Side Effects of Clinical Research Studies
Should I Expect Side Effects During a Clinical Research Study?
Side effects can happen during investigational drug or device trials, they certainly aren’t an inevitable part of clinical research study participation. As a potential participant, it’s important to remember that investigational drugs or devices are carefully studied in a laboratory setting before human studies can begin. This is true even for early phase clinical studies. Ultimately, a clinical research study cannot proceed if an investigational drug or device is suspected to be unsafe.
Clinical research study facilitators are also beholden to the principle of informed consent, which ensures that participants are informed of any risks associated with a clinical study before they enroll. If researchers are aware of a common side effect associated with an investigational drug or device, they are required to inform potential participants before the trial begins.
Finally, it’s important to remember that you may not be a part of the investigational drug or device group during a clinical study. As a participant, you may be placed in the control group, which means you will receive the existing standard drug or device, or the placebo group, which means you will not receive an investigational drug or device at all. If you are placed in the placebo group, you may not experience any side effects at all as you won’t be receiving an active drug or device.
What Happens If I Experience Side Effects?
As mentioned, before you enroll in a clinical research study, you will be informed of any known side effects or potential drawbacks of an investigational drug or device. If you experience side effects, you will need to alert the trial team so they can include those in the overall trial data. You will also need to inform your care provider and the trial team if you experience any severe side effects. In the case of severe side effects, you will be treated immediately and monitored closely until the side effects end. You can also withdraw from a clinical trial at any time if your side effects interfere with your daily life.
Deciding Whether to Participate in Clinical Research
Many participants feel nervous about the potential of experiencing side effects during clinical research. However, it’s important to note that participants receive the best medical care and constant monitoring during the trial process. This careful attention can greatly help reduce the impact of any potential side effects.
_____
While side effects can happen in any medical setting, clinical trial participants receive exceptional medical care to lessen any discomfort. Remember: If you’re interested in participating in a clinical trial, the facilitators see your health and safety as the top priority.
Have you ever thought about participating in a clinical research study? You could be a part of history! QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted more than 1,500 FDA-regulated studies, paying out nearly $50 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical trial.
To get started, you simply need to fill out an online application. After that, within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.