RESEARCH TIPS

This new column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

This Month’s Subject—IRBNet

Did you know?

• IRBNet has taken the place of the IRB webkit and is up and running.




• IRBNet training can be scheduled by contacting Lisandra Gonzalez or Marybeth Kennedy.




• The definition of a Clinical Trial is a research study designed to test the safety and/or effectiveness of drugs, devices, treatments, or preventive measures in humans.
  
  The 4 common phases of a clinical trial are:

Phase 1 - Requires 24 hour medical unit

1. Minimum number of healthy volunteers (20-30)
2. First use in humans
3. Testing for safety, tolerability of drug

Phase 2 - Frequently in-patient units

1. 20-300 selected group of volunteers
2. Designed to determine efficacy of the drug
3. Determination of dosing for next phase
4. Monitor for safety in larger population

Phase 3 - Determination of safety and efficacy for specific population

1. Higher number of volunteers 500-5,000
2. Randomized often involving multi-center
3. May determine if treatment is better, same, or worse than standard of care
4. Continues to monitor safety

Phase 4 - Post-Market Surveillance, Pharmacovigilance

1. After drug receives FDA approval
2. Largest population
3. Continue to collect information on safety and often efficacy