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Children are among the largest consumers of natural products with over 50% of American parents giving their kids supplements on a regular basis. Yet, when it comes to research, children are dramatically underrepresented.
Instead of child-focused trials, many formulators create products based on adult-focused research and simply reduce the dosing. But children are not just little adults; they have differences in metabolism, immune function, and other critical systems.
Using products on children without child-focused trials means we may be failing to use products in the most effective ways. It also means we can't quantify just how much these products support pediatric health.
Using adult-focused research to develop child-focused formulations is often seen as a way to protect children. Many believe that keeping kids out of clinical trials protects them from uncertainty. This approach, however, only holds when the test product is an untested medication. By avoiding the use of investigational new drugs in children, we protect them from the unknown risks that drug may pose.
Natural products, however, are not investigational drugs. The overwhelming majority of children are already consuming nutraceuticals, inhaling essential oils, and using herbal products. If a product is safe enough to be on the shelves, it is safe enough for clinical research.
Not only does leaving children out of clinical trials fail to protect them, it actually places them in harms way. Relying on adult-focused studies to establish formulations and dosing for children is prone to error. Children's bodies aren't small adult bodies. Their bodies work in very different ways than adult bodies. They have immature digestive, respiratory, and immune systems. Children absorb, distribute, metabolize, and eliminate natural products differently. Their dietary and lifestyle patterns differ. All of these factors play defining roles in how your product works in a child's body.
This means that when it comes to optimizing product dosing and administration, you need studies conducted not in adults, but directly in children. This is why the FDA and FTC guidance requires that people who are in your trials match the people who are actually using your essential oils, herbal products, or supplements. Studies on adults won't be able to accurately substantiate claims made about child health. If your product boosts immune function as kids head back to school, it needs to be studied in school age children. If it targets common childhood stressors, it needs to be tested in children experiencing those stressors. Only with trials conducted in the actual populations most likely to use your natural products can you deliver the high quality evidence your consumers–and the regulatory agencies–expect of you.
"Children are a unique population with distinct developmental and physiological differences from adults. Clinical trials in children are essential to develop age-specific, empirically-verified therapies and interventions to determine and improve the best medical treatment available."
Not only do you need children, rather than adults, in a trial for kid-focused products, you need the specific children who are most likely to benefit from your product. After all, your product is designed to keep kids healthy, not act as a pharmaceutical drug. You need children who are not sick, but who are at-risk of getting sick so that you can demonstrate your product's effects. Our multidisciplinary team includes experienced research professionals who can help identify which children are most likely to benefit. By enrolling children who have the greatest exposure to illness, we're able to capture the individuals who closely match the children who use your products and who are most likely to see benefits from your product. This boosts your trial's chances of success while also meeting the FDA and FTC requirements.
Identifying the right group of people to participate is one thing; getting them into the study and keeping them in a study is a whole different ballgame. Child-focused studies require both the child and the parent to agree to participate and are subject to far more stringent ethical oversight. These challenges are a leading cause of study failure, with industry-wide norms for enrollment failure hovering around 80%. Poor enrollment or compliance also dramatically reduces the quality of the trial and therefore, the potential for your trial to substantiate a claim.
Keeping the people who enrolled into a study involved and using your product correctly is critical for your trial's success. You already know that people need to actually use your product to experience its protective effects. If the people in your study are only sporadically taking it or sloppily using it, they are more likely to end up sick. This means that the resulting data will be unable to validate your product's effects.
Franklin navigates this journey by focusing on the participant experience for both children enrolled in the trial and their parents. We've invested into the cultivation of a large community of qualified parent-child dyads who are ready to join your trial. The community we've built is also demographically consistent with the populations most likely to purchase natural products for child health in the future.
By focusing on the participant experience, we're able to find the right enrollees for your study and keep them engaged throughout your trial. The end result for you? Recruitment costs that are a fraction of industry norms. Not only that, we average a 99% retention rate in our trials with near perfect protocol compliance.
Navigating child-focused trials becomes even more complex when looking for valid and reliable endpoints. This population requires a white-glove approach to meet the highest ethical standards, so invasive strategies are rarely justified for preventive-focused products. Yet, children are also frequently ignored in the development of standardized measurements for health-related outcomes, leaving few options for high quality trials.
This is where Franklin Health's experience with non-invasive approaches to high quality data collection becomes critical for success. Our interdisciplinary team, which includes advanced statisticians who are trained to create and validate measurement instruments, helps you meet this challenge with our proprietary suite of child-focused measurement instruments.
Franklin's pediatric suite of psychometrics represent the first and only non-invasive set of tools to measure the efficacy of natural products in healthy pediatric populations.
