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AHRQ: Mandatory Use of Data Safety and Monitoring Plans
Payment to Research Participants
Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist
Statement of Practice: Remote Study Procedures
Secondary Use Research
Michigan Medicine Clinical Research Position Statement
Guidelines for Studies Conducted Through MCOHR and the Dental School

Phase II Trial

Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIA and Phase IIB.                                  

  • Phase IIA is specifically designed to assess dosing requirements (how much drug should be given).
  • Phase IIB is specifically designed to study efficacy (how well the drug works at the prescribed dose(s)).

Some trials combine Phase I and Phase II, and test both efficacy and toxicity.