what you should know about participating in a clinical trial…

In the two weeks since the end of the ivabradine clinical trial, I have had a lot of time to reflect on the experience. Although the ivabradine ultimately did not prove to be my magical unicorn, I am more and more grateful for the opportunity to participate. I met some wonderful people, I learned a lot about myself, both physically and emotionally, and I had an adventure. And, hopefully, will have helped someone else discover their magical unicorn.

Although I never was able to confirm, I suspect my mom and I were the first mother-daughter team to participate in separate studies at this particular research institution. Through my experience participating in a clinical study, both as a caregiver and a participant, I gained a better understanding about the clinical trial process and what I wish I would have know before agreeing to participate.

Drug Trial Phases

Clinical trials fall into one of four phases:

• Phase I – studies the safety of the drug. The drug has likely been tested in rats or other laboratory animals, but not on humans. At this point, researchers are only looking into the safety of the drug, not the efficacy. This phase tests the drug on a handful to a hundred patients. About 70% of drugs move on from Phase I.
• Phase II – studies the efficacy of the drug in several hundred patients. This phase looks at both the safety and efficacy, often through blinded studies. Approximately 33% of drugs move on from Phase II.
• Phase III – studies the efficacy of the drug through randomized and blinded studies on a larger scale of patients, from several hundreds to several thousands of patients. Studies the benefits and possible adverse reactions to the drug/treatment. Approximately 25-30% of drugs move on from Phase III.
• Phase IV – conducted after the drug/treatment has been approved for sale to consumers and may test the FDA-approved drugs for off-label conditions or measure the long-term effectiveness. (source)

My POTS clinical trial was at Phase IV, my mom’s at Phase I, and the differences were interesting and obvious. Each time my mom was given the drug (or placebo), we were required to remain at the facility for 4 hours so she could be observed for possible side effects. She was constantly asked about any adverse reactions, including while present at the facility and in between appointments. No one ever asked about side effects for my study, and when I mentioned a few, I didn’t see anyone write them down.

Questions you should ask before participating in a clinical trial/research study

If you are considering participating in a clinical trial (I will post below how to find them), I have compiled a list of questions that I asked, or wish I would have asked, either to myself or the research team:

• What phase is the drug in?
• How long will the study last? What is your specific time commitment (are you expected to meet with the team once a week? Once per month?
• Will you have to stay overnight?
• Will you be compensated? Will they reimburse for travel?
• Will the study pay for all testing?
• Will you be given a copy of the results of any tests?
• Are you able to discuss the study with family and friends? Your doctor? The general public?
• What happens if you have an adverse reaction to the drug/treatment?
• Does the doctor/researcher have any financial interest in the study? How familiar is s/he with the condition the drug is designed to treat?
• Will you be given a copy of any published research?
• If the drug is working, will you be able to continue using it after the study ends?
• What happens after the study? What happens to your blood samples and other genetic material?

If you are interested in participating in a clinical trial for your illness, click here, or on the right side of this website you will see a red widget that allows you to search trials. There are currently a handful of studies recruiting for postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), Ehlers-Danlos Syndrome, and Sjogrens. I’m sure there are more – those are the only ones I searched.

It’s important to go into the study prepared that the drug or treatment might not work for you, and decide if you’re still willing to participate. It’s a lot of needle pricks and time away from your other commitments, but it could be someone’s unicorn.

“My constant prayer for myself is to be used in service for the greater good.” – Oprah Winfrey

Smell ya later.
– Linds