It is difficult not to wonder about the future of America’s health care system. As the legislative sessions are about to end for the summer it is difficult, in fact, to wonder what the goal of those in Washington D.C. really is. While some seem determined to find a replacement for the Affordable Care Act, it seems that just as many are consumed with fighting the battle, not finding a solution.
While the politicians continue to battle over who is covered and who is not, while the media continues to analyze and report the implications of the latest version of the proposed bill, and while consumers wonder whether they will continue to have the coverage that they need, the medical research industry is equally interested in the answers to many funding questions. In the meantime, though, unable to wait for the latest house or senate vote, large pharmaceutical companies continue to conduct medical research studies involving the various stages of clinical studies and clinical trials.
A Clinical Study Follows a Strict Schedule and List of Procedures
Clinical drug development follows a rigorous and detailed outline of procedures in order to protect the public and its overall health. In fact, medical research studies are regulated by government agencies to see that drug companies, researchers, and doctors all follow a specific protocol:
- Phase 1 Clinical Trials. In this stage of development, researchers test an experimental treatment or drug in a small group of people, a number between 20 and 80, for the first time. The purpose ion this stage s to identify side effects and evaluate safety.
- Phase 2 Clinical Trials. In this stage of development, the experimental treatment or drug is administered to a larger group of people, a number between 100 and 300, to further evaluate safety and determine effectiveness.
- Phase 3 Clinical Trials. In this stage of development, the experimental treatment or drug is administered to large groups of people, a number between 1,000 and 3,000, to monitor side effects, confirm its effectiveness, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
- After completing Phase 4, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000-10,000 drugs that enter the research and development stage a year, only 250 make it to pre-clinical trial testing; only five make it to clinical trial testing; and only one makes it to the final process of FDA approval.
Medical research studies continue every single day, in spite of the fact that politicians and consumers alike do not really know what drugs and treatments will be covered by any future changes to the Affordable Care Act.