Questions about Clinical Trials

Common questions from those who want to participate in clinical trials:

WHO CAN TAKE PART IN CLINICAL TRIALS?

As long as you meet the participant criteria of a particular trial, then you or any person able to legally consent, will be eligible to take part in any trial you wish to. Sometimes, due to the nature of the clinical study, the restrictions on trial participants are significant and you may be rejected from participation, even if you meet most of the criteria. In each clinical trial, the participant criteria will be different. The best advice we can give you is to first search for a trial that might be relevant to you, review the details of the study, and if you are comfortable with the information you have, then you can then decide if you’d like to register to take part in the trial.

DO YOU GET PAID FOR CLINICAL TRIALS IN AUSTRALIA?

In Australia there are times when trial study participants will be paid when taking part in a trial.  How much you will get paid will depend on the study and other factors. As a rule it may not be wise to participate in clinical trials simply for the money. Many people take part because they want to help the advance of science and medicine and taking part in a trial is a great way to do your bit for others. The money you might be paid, is a bonus for doing a good deed! So if you’d like to help drive research forward then you may end up being compensated for your time and / or travel costs.

If you are looking to take part in a trial, then you may want to ask the trial manager about whether or not it is a paid trial and if it is, what kind of payment you can expect for taking part.

HOW CAN I PARTICIPATE IN CLINICAL TRIALS?

If you’d like to take part in a clinical trial you will first need to find a trial that is relevant to your circumstances and also meet the criteria of the trial. In most cases, you will either be a healthy volunteer who would like to take part or you will be a person who is suffering from a particular ailment, disease or illness and you are seeking the newest experimental or early stage treatments available. Sometimes people look for clinical trials for their friends or loved ones as well. Participation will come down to the aims of the study and your ability to meet the trial participant criteria of those conducting the clinical study.

WHAT IS A HEALTHY VOLUNTEER FOR A CLINICAL TRIAL?

A healthy volunteer in a clinical trial is generally a person who is not suffering from any medical condition or illness or taking any current medication, but who is looking for ways to participate in clinical studies in order to assist the evolution of medical research and science. In a lot of cases, healthy volunteers will be paid for their participation in a trial. The exact level of payment for those taking part in a trial is determined by a number of factors including the trial type, your time to take part in the trial, and any other expenses you might incur such as travel expenses. Clinical Trials Australia lists trials that will be recruiting soon or that are recruiting for healthy volunteers right now. Please search our clinical studies registry if you believe you might qualify as a healthy volunteer.

CAN PEOPLE WITH ILLNESSES OR HEALTH CONDITIONS TAKE PART IN CLINICAL TRIALS?

Yes.

If you have an illness then it is possible you can take part in a clinical trial in Australia. The factors that determine your eligibility to take part in a clinical study are numerous and can include the ailment itself (the illness or condition), your location, your age, your gender, your current use of medicines, any current treatments you are undergoing, and others particular to the study. You can use Clinical Trials Australia to search for Australian clinical trials that are either recruiting for trial participants now or recruiting patients for a future study.

It is an excellent idea for you to get advice from your Doctor or GP if you are thinking of taking part in a clinical trial as they may be able to help place you into a relevant trial and are likely to be able to give you more information on the potential benefits and risks of trial participation for you.

WHAT IS A CLINICAL TRIAL SPONSOR?

A clinical trial ‘sponsor’ is any entity or body that assumes legal responsibility for managing a clinical trial or clinical study. They will often be responsible for financing, organising and getting the trail underway. An individual within the entity or employed by the entity and with the authority to do so, will need to register the trial through official channels in Australia and organise a HREC (Human Research Ethics Committee) to oversee all aspects of the trial from start to completion and data submission. A Sponsor is also responsible for the data accuracy and capture, such as published trial details and results and communications between parties collaborating on the trial.

WHAT IS A CLINICAL TRIAL SITE?

In Australia a clinical trial site is any location that undertakes registered clinical trials. Often, trial sites include universities or areas of universities, such as medical campuses. They can also be units within hospitals, medical centres or associated or independent research centres that are focused on particular conditions such as dermatitis, psoriasis, cancer or any number of other illnesses that require further research and medical treatments or device development. Different clinical trial sites and their investigators have different professional capabilities, resources and capacity to undertake trials.

If you are a clinical investigator with a trial site in Australia you can register it on Clinical Trials Australia for greater online awareness by trial sponsors in Australia or overseas. Please contact us here for details on how to register your trial site with us.

WHAT ARE CLINICAL TRIALS?

