For the Food and Drug Administration (FDA) to approve a drug or medical device for consumer use, all clinical research must have ended – right? Wrong. In fact, one critical phase of testing remains: a Phase IV (Post Marketed Research) clinical research study. While Phase I (Safety), Phase II (Effectiveness), and Phase III (Benefit) studies must occur before the FDA can approve a product, phase IV studies can only occur after FDA approval. So, what is a phase IV clinical research study and what purpose does it serve?
What Is a Phase IV clinical research study?
As the last phase of clinical research, phase IV trials involve lots of participants and lots of time. Sometimes they’re known as postmarketing surveillance. What is a phase IV clinical research study?
How many participants are involved?
Treatments being studied in phase IV research studies are already on the market and available to doctors and patients (even if they don’t join the study). In fact, the care provided in the study is very similar to the care patients can expect to receive outside of the study. In addition, because the treatments being studied have received FDA approval, phase IV studies are typically the safest phase to join as a participant.
So, how many people participate in phase IV studies? Typically, several hundreds or thousands of participants take part. In joining a phase IV trial, participants are helping researchers gather more information about the treatment, which may help people who will need the treatment in the future.
How long does the trial last?
Since phase IV trials aim to study how a treatment will perform in the long run, it shouldn’t come as a surprise that they’re quite long. Typically they’re conducted for a minimum of two years.
What is the goal of the trial?
By the time a phase IV clinical research study begins, the treatment has already gone through three to four phases of clinical research. Although researchers have studied the treatment extensively and secured FDA approval, they typically still have questions about its long-term safety and effectiveness. For example, does the treatment produce any rare side effects that haven’t been recorded yet? Do some side effects only arise after a person has taken the treatment for a lengthy period of time? Does the treatment’s effectiveness wane over time? How well does the treatment work when combined with other treatments?
Pharmaceutical companies may use phase IV studies to look at other aspects of a treatment as well. For example, they might compare the treatment with other available treatments. They might examine how the treatment impacts participants’ quality of life. Or, they might determine the cost-effectiveness of the treatment.
Ultimately, phase IV studies are trying to answer an important question for researchers and pharmaceutical companies: “What else do we need to know about this treatment?”
What happens next?
While extensive, the first three phases of clinical research involve a relatively small number of participants when compared to the general population. By testing more people over a longer period of time, phase IV studies provide important information about a treatment’s real-world effectiveness. If the trial reveals anything concerning, such as harmful side effects, the studied treatment may be placed under restrictions or be taken off the market.
Are you interested in joining a phase IV clinical research study? To learn more about participating in clinical research, check out QPS Missouri if you live in the southwest Missouri region. 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. 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.