Clinical research studies are a key tool, enabling researchers to determine if a new medical device or medication is safe and effective. However, these research studies can seem a bit confusing to trial newcomers. Read on if you’re interested in further understanding clinical research studies.
Understanding Clinical Research Studies
How Do Clinical Research Studies Work?
Take a moment to picture your medicine cabinet. There’s a good chance that you have at least one prescription medication in your home right now. Now, think about your loved ones who may rely on medical devices like diabetes testing strips. Medications, medical devices, and other core elements of medical treatment all have one thing in common: They must be rigorously tested for safety and effectiveness before they can be prescribed by doctors and sold to the public. This rigorous testing involves clinical research studies, which are regulated research studies involving human participants. These research studies aim to explore medical options ranging from medical and surgical interventions to behavioral treatment options.
What Can I Expect After Enrolling in a trial?
clinical research study procedures vary widely. After all, new drugs and medical devices require different testing than, say, a new type of bandage. When you enroll in a trial researchers will evaluate the medical protocol being tested to determine the goals of the study. You might be enrolled in a study exploring the safety of a new medical intervention, the overall effectiveness of a new medical intervention, or both. Depending on the type of the study, you may be asked to schedule frequent appointments at a clinic; however, you may also only need to appear in person a few times during the course of the study. Studies vary in location, participant demographics, and the number of participants. However, one thing is certain: The research team behind your study is required to inform you of any and all study protocols before the study begins. This is a concept known as “informed consent.”
What Is Informed Consent for Research Studies?
Per the American Medical Association’s rigid Code of Medical Ethics, informed consent is a communication process between researchers, doctors, and study participants. During the informed consent process, the researcher must ensure that the patient fully understands the treatment, any potential treatment alternatives, and the implications of the treatment. Once patients have all of this information, they can decide if they want to pursue trial participation.
Clinical Research Studies Are Safe and Regulated
Perhaps the most important thing to know about clinical research studies is the fact that they are highly regulated for patient safety. The Food and Drug Administration (FDA) heavily regulates research studies to protect participants’ health, as well as their rights. This means researchers must establish general safety guidelines long before a trial begins, which often involves fine-tuning medications using animal models. trial participants can rest assured that every reputable clinical research study has undergone countless layers of safety testing.
Understanding clinical research studies is the most important part of enrolling as a trial participant. Fortunately, researchers are required to follow rigorous informed consent practices to ensure that patients understand the trial protocol. This way, patients can trust that the researchers have their health and well-being top of mind at all times.
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 over 1,000 FDA-regulated studies, paying out over $35 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 potential 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 research study.
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.