Monday, August 22, 2016
Participating in medical studies
I get these pretty often--maybe once a week. I am not very mobile and am skeptical anyway.
The pitch they give is that you will be adding to scientific knowledge to help the next patient like you. They may also point out that you are already profiting from people who went before you in studies.
A cohort study is a large group of people, such as the Framingham Heart Study, which yielded a huge amount of info on heart disease and stroke (www,framinghamheartstudy.org). These studies usually run for many year, even decades.
Another type is a clinical study. In these, volunteers receive a new treatment, a medication, procedure or device, for example. Usually, you are randomly assigned to receive the new rtreatment or a comparison item such as a placebo or existing treatment.
In these cases, the researchers really don't know which is better--the new or the old. Both probably have pluses and minuses.
All clinical trials have specific requirements for participants. Some want healthy people, some want people with a specific condition.
You will undergo informed consent, meaning you will be told what will happen and the pluses and minuses (side effects). This will be overseen by an independent Institutional Review Board.
The FDA also checks out studies--and approves only those where the potential benefit is greater than the possible risk.
And you will receive free medical care during the study and maybe even access to new therapies before others get them.
If you are considering this:
--Ask if there are alternative treatments besides those in the trial.
--How will your safety be monitored?
--After the trial ends, can you stay on the treatment or switchto it if you were a control?
--What happens if you are harmed?
I would advise that if you have a bad condition and want to try a new therapy, you look into all this carefully. What if you are a control--and don't get the treatment and your condition gets worse?
Talk it over with your doctor.