Study Set Content:
to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options
Phase III
This involves randomly choosing some participants to receive the new medication and others to receive an existing medication
randomization
Investigators monitor participants for several months or years to see how effective the medication is and to gather more information about any side effects it might cause.
Phase II
To do this, investigators use a process called randomization
Phase III
are usually double-blind, which means that neither the participant nor the investigator knows which medication the participant is taking. This helps to eliminate bias when interpreting results.
Phase III
Participants: several hundred with disease/condition o Length: several months to 2 years o Purpose: Efficacy and Side Effects o ≈ 33% of medications proceeds to the next phase
Phase II
The FDA usually requires a blank before approving a new medication. Due to the larger number of participants and longer duration or phase III, rare and long-term side effects are more likely to show up during this phase.
Phase 3
Participants: 300-3,000 volunteers who have disease/condition o Length: 1-4 years o Purpose: Efficacy and Monitoring of Adverse Reactions o ≈ 25-30% of medications proceeds to the next phase
Phase III
Happen after the FDA has approved medication. This phase involves thousands of participants and can last for many years. Investigators use this phase to get more information about the medication’s longterm safety, effectiveness, and any other benefits.
Phase IV
Investigators use this phase to get more information about the medication’s longterm safety, effectiveness, and any other benefits.
o Participants: several thousand volunteers who have disease/condition
o Purpose: Safety and Efficacy
Phase IV
Asking for FDA assistance
Drug developers are free to ask for help from FDA at any point in the drug development process
Coordinates the team’s activities throughout the review process, and is the primary contact for the sponsor.
Project Manager
Reviews all clinical study information and data before, during, and after the trial is complete.
Medical Officer
Interprets clinical trial designs and data, and works closely with the medical officer to evaluate protocols and safety and efficacy data.
Statistician
Reviews preclinical studies.
Pharmacologist-
Focuses on the drug’s absorption, distribution, metabolism, and excretion processes.Interprets blood-level data at different time intervals from clinical trials, as a way to assess drug dosages and administration schedules.
Pharmakineticist
Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability, quality control, continuity, the presence of impurities, et
• Chemist
Reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
Microbiologist
The FDA review team has
30 days to review the original IND submission
FDA responds to IND applications in one of two ways:
Approval to begin clinical trials
