials have offered new hope.
- Clinical trials are carefully designed research studies that test how well the latest and most innovative medical treatments work in people.
- Participation is voluntary. Participants are legally entitled to the best available care possible, and have the right to withdraw from a clinical trial at any time.
- The goal of clinical studies is to increase our knowledge about diseases and develop more effective, less toxic treatments.
- For many patients, clinical trials lead to significant savings on treatment costs, access to new novel drugs not yet generally available, and improved quality of life.
- Clinical trial participants receive the attentive care of a research team in addition to their own doctor's.
- All clinical trials and results are regularly screened and monitored by safety committees and approved by national health authorities, under the strict guidelines of the U.S. Food and Drug Administration (FDA).
- The requirements for each clinical trial are highly specific. It is important that you consult with your physician or contact us to determine eligibility.
What are the different types of clinical trials?
"Cancer is a complicated disease. It has many stages. There are clinical trials for every stage – for prevention, initial treatment, relapsing, relapsing the second time ... It's not true that clinical trials are only for people in final stages of the disease."
-- Catherine Miller, M.D., cancer clinical trial physician
(via: National Cancer Institute)
(via: National Cancer Institute)
- Treatment trials test experimental treatments, new combinations of existing drugs, or new approaches to surgery or radiation therapy to treat existing diseases.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Registry trials are post market studies that examine patient care and treatment patterns to evaluate health outcomes. These studies are surveillance studies do not involve new drugs.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Each clinical trial is marked Phase I, II, III or IV. What do the phases mean?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:- In Phase I trials: Researchers test an experimental drug or treatment in a small group of people (up to 150) and sometimes healthy people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- In Phase II trials: The experimental study drug or treatment is given to a larger group of people (up to 500) with a specific disease, to see if it is effective and to further evaluate its safety.
- In Phase III trials: the experimental study drug or treatment is given to even larger groups of people (up to 5,000) with a specific disease, to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- In Phase IV trials: Also called Post Marketing Studies, these studies are performed to collect additional information about the drug's risks, benefits, and optimal use from the general consumer population.
