Are you considering participating in a clinical research study? If so, you may ask yourself: What kind of process can I expect? Understanding the clinical study process is an important part of participation. Fortunately, most clinical research studies are governed by a set of standards that make the process simple and straightforward. Read on to find out more about the trial process and what it means for participants.
Understanding the Clinical Research Study Process
The beginning of a clinical research study is an exciting time. For participants and researchers, it often feels like a new frontier – the start of a potentially groundbreaking adventure. But the clinical study process actually begins long before the first participants arrive at the trial site. All clinical studies are preceded by pre-clinical studies, which help researchers evaluate the safety and potential efficacy of a new investigation product or device on non-human subjects. Also called laboratory studies, pre-clinical studies often include cell studies, during which researchers will test an investigation product or device on human or animal cells grown in a lab. The pre-clinical period also often includes animal studies, during which researchers test new investigation products or devices on live animals to evaluate their safety.
Investigational New Drug Requests for Clinical Research Studies
The Investigational New Drug (IND) process is another behind-the-scenes precursor to most clinical research studies. During this process, the sponsor must file an application with the FDA noting their intention to begin human trials. The application includes a wide array of information, including how the drug is made, results from pre-clinical studies, and more. During this time, the research sponsor must also commit to working with an institutional review board (IRB).
Phase 1 Clinical Research Studies: Evaluating Safety
Phase I clinical research studies are all about evaluating the safety and potential side effects of a new investigation product or device. These studies typically include a smaller number of participants, which allows researchers to carefully monitor participants for any severe side effects. During Phase I studies, participants often receive a small dose of the new drug; the dosage is then gradually increased to find the highest dose without causing major side effects.
Phase II Clinical Research Studies: Evaluating Efficacy
Once a new investigational product or device is found to be generally safe, researchers may advance to a Phase II clinical research study. Phase II studies are all about efficacy – in other words, determining if it works. Evaluating efficacy depends on what is being studied. For example, cancer researchers may want to evaluate if a new drug impacts patient life expectancy. If a new cancer drug is found to meaningfully help trial participants live longer, it will likely advance to a Phase III trial.
Phase III Clinical Research Studies: Comparing to the Standard
Phase III clinical research studies exist to compare a new investigation product or device to the current standard. During these trials, researchers will often conduct double-blind studies in which participants are picked at random to get either the standard investigation product or device, the experimental, or a placebo. This helps researchers compare a new investigation product or device’s safety and effectiveness against current standards.
Safety is the top priority for each phase of a clinical research study, and understanding the process is an important part of being a participant. If you have questions about individual study processes, reach out to clinical research study administrators for a full outline of procedures.
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.