What is a clinical trial?
A cancer clinical trial is an important research study that aims to improve the safety and effectiveness of step-based treatment. It is also:
- A research study conducted with actual people.
- A controlled and monitored study in which new drug treatments or new approaches for diagnosing, controlling, or preventing cancers are compared to what is currently available.
- A study designed to answer key scientific questions that will advance medical knowledge.
- Always a voluntary choice for participation.
Four Types of Cancer Clinical Trials
- Treatment Trials: to find superior drugs or test for more effective approaches in using surgery or radiation for treating people who already have cancer.
- Prevention Trials: to test new approaches, such as certain medications, vitamins, minerals or food supplements, which may lower a person's risk of a certain type of cancer. These trials are for reducing the risk of developing cancer in healthy people who do not have cancer, or preventing the return of cancer in those who have already had cancer.
- Diagnostic/Screening Trials: to compare new techniques for finding cancer, especially early-stage cancers.
- Supportive Care/Cancer Control (also Quality of Life) Trials: to test new ways to improve comfort and quality of life for people with cancer. Some of these trials may also be referred to as "symptom control" trials which address the side effects that often accompany chemotherapy.
Important Parts of a Clinical Trial
- Provides the blueprint for how a trial is conducted.
- Defines the trial's action plan.
- Explains the purpose of the clinical trial.
- States the research question the trial is designed to answer.
- Defines who is and who is not eligible to participate.
- Outlines what will be done in the trial. For example, how much of a drug will be given, how often it must be taken, and what medical tests will be required to check on the progress of the study.
- Defines the inclusion and exclusion factors to protect patient safety.
- Ensures that the new treatment or approach is being tested on similar groups of people.
- Ensures key similarities among participants, e.g., the same type and stage of cancer.
An Informed Consent...
- Is an ongoing process; the participant should receive any new information about the treatment as it is learned.
- Explains key facts of the clinical trial - what will be done in the trial, what type of therapy will be conducted, i.e., radiation, chemotherapy, variation of drug dosages, and how long the intervention will last.
- States the potential benefits and potential risks/possible side effects of the clinical trial.
- Explains what kinds of tests will be conducted (X-rays, blood tests) during the trial to monitor study response.
- Must be signed by each participant. Individuals can freely decide to take part in a trial.
Why Are Participants Randomized...
- Participants’ randomization is needed to provide non-biased information for the clinical trial. The randomization process provides random selection of participants (similar to flipping a coin). A clinical trial can have two or more treatment assignments (also referred to as “arms”) that are being examined. For example, a drug study may compare the dosage of “Arm A" to “Arm B" and to “Arm C."
How are clinical trials conducted?
Clinical trials are conducted in phases. The answers received from Phase I determine whether the treatment will progress to Phase II and then to Phase III. Each thoroughly tested phase serves a specific purpose:
- Phase I: This first point of testing is primarily concerned with safety (How toxic is the treatment?) and the best way to deliver the new treatment.
- Phase II: This level tests effectiveness of a treatment for specific tumor types. It is designed to determine whether the agent has an anticancer effect and if it will reduce tumor size or alleviate symptoms.
- Phase III: For treatment trials, this phase compares the new therapy with the best available treatment currently known. Cancer prevention trials compare the outcome of one agent to another, or compare the results of taking a drug versus taking no drug.
Control Group vs. Intervention Group
Studies may use a “Control Group” to compare with an “Intervention Group”. The Control Group receives the best standard treatment or care available. The Intervention Group receives the new drug or therapy approach being tested by the study.
"Blinding" in Clinical Research
Blinding keeps one or more parties involved in conducting the trial unaware of the treatment assignment. In a "single-blinded clinical trial, the participant is unaware of which treatment she/he is receiving. In a "double-blinded" trial, neither the physician nor the study participant knows which treatment she/he is receiving. Double-blinded trials are valuable for eliminating the bias. In special situations, if a doctor needs to find out which study drug the participating patient is on, it is possible through the study sponsor's office.
Where Are Cancer Clinical Trials Conducted?
Clinical trials are made accessible through community-based cancer centers, community hospitals and physician offices, and local outpatient cancer clinics. These facilities provide cancer patients and individuals at risk for cancer greater opportunities to access many of the same trials that were once available only through major cancer centers.
Sponsored by both the federal government and/or private industry, cancer clinical trials are conducted through a variety of institutions:
- National Cancer Institute (NCI): The NCI, a federal government agency, serves as the major sponsor for cancer clinical trials in the United States. They are also a resource and clearinghouse for patients, health professionals, and the general public. The NCI publishes vast information on cancer, cancer research, and provides grant funding opportunities. For questions call 1-800-4-CANCER.
