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What are Clinical Trials

Clinical trials are carefully controlled research studies that are done with patients. These studies test whether a new treatment is safe and how well it works in patients, or they may test new ways to diagnose or prevent a disease. Clinical trials have led to many advances in cancer prevention, diagnosis, and treatment.

 

The Purpose of Clinical Trials

Clinical trials are done to get a closer look at promising new treatments or procedures in patients. A clinical trial is only done when there is good reason to believe that the treatment, test, or procedure being studied may be better than the one used now. Treatments used in clinical trials are often found to have real benefits and may go on to become tomorrow’s standard treatment.

Clinical trials can focus on many things, such as:

  • New uses of drugs that are already approved by the US Food and Drug Administration (FDA)

  • New drugs that have not yet been approved by the FDA

  • Non-drug treatments (such as radiation therapy)

  • Medical procedures (such as types of surgery)

  • Herbs and vitamins

  • Tools to improve the way medicines or diagnostic tests are used

  • Medicines or procedures to relieve symptoms or improve comfort

  • Combinations of treatments and procedures

Researchers conduct studies of new treatments to try to answer the following questions:

  • Is the treatment helpful?

  • What’s the best way to give it?

  • Does it work better than other treatments already available?

  • What side effects does the treatment cause?

  • Are there more of fewer side effects than the standard treatment used now?

  • Do the benefits outweigh the side effects?

  • In which patients is the treatment most likely to be helpful?


Phase of Clinic Trials

There are 4 phases of clinical trials, which are numbered I, II, III, and IV.

Phase I Clinical Trials

  • The purpose of a phase I study is to find the best way to give a new treatment safely to patients.

  • For phase I studies, the drug has already been tested in lab and animal studies, but the side effects in patients are not fully known. Doctors start by giving very low doses of the drug to the first patients and increase the doses for later groups of patients until side effects appear or the desired effect is seen.

  • Phase I clinical trials are often done in small groups of people with different cancers that have not responded to standard treatment, or that keep coming back (recurring) after treatment. If a drug is found to be reasonably safe in phase I studies, it can be tested in a phase II clinical trial.

Phase II Clinical Trials

  • These studies are designed to see if the drug works. Patients are given the best dose as determined from phase I studies. They are closely watched for an effect on the cancer.

  • Phase II trials are often done in larger groups or patients with a specific cancer type that has not responded to standard treatment. If a drug is found to be effective in phase II studies, it can be tested in a phase III clinical trial.

Phase III Clinical Trials

  • These studies involve large numbers of patients – most often those who have been diagnosed with a specific type of cancer. Phase III clinical trials may enroll thousands of patients.

  • Often, these studies are randomized, patients are randomly put in one of two (or more) groups. One group (called the control group) gets the standard, most accepted treatment. Other group get the new treatment being studied. All patients in phase III studies are closely watched. The study will be stopped early if the side effects of the new treatment are too severe or if one group has much better results than the others.

  • Phase III clinical trials are usually needed before the FDA will approve a treatment for use before the general public.

Phase IV Clinical Trials

  • Once a drug has been approved by the FDA and is available for all patients, it is still studied in other clinical trials (sometimes referred to as phase IV studies).

  • More can be learned about short-term and long-term side effects and safety as the drug is used in larger numbers of patients with many types of diseases.

  • Doctors can also learn more about how well the drug works, and if it might be helpful when used in other ways (such as in combination with other treatments).


What it will be like to be in a clinical trial

There will be a team of experts taking care of you and watching your progress very carefully. Depending on the phase of the clinical trial, you may receive more attention (such as having more doctor visits and lab tests) than you would if you were treated outside of a clinical trial.

There are some risks to being in a clinical trial. No one involved in the study knows in advance whether the treatment will work or exactly what side effects will occur. That is what the study is designed to find out. While most side effects go away in time, some may be long-lasting or even life threatening.

 

Deciding to enter a clinical trial

If you would like to take part in a clinical trial, you should begin by asking your doctor if your clinic or hospital conducts clinical trials. There are requirements you must meet to take part in any clinical trial. Entering a clinical trial is completely up to you.

The doctors and nurses will explain the study in detail. They will go over possible risks and benefits. After the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in a clinical trial does not keep you from getting any other medical care you may need.


Questions to ask to find out more about clinical trials:

  • Is there a clinical trial that I could take part in?

  • What is the purpose of the study?

  • What kinds of tests and treatment does the study involve?

  • What does this treatment do? Has it been used before?

  • Will I know which treatment I receive?

  • What is likely to happen in my case, or without, this new treatment?

  • What are my other choices and their pros and cons?

  • How could the study affect my daily life?

  • What side effects can I expect from the study? Can the side effects be controlled?

  • Will I have to stay in the hospital? If so, how often and for how long?

  • Will the study cost me anything? Will any of the treatment be free?

  • If I am harmed as a result of the research, what treatment would I be entitled to?

  • What type of long-term follow-up care is part of the study?

  • Has the treatment been used to treat other types of cancers?


Open Clinical Trials

Please note that our clinical trials listing is intended to be used aa a guide only. Clinical trials information is updated periodically resulting in a clinical trial being listed but not being open any longer. Similarly, there may be additional clinical trials that are not listed. It is highly recommended that you contact the clinical trials hotline to confirm availability.

For a full list of open clinical trials at UCLA, please contact the Clinical Trials Hotline at (888) 798-0719 or visit their website.

Breast Cancer Clinical Trials  
Colorectal Cancer Clinical Trials
Gastrointestinal Cancer Clinical Trials
Gastrointestinal Stromal Tumors (GIST) Clinical Trials
General Cancer Clinical Trials
Liver Cancer Clinical Trials
Lung Cancer Clinical Trials
Lymphoma Clinical Trials
Melanoma Clinical Trials
Non-Hodgkins Lymphoma Clinical Trials
Pancreatic Cancer Clinical Trials