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Clinical Development 301: Phase II/III

Clinical Development 301: Phase II/III focuses on the purpose and critical differences between well-controlled Phase II and III studies. This class expertly explains the art of trial design and how each protocol measures efficacy via primary and secondary endpoints. Section two focuses on pharmacovigilance and the pivotal role of independent Data Safety Monitoring Boards who exhaustively review data to make critical recommendations about trial continuation, modification, or termination. Clinical Development 301 reveals the regulatory considerations of special designations that can accelerate the drug candidates’ development. The class ends with an explanation of the New Drug Application (NDA) and Biologics License Application (BLA) that must be filed with and approved by the FDA to receive drug marketing approval. Join us to continue building your expertise in Clinical Development!

Section 1: Phase II/III Introduction

Identifies the principle elements of a well-controlled Phase I/II clinical trial with an in-depth look at study design, endpoints, and statistical analysis. The concepts of a null hypothesis, p-value, type 1 error, type 2 error, power, variability, and treatment size effects are explained.

Section 2: Phase II/III Objective and Design

Compares the general characteristics of Phase II and Phase III clinical trials. Defines pivotal study, adaptive trial, basket trial, and umbrella trial. Discusses the function and types of recommendations the Data Safety Monitoring Boards provide.

Section 3: Phase II/III Special Designations

Focuses rare disease and serious unmet medical need designations in both the US and Europe. Explains the challenges with clinical studies associated with rare diseases and provides examples of flexible clinical development approached for application to rare diseases. Lastly, the relationship between clinical trial endpoints and approved labeling claims are explained.

Five Takeaways

 

  1. Evaluate the purposes and key differences between Phase II and III clinical trials.
  2. Contrast the regulatory significance of clinical endpoints, primary endpoints, secondary endpoints, and surrogate endpoints.
  3. List the special designations that can accelerate the drug candidates’ development.
  4. Explain the basic statistical analysis completed in late-stage trials.
  5. State the critical role data safety monitoring boards play in patient safety.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

FAQ

  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at training@biotechprimer.com for group pricing.

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