Did you know that research studies are divided into four distinct phases? Each phase plays an important role in the process and adds to researchers’ understanding of the drug or medical device being tested. If a drug or device doesn’t successfully proceed through one of the phases, it cannot continue on to the next phase, forcing researchers to go back to the drawing board. According to one study, the success rate of drug discovery projects is just 50 percent at phase II. So, what is a phase II clinical research study?
What Is a Phase II clinical research study?
During phase II studies, researchers test the efficacy of a new drug or device and involve participants living with the condition meant to treat. In other words, does the drug or device work? Does it produce the desired result? How well does it work? In addition, despite focusing on safety in phase I, researchers will continue to assess the safety of the drug or device. As more people use the drug or device, researchers will keep an eye out for safety concerns and rare side effects.
How many participants are involved?
Although the number of participants involved in a phase II trial varies, typically several hundred participants are involved.
How long does the trial last?
Phase II trials usually last somewhere between several months and two years.
How do researchers assess the treatment’s efficacy?
To evaluate whether the drug or device works as intended, researchers typically use randomized trials. Participants are divided into separate groups by chance. One group will receive the drug or device being tested, while another group (known as the control group) receives a standard treatment or placebo. Typically, the process is “double blind,” which means that neither the researchers nor the participants know who has received the drug or device and who has received a placebo or standard treatment. If enough participants benefit from the drug or device, researchers may conclude that the drug or device is potentially effective.
What happens next?
If the drug or device is found to be reasonably effective and safe, researchers will continue their work in a phase III trial.
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Are you thinking about applying to participate in a clinical research study? Before you sign up, ask the patient care coordinator which phase you’ll be joining to get a little more insight into the process.
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. 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.