Module 3: Planning, Collecting and Managing Clinical Data

The planning, the choice of different trial designs, the randomisation modes and the choice of endpoints are discussed. The different aspects of the conduct of a trial, i.e. study monitoring, principles of good clinical practice (GCP), and data management are demonstrated. A basic introduction to biostatistics is given.

Key topics

  • Early studies in patients: dose-finding / proof of mechanism studies
  • Confirmatory clinical development plan
  • Different types of clinical studies
  • Planning and managing clinical trials
  • Planning of clinical trial supplies for test substance and comparators
  • Legislative requirements and Good Clinical Practice (GCP) in the clinical trial process
  • Investigator and site recruitment, investigative site management and conflict resolution
  • Statistical considerations in the design of clinical trial protocols and analysis of clinical trial data
  • Procedures for clinical trial data collection and data management

Learning outcomes

At the end of this module the student should be able to outline the:

  1. Management of early studies in patients and their impact on the drug development plan
  2. Design of various types of clinical studies and statistical methods used
  3. The confirmatory clinical development plan including the role of relevant study committees
  4. Key issues involved in the conduct of a clinical study in terms of Good clinical Practice (GCP)