• Treatment & Management

• Medication Assistance Programs in the U.S.
• 
  Adults Living with Hep B
  • Visiting Your Doctor
  • Protect Your Loved Ones
  • Healthy Liver Tips
  • Online Support Groups
• 
  Children Living with Hep B
  • Adoption
  • Advice for Parents
  • Healthy Liver Tips
  • Hepatitis B and School
  • Online Support Groups
  • Commonly Asked Questions
• 
  Pregnancy and Hep B
  • Protecting Your Baby Through Vaccination
  • Testing and Treatment During Pregnancy
  • Treatment After Pregnancy
  • Breastfeeding
• 
  Treatment Options
  • Approved Drugs for Adults
  • Approved Drugs for Children
  • Clinical Guidelines
  • Herbal Remedies and Supplements
• 
  Clinical Trials
  • About Clinical Trials
  • Helpful Terminology
  • Locating Clinical Trials
  • Narrowing Your Search Further
  • Talking with Your Doctor About Clinical Trials
  • Hepatitis B and Liver Cancer Clinical Trials
  • Hepatitis Delta Clinical Trials
  • About the Drug Development Process
• 
  Physician Directory
  • Physician Registration
• Drug Watch

About Clinical Trials

Before any drug is approved for general use, it must go through three phases of testing called "clinical trials." People volunteer to participate in these trials and must meet strict criteria before being accepted into a study. On average, it costs an estimated $800 million and takes 10-15 years for an experimental drug to move from the laboratory to patients.

Requirements for each clinical trial are different, so it is important to review clinical trials near you to see if you qualify to participate. Not everyone who is interested in a trial will be accepted. In most cases, participants will need to be able to travel to a participating doctor on a regular basis for monitoring, although in some cases your regular doctor may be able to send in your regular results. Your doctor may be able to help you determine if there are clinical trials that may work for you

Testing Phases

There are three primary stages that a new drug must go through before being approved by the U.S. Food and Drug Administration (FDA). After approval, a phase 4 study examines possible long-term effects.

• Phase I clinical trials test new treatments in small groups of people (20-100) to evaluate safety, determine dosage and identify side effects.
• Phase II trials test the drug on 100-500 people to further evaluate its safety and effectiveness.
• Phase III studies test the drug on 1000-5000 people to confirm its effectiveness, monitor side effects and compare it to commonly used treatments.
• Phase IV studies are done after the drug or treatment has been marketed to collect information about its effect in various populations and any side effects associated with long-term use.

Benefits of a Clinical Trial

Enrolling in clinical trial programs can be very beneficial. Expensive blood work, treatment medications, and clinical monitoring are usually provided free of charge for those accepted into a study. Clinical trials also provide the opportunity to potentially benefit from the latest advances in medical science.