In a cancer clinical trial, a consumer is someone who has experienced cancer, either as a patient, or as a family member of or carer for someone with cancer. Consumers bring their experience as a person affected by cancer and also their skills and learnings from their cancer journey, their careers and their life experience.

Consumer advisory panels

Cancer Cooperative Trials Groups (CCTGs) have a consumer advisory panel (CAP), which comprises consumer representatives. The CAP reviews the information that is provided to a patient before they decide to participate in a clinical trial. Patients need to know what will happen when they go on the trial, whether they can stop the trial and what to expect.

The CAP considers a range of issues but the 2 major elements are:

• the protocol of the clinical trial
• the information and the consent form that is provided to the participant.

The CAP members are also there to help clinicians understand the impact that a clinical trial can have on patients.

Protocol

The protocol outlines the aims and processes of the trial. The protocol document explains what type of trial it is – for example, is it a new drug, or a new treatment around blood tests or a new way of doing radiotherapy? If the CAP doesn’t understand the protocol document, they can advise on ways to make it more clear.

The protocol must include stopping rules. Stopping rules allow clinicians to review the safety and efficacy at certain points during the clinical trial. If the impact of the drug or treatment is too large for patients, then the clinical trial will be stopped. The CAP ensures that the stopping rules are explained in a way that the patient can understand.

Questions that CAP members may ask when reviewing a trial protocol include:

• Would I take part in this clinical trial?
• What are the benefits of this trial?
• Are there elements in relation to the research on this clinical trial that I have some major issues with?
• Will it have an impact on clinical practice?
• Is the number of patients involved in the study suitable for a robust statistical analysis?
• What are the eligibility criteria for patients to participate in this trial?
• Can the information gained from this trial be translated across other types of cancer?

Patient information and consent forms

Patient information sheets support the informed consent discussion between researchers and participants. The sheets explain the trial in simple language, to make sure patients understand what will happen and can make informed decisions around their participation in the trial. CAP members review patient information sheets to make sure they are suitable and relevant. 

Questions that CAP members may ask when reviewing patient information include: 

• How is the patient information set out? Is the language and terminology clear? Can patients who may not be fluent in English understand it?
• Are key concepts and terms clearly explained, such as randomisation and blinding?
• Does the information correctly reflect and explain the treatment or drug details and side effects outlined in the protocol?
• Are there details about time involved in this trial and the impact that this will have on the patient’s family?
• Is there any vital information missing?
• Is there any irrelevant or unnecessary information that should be removed?
• How will patients be involved and communicate during the trial, and do they have access to the communication channels?

Section 2.2.6 in the National Statement on Ethical Conduct in Human Research outlines the information that should be communicated to research participants.

Find out more about informed consent.

Types of consumer engagement

Consumer involvement in clinical trials is a core part of the National Framework for Consumer Involvement in Cancer Control. The framework outlines 5 types of consumer engagement: personal engagement, advocate, advisor, expert and partner.  See Types of consumer roles for more information.