Clinical research is a process of gathering data on human participants to test the safety and efficacy of new drugs, treatments, or devices. This type of research is essential to developing new and improved ways to prevent, diagnose, and treat disease, says the medical practitioner Dr Francene Gayle.
- Phase I: Small-scale safety testing in humans
- Phase II: Larger-scale testing for effectiveness
- Phase III: Comparative testing against existing treatments
- Phase IV: Post-marketing surveillance
Each successive phase builds on the knowledge gained in the previous one. The entire process can take many years from start to finish.
There are two main types of clinical studies: observational and interventional. Observational studies simply observe and record data without manipulating any variables. Interventional studies, on the other hand, involve manipulating one or more variables to see how it affects the outcome of interest. The vast majority of clinical research studies are interventional.
- Randomized controlled trials (RCTs): RCTs are the gold standard for clinical research. They involve randomly assigning participants to receive either the treatment being studied or a placebo (i.e., an inert “dummy” treatment). This allows researchers to control for all other potentially confounding factors and isolate the effects of the treatment under study.
- Case-control studies: In case-control studies, researchers compare people who have a particular disease or condition (cases) with people who do not (controls). They then look back retrospectively to see if there were any exposure differences between the two groups that could explain the observed differences in health outcomes.
- Cohort studies: Cohort studies prospectively follow large groups of people over time and track outcomes related to specific exposures of interest. For example, a cohort study might follow a group of smokers and a group of non-smokers over several years to see how their rates of lung cancer compared.
Once you find a study that you’re interested in, you can contact the study’s principal investigator (PI) directly to learn more about it and inquire about eligibility requirements. You will also be asked to read and sign an informed consent document before participating in any clinical research study.
Although participating in a clinical research study involves some risks, there are also many potential benefits.
- First and foremost, you will be playing an important role in advancing medical knowledge and helping develop new ways to prevent, diagnose, and treat disease.
- Additionally, you will receive expert medical care throughout the duration of the study from experienced physicians and other healthcare professionals.
- And last but not least, participating in a clinical research study gives you access to experimental treatments that are not yet available to the general public.
Clinical research is essential for developing new medical advances; however, it is also important to remember that not all experimental treatments are successful—some may even end up being harmful. That’s why it’s important to Weight the risks and benefits carefully before deciding whether or not participating in a particular clinical research study is right for you.
If you do decide to participate, be sure to ask lots of questions so that you fully understand what will be expected of you throughout the course of the study.