Frequently Asked Questions
Who is RDC Clinical?
RDC Clinical is a clinical research organisation (CRO) specialising in complementary medicines, dietary supplements, functional foods & cosmetics.
At RDC we strongly believe in evidence based medicine. Our passion is researching innovative products that have the potential to offer a real benefit to people’s lives.
Our Clinical Trial Team is lead by Amanda Rao who has been conducting clinical studies for over 12 years in the complementary medicine industry. We are a friendly group of professionals with extensive experience in medical research, natural health & nutrition.
What kinds of trials does RDC conduct?
RDC conducts a variety of trials including Phase III, IV, post-market surveys and pharmacokinetic studies.
The trial duration can be anywhere from one day to several months, depending on the specific product being studied.
Most trials will require participants to take or use a trial product over a designated time period. Assessments will occur at the beginning ‘baseline’ and also at the conclusion of the trial, and often at time points during the study.
What is a randomised clinical study?
Most of our trials are “randomised, double-blind, placebo controlled”.
Placebo controlled means that a group of participants will be given the active compound and another group will be given a placebo (inactive).
Double-blind means that neither the Trial Co-ordinators monitoring your progress, nor you will know which compound you are taking.
Randomised means that the allocation of product is selected by chance (using a validated software program) and not selected or controlled by the Trial Co-ordinators or Investigators.
Once the study is concluded it is ‘unblinded’ and we can reveal to you which group you were in (active or placebo).
If you were on the placebo during the study you may be eligible to receive active product free of charge for a period of 1-4 months. We do this where possible so that all trial participants have the opportunity to try the active product.
Why participate in a trial?
People participate in trials for a number of reasons; however, we have found the overwhelming reason is that people wish to contribute to the body of knowledge on products that can improve health and wellbeing in the population.
Certain condition specific trials may be of interest to people that are experiencing symptoms of that condition, as participating in a trial gains them access to innovative products that may improve their symptoms, and further detailed assessment of their personal situation.
Many trials also require participants to undergo tests such as body scans or blood tests. These tests are paid for by RDC, and participants have access to these results that they can take to their health professional if they choose.
Many trials will provide approximately 2-3 months of free treatment product to participants at the conclusion of the trial.
Some trials also offer a monetary payment for participation.
Are the trial products safe?
Yes The products used in our clinical trials are all compliant with relevant Australian safety legislation.
The complimentary medicines used in our trials are all listed with the Therapeutic Goods Administration (TGA). This means that they have undergone extensive investigation and have been approved for use within Australia.
All foods comply with Food Standards Australia and New Zealand and all cosmetics comply with the Australian Cosmetics Standard.
What is screening and how do I know if I'm eligible?
Each trial participant must pass a screening call to ensure they are eligible to participate and that the product is safe for use.
The screening questions are approved by an independent ethics committee so it’s important you answer these questions truthfully.
Your Trial Co-ordinator will let you know if you are able to participate in the trial according to the criteria set out by the ethics committee.
Where are the trials conducted?
All trials are conducted within Australia.
Physical trial sites may include Brisbane, Sydney, Melbourne, Gold Coast, Sunshine Coast and Northern NSW.
In addition, some trials are conducted remotely throughout Australia, utilising online reporting tools and telephone interviews.
How do I enrol in a trial?
Once you register your interest for one of our trials, you will be contacted by one of our Trial Co-ordinators who will carefully screen you against the specific inclusion and exclusion criteria for the trial.
After the initial screening phase, you will be provided with the full Participant Information Brochure, along with the official Consent Form. Our Trial Co-ordinators are available to answer any queries you may have regarding the trial process. After you have read the Participant Information Brochure, you will be asked to sign the Consent Form to officially enrol in the trial.
What can I expect as a trial participant?
Each trial is different, you may be asked to complete blood tests, DXA scans (body composition), online questionnaires and attend our office for interviews with our Trial Co-ordinators.
You will receive regular emails from us to help you keep track of your progress and remind you of any upcoming appointments or due dates. Our Trial Co-ordinators will ensure you are informed of what is required of you before you start any trial.
As a valued participant in an RDC trial you can expect:
- friendly and professional communication from the RDC team
- full information regarding the trial
- your wellbeing to be treated as a priority
- your questions answered in a timely manner
- your personal information to be kept secure at all times
We pride ourselves on providing a positive experience to our trial participants.
Are my personal details safe?
Yes – We adhere to Good Clinical Practice guidelines (GCP) and the National Privacy Principles. Your personal details are never disclosed to any third party, nor are they used during the data analysis phase.
All data is de-identified before any analysis occurs.
We use an internationally accredited software system to manage your personal details which ensures your details are secure. In addition, any hard copy files containing personal details are kept in locked storage.
What if I have a reaction to a product?
All of the products used in our studies have already been rigorously tested for safety so the chance of having any adverse reaction is very slim.
However, should you experience any symptoms or side effects after taking your product please contact the Trial Co-ordinator as soon as possible. You will be given a 24hr contact number with your paperwork and it is also printed on each bottle of product you receive
As always, in the case of an emergency, please contact emergency services on 000.
What happens with the results?
The results of the trials are compiled, analysed and used to assess the effectiveness of the product being studied. Product developers use trial results to continue innovating new products, and to find new uses for existing products.
In many cases, the results are written into a report and published in a relevant journal to be shared with the medical and academic community. Results are also used to provide evidence for product effectiveness to regulatory bodies, distributors, retail channels and end-users.
When will I know the results of the trial?
Most of our trials have a rolling recruitment over a period of 1- 4 months, so it can often take up to 12 months for all participants to complete and the research to be examined.
Once the results have been analysed, your individual results, and a summary of the trial outcomes will be sent to you.
I want to be involved but it says I'm not eligible?
All of our studies require participants that are ‘generally healthy’. This means, as a general guideline, we are unable to accept participants into any study who smoke, use recreational drugs or have a serious medical condition (such as cancer).
If you consider yourself ‘generally healthy’, we invite you to submit your details HERE to be notified of new studies as the become available.
Where it the RDC Clinic located?