These comprehensive measurement captures the accurate effects of outcomes such as immune support by focusing on a holistic model of health, recognizing the unique functions of immature pediatric bodily systems. These tools enables our research team to document your product's effects on child health in accordance with the regulatory guidelines for natural supplements.
Why do you need the CHIS? The endpoint you choose and the tools in which you measure these endpoints are the the most fundamental and critical elements of your study's design. This measurement is the tool that will be used to capture and document any and all health related enhancements that your product delivers.
There are three factors to consider with a measurement tool: validity (it measures what it is intended to measure), reliability (it does so consistently–time after time), and sensitivity (it is sensitive enough to capture even small changes in the specific effect). Collectively, these three elements determine the quality of a measurement tool, which plays a role in establishing whether or not it is fit for purpose.
A successful child-focused natural product trial requires tools that were developed specifically for use in children and for the natural products industry, and which are capable of documenting a holistic range of improvements in health among children who are already considered to be healthy.
Using the wrong tool to measure child health puts your entire study at risk of a false negative.
Not only does having the right endpoint measure boost your trial's chances of success, it ensures that your trial meets the FDA and FTC's requirements for claim substantiation. These regulatory agencies identify appropriate and clearly measured endpoints as essential for successful claim substantiation. Outcome measures are also one of the primary criteria the FDA uses when evaluating the quality of a substantiation trial.
Franklin addresses this vulnerability by exclusively relying on our proprietary suite of fit for purpose endpoint measures which our team developed specifically to meet these FDA and FTC guidelines. This comprehensive scale captures a wide range of health related symptoms, including objective epidemiological factors such as incidence and prevalence of disease, as well as subjective factors such as perceived health.
These outcomes are measured through real-world effects, ensuring that your study findings not only keep regulatory agencies happy, but that they meet the desires of your customers. Your customers want to know if your product helps keep the family healthy or reduces sick days missed from school. We help you achieve that.
Capturing general symptoms such as fever, irritability, or fatigue provides a clear overview of how well your product keeps children healthy.
Daily function scores capture outcomes of a strong immune system such as school attendance and ability to complete routine tasks.
Our perceived immune status tool captures both parent and child beliefs about how well their immune system is functioning.
Documenting incidence, prevalence, and duration of respiratory symptoms confirms that product provides respiratory-focused immune support.
Documenting incidence, prevalence, and duration of GI symptoms confirms that product provides gastrointestinal-focused immune support.
Documenting incidence, prevalence, and duration of dermal symptoms confirms that product provides skin-focused immune support.
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Child-focused trials may seem daunting for firms focused on pharmaceutical development. Untested, experimental drugs and children are a bad mix. Our team, however, embraces clinical trials for children because we know highly complex natural products differ in both function and purpose. We know your essential oil blend or herbal supplement can't be forced into a research paradigm developed for drug products, and that trying to do so usually ends with an outrageously expensive trial that suffers from poor quality design and ultimately ends in failure.
As a natural health research firm, we take a different approach to child-focused research studies. Each and every researcher on our team is also a trained natural health professional. Our team includes aromatherapists, herbalists, health coaches, dietitians, and a range of other specializations that cross the holistic health spectrum. We know the interactions between substances such as botanicals, nutraceuticals, or essential oils, and pediatric health status. This allows us to understand your product in ways no other firm can. We know your product doesn't rely on pharmaceutical-like mechanisms of action or protocols, and we won't treat it that way.
If your health supporting product is an aromatherapy blend, our expert aromatherapists will work with you to ensure that every element of your study maximizes the unique chemistry your oil blend has to offer. If your product is a supplement, you'll enjoy researchers who are nutrition experts and herbalists. You'll never have to explain the phytochemistry or holistic approaches your product uses to achieve its goals. We know how to maximize your product's effects, boosting not only your chances of success but the level of success your trial achieves.
As experienced natural health professionals, our team is also familiar with the ways in which natural health support products are inadvertently misused, especially in children. We know how to ensure that your aromatherapy blend is dosed sufficiently and applied consistently from day to day. Our culinary experts know how to keep children consuming your supplement even if they don't like the flavor or texture. These factors are often overlooked by conventional firms but have the potential to make or break your trial.
Not only will you enjoy the expertise of holistic health experts, your trial will be managed by highly trained clinical researchers. Our research firm is led by a Harvard-trained researcher and each of our team members have graduate training in health research fields. This ensures that your trial meets the highest scientific and methodological standards.
This expert approach to trial design reduces your chances of a false negative. Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed. These problems can involve a study being underpowered, poor choice in endpoint measures, inability to develop an effective intervention protocol, participant dropouts, or sloppy data analysis.
At Franklin Health, we use our extensive expertise to make you look good. We create trials based on your product's strongest effects. We ensure that the endpoints for your trial are hand-selected to match the effects your product actually delivers.
Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed.
Our power analysis standard cuts your chances of false negatives in half. In an effort to cut costs, many firms conduct studies that are developed to accept a 20% chance of producing a false negative. Roughly 1 in 5 trials are at risk of falling short of statistical significance simply because they are the wrong size. We cut that risk in half, designing high powered studies that are more likely to succeed.
Many others fail due to poor intervention strategies. Doses that are too low, schedules that are too complex for participants to follow, inconvenient preparations, or even improper application approaches can all lead to false negatives. When this happens, the problem isn't that your product doesn't keep kids healthy, the problem is that most researchers don't know how to help the families in your study use your product correctly. Our health experts create user-friendly intervention strategies which address all of the complex factors that contribute to study success.
We also develop comprehensive statistical analysis plans that eliminate the noise from your data, isolating your product's true effects. Many research firms use simplistic statistical measures which are incapable of sufficiently capturing the effects your product can deliver. Our natural product expertise allows our statisticians to identify and neutralize factors which can minimize the effects, producing trial results that accurately display the true size of your product's protective effects.
One of the biggest myths in natural product research is that clinical trials cost millions. That may be true for a novel biotech company with products that have dangerous side effects and high-stakes outcomes such as cancer or heart disease. These costs are directly associated with safeguarding the experimental use of untested medications on people who are very sick.
Pharmaceutical research firms have created procedures and systems which revolve around high risk drugs among high risk populations. Those pricey systems protect patients in these invasive clinical trials, but are wholly inept when it comes to the needs of trials targeting prevention.
Natural products such as essential oils, nutrition supplements, or herbal creams are self-prescribed at the health food store, not physician-prescribed through a highly regulated pharmacy. Natural products have hundreds if not thousands of years of safe use in human health, unlike novel isolated chemical extracts which lack human history. Natural products boost the structure and function of human health rather than treat diseases. Your health promoting product isn't an experimental pharmaceutical and your trial shouldn't be designed like one either.
Instead of forcing your product into an extraneous research model, we design custom trial strategies around your needs. Our expert approach to clinical trial design focuses on the quality of your trial and FDA/FTC natural product-specific guidelines such as those for dietary supplements or cosmetics. We prioritize ethics compliance, data protection, and quality control over wasteful and irrelevant systems borrowed from other industries. Through this approach, we're able to reduce inefficiencies in the research process and eliminate needless overhead costs that are not relevant to the standards for health-enhancing products. We also use cutting-edge designs such as decentralized trials and non-invasive measures. Most importantly, not only does this approach substantially reduce the cost of a clinical trial for your product, it also improves the quality of the trial. It's a win-win.
So what does this actually look like for your trial? At Franklin, we prioritize transparent pricing. Each and every trial is a bespoke design based on your product's unique needs, with your budget and goals in mind. With our extensive expertise in natural products and clinical research, we're often able to come up with creative solutions to work with any trial budget.
One of the most important reasons to conduct a clinical trial is to boost protection from legal challenges. If you want to say your product improves health or boosts general prevention, the FDA and FTC require you to bring the evidence. Not just any evidence; they require high quality evidence that meets key criteria.
The FDA identifies these criteria as: study population, study design and conduct, data collection and statistical analysis, and outcome measures. You may have a "successful" trial but if it doesn't meet these quality-based criteria, it doesn't substantiate a claim.
Unfortunately, poor quality trials are common in the natural products industry. Many large firms aren't equipped to manage the unique elements of natural products or to prioritize health-enhancing outcome measures and FDA guidelines. Others may use dubious techniques such as "p-hacking" or conduct multiple analyses without controlling for multiplicity. These may give the appearance of success, but ultimately fail to meet industry standards.
Here's the catch. Regulatory agencies can easily catch these common mistakes. Quick and cheap trial results that use shoddy statistical approaches don't fool expert statisticians. Neither does a long and overpriced trial conducted by drug researchers who know nothing about natural products. And when these trials are evaluated for quality, your company will be the one that pays the price.
We take our commitment to the integrity of your trial seriously. The overwhelming majority of our studies are published in peer reviewed literature and/or presented at academic or scientific conferences. This not only provides valuable free press for your health enhancing product, it also provides additional evidence that your trial is high quality and capable of substantiating your claims.
Not only do we keep quality at the forefront of what we do, each of our trials are backed by our Five-Point Promise, which details our commitment to ensuring trial outcomes that work, sample populations that matter, natural health expert researchers, high quality research methods, and direct access to researchers–not high pressure sales people or account managers. By focusing on quality over quantity, we're able to deliver high quality clinical trials faster and more affordably than any other firm in the natural products industry.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven."
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