The Necessity of Phase 4 Clinical Trials

Is there a necessity for Phase 4 Clinical Research and Clinical Trials? Of course, the answer is yes. Before drugs are marketed, drugs are considered clinical candidates. During Clinical Phases 1, 2, and 3, pharma studies are designed to test, determine and validate the overall efficacy and safety of the drug. Clinical Phase 1, 2 and 3 processes can take many years, filled with trials and errors. If FDA's action is to approve the drug after advisement, review and regulatory rigor, the pharma company is required to ensure that unanswered questions, viewed by FDA to be time sensitive, are answered.

Unanswered questions, for examples...

• How safe and effective is the drug's use in a diseased population
• How safe and effective is the drug's use in a compromised patient
• How safe and effective is the drug's use in special patient populations
• How safe and effective is the drug's use in a diseased population with varying degrees of illness, mild, moderate, life-threatening
• How safe and effective is the drug when used by a patient with more than one illness
• How safe and effective is the drug when taking multiple drugs
• How does the drug product compare in safety, efficacy and tolerability with other products in its class
• What are the risks of the drug
• What are the benefits of the drug
• Do the benefits outweigh the risks.

A comprehensive Phase 4 post-marketing safety surveillance plan/risk management plan developed by pharma and agreed with FDA is the essence of the Phase 4 clinical program. Phase 4 respective plans are developed to answer questions pertaining to drug performance, safety, efficacy and use. Data from Phase 4 clinical trials is essential to:

• Pharma and FDA in order to adequately evaluate patient safety post approval
• Pharma who face the daily challenges of answering post-approval questions
• FDA who closely monitors safety AE and SAE reporting during the post-marketing period.

More to come...