Clinical trials are studies that test new ideas and methods for treatments of all kinds of human ailments and health conditions. In clinical studies you will often access treatment or medical devices that are not readily available to the public, while you may also work with some of the best medical researchers and medical professionals in the world without the need to pay fees. Clinical trials aim to develop new treatments for people with specific conditions or illnesses and cover the entire spectrum of medicine and medicinal research, so they are incredibly diverse in nature and type. In Australia clinical trials that take volunteer participants, need to be registered for safety and have an ethics committee to oversee the entirety of activities and research outcomes. See links to resources at the base of this page for more information.

WHAT ARE THE RISKS OF CLINICAL TRIALS?

Many people wonder whether clinical trials are safe or dangerous and it’s a valid initial question to ask. In Australia, very specific regulations and laws are designed to ensure that clinical studies are as safe as can possibly be expected in an experimental setting. All trials need to be registered before taking on any trial participants and have an ethics committee (HREC) to oversee the study from start to finish.

Generally speaking, early stage trials are more risky than later stage trials, as the research is newer and has not progressed very far. There is less data to draw on for researchers and if you take part the data will come from you and other participants. So this is one thing to keep in mind and is part of your own weighing up of the risks versus the benefits.

When it comes down to it, you need to make the decision about whether you or a loved one take part in a trial and you should be able to do this based on all the information provided to you by the trial sponsor or the trial manager. If you are not clear about the risks of a clinical trial that you are thinking about taking part in, then you should request clarification from the researcher conducting the study or your main contact at the clinical trial. Another great option is to talk to your doctor or GP about the risk and reward potential of a clinical study for you or your loved one. See more information resources and links at the base of this page.

WHERE CAN I FIND CLINICAL TRIALS IN AUSTRALIA IN 2020?

Like many people you might be wondering how you can find a clinical trial in Australia. The simple answer is that you can search for a clinical trial across Australia through a number of registries including this website. The main difference with the Clinical Trials Australia clinical study register is that we only list clinical trials that are either taking participants now (recruiting now) or who have not yet taken on trial participants but who will be taking them in the future. So the trials on our site are looking for people or will be in the near future.

If you live in Australia and would like to find a clinical trial near you, then you can search our register here.

You can also leave your details here and we can alert you when a trial that might suit your requirements is listed on our site.

WHO CAN REGISTER A CLINICAL TRIAL ON THIS WEBSITE?

If you are the lead manager with ultimate individual authority to make decision about a clinical trial including trail registration, then you are eligible to register your trail with Clinical Trials Australia. Please contact us to register your clinical trial now or to begin a conversation about how our in-house, digital communications campaign and strategy development services can assist your patient and healthy volunteer recruitment targets.

For information about the process of additionally registering your clinical trial on Australia’s largest official clinical trials registry,  please see this link.

You can also find information links and resources at the base of page.

WHAT ARE THE RULES FOR ADVERTISING CLINICAL TRIALS IN AUSTRALIA?

While very specific advertising rules relating to clinical trials and online social media communications are still to be developed, the main focus of current advertising rules that relate to clinical trials is to ensure that messages included in clinical trials advertising do not breach ethics or accuracy standards. Presenting false or misleading information about any product in Australia is a crime with sometimes severe penalties. When it comes to advertising clinical studies, Australian law prevents the communications from making any statements about the effectiveness of the trial (unproven statements) and does not allow the messaging to mention as yet unapproved therapeutic goods such as new medicines. You will also need to provide a way for an interested potential patient or healthy volunteer to source further information to be fully informed about the trial so your communications will need to include links or references to online resources such as Clinical Trials Australia and your own website.

Another important consideration is that online social media messages about clinical trials are shareable and can encourage conversation and peer-to-peer distribution via networks and forums. Your communications strategy needs to include a plan for how to interact with potential patients who may ask all manner of questions (have a Q and A reference sheet developed prior) while you also need to manage your own reputation and ensure you understand the communications protocols of social media patient forums that might be highly targeted opportunities for your trail.

In each trial, all forms of all communications and messages for clinical trials are pre-approved by an ethics committee (HREC – Human Research Ethics Committee) who are responsible for overseeing the trial from the start to its finish. This provides a strong framework to ensure that trial communications do not push the boundaries of what is acceptable and do not overpromise to potential trial participants. All messages about paid trail participation, for example in the cases of trials involving healthy volunteers are required to be phrased and presented in such a way as to communicate that payment will be for time and / or travel, not ‘work’ as such.

Clinical Trials Australia can develop a highly targeted digital communications strategy to assist the patient recruitment targets for your clinical trial. Please contact us for a free 30-minute consultation and patient recruitment strategy session.

WHY SHOULD I MARKET MY CLINICAL TRIAL ONLINE?

Approximately 69% of non-participation in clinical trials is the result of a lack of awareness that trial is even taking place

Ref: Elizabeth Wilson – Tips for Success – Patient Recruitment in Clinical Trials – PDF.pdf

Are you failing to enrol patients or healthy volunteers into your clinical trial? Pre-planning and then advertising your trail online – the RIGHT way – might be the answer.

