Clinical Trials: What Is a Clinical Trial?
Clinical trials are research studies that use human participants. Participating in a clinical trial adds to our medical knowledge.
Clinical trials are used to examine and test new methods, procedures, protocols and medications for effectiveness before being released for wider use. Clinical trials are the last step in what can be a years-long effort by multiple researchers.
Testing begins in laboratories, moves to animals, and after scrutiny for safety and effectiveness, moves to study in humans. Participation in clinical trials is voluntary; you can withdraw at any time. Your decision to withdraw will not affect your medical care.
Patients who participate in clinical trials are given the same level of care as patients participating in conventional therapies.
The benefits include:
- You gain access to newer, novel treatments before they are available to others.
- You help other patients like yourself.
- Your participation contributes to the greater effort to find a cure.
Your participation helps future patients by providing information about:
- What is the safest dose that can be given?
- What are possible side effects?
- How often the experimental drug can be given safely?
- How long does the drug stay in the body after dosage?
There are four levels of clinical trials that involve human participation
Phase I: A new drug or treatment studied in a small group of cancer patients who have exhausted all other treatment possibilities. This drug or treatment is being tested in people for the first time.
- What is the safest dose?
- What is the best method for delivery (pill, injection, IV)
- What are the side effects?
Phase II: The drug or treatment moves to a larger pool of people with a specific type of disease.
- How well does this work on specific tumor types?
Phase III: An even larger group of people is given the drug or treatment. This will confirm effectiveness and monitor side effects in a more significant number of people, which can number in the thousands.
- How well the drug or treatment compares with other standard drugs, treatments or therapies?
- Does the drug have fewer side effects than conventional treatments?
Phase IV: This final study looks at the drug or treatment after it has been marketed to determine further information on the effect of the drug in varying populations. It also helps to track long-term side effects in a larger patient pool.
There are different types of trials: 98 percent of patient trials at the UT Health Cancer Center are treatment trials. Treatment trials examine how effective potential therapies, protocols or medications may be in treating various types of cancer. It may involve investigational drugs, vaccines, combination therapies or novel therapies.