About Clinical Trials
A Legacy of Learning - A Promise of Hope
For some people dealing with cancer, participating in a clinical trial may offer the psychological boost of "taking charge" — taking an even more proactive approach to battling their disease. For others there is the powerful knowledge that their participation will benefit generations to come. As one recent participant said, "You know you’re part of something important, and that your participation can make a real difference."
Making An Informed Decision
If you are a cancer patient, or at high risk for developing cancer, learning all you can about clinical trials is the first step to making an informed decision about whether you should participate. This page will introduce you to clinical trials, in general, and to the Clinical Research Program at the Comprehensive Cancer Center of Wake Forest University. We encourage you to talk to your family, friends and doctor to help weigh the benefits and risks of the particular trial, and then make your decision.
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What is a Clinical Trial?
Clinical trials evaluate new treatments and procedures in cancer prevention, detection and care. They contribute to our understanding of how cancer works and pave the way toward new treatments that can lead to longer life and improved quality of life. Clinical trials are teaching us how to detect cancer earlier and what we can do to prevent cancer from ever occurring.
How Does a Clinical Trial Work?
Clinical research generally proceeds in a series of steps or phases. Based on laboratory findings, current treatment method and previous trials, scientists formulate questions they would like to have answered. Then, a clinical study is carefully designed to provide answers. Each step builds on the previous one to expand knowledge about the drug or treatment program in question. While quality of life, prevention and screening trials typically compare groups of people using a particular anticancer strategy with those who do not, most other clinical trials are separated into sequential phases.
- Phase I trials evaluate the safety of a new therapy, such as a drug, how it should be administered (orally, intravenously, by injection), in what dosage and how often. Phase I trials usually enroll only a small number of patients.
- Phase II trials seek preliminary information on the benefits of a new treatment designed for a particular kind of cancer.
- Phase III trials compare new drugs, combinations of drugs or new procedures with the current standard of treatment. These trials often involve large numbers of people recruited through doctors’ offices, clinics and cancer centers across the nation. Participants are usually randomly assigned to one of two study groups, those receiving the new treatment and those receiving the standard treatment.
If you participate in a Phase III randomized control trial and are assigned to the standard treatment group, you will receive what experts agree is the best treatment currently offered in standard medical practice. As long as there is a standard treatment, patients will not receive placebos. If you are assigned to the new treatment program, you will receive a treatment that some experts think may have significant advantages over the standard treatment.
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Participating in Clinical Trials
Eligibility
Each protocol identifies characteristics that people must have to participate in the trial. They may include the type and stage of cancer, age, general health and other medical requirements. Eligibility criteria help investigators target certain groups who may benefit from the new treatment and assure that the study results answer the questions posed by the investigators.
Eligibility criteria also protect participants from known risks. Individuals with other medical problems such as abnormal kidney or liver functions, for instance, may not be eligible for certain drug therapies.
Safety and Protection
For the protection of our participants, every clinical trial offered through the Comprehensive Cancer Center receives a thorough review both by the sponsoring organization and the Internal Review Board (IRB) of Wake Forest University Baptist Medical Center. The IRB is an impartial group including doctors, pharmacists, researchers, nurses, community representatives and a chaplain; none can have a personal interest in the study being reviewed. These neutral reviewers make sure the trial is conducted fairly and safely. Clinical trials sponsored by the Comprehensive Cancer Center but administered through an affiliated hospital are further reviewed by that hospital’s IRB.
Costs
In many clinical trials, the sponsoring organization or pharmaceutical company may bear the cost of drug therapies. For other studies, your insurance company may cover certain costs of new treatments.
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Clinical Trial Protocols
Each clinical trial is designed and conducted according to strict scientific guidelines. The principal investigator, usually a doctor, prepares an action plan for the study called a protocol. The protocol spells out who is eligible for the study, how many participants there will be, what drugs or special treatments will be used, type and frequency of medical tests and how information will be collected. Clinical trials may be sponsored by a cancer center or health care institution, a cooperative group that links a number of cancer centers and clinics regionally or nationally, a national organization such as the National Cancer Institute, or a pharmaceutical or medical equipment company. All participants follow the same protocol to ensure that information is collected consistently.
The Comprehensive Cancer Center of Wake Forest University offers a wide range of clinical trials, many of which are developed by our own scientists and physicians. We also offer a number of trials made available through cooperative groups or consortia that sponsor national and/or regionally based clinical trials.
Types of Clinical Trials
- Prevention trials study ways to protect people from developing cancer and to prevent new types of cancer from developing in cancer survivors.
- Early detection trials are aimed at finding cancer in its early, most treatable stages.
- Treatment trials test new therapies such as drugs or radiation in current cancer patients.
- Quality of life trials focus on improving comfort and daily life for cancer patients.
- Other trials evaluate potential cancer-causing behavior, such as tobacco use, and ways to modify the behavior.
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Comprehensive Cancer Center Protocols
The Comprehensive Cancer Center of Wake Forest University publishes and updates a catalog of protocols that is made available to referring physicians through the Piedmont Oncology Association. All protocols listed are available at the Comprehensive Cancer Center. Some may be administered locally by oncologists under the sponsorship of the Comprehensive Cancer Center. Basic descriptions of protocols and eligibility requirements are also posted on our web site at http://www1.wfubmc.edu/cancer/Clinical+Trials/
Cooperative Group Protocols — National and Regional
Protocols sponsored by the following groups are available to eligible participants through Wake Forest University Baptist Medical Center.
Cancer and Leukemia Group B (CALGB) is a multidisciplinary cooperative cancer treatment group funded by the National Cancer Institute (NCI). More than 30 of the nation’s most prestigious medical centers and more than 185 affiliated hospitals participate.
Carolinas Conformal Therapy Consortium (CCTC) is a regional group of cancer centers that examine the role of 3-dimensional radiation treatment planning in several clinical trials.
Gynecologic Oncology Group (GOG) is a national organization dedicated to clinical research in gynecologic cancer. The American College of Obstetricians and Gynecologists (ACOG) and the National Cancer Institute (NCI) provide GOG support.
National Surgical Adjuvant Breast and Bowel Project (NSABP) conducts clinical trials in breast and colorectal cancer research. NSABP members’ clinical trials are funded primarily by the National Cancer Institute.
New Approaches to Brain Tumor Therapy (NABTT) is an elite group of nine leading American medical centers for brain tumor treatment. Funded by the NCI, NABTT investigates new brain tumor therapies and supportive care.
Children’s Oncology Group (COG) is a national consortium devoted to refining the treatment of childhood malignancies.
Pediatric Cancer Network of the Blue Cross and Blue Shield members, which include the country’s premier cancer centers, pool knowledge and evaluate treatment outcomes to help develop new cures. The network is built on the finding that children’s survival rates can be improved by 20 percent or more when care is coordinated by a pediatric oncologist at a comprehensive, multidisciplinary cancer center.
Radiation Therapy Oncology Group (RTOG) is the national organization that initiates and runs clinical trials involving radiation therapy.
The Comprehensive Cancer Center of Wake Forest University serves as its own Research Base, creating NCI-approved protocols for distribution through four community clinical oncology programs and other affiliates in a five-state region.
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