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 may help, or participate in a trial for a new drug or treatment, which may prove more effective. What do you do?
Understanding Clinical Trials
If you’re considering participating in a clinical trial, there are bound to be numerous questions and unknowns. Understanding why clinical trials are done may help ease some of your confusion.
Melanie Wheeler, ProMedica Research corporate director, explains why clinical trials are necessary.
“Without clinical trials and patients who are willing to participate, we cannot advance treatment,” Wheeler says. “Whether the trial involves a new drug, device or treatment, each one brings us a step closer to conquering the battle of cancer.”
But what is a clinical trial, exactly? Clinical trials test a drug or therapy on humans to make sure it’s safe and effective before it’s offered to the general public. The information collected helps improve medical care, as well as our understanding of the disease.
Clinical trials must follow a predetermined plan, or protocol, to ensure participants’ safety. And you must meet certain criteria to participate in a trial. Clinical trials are generally performed in four phases, with an increasing number of participants and different questions at each phase.
In addition, if you’re thinking about participating in a trial, you must meet with a member of the research team to discuss the study. This process, called informed consent, helps ensure that all your needs and issues are addressed from the beginning.
During your clinical trial, you will be closely monitored by the study team that is there to not only collect data, but also to provide you with some extra TLC. Members of the study team are available throughout the duration of the trial to answer your questions and offer assistance. Even in trials that have a placebo — an inactive substance referred to as “sugar-pill” or “water” — patients do better because of the extra care provided.
If you’ve already been through various treatments, which have proved ineffective, the treatment you receive in a clinical trial may be the only thing that actually works. Clinical trials offer hope of recovery, and might be exactly what you need to continue the fight.
Dispelling the Guinea Pig Myth
“Patients often make comments like ‘I don’t want to be a guinea pig.’ or ‘I’m not a research rat,’” says Wheeler. “We stress the benefits of participating, and always inform them that participation is voluntary.”
Wheeler explains that during a clinical trial, patients often receive free medication, devices, lab test, CT scans, or procedures — a valuable perk if you find yourself without insurance or struggling with high co-pays.
Still, participation levels are lower than you might expect. While some patients are unable to participate because they are too sick, others don’t know that clinical trials are available. Many are misinformed, believing that clinical trials are too risky.
Wheeler says that it’s important you feel comfortable with your decision to participate in a clinical trial. You should never feel coerced or pressured to participate, and you always have the option to withdraw from a trial at any point.
A Harris Interactive Inc. survey of almost 6,000 cancer patients found that the majority of patients who participated in a clinical trial said their overall experience was positive. Results of the survey done in 2000 also revealed that 97% of those who participated in a clinical trial said they were treated with dignity and respect, and that the quality of their care was “excellent” or “good.”
Wheeler says that the feedback local patients give is almost always positive. “They are grateful, and many make comments like, ‘Even if I don’t benefit, maybe others will.’”
Finding a Trial
You don’t need to live in a big city to take part in a cancer clinical trial. In 1983, the Toledo Community Oncology Program (TCOP) became one of the original 27 community clinical research programs sponsored by the National Cancer Institute. As of 2013, there are 45 programs, including TCOP, which form a comprehensive clinical trial network across the country called Clinical Community Oncology Programs.
And ProMedica Research is making progress as well.
“While our numbers are small, we are growing. And as we expand research within ProMedica, we want patients to be aware they can enroll in many of the same trials here at home. There is no need to travel out of town,” Wheeler says.
At any one time, more than 150 Phase II and III cancer clinical trials for children and adults are active at ProMedica. And if you are in search of Phase I trials, ProMedica collaborates with numerous area cancer institutes, such as the Barbara Ann Karmanos Cancer Institute in Detroit, The Ohio State University, Cleveland Clinic, and The University of Michigan.
“The goal of treating every patient is to provide the best possible care, and we value the relationships with the area comprehensive cancer centers,” Wheeler says.