Research And Trial

Duchenne Boys > About > Duchenne Boys Film > Research And Trial

The research conducted at the UW Asthma and Allergy Clinical Research Center helps the medical community to answer a particular question pertaining to the disease of asthma. A new drug or device must go through a series of well-defined trials. These research trials are intended to learn about the safety and effectiveness of a treatment in study participants. These trials provide new treatments that might otherwise be unavailable because the Food and Drug Administration (FDA) has not yet approved the treatment. Research trials are broken down into different phases, intended to answer different questions.

Phase I trials: first studies of new drugs in humans

 

  • Usually involves a small number of healthy volunteers
  • Drug dosages are monitored for safety and drug absorption
  • Each study requires frequent blood samples and other samples as well
  • Study participants are closely monitored by medical staff
  • Study participants are normally compensated for their time and travel

Phase II trials: first studies of new drugs in study participants

 

  • Study participants are individuals with a diagnosed disease for which the drug is intended
  • Drug is studied for safety and its potential effectiveness in treating the disease
  • Study participants will be monitored by medical staff
  • Study participants are normally compensated for their time and travel

Phase III trials: continued studies of new drugs as treatment in study participants

 

  • Study participants are individuals with a diagnosed disease for which the drug is intended
  • Usually a drug or device that is the current standard of care will be compared to the study agent.
  • Last phase of testing for a new drug to be submitted to the FDA (Federal Food and Drug Administration) for approval
  • Study participants will be monitored by medical staff
  • Study participants are normally compensated for their time and travel

Phase IV trials: post marketing surveillance of FDA approved drug

  • Drug is available by prescription or over-the-counter
  • Unusual events are reported by physicians and pharmacists
  • Verify new uses for a drug currently on the market
  • Study participants will be monitored by medical staff
  • Study participants are normally compensated for their time and travel