Do you take Lipitor to lower your cholesterol? Have you taken an over-the-counter pain reliever like Tylenol or Advil? If so, you’ve benefited from a clinical trial.
These research studies are vital because they help effective medications reach the marketplace and help healthcare professionals determine which approaches are best for certain situations.This means when you have strep throat, your doctor knows which type of treatment or medication is generally the most effective. These protocols wouldn’t exist without the researchers and patient volunteers who participate in clinical trials.
What are clinical trials?
It’s a long road for a drug to make it from a research lab into your local pharmacy. Before it hits the shelves, medication goes through an extensive process that includes:
- Preliminary research to create the compound or medication
- Laboratory testing, which may be performed on animals
- If the laboratory studies have been successful, and the Food and Drug Administration gives its approval, human clinical trials can begin.
Drug trials are conducted in different phases. Phase 1 studies determine the most common side effects and how well the drug is metabolized.
Phase 2 testing is determined to see how effective the drug is as compared to other treatment. If Phase 2 testing is successful, then a large-scale, phase 3 testing is conducted. Phase 3 testing involves a greater number of patients.
Granted, this is a very oversimplified version of how a medication makes it to your doctor. More detailed information can be found on the website for the Food and Drug Administration.
Helpful terms when discussing clinical trials
If you want to know more about clinical trials, here’s some vocabulary that may come in handy:
- Protocol: This is the general plan each trial must follow, including who can take part, how many patients will be involved and how the clinical trial will be conducted.
- PI (Principal investigator): The PI—typically a physician—prepares the protocols for the trial.
- Eligibility: Patients must meet certain qualifications to participate in a clinical trial. The PI will likely determine their eligibility, meaning whether or not they can participate in the trial.
- Bias: This means that human choices, rather than scientific evidence, is influencing the trial. Researchers go to great lengths to determine that there is no bias.
- Placebo: A substance that doesn’t contain medication. This is given to some participants in the study to compare the medicines effectiveness to a control group. Not all trials use a placebo. Placebos are used to help researchers determine between actual medical benefits and the “placebo effect.” This effect occurs when a patient takes a placebo and thinks he or she is experiencing symptoms or improvements.
- Blind: This means participants don’t know if they are receiving the actual medicine or a placebo.
Four things to consider before signing up for a clinical trial
Without doubt, there are several benefits to participating in a clinical trial. Not only do you receive new treatments before they are widely available, but often, you’re compensated for time and travel expenses. It’s always important to consider the benefits and risks of clinical trials.
1. Clinical trials are time-consuming
Participation may require you to travel to another city or a facility that is farther away. Researchers may also ask you to do other things outside of the clinic, such as keep a journal or record any symptoms. While medical care for the clinical trial is often provided free-of-charge, you may also have to participate in more checkups or tests than normal.
2. It’s always possible you could receive the placeboIf you are in a blind study, you won’t know if you are receiving the actual medication or a placebo. While not all trials use placebos, it’s very possible you may participate in a trial and not receive any treatment.
3. Health insurance and health care providers don’t always cover all costs
Some research trials may provide care for you, while others will only cover part of it. Be sure you understand what you will and will not be expected to pay before signing up.
4. The medication may make a big difference…or not
While you can have incredible benefits, sometimes researchers find that new medications and treatments aren’t any more effective than ones currently available.
Information on clinical trials
Periodically, the practices of Raleigh Medical Group, Raleigh Adult Medicine, and Cary Medical Group participate in clinical trials. We work with Accellacare for seamless collaboration. When available, new clinical trials are listed on this website under “News.”
If you’re interested in participation, please speak with your physician. If you decide to participate in a clinical trial outside of Raleigh Medical Group, it’s very important to keep your local doctor informed.
The National Institutes of Health also maintain an extensive database of current clinical trials.