- Cooperative Groups: The Clinical Trials Cooperative Group Program, which is sponsored by the NCI, is designed to promote and support clinical trials of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life issues and rehabilitation during and after treatment. Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe. They place more than 25,000 new patients into cancer treatment clinical trials each year.
- Community Clinical Oncology Programs: There are about 60 NCI-designated Community Clinical Oncology Programs (CCOPs). CCOPs are located throughout the Unites States and Puerto Rico. These community-based cancer programs offer large-scale cancer clinical trials to people in local communities. CCRP is an NCI-designated CCOP that reaches out into local communities to conduct cancer clinical trials.
- Cancer Centers: Throughout the United States, the NCI has designated over 65 institutions as Cancer Centers. These Cancer Centers are located both in teaching hospitals and in centers that only focus on cancer research. Their comprehensive research consists of laboratory research, clinical research, and prevention and control research.
- Pharmaceutical/Biotech Companies: More than 80 pharmaceutical/biotech companies conduct cancer clinical trials research, often early phase and drug-advancement studies.
Most of today's standard-care medicines are the results of yesterday's clinical trials. Clinical trials:
- Provide the viable link between the advancements made in medical science to the resulting improvements made in standard-care medicine.
- Demonstrate the effectiveness of new approaches to treating a cancer, controlling the side effects of treatments, or preventing the cancer altogether.
- Use an evidence-based process to test and make conclusions of treatment's safety and effectiveness.
- Only 3% to 5% of adult cancer patients actually participate in cancer clinical trials while approximately 20% may be eligible. The rate of clinical trials participation determines how fast science is advanced. Educating the public and increasing their awareness of cancer clinical trials is the first step towards increasing clinical trials participation.
- The primary sponsor of the clinical trials offered through Colorado Cancer Research Program (CCRP) is National Cancer Institute (NCI). These trials are NCI Phase II and Phase III.
- Clinical trials offer cancer patients a treatment option.
- Taking part in a cancer clinical trial is one way to receive high-quality care from cancer specialists. CCRP’s trained research specialists, in addition to your physician’s office, carefully and continually monitor clinical trial participants.
- In clinical trials participants receive the best available current treatment or a new approach that testing has shown may work better than the standard method.
- Taking part in a clinical trial means individuals are among the first to receive the latest drugs, procedures, and treatment or prevention approaches before they are publicly available.
The Decision to Participate Is Yours
Before you decide to participate in a clinical study, your doctor will discuss the potential benefits and risks with you. His or her insight and knowledge of your medical history and condition are the best basis for treatment selection. The ultimate decision, however, is always yours. Patients who take part in research studies may benefit themselves, as well as future patients.
The doctor will determine if a particular cancer protocol might be appropriate. The doctor studies the protocol's eligibility criteria to see whether the patient is a potential candidate, and offers the patient the cancer trial as a treatment option. The patient will be asked to first read the informed consent to more fully understand the trial before making any decisions.
Protection of Patient Safety
Once an individual becomes a research participant, a process begins for protecting the individual as a human subject.
Some of the regulatory patient-protection safeguards that clinical trials must comply to are the following:
• Human Subjects Protection Training: Participating physicians, who enroll patients in clinical trials, must be approved annually by the National Cancer Institute and are required to have Human Subjects Protection Training. The intent of this training guides the physician in how to protect the rights and welfare of all human participants in research.
• Informed Consent: Each clinical trial participant must be informed of the potential risks and benefits of the research study he/she is considering and must give signed consent to participate.
• Institutional Review Board (IRB): (Insert Link)
- Comprised of scientific and lay members.
- Reviews and approves each protocol activated by Colorado Cancer Research Program.
- Responsible for evaluating new and ongoing clinical trials on the basis of scientific, legal, and ethical merit.
- Assumes the responsibility to assure that no unreasonable risks, compared to potential benefits, are taken.
In protecting each research participant, Colorado Cancer Research Program (CCRP) adheres to the standards for scientific integrity recognized around the world. CCRP respects the dignity of research participants with regard to self-determination and full disclosure of information throughout the research process.
How to participate
- Facilitate the processes and support the physician enrolling a cancer patient in a cancer clinical trial.
- Provide a qualified research nurse to coordinate all patient pre-entry and on-study requirements, and to provide on-going patient/family education while the patient is receiving treatment.
- Ensure good clinical practices in the conduct and monitoring of individuals participating in a clinical trial.
- Ensure high standards for data management that meet or exceed National Cancer Institute's quality assurance requirements for the submitting of a participant’s study data information.
- Ensure compliance with US Federal Drug Administration's requirements for the handling and accountability of the investigational drugs used in the trials.
- Participate in quality assurance audits required by the National Cancer Institute (and the cooperative research groups) to assure research integrity in the conduct of human subjects research.