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.
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 recommend two resources for clinical trials:
- HCV Advocate News & Pipeline Blog – “Drugs in Development / Clinical Trials” – click on the pharmaceutical company name for a list of clinical trials. The trials are linked directly to www.clinicaltrials.gov where you can get more information. Also be sure to check out the HCV Advocate Treatment Issues page for easy to understand reference guides to current drugs in development.
- You can also go right to the source – www.clinicaltrials.gov. On the front page there is box “Search for Studies”—type in “hepatitis C” and the city where you live – for example “Sacramento.” The studies will be listed. There are all sorts of categories that will also be listed and it can be a bit overwhelming or there may be too many unrelated listings to read. A good way to narrow down the findings is to type in the name of a drug and city. For example: “hepatitis C and GS-5816 and San Francisco” or “hepatitis C and Gilead and Seattle” or “hepatitis C and daclatasvir and Denver” or “hepatitis C and MK-5172 and St. Louis” and so on…. Click on the study for more information.
Tips: Questions to Ask the Study Coordinator
- What are the possible risks, side effects and benefits of the study drugs?
- How many office visits will be required?
- 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?