I Volunteered for a Medical Research Study—and You Can, Too!

Maybe you’ve considered taking part in a clinical trial—perhaps to take advantage of a treatment not yet available to the general public—but you hesitated because you weren’t sure what it would be like. I recently participated in such a study. My experience might help you decide…

Thousands of medical research studies are going on all the time, and not just for life-threatening diseases and conditions. ClinicalTrials.gov recently listed 255,356 studies ongoing in 50 states and 200 countries. In fact, type any condition that interests you into the search box at ClinicalTrials.gov, and you’re likely to come up with at least one study being done on it somewhere. Add your city to the search, and you may find a study near you.

A nice perk of being a “lab rat” is that you often get paid! Participants in outpatient studies might get $20 per visit…hospital inpatients might be paid in the range of $500 to $3,000 or more. At a minimum, the care is free, and parking and transportation costs may be reimbursed.

HOW I GOT CHOSEN

Because I have a non-Parkinson’s tremor called “benign essential tremor” in my hands, my tremor doctor at New York City’s Mount Sinai Hospital asked if I was interested in joining a medical research study that was investigating whether perampanel, a drug used to treat Parkinson’s tremors, could relieve non-Parkinson’s tremors.

Before signing a consent form—and noting that at any point after entering the trial I could quit—my doctor gave me a 22-page report describing the trial, which I read thoroughly, and we discussed any possible side effects. I was reassured to learn that the study drug was already being prescribed in 30 countries and that more than 10,000 ­patients are currently taking it.

The study, designed to take nearly a year, was a double-blind cross-over—I would receive a drug or placebo during the first half of the study, then would switch to what­ever I hadn’t gotten (drug or placebo) for the second half. Neither I nor my doctor would know which I was getting at any time.

Mount Sinai agreed to pay me $600 (and sent me an IRS Form 1099). I agreed to keep a diary of the drug dosages to show that I’d taken them correctly and to be available for phone calls at their convenience and physical exams every two months.

Since videotaping was an essential part of the study, I had to agree to be videotaped. Interestingly, throughout the study, I had to wear the same type of tops that did not indicate any particular season so that the drug company would not have clues that could “unblind” the study.

Minor inconvenience: No coffee on the mornings of my physical ­exams!

STARTING OUT

I started with a screening visit with my tremor doctor, where I had a complete physical exam that took two-and-a-half hours. It included vital signs, medical history, medication review, a videotape of my tremor, various lab tests, an EKG and an electromyography (EMG) to test my muscles and nerves. I also drew spirals with both hands and did writing samples to show penmanship. Results were all recorded.

Having passed the screening visit, I moved on to the baseline #1 ­visit. This involved another physical exam, and I was given the first set of pills (drug or placebo) with instructions to take them before bed in case they caused temporary dizziness or sleepiness. Once it was clear that I didn’t have those symptoms, I was able to take the pills in the evening before I walked my dog and went to bed.

I had to keep all pill bottles to bring back to the study researchers so that they could “unlock” whether I was on the drug or placebo.

TESTING, TESTING

I started the trial taking one pill for three weeks…then I took two pills for three weeks…then three pills for three weeks…then four pills for five weeks. Then I waited a month for the drug or placebo to wash out of my system before following the same procedure and dosages with whatever I hadn’t gotten during the first half of the study (drug or ­placebo) for 14 weeks.

A researcher phoned me about every two weeks to ask how I felt. We were especially on the alert for dangerous side effects, including dizziness, vertigo, drowsiness, fatigue, irritability, nausea, balance problems, a fall, aggression, hostility, anger, homicidal thoughts and suicidal thoughts.

Fortunately, I had none of these side effects. (If I had any, I was told to immediately stop taking the drug and call my doctor.) I did point out to the researchers that sleepiness and fatigue aren’t necessarily caused by drugs and that living in a large city can make anyone irritable! A curious “side effect” I noticed was remarkably colorful dreams nearly every night, often involving very special men and events from my 20s. Generally, I don’t remember my dreams, and my researchers couldn’t explain this side effect. However, we both enjoyed all the glorious details!

MY THOUGHTS…

I wish I could say that I noticed improvements at some point during the study, but that wasn’t the case—either because the test drug doesn’t work for non-Parkinson’s tremors, or it just didn’t work for me. My doctor doesn’t know yet whether the drug manufacturer
who sponsored the study will share the results with me, but she has promised to keep me ­informed.

Meanwhile, I’ve become friends with my tremor doctor…and have learned a lot about the research process. Would I volunteer for a medical research study at Mount Sinai Hospital again? Definitely!

HOW TO PARTICIPATE IN A CLINICAL TRIAL

If you live in a large city and are being treated by specialists at a teaching hospital, ask your doctors if they know of any studies for which you qualify. Also check…

ClinicalTrials.gov, which has a database of cancer and non­cancer trials.

EmergingMed.com, which provides free and confidential matching services to patients looking for clinical trials.

CenterWatch.com, which offers a list of industry-sponsored and government-funded clinical trials for cancer and other diseases.