Clinical Development 101:  General Principles

Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understand the clinical development process. This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.

Section 1: Clinical Development Introduction

Describes the key milestones for drug development, specifically focusing on clinical development. Important terms including evidence-based medicine, translational medicine, and patient-centric clinical trials are explained. Finally, the purposes for which clinical trials are conducted are explored.

Section 2: Clinical Trials - Basic Principles

Explains how risk management is approached in terms of scientific method, Good Clinical Practices (GCPs), and trial design. Bias, blinding, randomization and endpoints are all explained in detail.

Section 3: Conducting Clinical Trials

Explains the various clinical trial participants and their roles, identifies the basic elements of a clinical protocol, describes informed consent, discusses inclusion/exclusion criteria, lists the steps in data management and reporting, and reviews the concept of clinical trial transparency.

Five Takeaways


  1. Enumerate the clinical trial phases in order, explain the purpose of each, and list their milestones.
  2. Identify the key individuals and groups involved in clinical trials and explain their roles in detail.
  3. Define foundational drug development concepts to control bias, such as control groups, blinding, and randomization.
  4. Choose the appropriate study design criteria to reduce bias and ensure patient safety.
  5. Compile a list of regulatory studies and the data each collects to enable follow-on studies.

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