Trials Enabling Program FAQs

Associate Professor Andrew Wei is helping to deliver the Leukaemia Foundation Trials Enabling Program

An overview

In an Australian first, the Leukaemia Foundation of Queensland and the nation’s leading blood cancer clinical trial group – the Australasian Leukaemia & Lymphoma Group (ALLG) – have established a new funding program to enable Australian patients to access promising new drugs that are currently being tested overseas.

The Trials Enabling Program (TEP) has been set up so that Australian patients can participate in internationallyrun clinical trials without leaving Australia. Many overseas trials do not get to be run in Australia due to funding limitations.

By participating in a clinical trial, patients have access to potentially life-saving treatments not currently available to them. Successful trials can lead to new treatment options for patients in the wider community.

We rely on the support of the community to fund this innovative new program and enable patients to access new drugs through the clinical trials at no extra cost.

What does this program mean for patients?

In many cases, an Australian wishing to access an international trial would have to find the money to finance the trip overseas, and associated medical expenses, themselves.

Thanks to this new program, eligible patients will now have an opportunity to participate in an international trial and access cutting edge drugs and treatments not currently available to them – and without leaving the country. While patients involved in a clinical trial will receive the new drug(s) free of charge, they still need to pay for their normal/standard health care costs.

The new treatments may be more effective than their current treatment and potentially save their life.

By participating in a trial, participants will be contributing to research that may help others. Once a new treatment has passed clinical trials it is made available to the public to help thousands more patients in the future.

For more information about clinical trials, please contact the ALLG on info@allg.org.au.

What trials are in the pipeline?

The first trial to be brought to Australia through the program is a study conducted by the UK National Cancer Research Institute, which is aiming to improve treatments for patients aged 60+ years with acute myeloid leukaemia (AML) and high risk myelodysplastic syndrome for whom conventional chemotherapy is not considered suitable.

How many trials are planned?

The Leukaemia Foundation hopes to fund additional trials later in 2015, which will benefit patients with other blood cancers. Upcoming trials will be listed on our website at leukaemiaqld.org.au as they are confirmed.

How do I get on a trial?

Please discuss your interest in participating in a trial with your treating doctor who will assess you to ensure a clinical trial is the right treatment option for you.

Your participation in a trial will depend on you meeting certain criteria.

The Australasian Leukaemia & Lymphoma Group (ALLG) is managing the trials. For more details about a specific trial, please contact them on info@allg.org.au or visit www.allg.org.au.

For general information about participating in a clinical trial, please see the clinical trial section at leukaemiaqld.org.au.

Why do we need to tap into international trials – don’t we offer trials in Australia already?

Yes, many trials are run specifically in Australia to benefit Australians. However many of the large international clinical trials operating around the world are not available in Australia due to limited funding.

Furthermore, blood cancers taken as individual diseases are rare. It is therefore difficult to recruit enough patients onto a trial that has very specific requirements and so some trials are unlikely to get the patient numbers required to be completed in Australia alone.

By collaborating internationally, clinical trials can be done faster, results known sooner, and the road to cures shorter. Joining with our international collaborators enables researchers/doctors to source the required patient numbers sooner.

Are international trials as safe as Australian trials?

Yes. The trials conducted via the special Leukaemia Foundation of Queensland and ALLG partnership will all be initially approved by a medical advisory board, an independent safety board, relevant regulatory authorities (TGA in Australia) and hospital ethics committees.

The process is extensive and rigorous to ensure people participating in clinical trials are safe and monitored frequently for effects/effectiveness of the new drug(s).

Who will run the Trials Enabling Program?

The trials program will be run in a partnership between the Leukaemia Foundation of Queensland and the nation’s leading blood cancer clinical trial group – the Australasian Leukaemia & Lymphoma Group (ALLG). As the facilitators of the program, ALLG will work with haematologists to manage the delivery of the international clinical trials to Australians, administration and data collection. A scientific committee at ALLG will identify suitable trials.

The Leukaemia Foundation’s role is to find consistent funding to ensure as many patients as possible can benefit from the program.

What is a clinical trial?

Promising new cancer drugs are developed in the laboratory and translated into better treatments for cancer patients using clinical trials.

