Participating in clinical trials and what "informed consent" means

Posted in research, clinical trials, gynaecological cancer; Posted 2 years ago by Andreas Obermair

A clinical trial is a formal assessment in which patients, doctors and researchers come together to find better ways to prevent, diagnose or treat a medical condition.

Clinical trials are beneficial to patients as they offer access to the latest and potentially beneficial treatments before they are available to everyone else as standard practice. I discuss more about the benefits and possible risks of participating in clinical trials in a previous article here. To participate in a clinical trial patients will be asked to provide informed consent.

What informed consent means in healthcare

All clinical trials will have a participant information sheet and consent form which describes the study procedures including benefits and risks involved. Before enrolling in a clinical trial, patients will be told what to expect and must give informed consent. Consent in clinical trials is a patient's voluntary agreement for a healthcare professional to provide them with treatment and care, including any medicines, treatments, procedures or other interventions. Informed consent means that a person fully understands their condition and its proposed treatment.

Patient Suitability

For virtually all clinical trials, patients need to be suitable. Clinical trials define those suitability criteria. If patients do not meet these criteria, the doctor is unable to offer participation in this particular trial. Whether a patient is suitable for a clinical trial should be discussed with the treating doctor. Clinical trials will have eligibility criteria, and patients must meet all these criteria to participate. Eligibility criteria may include the patient's type and stage of cancer, age and general health among others.

Once patients are eligible and the healthcare team has offered participation to the patient, the decision is completely up to the patient to take part in a clinical trial or not. The care that you receive if you don’t agree to take part in a clinical trial, is the standard care.

Minimising Risk

All trials that I manage and lead minimise risks to patients. In trials that I am involved with, we design them in a way that a patient will receive either standard treatment (which she would have received anyway) or a potentially better treatment (of which we don’t know if it actually leads to better outcomes).

Before treatments or any other interventions get to the stage of a clinical trial, they would have been tested in other research settings. A clinical trial is almost never the first attempt to test a new treatment method (patients are not used as guinea pigs).

Giving informed consent is not a contract and participants can withdraw at any time. Before participating in a clinical trial questions to ask the researchers include:

• What is the aim of the clinical trial?
• Has this procedure been tested before?
• How long is the clinical trial?
• What will my participation involve (will it include medical tests, medications, surgery, lifestyle modifications)?
• What are the benefits and risks?
• Who will pay for the healthcare I receive in this trial?
• Who will be in charge of my healthcare?
• Who has reviewed and approved the clinical trial?
• Who is funding the research?
• What will happen after the trial has ended?

Example of a current clinical trial

As the Director of Research at the Queensland Centre for Gynaecological Cancer (QCGC), we always have several clinical trials running. Most of the time, other gynaecological oncologists also join in and offer their patients trial participation also.

One of the most recent trials is the ENDO-3 trial, a randomised controlled trial that started in March 2021 and compares sentinel node biopsy to no node biopsy in patients who require surgery for endometrial cancer. Sentinel node biopsy is a surgical procedure that allows us to see if endometrial cancer has spread to lymph nodes (“surgical staging”). While sentinel node biopsy is regularly performed by all gynaecological oncologists in Australia, the USA and in Europe, there is limited knowledge on the effectiveness of the procedure and whether it adds value to patients, or has potential harms.  

The outcomes from this trial will provide evidence to determine the value of retaining or discontinuing this procedure in the treatment of early stage endometrial cancer. This approved trial is open for recruitment at most hospitals in Brisbane and in some hospitals in Sydney and Melbourne.

How to participate in clinical trials

Patients who wish to participate in a clinical trial should first discuss their situation with their doctor, who can provide advice on clinical trial options available to them. Clinical trials currently underway for gynaecological cancer research are listed at the QCGC Research website.

If you would like further information about the ENDO-3 trial or participating in other clinical trials, please contact me.