CLINICAL TRIALS

Over one million people in North America alone were affected with blood cancer this year, according to the Leukemia & Lymphoma Society. Anyone can get blood cancer. Scientists are studying the possible familial connection or environmental connection. Sometimes it is just plain luck of the draw.

Last month I attended an informative Leukemia & Lymphoma Society event at Arizona State University’s Sky Song in Scottsdale on the topic of clinical trials. I now wish to take this gift of knowledge and pass it on to all the readers of my blog.

CLINICAL TRIALS

If you qualify for a cancer clinical trial, my first response would be: “What are you waiting for?” The majority of participants find that a clinical trial is a positive experience, and that they were treated with quality medical care, dignity, and respect (Harris Interactive 2001). I will second that motion. Having a research doctor answer the questions you have submitted by email with a personal phone call is the best kind of medicine. I know how busy they are, so I try not to abuse this wonderful option.

On the practical side, it does cost money, if the clinical trial is far from your home. We have spent a good amount of money this past year on flights, hotels, and meal stipends to travel across the United States from Arizona. NIH reimbursed about one-third of the costs, which helped a lot. Some sites do not reimburse any travel costs. Many participants are lucky to find a clinical trial near their home and they can drive or have someone drive them. Since traveling is stressful, you also need to consider whether the patient is physically able to travel and be away from home.

Every available cancer therapy begins with research. Researchers are not able to begin their discovery without funding. That is why research grants are so vital. So here is a shout out to all those people who raise funds for research! Thank you.

Once funding is available, the development of the therapy is accelerated through clinical trials. The trial, however, is at a standstill until cancer patients volunteer to participate. The sooner the number of participants is reached, the sooner the research is conducted and presented.

 Clinical trials go through several phases. In a nutshell, here is a summary of the phases:

• Phase I trials test for safety of the drug, the best way to administer it, and if cancer responds.

• Phase II trials test if one particular type of cancer responds to the new treatment. Everyone gets the drug. For example, I am in a Phase II clinical trial and the arm of the trial I am in is for participants over the age of 18, who are untreated or treated, who have the poor prognosis of 17p deletion.

• Phase III trials compare the new treatment to the standard treatment, and test to see if it works better. There is no placebo. The computer determines whether you get the new drug or the standard treatment.

• Phase IV trials continue researching long-term benefits and side effects.

The process costs time and money, and requires investigators, institutions, the federal government, the pharmaceutical industry, and the public to cooperate and trust the process. Here is an interesting fact from Banner M.D. Anderson (MDA): Out of 5,000 great ideas, five go to clinical trial, but usually only one gets approved by the United States Food & Drug Administration (FDA). The average cost is over one billion dollars for a new drug application (NDA). The NDA is the process through which drug sponsors propose that the FDA approve of a drug for sale to be marketed in the U.S and become commercialized and available to patients.

Without clinical trials there would be no new cancer therapies. Funding and participants are integral to the success of cancer research.