What are clinical trials?

Clinical trials are research studies done to find out if a treatment can improve people’s health. A treatment can be a drug, medical device, medical procedure, or a change in a person’s behavior such as diet or exercise. People who take part in clinical trials are volunteers. They may also be called “participants” or “subjects.”

What are the advantages of being a participant in a clinical trial?

Patients taking part in clinical trials often benefit from a greater degree of clinical oversight and monitoring of their disease by their healthcare team – so more frequent visits and more thorough assessments of their disease status.

For some patients who are perhaps unable to access alternative treatment options, or where existing medicines have failed to provide benefit, clinical trials can enable earlier access to new, innovative medicines.

Additionally, supporting clinical trials helps progress scientific understanding of medicine and improves healthcare options for future generations.

Why should I participate?

The health of millions of people has been improved because of advances in medical care, made possible by clinical trial participants. People choose to participate in clinical trials for a variety of reasons, including the chance to play a more active role in their own health care, gain access to new medical treatments before they are available to the wider public, and help others by contributing to the future of medical science.

Are there risks involved participating in a clinical trial?

There are risks involved when participating in a clinical trial. When evaluating the risks of research, it is best to consider both the “type of harm” that might result from being a clinical trial participant and the “likelihood” of harm happening. Most clinical trials pose risks of minor discomfort, lasting only a short time, although some participants do experience more serious complications that require medical attention. The specific risks associated with any clinical trial will always be described in detail in the informed consent form, which a participant is asked to review before agreeing to take part in a clinical trial. The major risks will also be explained to a potential participant, by a member of the research team, who will answer any questions about the trial. Before making a decision about whether to participate in a clinical trial, a person should carefully evaluate these risks.

What safeguards are there to protect participants in clinical research?

Many measures are in place to protect the safety of clinical trial participants including careful protocol design, oversight of the trial by ethical review committees, and regular monitoring of the data collected. An ethical review committee is a group of doctors, scientists, advocates, researchers, and members of the community that has been formally designated to review and monitor all research involving humans. The role of the committee is to provide ethical oversight and to minimize risk to participants. During the study, the research team must inform participants of any new risks or side effects that are discovered during the course of the trial.

The following safeguards are also in place to protect the safety and rights of trial participants.

Protocol review. In almost every country, all new clinical trials are reviewed by a regulated independent review board or committee that is typically made up of medical specialists, statisticians, nurses, social workers, patient advocates, and medical ethicists. The purpose of these committees is to ensure that the trial is safe for participants before a clinical trial begins.

Informed consent. Participation in any clinical research trial is always voluntary. For every trial, a potential trial participant will receive a document called an informed consent form that outlines the protocol and explains the details of the trial in straightforward language. It will outline items such as the trial’s purpose, risks and potential benefits, duration of the trial, required procedures, and key contacts. A member of the research team will also review the informed consent with each potential trial participant and answer any questions the potential trial participant may have. A potential trial participant may discuss the informed consent form with family and friends and will not be hurried into making a decision. The potential trial participant will be asked to sign the informed consent document only after they have a full understanding of the trial protocol and have decided to agree to participate. The informed consent is not a contract, and a participant may withdraw from the trial at any time and for any reason.

Can I stop participation at any time?

Yes. Clinical trial participants have the right to change their minds at any time even after they have started the clinical trial or at any time during the trial. It is important to contact the clinical trial site and inform the research team of a decision to stop participating to make sure steps are taken to safely transition a participant back to their previous care.

 How long can a clinical trial last?

The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched. For example, if the study is researching a treatment for a chronic condition, participants’ progress on the trial may be tracked over a relatively long period of time. 

What are eligibility criteria?

All clinical trials have rules about who can and cannot participate. These rules are called “eligibility criteria” but may also be referred to as inclusion/exclusion criteria. The criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The eligibility criteria define the patient population that is being studied and are designed to protect the safety of participants in the trial. Because of the criteria, not everyone will qualify to participate in the trial.

What is a pre-screening or screening visit?

A pre-screening visit is where you have a general visit with the clinical research doctor or nurse to assess if there may be any obvious reasons why you would generally not be eligible for a clinical trial. Before this visit you will be asked to provide your consent to review your medical history and historic test results, which will assist the medical practitioner to perform a thorough assessment. 

A screening visit is the first step to participate in a clinical trial. The clinical research doctor will discuss the clinical trial in detail by using a Participant Information and Consent Form that will outline the benefits and risks to consider. You will have the opportunity to ask questions or discuss this further with your family or treating doctor. The screening process can take up to 28 days to complete and starts with you and the doctor signing the Participant Information and Consent Form. Once this document has been signed the next part of the process can commence which includes very specific assessments to determine if you are eligible for the clinical trial. You don't have to take part in the clinical trial and your decision to decline participation won't have a negative impact on your future treatments with your treating doctor. 

If I'm interested in a specific clinical trial, how do I learn more?

To learn more about a specific trial, it is best to contact Linear Clinical Research for more information. It is important to note that a referral is required from your current treating doctor to be considered for a clinical trial. 

How can I get referred for a clinical trial at Linear Clinical Research?

We suggest that you have a conversation with your treating doctor, who has your best interest at heart and understand the stage and progress of your cancer. Together you can determine if a clinical trial is a good option as part of your treatment journey. Your doctor can refer you to Linear Clinical Research for an opinion and consideration for a clinical trial. 

 Why do I wait so long to be considered for a clinical trial?

The majority of clinical trials are open globally and sometimes with limited slots or opportunities available to participate. The clinical trial staff have to wait for specific checks to be completed before these slots become available, at which point a patient can be considered for a particular study. Once a slot is available, the staff will communicate this with you as the potential patient and the screening process will commence.