Clinical Trials - Could they help you?

Have you ever been curious about clinical trials? Ever wondered if you should try to get into one? I’ve been in a few trials myself and two of them led to extremely positive changes in my life. I’ll tell a little about my experiences further down the page, but let me give you the basics about what clinical trials are...

At first, a trial can seem a little scary and daunting. You might think all trials are difficult and dangerous, but that isn’t true. It can be an excellent way to get treatment when you can’t afford it, a chance to meet doctors who have been studying your medical condition, you may gain access to new research treatments before they are widely available, and of course it’s an opportunity to further scientific knowledge which will help other people - perhaps even a member of your own family.

The FDA is particularly interested in women and minorities being a part of clinical trials. In the past, white men were used as the primary participants. This means some groups, particularly women, African Americans, Hispanics/Latinos, American Indians, Asians, and Pacific Islanders have not always been included. However, drugs and therapies can often work differently for these groups, so the FDA is aiming for more diversity among those enrolled in studies.

~* WHAT ARE THE DIFFERENT TYPES OF CLINICAL TRIALS? *~

*Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

*Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

*Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

*Screening trials test the best way to detect certain diseases or health conditions.

*Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and quality of life for individuals with a chronic illness.

~* WHAT ARE THE POSSIBLE RISKS? *~

There can be risks to the participants in clinical trials:

~There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

~The treatment may not be effective for the participant.

~The trial may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

~* WHAT IS 'INFORMED CONSENT' AND

HOW DOES IT PROTECT YOU? *~

To help you decide if you want to be in a study, the FDA requires that you be given complete information about the study before you agree to take part. This is known as informed consent. You must be told absolutely everything, including:

~the purpose of the research & how long the study will take

~if the study involves research of an unproven drug or device

~the possible risks or discomforts & the possible benefits of the study

~what other procedures or treatments you might want to consider instead of the treatment being studied

~whether any medical treatments are available if you are hurt, what those treatments are, where they can be found, and who will pay for it

Informed consents must be written out and you must sign it before you can be in the study. Make sure you understand all of it before you agree to be involved. The informed consent form is NOT a contract and you can quit the study at any time, for any reason.

There are a lot more things to know about clinical trials before you join one. Here is an FDA web page which can offer you more insight: Understanding Clinical Trials

~* MY EXPERIENCES AS A CLINICAL TRIAL PARTICIPANT *~

I’ve taken part in four different clinical trials, but I’ll talk about the two which most affected my life...

In the emotional struggle dealing with the chronic onset of my genetic disorder, I became anorexic. At that time, my insurance did not offer any treatment for people with eating disorders and I was desperate to get help. I found out about an eating disorder clinical trial at Stanford University which was offering talk-therapy as part of a nine-month study. The catch was, there would be three trial groups. One group would take the antidepressant Prozac and get therapy with a psychologist, the second group would have the therapy but take a placebo (which has no real medication in it but the patient does not know), and the third group which would get neither therapy nor drugs and just be studied as a control group. The trial would provide monthly health screenings with a doctor, regular blood and urine tests, and nutritional counseling. We were also offered a fee.

I was hoping to get placed in the “therapy with no meds” group because I didn’t want to take any medication. However, the free therapy was such a prize that I consented and was randomly placed in one of the first two groups. I didn’t know until after the study was completed that I was actually taking the antidepressant and not the placebo. The trial ended up being extended and twice a year for the next two years I had follow up interviews; one was by phone but the second required a face-to-face meeting and included an additional fee. I agreed to continue; I figured since my illness was taking so much from me that I ought to make a little money off of it!

The second major trial I took part in was at the National Institutes of Health (NIH) in Bethesda, Maryland. After being diagnosed as having a certain type of genetic collagen disorder by Stanford University, I was told NIH was recruiting for a study which would fully evaluate patients with all sorts of diagnostic tests and follow us (and in some cases, our entire families) for 10 years. It was not a drug trial; it was meant to find out about our genes and our long-term prognosis. I was thrilled to be accepted into the trial and equally thrilled to meet doctors who actually knew more about my illness than I did! 

I flew alone to NIH and for a whole week I had tons of tests done, from X-raying every bone in my body, to extreme eye exams I can’t even begin to explain, and other tests you don’t want to hear about! When I left... 

...I had a complete report on my current state of health and a real treatment plan to follow for the first time.

When I returned for my follow-up two years later, this time with my husband in tow, I had all the same tests done. But in order to truly follow study participants, they had to know what other problems I’d been having, even if seemingly unrelated. In that visit, they discovered a small brain tumor I didn’t know I had. They also completely changed the quality of my daily life by referring me to the NIH Pain Clinic. There I was first introduced to time-release narcotics and to trigger-point needle therapy, and offered the choice to try them if I wanted to. (You can read what I have say about the meds in a previous blog post HERE)

My husband was with me in the Pain Clinic and it was the day that transformed his entire perception of my illness. He had always been supportive but I’d never really felt he understood the scope of my pain and suffering which had caused me so much emotional struggle. He said that hearing what those doctors said about my pain level really opened his eyes. Although he was at first upset about the medication they wanted me to take, after three days of watching me adjust to the drug and seeing how my whole demeanor changed, he said this, “It’s like having my real wife back again.” Just typing it gives me a lump in my throat. 

I’m so grateful for both the clinical trials I took part in. Each gave me treatment and support, showed me other ways to cope and adjust my lifestyle, improved my health and revealed things I didn’t know about so I could have them treated. I consider myself very lucky to have found those clinical trials when I did... as it turned out, when I needed them most. Each one was life-altering for the better.

~* HOW CAN YOU FIND CLINICAL TRIALS? *~

There are lots of clinical trials going on at any given time. You can check your local university hospital’s web site, like Stanford’s HERE and see what studies are being offered near you. 

In my opinion, the best trial listings to check are the ones at NIH which you can find here: ClinicalTrials.gov  (I always have this link on my page at the right, under Recommended Websites)

Other ways to find clinical trials:

~ask your doctor

~contact the national foundation for your medical condition

~connect with other people like you through patient advocacy groups or online support sites

I hope you’ll check out the trial listings and see if there are any which might help you. If you are really interested in a study, make sure to check the requirements to see whether you are eligible and then contact the study coordinator to find out all the details. Talk to your own doctor about the idea before going any further. If everything seems right and you are able to get all your questions answered about every aspect of the study and its possible effect on your life... then you should consider the opportunity to enroll. 

If you do, I wish you luck and all the success I had!