Clinical Trials

Summary

Cancer clinical trials are pivotal research studies that aim to advance our understanding of cancer and develop new treatment options. They involve rigorous testing of novel therapies, drugs, or interventions to assess their safety and efficacy in real-world patient scenarios.

This module will cover the basics of running and managing clinical trials. We will examine topics like good practice in clinical trials, the different kinds of clinical trials, data protection, and legislation.

This course is aimed at new researchers running clinical trials for the first time as well as experienced researchers who would like a refresher on the basics.

Learning outcomes

Section 1: Basics of Cancer Clinical Trials

  • Describe what a clinical trial is
  • Understand the importance of compliance with GCP (to assure that the rights, safety and well-being of trial subjects are protected, and that clinical trial data are credible)
  • Outline the main elements of informed consent
  • Describe the four phases of drug trials
  • Explain the differences between drug and non-drug trials
  • Understand the legislative context for clinical trials

Section 2: Protocol Development

  • Describe what a clinical trial protocol is
  • List the main sections of a protocol and explain the purpose of each section
  • Create a protocol using the standard template

Section 3: Ethics and Regulatory

  • Outline the regulatory and ethical authorities who have oversight of clinical trials
  • Describe the main regulations that apply to clinical trials
  • Explain the process by which clinical trials can be authorised

Section 4: Data Protection

  • Define what the terms General Data Protection Regulation (GDPR) and personal data mean
  • Describe the roles of a Data Protection Authority and a Data Protection Officer
  • Explain the relevance of GDPR to clinical trials