Frequently Asked Questions
I don’t sell my product/ingredient in Australia, so why should I get a study done in Australia?
Even if you do not distribute your product in Australia, or if the Australian consumer forms only a small part of your market segment, conducting a study in Australia can still be beneficial for you. Because Australia has a strong scientific reputation, your study will be positively perceived by practitioners, academics, and consumers. Australia also has one of the most diverse multicultural populations in the world, making the results of your study more generalisable throughout the world.
How do you have the expertise to complete high-quality clinical trials?
In house, we have specific expertise in conducting trials in the following areas:
- Mental health
- Cognitive health
- Digestive health
- Men’s health
- Sports performance
If we require support from other experts in the field, we have a network of academics and clinicians that can form part of our clinical trials team. Occasionally this involves working with academics at universities. In particular, we have a strong affiliation with Murdoch University, located in Western Australia. During such collaborative trials, we maintain control of the study processes and simply utilise the services/support of relevant experts in the field.
Can you help us with the design of the clinical trial?
Our preference is to be actively involved in the design process. This ensures the study has a robust design that increases the likelihood of obtaining accurate outcomes. In developing clinical trials, we use the “Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist”. SPIRIT is widely endorsed as an international standard for trial protocols.
Having a high-quality study design increases the chances of getting the study results published in a high-quality journal. We prefer not to submit to low-quality journals with questionable reputations.
Can you do statistical analyses of outcome data and write the manuscript for publication in a high-impact journal?
We have competence in the statistical analysis of outcome data. Therefore, we offer this as part of our clinical-trials service. We also have a strong publication record and have published in high-impact, peer-reviewed journals. You will notice that our managing director, Dr Adrian Lopresti, is the first author on most of his publications, meaning he had a major role in the analysis of the results and the preparation of the manuscript. A list of Dr Lopresti’s publications can be found at: www.clinicalresearch.com.au/about.
Can you conduct trials in all fields?
We only conduct trials in fields we have expertise in, or where we can access the services/support of appropriate experts. This means that we cannot conduct studies in all areas. We will always openly and honestly discuss our capabilities with you.
How quickly can you conduct your clinical trials?
Employing the services of a CRO and then waiting an excessive amount of time for the study to be completed, can be both costly and frustrating. Our streamlined processes ensure the studies we conduct are done so in a timely manner, but also without compromising study quality. In fact, depending on the sample size, most studies we conduct are completed within 6 months after ethics approval is received. Here are some examples:
Saffron sleep study (4 weeks of recruitment)
- Mid-July 2019: first participant recruited
- Mid -August 2019: final participant recruited (sample size of 63)
- Feb 2020: Paper accepted for publication in a high-impact journal
Saffron as and adjunct to antidepressants study (16 weeks of recruitment)
- Late Sept 2018: first participant recruited
- Mid-January 2019: final participant recruited (sample size of 160)
- Sept 2019: Paper accepted for publication in a high-impact journal
Ashwagandha men’s health study (6 weeks of recruitment)
- Mid December 2017: first participant recruited
- Late January 2018: final participant recruited (sample size of 58)
- Feb 2019: Paper accepted for publication in a high-impact journal
Curcumin gut study (12 weeks of recruitment)
- Early September 2019: first participant recruited
- Early December 2019: final participant recruited (sample size of 80)
It seems that other CROs have much larger teams. How do you complete so many studies so quickly?
Even though there are benefits in employing the services of a CRO with a large team, this can often increase the number of steps involved in the study process, slowing down the progress of the study. We have streamlined processes that ensure studies are conducted efficiently. Rather than employing a large team, we prefer to pay for relevant services from organisations (e.g., biomarker testing) that have exceptional expertise in the area. This often decreases the costs of the study and ensures rapid delivery of results. Furthermore, some testing of participants may be conducted at one of many labs located throughout Australia, meaning there is no requirement for some participants to travel an excessive distance to one central location. This makes volunteering for the study more appealing and reduces the likelihood of treatment dropouts.
Do you obtain ethics approval for your trials?
Prior to the commencement of all our studies, we obtain ethics approval from a National Health and Medical Research Council (NHMRC)-approved ethics committee.
How do you complete specimen collections and analyses for your clinical trial?
We have established relationships with large commercial pathology centres. For typical assessments we utilise the services of one of Australia’s largest pathology centres. This organisation has over 80 National Association of Testing Authorities, Australia (NATA)-accredited laboratories and over 900 collection centres throughout Australia. Typically, registered phlebotomists collect blood samples for us. Where possible, we prefer to utilise the services of this organisation as it allows study volunteers to visit their nearest collection centre rather than travel to a single location.
If more sensitive collections are required, or we need to travel to people’s homes for sample collection, we utilise the services of contract phlebotomists/nurses. For more specialised specimen analysis, we utilise the services of one of Australia’s largest functional-testing laboratories. This company has ISO 13485 certification. In addition, we have relationships with universities across Australia that can complete very specialised biomarker assessments if required.
Do you conduct stool testing in your clinical trials? If so, how do you do this?
Yes, we have completed several trials where we have collected stool samples for assessment. Typically, this involved microbial profile analyses, although we can test for other relevant stool markers as well. Our stool collections comprise home collection kits which minimises the demands on participants. Participants collect a faecal sample in a collection tube specifically designed for the collection and preservation of nucleic acids from stool specimens. We then contract the services of relevant NATA-accredited laboratories across Australia to complete the relevant analyses.
Can you conduct fitness and strength testing as an outcome measure in clinical trials?
Due to our relationship with Murdoch University, we have access to facilities offering an extensive range of fitness tests.
Do you organise clinical trials’ insurance?
Yes. Before completing any clinical trial, we arrange/organise appropriate indemnity insurance.
Do you list your trials?
All our trials are prospectively listed with the Australian and New Zealand Clinical Trials Register (ANZCTR). In 2007 the ANZCTR was one of the first three trial registries to be recognised by the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) as a Primary Registry.
What are your arrangements on intellectual property (IP)?
We acknowledge the work and investment of time and capital that companies put into creating their product/ingredient. Furthermore, we appreciate companies employing our services. Therefore, when we conduct a clinical trial, the IP remains with the company. Unlike many large universities, we are not interested in having IP on your product. Our goal is simply to support our clients and the promotion of their ingredient/ product as best we possibly can; their success is our success!
How do you recruit your volunteers?
We have developed a very efficient and rapid recruitment protocol. Typically, our recruitment is via social media where we have had an excellent response. Other recruitment options are available, although we have found social media advertisements the most effective.
Where do you get your studies published?
We publish our studies in high-impact, peer-reviewed journals with strong scientific reputations. We believe that this is important as it increases the credibility of the study, and ultimately, the ingredient/ product. Publishing in a high-impact journal also increases the likelihood of greater awareness of your ingredient/ product by practitioners, consumers, and academics. Publishing poorly-written papers in obscure journals reduces the potential of your product, negatively affects its credibility, and decreases the rate of return from investment in the study.
How much do your trials cost?
This is a very difficult question to answer as it depends on the sample size, recruited population, and outcome measures that will be used. Typically, studies that include only self-report outcome measures are the cheapest. Including biomarker testing, lengthy computer-based cognitive tests, and specialised fitness testing as outcome measures can significantly add to costs. As a general guide, a simple-design clinical trial will cost a minimum of $40,000 AUD.