A clinical trial is a research study that helps to determine whether a new drug or treatment option is safe and effective.

Each clinical trial has a plan (protocol) that maps out the procedures of the study – what will be done, by whom, when and why. The protocol also explains who is eligible to participate in a trial and what is expected of each person.

Clinical trial participants are managed by a team of doctors and nurses.

Are all clinical trials the same?

There are four different types of clinical trials, each one associated with a different phase in the development of a new medicine or treatment:

Phase 1: Determines the safety of the medicine, how it works and how well it is tolerated in small groups of people
Phase 2: Determines the effectiveness of the medicine and further evaluates the safety in a larger group of people
Phase 3: Determines the effectiveness, monitors sideeffects and compares it to commonly used treatments in large groups of people
Phase 4: Post marketing studies reflect additional information including the drugs risks, benefits and optimal use

Who can participate in a trial?

Patients from metropolitan, rural, regional and remote areas who meet the criteria for the trial will be able to participate.

What’s different about the Trials Enabling Program?

Although the ALLG conducts many clinical trials, there is currently no funding mechanism to support the conduct of ongoing international collaborative clinical trials into blood cancer in Australia.

The Trials Enabling Program is the first time that an Australian charity has established a grant partnership to help Australian patients access international blood cancer trials.

How much will it cost?

There will be no cost for patients to access the drugs through the clinical trials, however patients do have to pay for their standard health care costs. Medical tests and medical care related to the trial are at no cost.

On average it will cost $5,000 for one Australian to access a trial through the Trials Enabling Program, including the transportation and logistics of getting the drugs from overseas, and operating the clinical trials at treatment centres across Australia.

The Leukaemia Foundation, with community support, will cover this cost so that patients can access the clinical trial treatment/drug free of charge. The Leukaemia Foundation of Queensland initially hopes to enable up to 125 patients to participate in a trial at an estimated total cost of more than $600,000.

How can I donate to the Leukaemia Foundation Trials Enabling Program?

The success of the program will rely on having a consistent funding source to ensure that as many patients as possible can access the trials.

The Leukaemia Foundation relies on the generous support of the community to make new treatment options a reality for as many blood cancer patients as possible.

You can donate over the phone or securely on our website at leukaemiaqld.org.au.

If I find a clinical trial running in another country, can the Leukaemia Foundation help fund my participation in the trial through the Trials Enabling Program?

Unfortunately, no. TEP was established to ensure as many Australian blood cancer patients can benefit from a trial as possible. To achieve this, a scientific committee at ALLG will identify suitable international trials.

Will the trial proceed if the funds aren’t raised?

The Leukaemia Foundation of Queensland is committed to beating blood cancers. Each clinical trial will operate as a separate research study (good ethical and regulatory rules require this). We will continue to fundraise to ensure as many patients can benefit from the clinical trials as possible.

Why is the Leukaemia Foundation of Queensland funding this program?

Every day, 31 Australians are diagnosed with a blood cancer such as leukaemia, lymphoma or myeloma. While there has been remarkable progress in the development of new blood cancer treatments, every two hours someone still loses their life to a blood cancer.

While continuing investments across all streams of research, the Leukaemia Foundation sees additional support for clinical trials as necessary to fast-track the delivery of new drugs and therapies to improve outcomes for blood cancer patients.

What happens with the trial results?

As well as being reviewed by government authorities such as the Therapeutic Goods Administration, the results of a clinical trial may be reported in the medical press. The results are published so that doctors can make scientifically valid assessments of the risks and benefits of a new medicine.

Although the results are published, nothing that identifies individual patients will be released. Clinical trial participants are de-identified for the purpose of the research data.

Clinical trial results become the platform that doctors use to get new drugs available to the Australian community. The data produced is the crucial evidence that government bodies need to be certain that the new drug is better, safer and superior compared to what is currently on offer.

Contact us

For more information about the Trials Enabling Program, the coordination of trials, or details about patient recruitment, please contact the Australasian Leukaemia & Lymphoma Group (ALLG) on info@allg.org.au or visit www.allg.org.au.

To donate to the Trials Enabling Program, please contact the Leukaemia Foundation of Queensland on 1800 620 420 or donate online.

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