The process of testing a new drug involves establishing its safety and tolerability (Phase 1 trials), measuring effectiveness (Phase 2 trials), and comparing the new drug to the current standard treatment (Phase 3 trials). After the FDA has granted approval and the new drug is marketed, ongoing studies are done to refine treatment for maximum safety and effectiveness (Phase 4 trial) also called post-marketing studies.
Clinical trials are an excellent way to get medical care and access to new drugs to treat hepatitis C. It is important, however, to know that the drugs are being studied to find out if the drugs are safe and effective. Clinical trials also include medications that have been approved by the FDA. These are called post-marketing studies.
Every clinical trial in the United States is approved and monitored by a local Institutional Review Board (IRB) to make sure that any potential hazards are avoided. In addition, every clinical trial has a data safety monitoring committee that reviews the medical data to make sure that the study drug(s) are not doing any harm to the trial participants. There is also a clinical trial coordinator who is responsible for informing the patients and making sure that the patient understands the potential benefits and risks involved. The clinical trial coordinator will also follow the patient through the entire study.
We have a Clinical Trials Data Base that you can search by genotype, country, and many more parameters. We update it on a bi-weekly basis, Click here
- Will I be able to carry on with my regular life—work, play, etc.?
- What costs (drugs, tests, office visits) are covered?
- If I get the placebo drug (sugar pill) will I be offered the study drug at the end of the study?
To learn more about clinical trials, read our Making Sense of Hepatitis C Research and Medical Literature