Frequently Asked Questions
WHAT IS THE RESEARCH USED FOR?
The research we conduct is used in a number of ways:
- to be published in relevant journals to share publicly with the scientific, medical and general community which are essential to GRAS and NDI notifications within the US
- to present to regulatory authorities around the world to assist regulatory compliance and marketing approvals
- for product developers to learn more about the performance of their products which assists in further advancements of the product and branding with real-time consumer intelligence
- for proof of concept and investor or funding purposes
- brand differentiation through claim substantiation and establishment of clear competitive or performance advantages
WHAT KINDS OF THINGS ARE STUDIED?
FOOD INGREDIENTS. At Reclinica, we conduct studies for ingredients that have not yet been reviewed by the FDA. These human studies are referred to as consumption and safety studies from which the results are presented to the FDA. Upon the FDA’s “approval “no question” of the ingredient, the manufacturer may begin selling the ingredient for human consumption within the United States.
DIETARY INGREDIENTS. Human safety and consumption studies for dietary ingredients are the gold standard. These human studies are performed for being presentation-ready to the FDA and intended for publication, as well as support the proper development of substantiated structure-function claims that can be potentially used in finished products. Upon the FDA’s “no objection” of the ingredient, the manufacturer may begin selling the ingredient for human consumption within the United States.
COSMETIC INGREDIENTS. We conduct studies for new or novel cosmetic ingredients that currently in the market that are key to product claims being developed or going through an INCI submission process. Cosmetic ingredient interactions are key to also building unique intellectual property backed by scientific data.
HOMEOPATHIC DRUG INGREDIENTS. Drug ingredients conforming to the respective HPUS Monographs or for the development and submission of new monographs, are a core offering. Claims around specific ingredients and ingredient safety are essential to marketing such ingredients United States.
NOVEL INGREDIENT COATINGS. Human studies and/or clinicals designed to evaluate the performance oriented components supporting the bioavailability or absorptivity, stability, or other aspects of enhancing a given ingredients function on or in the human body, are crucial to ensuring compliance of marketing and brand differentiation.
FOODS & BEVERAGES. Clinical studies for finished products in support of consumption recommendation or health claims and other allowances are a must have. These human studies can be presented to the FDA upon request and better ensure the positioning of a product in the marketplace, which can stand up to stringent legal and regulatory challenges.
DIETARY SUPPLEMENTS. When it comes to safety or claims substantiation, a properly designed and managed human clinical is essential to positioning a product in the market place and adhering to FDA’s requirements. Whether proof of concept, branding or the unique positioning of a given product in the marketplace that can be used in other international markets, Reclinca is the place to do it.
COSMETICS. Cometic finished products’ claims around the specific performance or beautification benefits thereof are just part of the benefit of a conducting human study. The evaluation of a formulation to ensure warnings or allergic responses are properly investigated helps with mitigating legal and regulatory risks of finished products, especially for sensitive demographics and Topical OTC products.
HOMEOPATHIC DRUGS. Homeopathic Drug products are governed by OTC regulations, and thus the manufacturing and safety data must adhere to pharmaceutical standards. Studies around existing or novel Homeopathic products and their ingredients, address the challenges related to the safety as well as define the marketing allowances of such products and any distinct drug claims.
NOVEL PACKAGING. Novel packaging or other delivery components and food-contact impacts can be evaluated as part of a human trial to gauge the the overall effect, user feedback, integrity of the product or ingredients and number of other key characteristics to launching an ingredient or building a brand in the United States.
WHAT IS A RANDOMIZED CLINICAL STUDY?
Most of our trials are “randomized, 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 coordinators monitor your progress, nor you will know which compound you are taking.
Randomized 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 an 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.
From time to time we also conduct “open-label” studies. This means that the study product comes in the same branded packaging as you would find for sale in a store. All participants receive the active study product as there is no placebo. These types of studies are most likely post-market studies where the product is already for sale, and most common for studies on cosmetics.
WHAT HAPPENS WITH THE RESULTS?
The results of the trials are compiled, analyzed, and used to assess the effectiveness of the product being studied. Product developers use trial results to provide evidence of the product’s effectiveness, 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?
Conducting and analyzing research can be a lengthy process. Most of our trials have a rolling recruitment over a period of 2- 12 months, so it can often take up to 6-18 months for all participants to complete and the research to be examined.
Rest assured though, that your contribution is valued, and conducting the research could not be possible without the generous help of people like you.
Once the results have been analyzed, your individual results and a summary of the trial outcomes will be sent to you.
HOW DO I ENROLL IN A TRIAL?
Once you register for one of our trials, you will be contacted by one of our Trial Coordinators 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 Coordinators 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 enroll in the trial.
We understand that it can be disappointing to be deemed ineligible to participate in a study; however, please know that the inclusion and exclusion criteria are carefully designed so as to ensure both participant safety and accurate study results. Each study has different criteria so it is likely that if you are generally healthy, you will be able to find a study that does suit you either now or in the future.
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 RECLINICA, and participants have access to these results that they can take to their health professional if they choose.
Most of our studies also offer a small monetary payment for participation.
WHAT CAN I EXPECT AS A TRIAL PARTICIPANT?
As a valued participant in a Reclinica trial you can expect:
- friendly and professional communication from the Reclinica 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
Each trial is different, you may be asked to complete blood tests, DXA scans (body composition), saliva samples, online questionnaires, and attend online interviews with our Trial Coordinators.
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 Coordinators will ensure you are informed of what is required of you before you start any trial.
We pride ourselves on providing a positive experience to our trial participants.
I WANT TO BE INVOLVED BUT IT SAYS I’M NOT ELIGIBLE.
Each study has different eligibility criteria which are put in place to ensure both participant safety and robust trial design. Should you not be eligible for a particular study, it is possible that you may be eligible for one of our other studies.
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 or unstable medical condition.
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 in the study.
For each study, a number of inclusion and exclusion criteria are agreed in consultation with the study sponsor and the ethics committee.
The questions asked during the screening process are to ascertain whether potential participants meet the inclusion/exclusion criteria and are eligible to participate, so it is important that you answer these questions truthfully.
As the majority of products we are assessing fall into the category of supplements or complementary medicines, we are required to enrol ‘otherwise healthy participants’ in our studies. This means that for most studies, anyone with a life threatening or unstable illness, a smoker or with a BMI of greater than 40 is likely to be ineligible to participate.
WHY IS THERE AN AGE LIMIT ON SOME STUDIES?
We are required to work within parameters dictated to us by both the Trial Sponsor (who may wish to look at results specific to their targeted demographic), and the independent Ethics Committee that approves our trials (who may have concerns about placing extra risk on an already vulnerable population).
As people age, differences can occur in the gastrointestinal tract. This can affect the absorption of nutrients which can in turn affect the study outcome. By limiting the age range included in a trial, we can have better consistency in the physiological response of the participants.
Usually, in the early development stage of a product, studies are done on a younger population. If results are positive with minimal adverse reactions, then additional studies may be conducted on more specific population groups.
ARE THE TRIAL PRODUCTS SAFE?
Yes The products used in our clinical trials have all been approved for trial use.
The majority of the complimentary medicines used in our trials are listed with the Therapeutic Goods Administration (TGA). This means that they have undergone extensive investigation and have been approved for use within United States.
All foods comply with Food Standards Australia and New Zealand and all cosmetics comply with the Australian Cosmetics Standard.
WHERE ARE THE TRIALS CONDUCTED?
All trials will be held remotely. RECLINICA will supply each participant with a kit consisting of necessary items to complete the trial.
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 911.