Should You Take Part in a Medical Study? (free issue)
Clinical trials and studies save lives. But what’s in it for you?
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Clinical trials have been part of the medical world since medicine began. Because humans are so different in many ways, clinical trials are pretty well the only way researchers can reliably learn why or how the body gets sick or injured, and how to heal it.
In 1747, Scottish naval surgeon James Lind performed what is considered the first randomized clinical trial. Scurvy, a disease caused by a lack of vitamin C, was a serious problem among sailors who were at sea for months. Lind had noticed this and devised a study. After sailing for two months, some sailors on Lind’s ship started showing signs of scurvy. He divided the 12 men into six pairs. He provided all the men with the same food and drink, but each pair received a different treatment:
Cider
Elixir vitriol (dilute sulfuric acid)
Vinegar
Seawater
A paste of plant extracts
Two oranges and a lemon each day.
Only the pair who received the fruit recovered.
Although today, this would be too small a study to declare that the fruit was the cure, it would definitely show that there was potential and lead to more studies.
Different types of studies
There are several types of studies. The ones most people may have heard of are:
Randomized controlled studies, which is what Lind did, help researchers find or fine-tune treatments. The researchers randomly assign subjects into one of two or more groups. A trial with two groups would have a study group, which gets the treatment, and a control group, which does not get the treatment. Treatments could be medications, surgeries, diet interventions, or just about anything that could help manage a condition. Larger trials may have more groups with different dosages, medications, or types of treatments, in addition to a control group.
Observational studies can be done in a few ways. One is to evaluate previously collected data, such as census information, insurance claims, etc., and researchers gather what they need and look for patterns. Another is to follow a group or cohort over a set amount of time. One of the biggest examples of this type of study is the Nurse Health Study and its two follow-up studies, which involved more than 280,000 people. The goal was to determine risk factors for major chronic diseases in women.
Volunteers needed!
Without volunteers, there is no such research. The researchers need subjects to study. Who are the people who volunteer? People like you and me.
During the pandemic, two new studies in Montreal caught my attention – one for heart disease and one for ovarian cancer. Both interested me for two reasons. The first was I could be tested and see if I was at risk. The second was that I would be helping researchers learn more about their topic and this would help people further down the road. Oh, and a third reason - since women are often underrepresented in clinical trials, I could help out there.
The heart study
I heard about the McGill University heart study through an ad on the radio. Researchers wanted people of all ages and all walks of life to fill out a (very!) extensive questionnaire that covered everything from stress and mental and physical health to family history. We also underwent several tests to see if we had any risks or signs of cardiac problems. These included blood tests, a stool test, an EKG, brain and heart MRIs, an exercise test, and a few others. After that initial appointment, there were follow-up questionnaires to see if there were any changes in our health.
The study is ongoing and its goal is to learn why some people at high risk for heart disease never get it, while others with no risk factors do. Given that women are underrepresented in medical studies and that heart disease runs in my family through my mother’s side, I thought it would be interesting to participate.
When I registered, the documentation said that while I would not be told any of the results (not uncommon), if at any time the researchers found something concerning that could lead them to suspect I was at risk for a cardiac event or danger of any kind, they would contact my primary physician immediately. This was reassuring. (Nothing untoward was found!)
I do admit that the first visit was time-consuming. It took a half day and not everyone can afford to give up that time. I am fortunate that I can adjust my schedule to accommodate something like this. But after that initial appointment, the only time required for the study is to complete some online questionnaires sent by email. That’s it.
The ovarian cancer study
The other study I enrolled in is the DOVEE project. The study’s goal is to find a way to detect ovarian cancer early. When detected early, the 5-year survival rate, the number of people alive five years after diagnosis, is 93%. but fewer than 20% of women are diagnosed in the early stages. There are no early symptoms. The 5-year survival rate drops after stage 1:
Stage 2 – 74%
Stage 3 – 41%
Stage 4 – 31%
I don’t have risk factors for this disease, other than having ovaries, of course, but we all know that sometimes cancer strikes out of nowhere, right? What also interested me were thoughts of the future because I have a daughter, daughters-in-law, and a granddaughter – as do many of my friends. I would love for them to be part of a society that can detect this silent killer before it gets too far.
The tests were more uncomfortable than the heart study but they weren’t terrible. The first time I had blood tests, ultrasounds, a Pap smear, and a tissue sample taken from my uterus (that was the “uncomfortable” one). One blood test looked for a specific gene that could mean you are at risk for this type of cancer. The best part? The head of the study called every participant personally to tell them their test results. For me, she said, “Mrs. Vroomen, your test was normal. There is no increased risk for ovarian cancer.” Music to my ears! I wasn’t worried, but hearing those words was comforting.
There was a repeat blood test several months later, and I’m going today for the 2-year follow-up ultrasound. And then that’s it.
Data gathering
Once the two studies are completed, the results will be published and I hope to find them in a journal. Not all studies are published in journals, but their information does get out to the medical community. It’s a lengthy process though. First, the studies need to reach their target goal for participants. Then when the tests and follow-ups are complete, the data need to be gathered and interpreted, and the conclusions written.
Whenever the results are available though, I’ll know that I played a small, tiny role, but an important one.
But what about drug studies?
Some people may be ok with participating in the studies I was part of, but less ok with studies that test drugs. And I get that. The heart and ovarian cancer studies involved some tests, but I didn’t have to take any medications, putting something in my body that could have an effect on me. But I think there is so much information that is important to know about drug studies that I don’t want to shortchange anyone by trying to squeeze it in here. I’ll address it in another newsletter issue, where I can really explain the different issues involved.
So what about you? Have you ever taken part in a medical study? Is this something you’re not interested in at all? Leave your comment below. Let’s get a conversation started!
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