How do clinical research studies work? This simple question can have a variety of answers, depending on what is meant exactly. Someone asking this question might be wondering about the process of joining a clinical research study, the phases of clinical research studies, or what happens during a clinical research study. To clarify all of these topics and provide some helpful basic information about clinical research, we’ve compiled a list of frequently asked questions. Scroll down to peruse the FAQs.
How Do Clinical Research Studies Work?
It’s helpful to start with the basics if you’re wondering, “How do clinical research studies work?” So let’s begin with the most simple question of all and work from there . . .
What is a clinical research study?
New medical treatments must be tested for safety and effectiveness before they can be prescribed by doctors and sold to the general public. They’re tested through clinical research studies, which are research studies involving human participants that aim to add to medical knowledge by evaluating a medical, surgical, or behavioral treatment. To learn more, check out our blog post What Is a Clinical Research Study?
What are the different phases of clinical research studies?
There are four typical phases in clinical research, and the phase of the research study will affect the number of participants, the researchers’ goals, the length of the research study, and more.
- Phase I: Phase I studies assess the safety of the treatment and evaluate what the drug or device does to the human body. A small number of participants take part – approximately 20 and 100 people – and the research study typically lasts several months.
- Phase II: Phase II studies assess the efficacy of the treatment, while continuing to evaluate safety. Up to several hundreds participants are involved at this stage of the research, which typically lasts between several months and two years.
- Phase III: Phase III studies compare the new treatment to the current standard treatment, while continuing to test safety, efficacy, and effectiveness. These large-scale studies may last several years and involve several hundred participants.
- Phase IV: Phase IV studies occur after the FDA has approved the drug or device, with the goal of learning more about the long-term side effects and safety. They involve hundreds or thousands of patients and last at least two years.
To better understand what occurs during each of these phases, review our blog post clinical research study Phases: What Happens in Each Phase of a Research Studies?
What happens during a clinical research study?
Clinical research study procedures vary widely based on the nature of the treatment and the goals of the research. What sort of drug or device is being studied? What phase of research is being conducted? Is the study exploring safety or effectiveness (or both)? Some studies will require frequent appointments at a clinic, while others will require just a few appointments over the course of a year. Some will include 20 participants, while others will include thousands. Some take place at a hospital or medical center, while others occur at universities or research sites. To learn more about a specific clinical research study, contact the research team.
How can I find clinical research studies to join?
If you’re interested in taking part in clinical research, the internet is a great resource. You can start by exploring ClinicalTrials.gov, a registry maintained by the U.S. National Library of Medicine that lists hundreds of thousands of studies conducted across the United States. You might also consider joining ResearchMatch, which matches research studies with interested participants, almost like an online dating service. Of course, you could also simply google “clinical research” or “clinical research studies” and then add your city and state. If you’re struggling to find clinical research studies to join, review our resource How to Find Clinical Research Studies.
What is the sign-up process like?
As you might expect, the process begins with an application. You’ll need to provide your contact information and some pertinent details about your health. Once the clinical research study team has reviewed your application, someone will contact you to ask some questions to determine if you qualify for the study.
If you meet the pre-screening qualifications, you will be asked to schedule your initial appointment. During this first visit, you will receive an Informed Consent Form (ICF) that explains the study in further detail, including safety and scheduling information. You may also receive a free physical to ensure you qualify for the study. After this appointment, the researchers will let you know if you qualify for the study.
Are you interested in joining a clinical research study? 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 breakthroughs in pharmaceutical innovation. If you would like to join us in this mission, consider applying for a clinical research study.
To get started, you simply need to fill out an online application. 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 FAQ.