Clinical trials for IBD

You may have heard of, or been invited to participate in, clinical trials for research into treatments for Crohn’s and Colitis.

Why are trials necessary?

Clinical trials are an important part of progressing treatment. They allow drug companies to ascertain safety and effectiveness of new medications, which ultimately finds new medications to help patients.

Who reviews and approves trials?

Human Research Ethics Committees at each participating hospital review and approve clinical trials. They make sure that the trial complies with the National Guidelines on ethical conduct in human research. Before a medication is allowed to be trialed on humans, it has already been well tested in other ways to help reduce the risk to humans. This ensures the interests, safety and wellbeing of all patients who participate are protected.

What information is collected?

When you agree to participate in a clinical trial the researchers will need to collect information about you. This may include information on your past and current health status, and in the case of IBD, blood, tissue and stool samples.

Any information collected is de-identified.

What is the benefit in participating in a trial?

The biggest benefit is access to medications sometimes years before they are released to the general market. You are also given the medications free of charge.

As well as the medications themselves, you are also often reviewed regularly with the medical and nursing team. And you may also be reimbursed for your time and/or travel.

If I’ve agreed to participate, can I leave the trial?

You can stop taking part in the trial at any time. This might be because your condition is getting worse, suffering from side effects, have difficult participating (for example getting to appointments) or have concerns.

What level of commitment is required?

When taking part in a trial you will be required to attend regular appointments, which may be to meet with the team or get your medication. You may also be required to provide patient diaries, provide blood and stool samples, or even undergo colonoscopies.

The team at IBD SA has links with the research teams Flinders Medical Centre, the Royal Adelaide Hospital and Lyell McEwen Hospital, and can refer you out if there are clinical trials that may be of use. From time to time, we may also publish information on trials from our practitioners.

Contributed by Dr Paul Spizzo