What is involved when you join a "scary" new treatment clinical trial?

Often when I approach someone about a new treatment clinical trial, they say, "No way am I going to put some untested stuff in my body!" This reaction is perfectly understandable, but we should never forget that we have the medicines we have today, only because others who came before us assumed the risk of clinical trials. As someone who HAS participated in a new treatment clinical trial, I want to share with you some of the requirements I considered before enrolling, and some of the experiences I actually had during the trial. The list below is not meant to address every issue, but hopefully enlightens you about some of the most important ones.

What commonly happens when you are in a new treatment clinical trial?

• You will be required to go to the study center at regularly scheduled visits. This may involve travel or overnight visits. In addition to local study center visits, I traveled to the INDD at Yale for brain scans.
• There may be scans, bloodwork , psychological tests, and other medical tests scheduled on a regular basis. In my case, I had brain scans, EKGs, bloodwork, regular neurological exams.
• Most new drug trials may involve some risk of harm or injury to the participant, although it may not be more than the risks related to routine medical care of disease progression. In my study I was told I might be at greater risk for cancer.
• You may be asked to keep a notebook or log of your symptoms. I did not keep a log, but did keep track of new symptoms I thought were study-related.
• If your trial involves taking a new drug, you will need to notify your study center if you miss a dose. I did this.
• You will be probably be seen by top researchers in the country. Yes, I met Dr. Ken Marek at INDD.
• If your trial is placebo controlled, it is possible that neither you nor your doctor will know who is on placebo and who is getting the treatment. True for me.
• You may experience side affects. I reported fatigue and nausea as side affects.
• You may be affected by the "Placebo affect," where the patient believes s/he were receiving benefit, but in actuality was not taking the new drug. In my trial, I knew people who were affected by the "placebo affect." (I was not.)
• You may be followed for several years, as I was.

If you think you might want to join a new treatment clinical trial: Research!

• Learn all you can about the results of its previous animal and human trials.
  
• Talk to your family and friends
• Read a checklist of what questions you should ask before joining a trial.
• Contact your doctor to see what s/he thinks of the idea
• Contact the study center and ask questions
• If you feel uncomfortable at all with the idea of joining any trial, don't do it.
• Before proceeding, be as sure as you can that this is the right choice for you. But remember that you can quit a clinical trial at any time.

So what about my future plans? I am open to participating in a new treatment clinical trial, so I am signed up at Fox Trial Finder. And I follow the latest research. Of course participating in a clinical trial (scary or not) is your decision alone. Make sure your decision is an informed one.

download PDPlan4Life's clinical trial brochure (2 files): file 1 &file 2

email us directly at: Sheryl@pdplan4life.com

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Without express written consent, this material may only be used for your own personal and noncommercial uses which do not harm the reputation of PDPlan LLC, provided that you do not remove any copyright. To request permission to reproduce, please contact PDPlan LLC at Sheryl@pdplan4life.com