Each year, millions of people sign up to become what is in essence a human ‘guinea pig’ as part of a clinical trial. The popularity of participating in these clinical trials, under the supervision of the Food and Drug Administration, has exploded in recent years. There are ongoing trials in all 50 states, according to the website clinicaltrials.gov. What are the rules for applying, and what should you expect? Veteran plastic surgeon Dr. Pat McGuire discusses what you need to know before agreeing to become a part of a clinical trial.
What is a Clinical Trial
You’ve no doubt seen a television commercial or a newspaper ad for a clinical trail, promising a paycheck in exchange for trying out a medication or a medical device. It usually requires a time commitment, sometimes several years. As of this moment, ClinicalTrials.gov lists 283,756 clinical studies with locations in all 50 states, including more than 200 countries. The majority of the tests are being conducted on products already established outside the borders of the United States, according to Dr. McGuire. “These are usually not new devices. They’ve been in use in other parts of the world, like in Canada or South America or Asia, before they come here. They have a pretty proven track record, but the FDA is very picky about who they will allow to sell their devices in the United States.”
McGuire, a board certified plastic surgeon in St. Louis, says the FDA has to approve all new devices that hit the market, so the protocol calls for an institutional review board, or IRB, to set up specific standards on how the study will be conducted.
How Your Feedback Counts
There is enormous interest among the general public in joining a clinical trial. Each month the clinical trials website receives more than 171 million page views, or roughly 93,000 unique visitors each day. That’s a lot of people who want to know more about becoming part of a trial. McGuire says for those people who are curious, the first thing to know is that any study is highly supervised. “In order for a new device to be approved in the United States, it has to go through a clinical trial that is supervised by the FDA,” she explains.
She says the standards and protocols are high.”The IRB has specific parameters that are set for the study. There’s usually a number of patients who are enrolled and a number of doctors who have been approved to be in the study and they go through extensive training prior to the procedure.”
The sites for the study are also evaluated and approved ahead of time; every part of the study is given a careful look. “The devices are not FDA approved, but the study itself is approved by the FDA and monitored very closely,” details McGuire.
What Are You REALLY Signing Up For?
Nearly half of all registered studies underway right now are being conducted somewhere besides the United States. About 35 percent are being done in this country, according to a report by ClinicalTrials.gov. McGuire says it’s important to know that there are strings attached to being part of a study. “The important thing to know about an FDA clinical trial is that it’s not just a one time thing. You will have your surgery and then you can be followed for up to ten years.” She says it’s important to stay active in the study so appropriate data can be collected. “We will be collecting data on the efficacy and safety of the device, so it’s really important that the rules be followed.”
Some people may think it’s a free ride, but that’s not usually true. “You usually have to pay for any surgery,” explains McGuire. “The device will be at a reduced cost or no cost and the followup visits are free. You will get paid for any time required to go for doctor visits and filling out paperwork.” She reminds participants that the research collected will benefit others. “The other thing is you are helping other patients, because these devices could be beneficial in the future. It’s a collaboration between you, the surgeon, the IRB and the device company to help promote a new product for use in the United States.”