Volunteering to Advance Science
If you’ve been diagnosed with cancer, you’re more than likely overwhelmed with the decisions you need to make about your treatment. What if your doctor gives you a choice: try a conventional therapy which might help or participate in a trial for a new drug or treatment which might prove more effective. What do you do?
In 1983, our TCOP became one of the original 27 community clinical research programs sponsored by the National Cancer Institute. Now 45 programs, including TCOP, form a comprehensive clinical trial network across the country called Clinical Community Oncology Programs. At any one time, more than 150 Phase II and III cancer clinical trials for children and adults are active at ProMedica. For those patients in search of Phase I trials, ProMedica collaborates with the Barbara Ann Karmanos Cancer Institute in Detroit, one of 40 NCI-designated comprehensive cancer centers in the United States.
Even greater access is on the horizon. As the Academic Health Center, a partnership between The University of Toledo (UT) and ProMedica, continues to develop, UT will provide administrative assistance to help facilitate more clinical research at ProMedica.
Oncology Clinical Research
Oncology clinical research trials play an important role in the development of new techniques, technology and treatments in the war on cancer. In cooperation with the Toledo Community Oncology Program, more than 70 cooperative oncology clinical trials are currently open for patient enrollment.
These trials are either Phase II or Phase III and include all primary sites of cancer including newly diagnosed cancers, metastatic and/or recurrent cancer as well as cancer control studies. (Physicians interested in discussing clinical trials available for patients may call the oncology research coordinators at 419-824-1011.)
9 important questions about clinical trials
What are clinical trials, and why are they important?
Clinical trials are research studies that involve people to test new ways to prevent, detect, diagnose or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge and receive state-of-the-art care from cancer experts.
Are there different types of cancer clinical trials?
Yes. Cancer clinical trials differ according to their primary purpose. They include treatment, prevention, screening, diagnostic and quality of life (or supportive care).
Who sponsors clinical trials?
Government agencies, such as the National Cancer Institute and other parts of the National Institutes of Health (NIH), the Department of Defense, and the Department of Veterans Affairs, sponsor and conduct clinical trials. In addition, organizations or individuals, including physicians, academic medical centers, foundations, volunteer groups, and biotechnology and pharmaceutical companies, also sponsor cancer clinical trials.
Where do cancer clinical trials take place?
Cancer clinical trials take place in cities and towns across the United States and in other countries. They take place in doctors’ offices, cancer centers and other medical centers, community hospitals and clinics, and veterans’ and military hospitals.
Who manages clinical trials?
Each clinical trial is managed by a research team that can include doctors, nurses, research assistants, data analysts and other specialists. The research team works closely with other health professionals, including other doctors and nurses, laboratory technicians, pharmacists, dietitians and social workers to provide medical and supportive care to people who take part in a clinical trial.
What are the eligibility criteria, and why are they important?
Every clinical trial has a protocol, or action plan, that describes what will be done, how the trial will be conducted and why each part of the trial is necessary. The protocol also includes guidelines for who can and cannot participate in the trial.
How is the safety of clinical trial participants protected?
National and international regulations and policies have been developed to help ensure that research involving people is conducted according to strict scientific and ethical principles. In these regulations and policies, people who participate in research are usually referred to as “human subjects.”
What is informed consent?
Informed consent is a process through which people learn the important facts about a clinical trial to help them decide whether or not to take part in it, and continue to learn new information about the trial that helps them decide whether or not to continue participating in it. The informed consent process continues throughout a trial. If new benefits, risks or side effects are discovered during the course of a trial, the researchers must inform the participants so they can decide whether or not they want to continue to take part in the trial.
What does a trial’s “phase” mean?
New interventions are often studied in a stepwise fashion, with each step representing a different “phase” in the clinical research process. The following phases are used for cancer treatment trials:
- Phase 0. These trials represent the earliest step in testing new treatments in humans. In a phase 0 trial, a very small dose of a chemical or biologic agent is given to a small number of people (approximately 10-15) to gather preliminary information about how the agent is processed by the body (pharmacokinetics) and how the agent affects the body (pharmacodynamics).
- Phase I (also called phase 1). These trials are conducted mainly to evaluate the safety of chemical or biologic agents or other types of interventions (e.g., a new radiation therapy technique). They help determine the maximum dose that can be given safely (also known as the maximum tolerated dose) and whether an intervention causes harmful side effects.
- Phase II (also called phase 2). These trials test the effectiveness of interventions in people who have a specific type of cancer or related cancers. They also continue to look at the safety of interventions. Phase II trials usually enroll fewer than 100 people but may include as many as 300.
- Phase III (also called phase 3). These trials compare the effectiveness of a new intervention, or new use of an existing intervention, with the current standard of care (usual treatment) for a particular type of cancer. Phase III trials usually involve large groups of people (100 to several thousand), who are randomly assigned to one of two treatment groups.
- Phase IV (also called phase 4). These trials further evaluate the effectiveness and long-term safety of drugs or other interventions. They usually take place after a drug or intervention has been approved by the FDA for standard use. Several hundred to several thousand people may take part in a phase IV trial.