What are Clinical Trials?
Clinical trials are research studies conducted with patients or with healthy people. They are designed to answer specific questions about the effectiveness of new ways to prevent, detect, diagnose, and treat cancer. Today’s clinical trials lead to tomorrow’s standard of care.
Who are the Principal Investigators?
Click to learn more about SJPHS’s principal research investigators:
A cancer clinical trial is a medical research study in which people participate as volunteers to test new methods of prevention, screening, diagnosis, or treatment of a disease.
Some cancer patients may fear that enrolling in a cancer trial means they have a chance of receiving no cancer treatment at all, but the reality is that patients in clinical trials receive either the best cancer treatment currently known for their cancer, or a new, and possibly more effective, therapy. Cancer clinical trials exist for all types and stages of cancer, as well as for cancer prevention.
Cancer clinical trials are conducted in doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals in cities and towns across the United States and around the world. Cancer clinical trials may include participants at one or two highly specialized centers or they may involve hundreds of locations at the same time.
Cancer clinical trials are usually conducted in phases. Phase I trials evaluate safety, Phase II trials measure effectiveness, and Phase III trials test against best existing cancer treatment. Phase IV trials are conducted to further evaluate new uses or long-term effects of the treatment.
A randomized cancer clinical trial is a study in which the participants are assigned by chance to either a standard treatment group (control group) or investigational treatment group. The control group invariably receives the standard treatment currently available. Randomization in a cancer clinical trial gives each cancer patient an equal chance of being assigned to any of the groups. It is one method used to prevent bias in cancer research.
Standard therapy is the treatment that experts agree is appropriate, accepted, and widely used. Healthcare providers are obligated to provide patients with standard therapy. Standard therapy is also called standard of care or best practice. In cancer clinical trials, experimental therapy refers to a drug (including a new drug, new dose, combination with other drugs, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the FDA to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but may be considered experimental in other diseases or conditions. Experimental therapy is also called investigational therapy.
A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The use of placebos in cancer treatment studies is very uncommon.
This misunderstanding is why some cancer patients are reluctant to enter cancer clinical trials. Placebos (also called sugar pills) are rarely used in cancer clinical trials and are never used in place of treatment. Patients who join cancer clinical trials are either given the standard of care, (best treatment available for their specific cancer) or receive a new treatment being investigated. Remember that although you are the only one who can decide whether to take part in a cancer clinical trial, your doctor and the research team provide important and valuable information about the risks and benefits of participation.
An important benefit to participating in a cancer clinical trial is the high level of patient care, as patients in cancer clinical trials are followed more closely by their doctors and nurses. This monitoring is an integral part of the cancer clinical trial process, and undoubtedly provides cancer patients with a high quality experience, whether they are in the treatment or control group.
Yes, very. Survivors who participated in a study conducted by the Coalition reported they were very satisfied with the cancer clinical trial experience, with 91% indicating they would recommend participating in a trial to a friend.
Choosing to Participate
Participation in clinical trials is voluntary. Choosing to participate in a clinical trial is an important personal decision. It is often helpful to talk to your doctor, family members, or friends about deciding to join a trial. You can also talk to the study research staff and ask questions about specific trials.
Access through our Cancer Center of Excellence
At St. John Providence Health System’s Cancer Center of Excellence, our patients have access to hundreds of clinical trials through the Community Clinical Oncology Program (CCOP). Locally, St. John Providence Health System is a member of the Michigan Cancer Research Consortium CCOP, which includes Foote Health System in Jackson, Genesys-Hurley Cancer Institute in Flint, Oakwood Health System in Dearborn, St. John Hospital and Medical Center in Detroit, St. John Macomb-Oakland in Warren, Sparrow Hospital in Lansing, St. Mary’s of Michigan in Saginaw, St. Joseph Mercy Oakland in Pontiac, St. Mary Mercy in Livonia, and Mercy Hospital in Port Huron.
Through our CCOP, we are affiliated with the following research centers:
- Cancer Trials Support Unit (CTSU)
- Eastern Cooperative Oncology Group (ECOG)
- MD Anderson (MDA)
- National Surgical Adjuvant Breast and Bowel Project (NSABP)
- North Central Cancer Treatment Group (NCCTG)
- Radiation Therapy Oncology Group (RTOG)
- Southwest Oncology Group (SWOG)
- University of Michigan CCOP Research Base
Providence and Providence Park Hospitals
Providence and Providence Park Hospitals participate in Phase II, III and IV studies. Most of the phase II and III studies are randomized studies. We participate in these studies via the National Cancer Institute (NCI) network of cooperative groups. Providence has been a member of SWOG and NSABP (funded by National Cancer Institute) for the past 10 years. SWOG is one of the largest of the National Cancer Institute-supported cancer clinical trials cooperative group (www.swog.org). We can also access studies for other cooperative groups through Clinical Trials Support Unit (CTSU). The Cancer Trials Support Unit (CTSU, www.ctsu.org) is a project sponsored by the National Cancer Institute (NCI) for the support of a national network of physicians to participate in NCI-sponsored Phase III cancer treatment trials. The majority of these trials are sponsored by the adult Cooperative Clinical Trials Groups listed here.
- ACOSOG - (American College of Surgeons Oncology Group)
- CALGB - (Cancer and Leukemia Group B)
- ECOG - (Eastern Cooperative Oncology Group)
- GOG - (Gynecologic Oncology Group)
- NCIC CTG - (National Cancer Institute of Canada Clinical Trials Group)
- NCCTG - (North Central Cancer Treatment Group)
- RTOG - (Radiation Therapy Oncology Group)