Exploring new treatments for early-stage breast cancer

What is a clinical trial protocol?

A clinical trial protocol is a comprehensive plan that outlines the study’s objectives, design, methodology, statistical considerations, and organisation. It specifies: 

• The purpose of the study 

• Eligibility criteria for participants 

• Details of tests, procedures, medications, and dosages 

• The schedule of activities 

• Information to be collected about participants 

This protocol ensures the study is conducted consistently and safely across all participants.  

What types of clinical trials are available?

Clinical trials encompass various study types, including: 

• Prevention Trials: Explore methods to prevent diseases in individuals who have not had them or to prevent recurrence. 

• Treatment Trials: Test new treatments, drug combinations, or approaches to therapy. 

• Diagnostic Trials: Seek better tests or procedures for diagnosing specific conditions. 

• Screening Trials: Evaluate ways to detect diseases or health conditions. 

• Quality of Life Trials: Aim to improve comfort and life quality for individuals with chronic illnesses. 

Many trials compare a new product or therapy to existing treatments or placebos to determine effectiveness. Potential participants are informed beforehand if placebos are part of the study design.

Why should I participate in a clinical trial?

Participating in a clinical trial offers several potential benefits: 

• Access to New Treatments: You may receive investigational therapies not yet available to the public, potentially improving your health condition. 

• Contribute to Medical Research: Your involvement aids in understanding how treatments work across different populations, helping to develop better therapies for future patients. 

• Comprehensive Care: Participants receive close monitoring and additional healthcare assessments related to the study. 

• Voluntary Participation: You can withdraw from the study at any time without any obligation. 

Each study has specific eligibility criteria, so not everyone who applies will be accepted.  

What do the different phases of a clinical trial mean?

Clinical trials progress through several phases, each designed to answer specific research questions: 

• Phase 1: Involves a small group (20-80 participants), often healthy volunteers or patients with advanced diseases. The focus is on evaluating safety, identifying side effects, determining safe dosage ranges, and understanding how the body processes the investigational product. This phase typically lasts several months, with about 70% of studies advancing to Phase 2. 

• Phase 2: Enrols 100-300 participants with the condition under study to further assess safety and effectiveness. These trials may be randomised and controlled, comparing the investigational product to standard treatments or placebos. Blinding is often used to prevent bias. Phase 2 studies usually take up to two years, with approximately 33% progressing to Phase 3. 

• Phase 3: Includes larger groups (thousands of participants) to confirm effectiveness, monitor side effects, and compare the investigational product to standard treatments. These randomised and blinded trials can last from one to four years, with 25-30% successfully leading to regulatory approval submissions. 

• Phase 4: Conducted after regulatory approval, these post-marketing studies gather additional information on risks, benefits, and optimal use in various populations over extended periods. Findings can influence whether a product remains on the market or if usage guidelines need adjustments.  

What is a clinical trial?

A clinical trial is a medical research study involving volunteers to explore new ways to prevent, detect, or treat diseases, illnesses or ailments. These studies assess investigational treatments, which may include new drugs, combinations of drugs, new delivery methods for existing medications, or medical devices. Before approval, these treatments undergo rigorous testing to ensure they are safe and effective. Each trial follows a detailed protocol outlining the study’s purpose, participant criteria, procedures, and duration. A principal investigator, often a medical doctor, leads the research team, which includes various healthcare professionals. Participation is entirely voluntary, and diverse involvement is crucial to understand different responses to the investigational product.