Have you ever wondered how a medical treatment or pharmaceutical product is declared safe for us to use? Are you interested in supporting the extensive research that makes modern medicine possible? Clinical studies are crucial to understanding how a new treatment will affect patients. So, what is clinical research, and how does it work? DeNova Research of Chicago Illinois has the answers.
What Is Clinical Research? 4 Things to Know
1. An Essential Practice
What is clinical research for? The end goal of any research project is to demonstrate that a treatment is not only safe but more effective than other available options. This is accomplished through three phases of trials.
Phase I
The smallest trial goes first, with maybe only a few dozen participants. The goal of this phase is to explore the range of safe doses for the drug in question. How do researchers know if phase one was successful?
Two important measurements help in every phase: Retention and complications. Every drug has some level of side effects, so researchers look to see how often they appear and how many participants stay in the study. If the side effects are too uncomfortable, people may opt-out of the trial, and this would suggest it isn’t ready for phase two.
Phase II
This trial is much larger in scope and takes months to complete. The goal is to see how effective the drug is and if it can be tolerated in a wider population. The phase one group tends to be small and more homogenous, while phase two will include a variety of ages, ethnic backgrounds, and medical histories.
If the results are promising, it’s possible to start phase three trials simultaneously.
Phase III
By now, it’s clear that this drug is safe and probably effective. The question then becomes how effective is it compared to other products on the market. The FDA requires a drug to be at least 50% as effective as another treatment. Phase three trials can take years to complete and may involve thousands of participants.
2. Clinical Research Is Not the Beginning
What is clinical research like before the trial phase? Many people are unaware that years of development and tests have been performed before ever starting a phase one trial. This is important to ensure the safety of participants and to justify the expensive investment in the trials.
Preclinical Phase
Before any drug proceeds to trials, there is a preclinical phase. In this phase, animal tests are used to determine safety. A full report of the laboratory studies and a proposed trial method needs to be submitted to the FDA for review. Only after all of these steps have been completed can a researcher begin trials.
If you are interested in participating in a clinical trial, understand that the researchers have already taken great steps forward to ensure your safety and the success of their project.
3. Safety First
Speaking of safety, it’s our highest priority in any clinical study. The drug approval process has strict requirements for how patients are admitted into clinical research projects. These are in place to prevent accidents and serious side effects.
An FDA report from 2016 revealed that over 40,000 Americans took part in clinical trials that year. While about one in five participants drops out of studies, this is almost never due to complications with the treatment. Most people leave a trial because they don’t have the time or found the process stressful.
In short, clinical trials are safe, but they do require you to make an informed decision. Here is how we strive to ensure our participants feel safe and secure throughout the process.
Informed Consent
Before agreeing to any trial, you would be given an informed consent form that explains everything that is involved in the trial. If you accept the terms, you will be allowed to participate. You can also revoke your consent at any time, for any reason. Signing on that dotted line does not mean you belong to the researchers.
If English is not your native language, you have the right to receive information in the language you best understand, and you can also take time to decide. No one should ever pressure you to participate in clinical research.
Screening Process
Not every patient is suitable for every trial at every phase. For example, in phase one trials, it’s common to exclude people with conditions that could have an adverse reaction to the new drug. Your medical history will be thoroughly reviewed to make sure you are a good fit for the trial.
Follow Up Care
One of the best parts of participating in clinical research is that you will receive lots of free follow up treatment from medical staff. We strive to make these visits as convenient as possible. Your regular visits will help us understand how well the treatment is working.
4. Reliable Research
What is clinical research required to do for it to be valid? Blind and double-blind studies are the norm. This means you may receive a placebo instead of the actual drug being tested. Neither you nor the researchers know which treatment you’ve received, which will help researchers determine if the medicine really works.
You can trust clinical research when it is well done, and we always hold our researchers to the highest standards.
Participate Today
If you are interested in becoming a participant in a clinical trial or are just curious about emerging treatments, contact DeNova Research of Chicago, IL today.
