Our Austin IVF center participates in world-wide clinical research studies for fertility research
Clinical research studies (sometimes called trials or protocols) are a means of developing and evaluating new treatments and/or medications for specific types of diseases or other medical conditions. There are many different types of studies – some evaluate new surgical techniques or instruments, some evaluate new ways of administering medications that are already in common use, and some evaluate new medications. Regardless of the type of study, there are very strict rules for clinical trials, which are typically monitored by the National Institutes of Health and the U.S. Food and Drug Administration, among other organizations. Most of the research studies that we perform at Texas Fertility Center involve promising new treatments that we hope will directly benefit our patients.
When pharmaceutical companies or medical device manufacturers develop promising new medications or instruments, these new products are required to undergo rigorous evaluation and testing before they can be used for the general public. First, these products are typically evaluated in very tightly controlled laboratory experiments designed to detect any obvious problems – such as defects in manufacturing or production. They are then frequently evaluated in animal studies, to confirm that they are safe. Following the successful completion of these studies, these products are ready for human trials.
The primary goals of human studies are to establish that new treatments are both safe and effective. Once this has been confirmed, additional studies – such as those designed to identify the optimal dosing schedule for a new medication – are performed. If the studies all support the therapeutic benefit of the treatment, then the sponsoring company will proceed with submission of their data to the Federal Food and Drug Administration (FDA) for approval. The FDA submission and approval process is both time consuming and expensive for product manufacturers. They therefore spend a significant amount of time and resources performing rigorous testing of all new products prior to proceeding to the FDA, in order to maximize the likelihood of approval.
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are ‘post-approval’ studies.
Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.