In simple terms, when you advertise your clinical trial online, you are following the market and using the communications channels most relevant to today’s market and most often used on a daily basis. And today’s online market includes all demographics, all psychographics and all ages.

The use of social media and online forums in clinical trials advertising is growing significantly and as such, Clinical Trials Australia offers in house social media strategy and digital communications services to trial sponsors or researchers who wish to take their trial recruitment online and into the social media feeds of millions of Australians.

Only 11% of clinical trials currently use social media to recruit patients.

Ref: https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa2c29e4192023932fec89d/1520616094463/02+-+Jan+15%2C+2013+-+Recruitment-Retention.pdf

Social media advertising allows you to target highly specific patient groups in one or more specific locations which means it is a great way to focus your advertising and marketing spend for a better potential return. You can develop your HREC (Ethics Committee) approved ads, including format and message variations ahead of time, and then launch them into market to test their effectiveness. From there you can adjust your messaging and your targeting, refine what works and discard messages that do not engage the market as strongly.

Importantly, studies have confirmed that not only do the majority of patients remember and recall seeing ads relevant to their condition online, but more than 80% of patients with a health condition that is negative to their way of life, preferred longer copy in advertising and a greater level of information.

Almost half of all clinical trials fail to fully enroll.

Ref: https://static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa2c29e4192023932fec89d/1520616094463/02+-+Jan+15%2C+2013+-+Recruitment-Retention.pdf

You will need to consider the best media channels for your patient recruitment target market and how best to target that market once you understand the channels that are most appropriate. Often, an integrated campaign approach is most effective, meaning the use of social media and other digital channels such as search marketing is supported in other traditional media such as print or TV.

Contact the Clinical Trials Australia health communications team here for a 30 minute free consult on your clinical trials advertising needs.

WHAT ARE THE ADVANTAGES OF CONDUCTING CLINICAL TRIALS IN AUSTRALIA?

There are numerous, compelling reasons to choose Australia as a place to conduct your clinical trial. We are a large western democracy with a stable government and very strong regulatory and legal framework that includes the highest ethical standards based on several benchmark international protocols. The government is also very focused on making Australia a world-leading hub for clinical research in Asia-Pacific. But that is just the start of the many advantages you will enjoy when you conduct a clinical trial in Australia.

One of the most important aspects when undertaking a clinical study is the standard of medicine in the host country. In Australia, our highly trained and experienced professional medical workforce includes some of the best doctors, specialists and medical researchers in the world. Further to this, our health system and lifestyle attracts some of the world’s best international medical experts, who are now living and working in Australia. You have a genuinely world class medical team to draw upon and assist your medical research and help you conduct a clinical trial of the highest integrity and standard.

Supporting the medical expertise on the ground in Australia, is the hospital and medical system, similar in nature and standard to countries including USA, New Zealand, United Kingdom and European countries. You will be playing on familiar ground.

In terms of geography and population, Australia has real benefits for conducting clinical trials too. Due to the fact of our place ‘down under’ in the southern hemisphere, studies that require a seasonal aspect can be conducted at times of the year that do not apply in the northern hemisphere. This means you can rotate your trial through Australia and maintain studies across the world during the year.

Our capital cities all have millions of potential trial participants to draw upon, with a huge diversity of backgrounds. With our population drawn from every nation in the world, the genetic and cultural diversity in Australia is second to none.

Awareness of trials is growing in Australia and we are able to regularly recruit a wide range of members of our population who are willing to take part in trials due to altruism and the desire to advance medical research, or due to their intent to access new, cutting edge medicines, medical treatments, medical interventions or devices not accessible by the general population.

If all that is not enough, then you might also enjoy genuine investor benefits when undertaking a clinical trial in Australia. Certain tax initiatives make Australia particularly attractive to investment in clinical studies. The research and development tax incentive scheme (R&D Tax Incentive) can return eligible companies up to 45 cents in each dollar spent on research and development in Australia. This is made even more attractive to overseas investors due to the fact that IP does not have to reside in Australia in order for the company to be eligible for the tax incentive and that overseas support activity can also be claimed under some circumstances. For more information please refer to this link

For consumers

Comprehensive Understanding of Clinical Trials in Australia

All persons who find and decide to participate in any clinical trial listed on this website do so as part of an agreement with the trial sponsor and the trial manager and not any agreement with Clinical Trials Australia. For a comprehensive understanding of clinical trials in Australia for consumers, please click at the button below:

Sponsors looking to advertise clinical trials online to find trial participants in Australia

Would you like to advertise a clinical trial that you are conducting, on Clinical Trials Australia? You’ve come to the right place. We also organise and run specialist social media campaigns for clinical trials recruitment too. If this is of interest, please click the button below.