Have you ever taken any medicine of any kind? Well, most medicines started in the same process – as a new drug under development going through clinical trials to determine its efficacy and safety. All new drugs in the U.S. must go through this rigorous process and be approved by the FDA before they ever get to the public.
According to the Pharmaceutical Research and Manufactures of America, it takes an average of 10 years and over $2 billion for a new drug to make it from concept to public access. Clinical research affects our day to day life by making it possible for treatments that we use to become available to us.
How medicines and treatments are developed
Generally, medications undergo a rigorous five step process before they can be approved for use in the public. “Preclinical” is the first step, and involves the concept design and early lab testing not on humans. From there, the drug research enters “Phase 1.” Here researchers are usually trying to determine effective dosages, often in healthy volunteers, monitoring safety and to determine if the drug should move on to “Phase 2” and “Phase 3”, which test the drugs in patients at therapeutic doses in controlled settings. From there, the drug must be approved by the FDA before it can finally be approved for use. Even after FDA approval, adverse events continue to be reported to the FDA, and some drugs go through additional testing after approval in “Phase 4.”
Clinical research brings new treatments to life
Clearly clinical research is a very important process in how a new treatment can get from concept to use, so its impact is incredibly important on the day-to-day life of anyone who uses medications or might in the future. DaVita Clinical Research (DCR) conducts trials in all phases of development, and there are many clinical research participation options for both healthy participants and those suffering from specific conditions.
How clinical research can impact your day today
There’s another way that clinical research could have a major impact on your life. By signing up as a participant in a clinical trial, you could help us in our pursuit of life-enhancing discoveries. If chosen to continue on with the trial, you may be compensated for your time.
Disclaimer: Phase 1 (in-patient) clinical trials are not intended to treat a disease or condition. Phase 3 (out-patient) clinical trials may help treat an existing disease or condition. The information presented in this blog may be referring to either a phase 1 clinical trial or to a phase 3 clinical trial or to both. If you contact us regarding a trial, be sure to speak with the recruiter about whether or not the trial is intended to treat a condition.