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MENSTRUAL WELL-BEING

Clinical trials for PMS-relieving natural products

period pain

Over 90% of females report experiencing a combination of symptoms before or during their period. Products capable of reducing or eliminating these symptoms deliver improved quality of life, enhanced productivity, and higher quality emotional health, resulting in a substantial market for natural supplements. With more and more consumers expecting scientific substantiation for marketing promises made, clinical trials on PMS products are now a must.

Findings from a clinical trial unlock numerous new avenues for marketing, brand integrity, and even stability. These findings allow you to legally and ethically make marketing claims that your product improves menstrual health. They also supply the documentation required for FDA and FTC compliance.  

ENDPOINTS FOR SUCCESS

Pre-menstrual symptoms vary dramatically from woman to woman and are historically difficult to quantify. This makes the challenge of proving that your product improves PMS a challenge. Should you concentrate on a single symptom, such as pain, ignoring the rest? Or should you ignore symptoms altogether and focus on hormone tests which are poor indicators of PMS but easier to measure? 

To substantiate a PMS alleviating claim, you need endpoints that accurately and directly measure the target of your claim. Your trial endpoints need to match your product's effects, and most importantly, these endpoints shouldn't result in FDA warning letters.  

So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical relieves symptoms of PMS? Franklin Health Research helps you achieve this with our proprietary Franklin Health Menstrual Symptom Scale (FH-MSS). 

The FH-MSS was developed for women by female scientists and is the first tool of its kind to not only be created with the natural products industry in mind, but to represent a comprehensive and holistic view of PMS-related symptoms. This comprehensive symptom measurement is capable of capturing improvements to PMS regardless of which specific symptoms your product targets. It concentrates on the wide range of areas in which menstrual health can be improved and focuses on real world outcomes that matter to your consumers. 

Measurement can make or break your PMS study

Why do you need the FH-MSS? The single most important component of study design is the endpoint measurement. This is the tool that will be used to capture and document all improvements to PMS symptoms that your product delivers. The entire trial depends on this measurement's ability to document that PMS symptoms have been reduced as a result of the use of your product. If it can't accurately measure PMS symptoms, it can't capture changes to these symptoms and the end result is a false negative. 

In clinical research, measurement tools are evaluated through three factors: 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.

When a clinical trial for PMS-reducing supplements or essential oils rely on single symptom endpoints such as pain or proxy endpoints such as hormone levels, they place your entire study at risk because these measures are not fit for purpose. Many women don't experience pain as a symptom of PMS, so their pain levels will start and remain low during your study. Many other women may experience improvements to non-pain related symptoms, again leaving you with a study that failed to capture the benefits of your product. Additionally, hormone levels may change due to a wide range of unrelated factors. If your outcome measurements are not sensitive to changes in PMS symptoms, they can destroy your entire trial. 

A successful natural product PMS-reduction trial requires tools that were developed specifically for use in the natural products industry and which are capable of directly measuring improvements to well-being during the complex natural process of premenstrual syndrome. 

Using the wrong tool to measure PMS symptoms will put 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 guidelines for claim substantiation. These regulatory agencies clearly state that appropriate and clearly measured endpoints are required for successful claim substantiation. Outcome measures are also one of the primary criteria the FDA uses when evaluating the quality of a substantiation trial. 

How we design your PMS trial

Franklin reduces 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. Our comprehensive PMS symptom measurement scale directly captures a wide range of symptoms, including objective factors such as weight gain and bloating, as well as subjective factors such as mood and emotional well-being. 

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 can help reduce the bloating that prevents them from buttoning up their favorite jeans or can improve their levels of concentration while juggling multiple tasks. We design studies with endpoints that satisfy the FDA and FTC as well as unlock claims that your customers want to hear.

A natural products PMS trial at Franklin Health will typically focus on 5 - 6 primary endpoints. Each product has unique needs, so your trial's specific endpoints will be determined through collaboration between your marketing goals and our research team, ensuring that they match your product's greatest effects. Our most commonly used endpoints include: 

pain

Pain

Our pain scale was created for women by women and captures the unique ways in which women experience pain. This scale measures not only pain severity but also duration and frequency. 

cognition

Cognition

For many women, PMS means brain fog. Poor concentration, struggling to remember things, and difficulty coming to decisions are all within the cognition realm of PMS symptoms. 

digestion

Bloating

Gastrointestinal symptoms such as bloating, indigestion, gas, and other digestive complaints are common PMS symptoms and are targets of PMS-alleviating natural products. 

stress

Stress

The perceived stress subdomain refers to the extent to which a participant considers their demands to exceed their ability to cope as a result of PMS. 

sleep

Sleep

One of the most common symptoms of PMS is disrupted sleep. Women experience symptoms ranging from insomnia to daytime fatigue. This subdomain captures changes to sleep. 

sadness

Emotion

Emotional responses range from anger to sadness to depression. While most PMS scales capture anger, we focus on the symptoms that most affect your customer. 

