A simple way to understand clinical trials

Caroline Rich gives a brief outline of how to understand published clinical trials.

You can listen to this article below, or by using your favourite podcast player at pod.link/oncologybuddies

You have been diagnosed with cancer, so what does this mean for you? The doctors will give you information but it’s normal to want to learn more about your condition and what may happen to you going forward. 

In most cases, you’ll go online, and now with AI, detailed information is at your fingertips. As with any research, it’s important to ensure that you look at reliable sources, as not all the information will be accurate and properly accredited. 

One size doesn’t fit all

As cancer is so common (unfortunately), everyone will know of someone that has had the disease. However, the lay person will not understand how complex it is, as there are many different types and treatment options available. 

With medical advances and new treatment options available, things are changing all the time. Each person is different, and these factors need to be taken into consideration when assessing your cancer journey. Examples would be differences in age, general health, habits, gender, etc. This means that you may not respond to treatment the same as another person with your exact type of cancer. The most accurate way to gather information is to research accredited clinical trials that are published in reputable medical journals.

 The issue though is that the scientific terms can be daunting and difficult to understand. 

What is a clinical trial?

A clinical trial is a research study paper that is mainly used to test new drugs and treatment options available for different conditions.

There are three different phases of a clinical trial for testing new drugs:

Phase I: Is the drug safe? Looks at effects on the body. 

Phase II: Does the drug have an effect? Does it work (efficiency)? 

Phase III: Compares this new drug to the standard treatment to see if there is a benefit.

Key parts of a clinical trial

Purpose

Firstly, when looking at a clinical trial, you need to see what the purpose is. What questions are the researchers trying to answer, in other words, what is the outcome? For example:

• How long and how often must the drug be taken (treatment schedule)?
• Is the drug safe and effective?
• What side effects are there?
• Which is the best dose to use?
• Does this protocol improve the quality of life of the patient?

The purpose will be explained at the beginning of the trial, and at the end you will find the results relating to these questions.

Participants

Who was included in the study? Commonly referred to as the cohort or sample. This information will be laid out at the beginning of the trial, and will show the number of participants (patients), the details of the type and stage of the cancer, age, etc.  

The idea is to include participants that have very similar characteristics so that the results and outcome can be as accurate as possible. Clinical trials with a higher number of participants hold more weight.

Terminology

This is the most daunting aspect of reading a clinical trial, as you may not understand the different terms that are used. Here is the most common terminology used.

Study design

• Treatment group: Patients receiving the new drug.
• Control group: Standard treatment or placebo (no treatment).
• Randomised: Patients are randomly assigned to a group to balance the study.
• Double-blind: Neither the patient nor the doctor knows which treatment they are receiving.

Outcomes and endpoints

• Overall survival (OS): How long patients live after starting the treatment.
• Progression-free survival (PFS): How long the cancer stays stable (does not grow).
• Response rate (RR): The number of patients whose cancer shrinks or disappears after treatment.
• Complete response (CR): This shows that the cancer has completely disappeared.
• Partial response (PR): The cancer has shrunk, but still present.
• Stable disease (SD): The cancer pretty much stays the same.
• Disease control rate (DCR): Number of patients with complete response, partial response, and stable disease combined.

Final thought

There is information out there with regards to cancer which can create confusion and misunderstandings. It’s vital to make sure that you only look at reputable sites and proper scientifically researched data. So, it’s a good idea to have a basic understanding of how to read and interpret clinical trials. However, it’s always best to discuss your disease with the doctor and nurses first and ask for their guidance as to where you should get further information.

Caroline Rich qualified as a radiographer in 1991 and worked in the pharmaceutical industry for 25 years. Her area of expertise became oncology/haematology, and she started working in the NGO space in this field 13 years ago. She now works as a patient advocate, guiding and empowering patients and families through their cancer journey.

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