What’s a clinical trial? You may not know until you need one.

State Rep. Gail Haines (R-Waterford) with Gerold Bepler, M.D., Ph.D., president and CEO, Karmanos Cancer Institute

State Rep. Gail Haines (R-Waterford) with Gerold Bepler, M.D., Ph.D., president and CEO, Karmanos Cancer Institute

State Rep. Gail Haines (R-Waterford) hosted the second annual Clinical Trials Awareness Day at the Capitol in Lansing on June 4, 2014. Karmanos’ own President and CEO Dr. Gerold Bepler was invited to speak at the press conference and present information to legislators about the more than 340 clinical trials open to Karmanos cancer patients. According to Rep. Haines, 4,340 clinical trials are being studied in Michigan for diseases ranging from diabetes to mental illness.Clinical trials are much discussed in the medical community, though they aren’t likely to be a  topic of conversation at the average family dinner table. But maybe they should be, because clinical trials are what fuels new treatments that fight cancer, control heart disease and prevent asthma attacks.

 What exactly is a clinical trial?

Clinical trials come in phases and, at least at Karmanos, they begin in a medical research laboratory. It can take years of trial and error in the lab before a drug or treatment protocol appears to be promising in treating a particular type of cancer. Once a potential treatment is identified, its toxicity is tested. Based on those results, the drug or other intervention is submitted to the U.S. Food and Drug Administration for approval for a Phase I clinical trial, the first time it will be tested in people.

Clinical trials are sometimes called translational therapeutics because they translate treatments from the laboratory environment to the clinic or hospital where patients are cared for. Eligible patients are carefully screened and then educated about what it means to participate in a clinical trial. At Karmanos, every patient who is accepted into a Phase I trial receives the treatment. There are no placebos or control groups. And every patient is closely monitored for side effects and response to treatment.

Phase I trials are usually limited to a small group. The information gathered in the first trial about dosages and potential side effects is then used in a larger Phase II trial of up to 100 patients that often focuses on a particular type of cancer. Next comes a Phase III trial where the new treatment is compared with the current standard of care for that disease. Once the treatment has been approved for standard use, Phase IV trials study long-term effectiveness and safety.

Why does it matter if a clinical trial is available near me?

Patients who are eligible for a clinical trial are often people who have not responded to standard treatments. They are referred to a clinical trial when their doctor has exhausted all other treatment options. Patients often rely on family and friends to drive them to appointments and for other support, so many prefer to be treated as close to home as possible. That’s why making clinical trials available to patients in more communities across Michigan is so important. Rep. Haines’ focus on clinical trials awareness has the potential to help increase the number of clinical trials taking place in Michigan, which means more treatment options close to home for more Michiganders.

Karmanos also is working hard to bring clinical trials out to more communities across Michigan. Since we became part of McLaren Health Care, we’ve launched an initial five clinical trials in the communities that McLaren serves, with additional trials to come. And more clinical trials mean better outcomes for our patients and more time with loved ones.

Video: Karmanos melanoma patient finds hope in clinical trial — WDIV Local 4 Health Reporter Dr. Frank McGeorge shares the story.

To learn more about clinical trials taking place at Karmanos, call 1-800-KARMANOS (800-527-6266) or visit Karmanos.org.  For information about other clinical trials for other diseases taking place in Michigan, visit clinicaltrials.gov.


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