ENROLLING YOUR TARGET MARKET

The key to demonstrating improvements to PMS symptoms is to focus on a study sample of people who have high symptom loads but are not diagnosed with PMDD or related disorders. Regulatory requirements emphasize the importance of studying improvements to normal processes (i.e. PMS) among already-healthy populations.

That's where our multidisciplinary team saves the day. Our team includes public health professionals–experts who can pinpoint exactly which demographics and screening procedures will deliver individuals who are in that perfect spot of being disease-free yet still present a high symptom load. This allows us to capture the individuals who are most likely to buy your products and who are most likely to benefit from your products. This boosts your trial's chances of success while also meeting the FDA and FTC requirements.

Claim substantiation also requires that the people in your study's trials match the people who consume your products. Different people respond differently to natural products, so it's critical that the people in your trials are similar to the people who will actually use your essential oils, herbal products, or nutraceuticals. If your average customer is the newly menstruating teen, your trial needs to be conducted on young females. If you market to postpartum women, your trial needs to include them. 

Enrollment, Protocol Compliance, and Drop-outs 

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. Across the industry, over 80% of clinical trials are unable to meet enrollment goals; this inadequacy is a leading cause of study failure. Some firms address this challenge by lowering their standards–enrolling anyone and everyone they can find into a trial. This approach looks great at first, but the resulting poor compliance and large drop-out rates destroy the quality of a study. This introduces a form of bias to your dataset, dramatically reducing the quality of the trial and therefore, the potential for your trial to substantiate a claim. 

Keeping people who enrolled into a study involved in the study and using the product correctly is critical for your trial's success. You already know that people need to actually use your product to experience its benefits. If the people in your study are only sporadically taking it or sloppily using it, the resulting data will be unable to validate your product's effects. Similarly, large dropout rates will also reduce the quality of your study while increasing the risks of a false negative. 

The MY Franklin Health Community

Franklin takes a different approach to enrollment and retention. Rather than simply accepting noncompliance and dropouts as inevitable, we've invested in the cultivation of a large community of willing and eager volunteers who want to join your trial. The community we've built is also demographically consistent with the populations most likely to purchase natural PMS management products. 

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. 

period glitter
black woman relaxing
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WE ARE NATURAL HEALTH PEOPLE TOO 

One of the biggest challenges to natural product research is finding someone who understands both the natural health field and clinical research. Most research firms are pharmaceutical firms first, with nutrition or supplement research as a side gig. These firms simply take the same assembly line approach and cram your unique PMS product into a preexisting strategy. But your highly complex natural product isn't a drug. Your endpoint isn't a disease. Cramming it into these study designs falls short when it comes to capturing what makes your oil blend or natural product actually work. The end result is usually 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. 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 the female reproductive cycle. 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 PMS 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 PMS-related products are inadvertently misused. 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 participants 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. 

WE BOOST YOUR CHANCES OF SUCCESS

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 PMS management 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 reduce PMS symptoms, the problem is that most researchers don't know how to help study participants 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. With simplistic measures, many research firms are incapable of data analysis that sufficiently captures 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 PMS-related effects. 

A clinical trial helps you gain:

Specificity

Now you can quantify your product's effects. i.e. It reduces PMS by XX%! 

Target Marketing

Identify who benefits the most from your product so you can customize marketing campaigns.

Substantiation

Gain credible, high quality substantiation for your proprietary products. 

Protection

Clinical trials protect you from legal challenges, but only if they are high quality. 

Press

Scientific publications or presentations deliver the right kind of media attention.

Expert Allies

Clinical trials help you market to key community leaders including MDs and RNs.  

Free CONSULTATION

Meet with a Researcher

No high pressured sales events; meet directly with a scientist who can help you explore how Franklin can help you promote your PMS management products with clinical evidence. 

Meet with a Scientist

YOUr budget

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 natural product trials. 

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 PMS product isn't an experimental pharmaceutical and your trial shouldn't be designed like one either.  

Instead of forcing your premenstrual syndrome 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 women's health product, it also improves the quality of the trial. It's a win-win. 

Actual Clinical Trial Costs

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 PMS management 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.

The typical randomized, double-blinded placebo-controlled clinical trial for a PMS product varies based on a number of factors. On the lower end, a trial may run anywhere from $45,000-$65,000 for a 1-2 day-long aromatherapy based study with 60 people. On the upper end, a 3-4 month intervention that captures changes through multiple monthly cycles with larger groups and more complex analyses can run into the upper-$200,000 range. Our scientists will work with you to develop a PMS trial that captures the real world effects of your product while staying within the confines of your budget. 

Getting started is easy

One

Schedule a FREE, no obligation meeting with a Franklin Health scientist. 

Two

Tell us more about your product and your marketing goals. 

Three

Review our proposals, discuss any changes, and we'll take it from there! 

LEGAL WILL LOVE YOU 

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 reduces PMS symptoms, 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 PMS related 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. 

LET'S TALK

You know your product improves PMS; we'll help you prove it. 

Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven." 

 

Meet with a Scientist