Clinical trials—or voluntary research studies that determine the efficacy and safety of new medical treatments, devices and procedures—are essential to the advancement of medicine.
“Here’s an example of how beneficial clinical trials can be,” says Shirish Gadgeel, M.D., a medical oncologist at Henry Ford Health. “I’ve been a lung cancer doctor since 2000. When I started, the average survival of stage 4 lung cancer patients was 8 to 9 months. Now, the average survival is 2 years, with a small minority of patients alive for more than 10 years. We’re still working toward better outcomes, but thanks to clinical trials, it’s almost three times better than what it was 20 years ago. I believe this is only the beginning. With all the scientific advances that are occurring, we expect that outcomes will be even better in the coming years.”
Clinical trials aren’t just beneficial for the future of medicine, but also for each individual patient enrolling in them—especially if traditional treatment options haven’t worked.
“Clinical trials give patients access to new drugs that may not be available to the general public – particularly patients with diseases that don’t have great outcomes,” says Dr. Gadgeel. “Also, clinical trials involve multiple people who are experts in that particular disease, so in a way patients get opinions from experts other than their oncologist.”
And clinical trial patients are often closely monitored, which means you may receive more care or advice during the trial.
Types of Clinical Trials
Every clinical trial is conducted according to a very rigid plan that outlines what types of patients can be included in the trial, which procedures will be done, what drugs and dosages will be given, and what results will be measured to determine the effectiveness of the trial. It also describes what type of information will be collected and the length of the study.
While treatment-based clinical trials are probably the most well-known (such as testing new drugs to treat cancer) there are other types of clinical trials, such as:
- Device-based clinical trials. These trials don’t test treatments, they test medical devices. “Around 2004, the National Cancer Institute started a clinical trial to see if CT scans could better detect early stages of lung cancer than chest X-rays,” says Dr. Gadgeel. “They enrolled over 50,000 individuals with a specific history or risk background of lung cancer. They learned that CT scans can, in fact, help us detect lung cancer earlier than chest X-rays, and reduce the mortality of lung cancer.”
- Observational-based clinical trials. These trials, also known as population science trials, examine environmental and lifestyle factors that might be correlated to certain diseases. “About 50 years ago, this type of clinical trial proved that smoking increases the risk of lung cancer,” says Dr. Gadgeel. “And right now, population science trials are being conducted to see why rates of colon cancer are rising in younger people.”
Clinical Trials at Henry Ford Health
Who Qualifies For Treatment-Based Clinical Trials
All clinical trials are approved and monitored by the Institutional Review Board (IRB), which ensures patient safety and protects their rights and privacy.
"It is critical that physicians communicate clearly to the people participating in the trial about the experimental nature of the drugs being tested and the lack of information regarding safety and benefits from such treatments," says Dr. Gadgeel.
Because treatment clinical trials test experimental drugs, doctors want to ensure the patients involved don’t have any other major illnesses that may impact their ability to tolerate a new drug. “We want to make sure other organs such as the liver, kidneys and heart are in good condition,” says Dr. Gadgeel. “If, in addition to cancer, they also have heart or kidney disease, there could be side effects we hadn’t anticipated.”
Most of the time, patients don’t have to pay to participate in a clinical trial – nor will they be paid for their participation. That said, there are two types of costs associated with a clinical trial: routine patient care costs, such as doctor visits, hospital stays and lab tests; and research costs such as the cost of the study drug or tests performed for research purposes. Insurance companies are not required to cover research costs, though they are often covered by a trial’s sponsor.
How To Get Matched With A Clinical Trial
To enroll in a clinical trial, the patient’s physician will review and assess the patient’s records, says Dr. Gadgeel. Based upon the disease, stage of the disease, and the patient’s eligibility, the physician will discuss clinical trial options with the patient. Some patients also seek out clinical trials through online forums and websites and discuss them with their oncologist.
Most of the time, clinical trials have strict requirements for the groups of people they wish to study. If you want to participate, you’ll be screened to see if you match the requirements (age, gender, family history, stage of disease, etc.) and then you’ll be fully informed of the trial’s details. Once you provide your consent, you’ll be enrolled.
“More and more patients are being offered and accepting trials, especially when it comes to lung and pancreatic cancer, because with these cancers, even if they’re found at an early stage, not everyone is cured," says Dr. Gadgeel. "The more that eligible patients enroll in clinical trials, the more breakthroughs there will be.”
Reviewed by Shirish Gadgeel, M.D., a medical oncologist who specializes in lung and thoracic cancer. He is the Associate Chief for Academics in the Division of Hematology and Oncology, and Professor of Internal Medicine at Michigan State University, Lansing. He sees patients at Henry Ford Cancer - Detroit and Henry Ford Medical Center in Novi.
