The Skinny On Clinical Trials...A Laypersons View
by Colette Johnston
Moab Skinny Tire Events Event Coordinator

 
Up until four years ago I, like many others, thought that clinical trials were the government's way of testing drugs on terminally ill people in an effort to find cures for future generations. Boy have I learned a lot in the last four years!

While my older brother was fighting cancer I came to realize how quickly treatments changed, drugs were approved for use and new medical devices became available. This was most profoundly driven home when his Oncologist told him to do everything he could to stay alive because cancer treatments were changing so fast that a person that would have been untreatable six months ago may be treatable with good results today. It was then that I began my quest into the world of clinical trials.

I began reading and learning about clinical trials online and also with information obtained at the cancer treatment center for my brother. I quickly came to realize this was not a dark ominous world of human sacrificial pigs but to the contrary, great lengths are taken to ensure human participants are protected.

There are hundreds if not thousands of areas that clinical trials are used for the advancement of human treatment. Everything from behavior trials for veterans to new drug therapy's for every type of illness. I even reviewed one trial based on using cycling for specific muscle group rehabilitation. For me, of course, cancer became my field of interest so that is where I placed my focus.

There are hundreds if not thousands of areas that clinical trials are used for the advancement of human treatment. Everything from behavior trials for veterans to new drug therapy’s for every type of illness. I even reviewed one trial based on using cycling for specific muscle group rehabilitation. For me, of course, cancer became my field of interest so that is where I placed my focus.

What’s the process? In a nutshell, after many years of research in a laboratory (very strongly regulated by the U.S. government and most other advancing countries), scientists provide documentation that the program on which they have been working has a very strong potential of being successful in the treatment of humans and is ready to go into the clinical trial process. Their documentation has to prove that the projected benefit of the treatment outweighs the known risks; they must also provide proof that known risks have been completely researched and revealed. Often at this level they are requesting funding for the advancements of their new treatment. This funding comes from different sources but most often from private industry (pharmaceutical companies), government programs like the National Cancer Institute (NCI), or non-profit organizations like the Lance Armstrong Foundation (LAF).

So how do we keep from losing sight of humanity in the science, you may ask? Every phase of every clinical trial must undergo rigorous scrutiny by a board of peers. This review board is comprised of physicians with expertise in the specific field of medicine, statisticians, fellow scientists and (here’s the part I groove on) citizen/patient representatives. These boards are usually referred to as Peer Review Boards or Institutional Review Boards (IRB).

These boards are completely volunteer and no member can have a vested or sizable financial investment in any of the research they are reviewing. The mandate of these Boards is directed from our government and is very clear: “To serve and protect the rights and welfare of research subjects”, as stated in the IRB handbook by Robert Amdur, MD. This is achieved by learning the science behind the research. Once they are convinced it is “good science” a huge amount of time is spent being sure that every word of the informed consent documents is correct and that the forms are understandable and accurate to the population likely to participate in each trial.

I will tell you from personal experience that the Board volunteers are very dedicated and morally motivated people. I sit on three Boards and have come to know many of these medical professionals. They are high ranking individuals in their fields. They are very busy people and yet they are so driven to protect the human subject that they give hundreds of hours a year to this. As a layperson, I am always treated with respect and my vote is given the same weight as the professionals. I find it to be a very personally gratifying experience.

So if you or someone you know is considering participating in the clinical trial process I assure you that your rights and best interests are well served. Even if you do not receive a direct benefit, there is a benefit to society and much to be gained from the knowledge obtained. Just ask someone who has gained a quality of life from a newly approved treatment that may not have been available six months ago.

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