Understanding Clinical Trials
Finding a Clinical Trial
Understanding Clinical Trials
What Is a Clinical Trial?
Clinical trials are research studies that are performed in people to test the effectiveness and safety of a new therapy that has shown promise in laboratory or animal studies. Such a therapy is also commonly referred to as investigational or experimental. The therapy can be a new drug or other treatment approach, such as radiation therapy or gene therapy, or a new combination of drugs or treatment methods. While clinical trials are done to study the prevention of illness, clinical trials are also a valuable option for many people who have been diagnosed with a serious disease, such as cancer. This may be especially true for those in whom the best standard cancer treatments are not working.
Cancer clinical trials are sponsored by government agees such as the National Institutes of Health, National Cancer Institute, pharmaceutical companies, and individual hospitals or treatment centers. People can participate in cancer clinical trials at hospitals, medical colleges, doctors' offices, or community cancer centers. Some clinical trials offer payment, while others do not.
What Is the Purpose of the Trial Phases?
Before a treatment is approved by the US Food and Drug Administration (FDA), it is studied in three stages, or phases, of clinical trials:
Phase I: In a phase I clinical trial, doctors have observed promising results with the new treatment in animal or laboratory studies, but do not know for sure what the effectiveness and side effects will be in people. The purpose of this type of trial is to find out how and how much of the treatment can be given safely.
Phase II: A phase II clinical trial is conducted after a phase I clinical trial. This type of trial is designed to see if the drug is effective against the disease. Patients receive the highest treatment dose that did not cause severe side effects in the phase I clinical trial. Doctors then evaluate carefully the effect of the treatment on cancer, as well as any side effects that occur.
Phase III: A phase III clinical trial is performed after a phase II clinical trial. This type of trial involves the treatment of large numbers of patients and serves to compare the new treatment to the best standard treatment. One group (called the control group) receives the best standard treatment, while the other group receives the new experimental therapy. The patients may not know which treatment they are receiving. If patients experience side effects that are too severe-or if one group's treatment is far more effective than the other-the study will be stopped.
Who Can Participate in a Clinical Trial?
For each clinical trial, there are guidelines stating who can participate in the trial (called inclusion or eligibility criteria) and who cannot participate (called exclusion criteria). These criteria are based on many factors, including type of cancer, stage of cancer, previous treatment received, and patient age and overall health. In addition, a study protocol describes the inclusion and exclusion criteria; the schedule of tests, procedures, medications, and dosages; and the length of the study.
What Are the Risks and Benefits?
There is some risk in participating in a clinical trial, such as the occurrence of side effects. However, there is also the potential benefit of receiving a new therapy that has activity against your cancer. In general, people who enroll in a clinical trial receive excellent, high-quality care. The research team includes doctors, nurses, social workers, and other healthcare professionals. These professionals follow each patient's health closely, before, during, and after the study. Importantly, people who enroll in a clinical trial are free to leave the study at any time, for any reason.
Finding a Clinical Trial
If you are interested in participating in a GI cancer clinical trial, the best first step is to ask your doctor for his or her recommendation. You may also search cancer clinical trials nationally, and discuss these options with your doctor. There are numerous cancer clinical trials listings available, including the following:
NewYork-Presbyterian Hospital provides a searchable database that includes a listing of all clinical trials being conducted at the institution, including those focused on GI cancers
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
The Jay Monahan Center for Gastrointestinal Health and NewYork-Presbyterian Hospital/Weill Cornell Medical Center researchers offer a comprehensive and up-to-date listing of clinical trials in the treatment of gastrointestinal cancers. Clinical trials are listed by type of cancer.
EIF's National Colorectal Cancer Research Alliance (NCCRA)
The NCCRA, established by Katie Couric and the Entertainment Industry Foundation, is working to reduce the lengthy enrollment periods for colorectal cancer clinical trials. This site provides a Clinical Trials Resource Center, including important information
on how to participate in a clinical trial.
Lance Armstrong Foundation (LAF)
The LAF, a non-profit organization founded by cancer survivor and cyclist, Lance Armstrong, provides a LIVESTRONG Cancer Clinical Trial Matching Service for people with cancer. The service provides a list of matching trials using a number of factors, including specific diagnosis and treatment history.
National Cancer Institute (NCI)
The NCI, which is part of the National Institutes of Health, is the Federal agency that provides funding for many cancer clinical trials. This site provides a clinical trials database that can be searched online by cancer type. In addition, you can call 800-4-CANCER to speak with an information specialist who will help you to perform a clinical trials search.
National Institutes of Health (NIH)
The NIH provides a listing of federally and privately supported clinical trials, including those for GI cancers. In fact, the FDA mandates that the pharmaceutical industry report all clinical trials (above phase I) involving life-threatening diseases to the clinicaltrials.gov database.
American Cancer Society (ACS)
The American Cancer Society offers a clinical trials matching service for people with cancer nationwide. This service can be reached through the ACS cancer information center at 800-ACS-2345 or http://www.cancer.org/Treatment/TreatmentsandSideEffects/ClinicalTrials/app/clinical-trials-matching-service.
National Coalition of Cancer Cooperative Groups
This group offers a searchable list of trials sponsored by its members, which include large research groups where more than one hospital, university, or cancer center collaborate in conducting a clinical trial.
Pancreatic Cancer Action Network
PanCAN is a national non-profit patient advocacy organization dedicated to focusing national attention on the need to find a cure for pancreatic cancer. Through its PALS program, PanCAN maintains a national database of clinical trials on pancreatic cancer, accessible by phone at 877-272-6226.
Center Watch provides a variety of information services about clinical trials, with extensive listings of trials being conducted nationally and internationally.