What is a Clinical Trial?
Clinical Trials are best described as research studies in which people help doctors find ways to improve health and cancer care. Each study focuses on a specific method to find better ways for preventing, diagnosing, or treating cancer.
For more information on Clinical Trials and Clinical Research Studies, please visit any of the sites below:
Why are Clinical Trials Important?
Clinical trials show us what works in medicine. They are the best way for doctors to decide what is safe and effective in treating diseases such as cancer. Many of today's standard treatments for cancer began in clinical trials. Many people who receive treatment for cancer are now living longer thanks to the knowledge gained through clinical trials.
What are the different types of Clinical Trials?
There are four types of clinical trials, all important in finding new innovative ways to lessen the burden of cancer.
- Treatment Trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods such as gene therapy).
- Prevention Trials test new approaches, such as medicines, vitamins, minerals, or other supplements that doctors believe may lower the risk of a certain type of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer occurring in people who have already had cancer.
- Screening Trials test the best way to find cancer, especially in its early stages.
- Quality of Life Trials (also called Supportive Care Trials) explore ways to improve comfort and quality of life for cancer patients.
What are the phases of Clinical Trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to ask and answer questions in a way that results in reliable information about the drug and protects the patients. Clinical trials are usually classified into one of four phases:
- Phase I Clinical Trials: Is the Treatment Safe? – These studies are the first ones to involve people as participants. Although the treatment has been well tested in laboratory and animal studies, the side effects in people can't always be predicted. For this reason, these studies usually include small numbers of people (15-40) and are generally reserved for those who do not have good treatment options left to them. Often, people with different types of cancer are eligible for the same study. These studies are usually conducted in major cancer centers.
- Phase II Clinical Trials: Does It Work? – If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then be tested for effectiveness in a phase II clinical trial. Usually, a group of anywhere from 25-100 patients with the same type of cancer receive the new treatment in a phase II study. They are treated using the dose and method that were determined to be the safest in the phase I study. In a typical phase II clinical trial, participants all receive the same dose, and no placebo is involved. Phase II studies are often conducted at major cancer centers but may also be done in community hospitals or even doctors' offices.
- Phase III Clinical Trials: Is It Better Than What's Already Available? – Treatments that show a certain level of effectiveness in phase II studies must go through one more stage of testing before being considered for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment. Phase III clinical trials require a large number of patients, usually at least several hundred. These studies are generally conducted in many places across the country (or even across the world) at the same time.
- Phase IV Clinical Trials: Is There a Better Way to Use Them? – When a treatment is shown to be more effective and/or safer than the current standard treatment in a phase III clinical trial, it is submitted for approval to the FDA. Based on the results of the clinical trials, the FDA decides whether or not it is appropriate for use in the general public. When this happens, the treatment often becomes the new standard of care, and newer drugs must be tested against it before being approved. Phase IV studies look at drugs that have already received FDA approval. Therefore they are already available for doctors to give to patients. These studies, however, are still needed to answer important questions. The type of questions, which may not be critical for getting a medicine to market, that are often addressed in phase IV clinical trials are:
- Would the medicine work better if given twice a week instead of once a week?
- Are 6 months of treatment better than 4 months?
- Are there rare side effects that haven't been seen yet?
Why participate in Clinical Trials?
By participating in a clinical trial, patients have access to the latest drugs or procedures and are among the first to receive potentially effective new therapies. Studies have shown that trial participants have outcomes that are as good as, if not better than, those who do not participate, even if they get the standard of care and not the treatment that is being tested.
Who conducts Clinical Trials?
Cancer clinical trials are sponsored by various organizations in both government and industry, including cooperative groups, academic medical centers, community oncology centers, federal agencies, and pharmaceutical companies. They are conducted at thousands of sites throughout the United States every year.
What kinds of Clinical Trials are available to me in Pennsylvania?
Please see the links below to search for active clinical trials in Pennsylvania:
What kinds of Clinical Trials are available to me, nationally?
The following websites will allow you to search for available Clinical Trials nationwide:
