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Check Your Health: Clinical Trials Can Help All Patients

November 5, 2012 by Special To The ...

Check Your Health_6.jpgCheck Your Health is a web-only feature being offered monthly by The Cheshire Herald. Each month, a professional from MidState Medical Center will offer advice on a different issue pertaining to health.

Cancer. A word that can silence a room and bring tears to otherwise dry eyes. It is also a word that can generate sincere gratitude from survivors, draw families closer together, bring about a person’s life purpose, and can even have NFL teams showing their support by wearing pink ribbons on their jerseys. Most of us either know someone who has/had cancer or have battled it personally. We see information about it in the movies, in books, on television. There are blogs, support groups, seminars, websites and news articles that speak to this disease. We learn of new therapies and scientists who continue to search for new medication to help in the fight.

One thing is certain about this one word cancer, there are many people who come together and dedicate their career to find a way to help us live longer, better and healthier lives. These are people on the front line, like your cancer doctor (oncologist), or those in the lab, attempting to provide us with options for treating this disease. Although we have many people who have been successful in their struggle with cancer, it can be very difficult to treat. Many oncologists provide you with options using the standards of care. The standards of care are the best known treatments for a particular type of cancer. More and more, another option your oncologist may present to you is a cancer clinical trial using a therapy that is being researched.

Many people cringe at the thought of research. The term “guinea pig” often comes to mind. Although the FDA has made great strides in the training of medical personnel, providing guidance and policies to protect patients and in some extreme rare cases discipline those found to abuse the system. Research brings together the brightest minds in an effort to make life just a little better. However, that effort can take 10-15 years for a particular therapy. The process timeline starts with scientists formulating an idea about a medication to treat a specific cancer; laboratory studies determine its effectiveness and safety; and then after many more years a clinical trial is proposed and carried out.

Many would be surprised to know that all medications that are currently prescribed to patients have been through the rigors of a clinical trial. Be it a medication for a headache or chemotherapy for breast cancer, research was conducted to provide information necessary for it to finally become available to friends, family and our children.

Today many people seek out clinical trials as an option in their plan of care, not only to enhance their life, but to provide needed information to researchers for the younger generations that may develop the same cancer. Many clinical trials provide a standard treatment plus an additional study medication. Patients in FDA approved trials are never given a treatment that may be inferior to what is already available.

In addition, it is very important to researchers that everyone offered a clinical trial is comfortable participating. Patients will go through an “informed consent” process safeguarding that they fully understand the details, risk and potential benefit. Patients are always given the option to decline participation without any adverse consequence to their care. Conversely, not all patients will be eligible for clinical trials. Prior to opening a trial to the public, strict and specific guidelines are established that either include or exclude patients based on a variety of factors. This helps to ensure that the information discovered is clean and reliable.

There may also be different types of trials available to a patient. This may have to do with how advanced a drug is in the development process. Phase I clinical trials test drugs in humans soon after being tested in the laboratory and are deemed safe. This is the very earliest phase of drug development and helps to establish the proper dose of drug. Phase II clinical trials determine how well the drug works, if they are effective enough the process will move on to a much larger scale. Phase III trials, which have the largest number of participants, are where researchers attempt to prove the benefit of a new drug or therapy against the standard of care. If the drug does well after this phase, then it goes to the FDA for final review and approval.

Although research is a very complex specialty, clinical trials are very important for the ongoing success of our quest to treat and one day, cure cancer and other diseases. While they are important for this mission, it is equally important that they be carried out safely and with the free will of participants. If you know someone or are someone given the option to participate in research think about the benefits, understand the risk and always ask questions until you fully understand all the options. Although a clinical trial may be a great opportunity, it may not be for everyone.

Gerard Fumo, DO
Medical Oncologist and Clinical Research
MidState Medical Center

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