This is Cancer by Laura Holmes Haddad

Author:Laura Holmes Haddad
Language: eng
Format: epub
ISBN: 9781580056274
Publisher: Seal Press
Published: 2016-08-25T16:00:00+00:00

CLINICAL TRIALS: TO BE A GUINEA PIG OR NOT?

Clinical trials are research studies on people. When I first heard the phrase “clinical trial,” I shook my head, stomped my foot, and said no one was testing a thing on me. The word “experimental” can strike fear in a patient; after all, who wants to be the first person in line for a potentially life-threatening treatment? But without clinical trials, medical research—particularly oncology—would be at a standstill. Clinical trials allow a drug manufacturer to prove the efficacy of a new drug or treatment before it can be prescribed by a physician (or before it “goes to market”). Trials go on all over the world, and they need human volunteers—patients, called participants or subjects. One example of just how important trials are to medicine is evident in the standard treatment for breast cancer. In 1970, the only viable treatment was the radical mastectomy. Since many clinical trials have shown other options to be just as effective (less-invasive surgery, radiation therapy, and less-intensive chemotherapy regimens), breast cancer patients now have many more treatment options. I had to switch my thinking from viewing clinical trials as exposing me to “life-threatening” experimental drugs to seeing the drugs as “potentially life-saving.”

Clinical trials are many-years-in-the-making sorts of things, and they are monitored very closely. The trials are overseen by the FDA and run by the drug company (called a drug sponsor) through medical centers. There are strict protocols; ignore the mythical image of a bunch of mad scientists looking for a few willing volunteers. It takes an average of twelve years for a drug to go from discovery to FDA approval, and ninety percent of drugs in trials fail to get approval. A lot of thought, effort, and research goes into the drugs that do make it to the trial stage.

Another myth I had to overcome was that clinical trial participants are always facing a last option; there are trials for every stage and every type of cancer. At the same time, you, the patient, have to qualify for the trial—they don’t accept every patient that comes along. It’s an interesting juxtaposition; the drug company needs you and you might need them, but it’s a delicate dance. Factors such as the type and stage of your cancer as well as your age, gender, race, and prior treatment (if any) are considered before you are admitted, because every trial is very specific. It’s often a complicated process to find, and enter, a clinical trial.

Finally, you must remember that you are volunteering to participate. You can decide to leave the trial at any time.

Here’s a very basic summary to help explain what exactly goes on in clinical trials. First, there are three types: The first is a treatment trial, which evaluates a new type of treatment (surgery, drug, radiation therapy) or a combination of treatments to see if they are better than the treatments currently available to cancer patients. The second is a quality-of-life (also called supportive care) trial,

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