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
