Day 6

Scenario:

You are being asked to run a Phase I Clinical Trial on a drug that we hope will help with shortness of breath related to COVID.

Questions: 

  • What would you want to learn about how and when a future patient will take the drug?
We want to learn how much time the drug's distribution will take.
  • What would you want to know about the side effects of the drug that you are testing for?
We want to know which are the side effects and how to decrease them.

Phase II Clinical Trials

- What has happened so far?
  • Pre-Clinical Trials
  • Phase I Clinical Trials
  • Phase II Clinical Trials start with doses and formulations that were found to be the safest during the Phase I Clinical trials.

-Phase II: Key Takeaway
  • This is the first time that researchers give the drug to patients with the disease for which the drug is being developed (FDA)
  • We are now looking at drug/vaccine efficacy!
  • Phase II studies typically involve up to a few hundred patients.
  • They aren't big enough to definitively prove whether the drug works or not.
  • Studies are looking for hints or signals to see if the drug/vaccine works.

-Phase II: What happens if the drug/vaccine doesn't work?
  • Previously, the study might have been discontinued and not been communicated to the public.
  • NOW: All studies must be reported on Clinicaltrials.gov

-Why clinicaltrials.gov helps scientific thinking?
  • Full transparency.
  • Even if the drug/vaccine doesn't work, we still learn valuable information about the drug/vaccine.

-Phase II: Continuing the search
  • We continue the search for the correct dose.
  • Now in patients with the disease.

-Phase II: Safety
  • Still exploring and studying safety of the drug/vaccine.

-Phase II: Patients

Broadening the patient population of the study
  • Age
  • Gender
  • Race
  • Region of the world

-Phase II

Researchers use Phase II data to:
  • Refine research questions
  • Develop research methods
  • Design new Phase III research protocols
ARTICLE - Types and Phases of Clinical Trials

The article in my opinion is well done. It convinced me of the need to test the drugs also on humans, took the necessary precautions.



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