Research is broadly defined as a systematic investigation of facts based on a collection of information. A clinical study takes the results obtained through research and extends the research process to include human participants. This process is especially important when it comes to aesthetic procedures or treatments. Take a moment to learn about how and why quality clinical research can make a big difference for both practitioners and patients.
Expanding On Results from Observational Research
Before clinical research begins, there’s what’s known as observational research. This simply refers to the collected information based on how patients respond to treatment that is not altered. For instance, an observational study may involve a review of the results patients experienced when having plastic surgery or a cosmetic procedure that has already been approved for use for certain conditions by the FDA. This information may be used to determine if patients who didn’t respond well to certain treatments may benefit from a different approach to the same type of treatment.
A Reliable Comparisons of Results
Clinical research involves very specific guidelines, or protocols. It’s more controlled than observational studies since subjects (participants) are carefully selected and broken down into various groups.
You might, for example, have 100 individuals with severe acne scarring. Half of these people may be asked to have a new injectable treatment to minimize scarring. However, the other half may be participants who agreed to have a certain type of laser treatment that’s been approved for use in clinical trials for the same purpose.
Dividing the subjects up like this allows for a specific comparison of results to be made. A clinical study can be further broken down by other factors researchers wish to evaluate. If this is the goal, study groups may be further divided by:
• Age range and gender (if applicable)
• Skin type and tone
• Severity of the aesthetic issue being treated
A Safe, Reliable Collection of Data
Quality clinical research involves evaluating results in phases. The reason for following this standard procedure is to maintain the safety of the participants. Before any humans are involved, there must be sound data available from non-human sources. Once the procedure, drug, or treatment that’s being evaluated is deemed safe enough for human tests, clinical studies will be conducted in phases. These are the four possible clinical study phases that can take place:
1. Phase I: Clinical research starts with smaller studies involving 20-100 participants.
2. Phase II: If results from smaller studies are promising, studies are usually conducted with up to 200 participants. This is done to see if similar results can be achieved if the initial smaller studies were largely successfully.
3. Phase III: This is the phase that occurs if results are promising but there are still some unknowns – e.g., whether or not the procedure, substance, or treatment being tested will produce similar results with larger groups. This phase can involve thousands of subjects from across the U.S. and abroad.
4. Phase IV: By the time this clinical research phase is reached, the focus shifts to ongoing monitoring of subjects from previous studies. There is also a greater emphasis on adverse reactions and potential side effects.
The FDA must approve each phase. A clinical research team will then evaluate the results from each phase and present their findings. Recommendations are often included with the findings so informed decisions about what steps to take next can be made. Results may, for instance, be inconclusive. If this is the case, the recommendation would likely be to conduct further research. It’s also possible for results from one phase to cause researchers to recommend going back to the non-human testing phase if there is a need to address any issues that could affect patient health.
Testing for Multiple Variables
Quality clinical research also produces results that account for multiple variables. Patients of all shapes, sizes, and ages can be tested to determine if there are certain risk factors that need to be taken into account for certain types of patients when recommending procedures or treatments.
The testing of multiple variables further allows plastic and cosmetic surgeons and other professionals who perform aesthetic treatments to establish reliable guidelines. These guidelines help determine the criteria for who would likely be an ideal candidate for a specific procedure.
Peace of Mind
Understandably, nobody discussing or considering aesthetic procedures wants to feel like a human guinea pig. There’s nothing wrong with exploring your options with new treatments, techniques, procedures, and methods. However, quality clinical research can provide much-appreciated peace of mind as you decide what’s right for you.
The results from quality clinical research can ultimately be used to make the treatments available to you as safe and effective as possible. Research of this nature also allows practitioners to gain valuable insights into both traditional and modern innovative treatments.