Scott Nelson

How One Company Is Changing The Game Of Clinical Trials

Joovv is excited to partner with ProofPilot to run forthcoming research studies and clinical trials on red light therapy for many aspects of our health. ProofPilot is expanding the reaches of clinical research by operating trials in partnership with organizations and the public. Joovv and ProofPilot will be launching trials in 2020 and beyond, analyzing Joovv red light therapy treatments for hormonal health & sleep quality.

We spoke with ProofPilot’s founder and CEO Matthew Amsden about the future of clinical research, and Joovv’s red light therapy trials.

Matt Amsden Joovv

Joovv: What is ProofPilot’s backstory? 

Matthew: When you think “clinical trials,” everyone thinks pharmaceutical drugs. But there’s really nothing stopping other sectors from using these tools to prove what works and what does not. I’m personally very interested in looking at what works to optimize health. So, we’re really pushing to make the same tools we use in pharma trials available to those products and services designed to improve health and optimize performance.

Prior to starting ProofPilot, I was working as a healthcare consultant and became fascinated with the gap between the questions the general population had, and the lack of real-world research to answer those questions. There were questions I saw where good clinical trial data with a reasonable sized sample didn’t exist. Before every new study, I figured there must be a solution to make trials easier and less expensive. There wasn’t! 

This was a problem that needed to be fixed, so more people can have access to different treatment modalities, and get data faster. That’s why we created ProofPilot. 

Joovv: What’s the 411 on clinical trials?

Everyone has stories that they tell about a supplement they took that really worked, or an antibiotic that made them sick. These stories are anecdotes. Anecdotes are useful in clinical research because they help us identify things to test in clinical trials. But anecdotes are not scientifically valid studies. 

Clinical trials study how people react to treatments or interventions. For example, a clinical trial would take people with inflammatory arthritis in their hands and have them try regimented red light therapy over a specified period of time. The results are recorded and repeated.

Sometimes clinical trials have a control. Sometimes they don’t. Sometimes clinical trials are blinded, sometimes they aren’t. In these trials, we analyze these repeated measurements over time in relationship to the intervention. Is there a positive, statistically significant change? If so, there’s an initial finding. 

Joovv: What is the current state of clinical trials? How does ProofPilot solve for these problems? 

Clinical trials are at a crisis stage right now. It takes forever to launch a study, there are inconsistently applied regulations, it’s difficult to recruit patients, and the costs are extremely high. This makes success even in pharma and academia virtually impossible. But, in my opinion, the problem is bigger than operational issues. 

Most trials are so wonky, difficult and expensive, that very few of them get done. Unless you work in pharma or academia, you’re probably never going to conduct a trial. That means we’re making important decisions about our health based on anecdotal data, questionable marketing, or politicians. There’s so much more out there that can benefit from scientifically valid research if we make it easy, fun, and rewarding.  

Joovv: What other companies and/or institutions are currently using ProofPilot? 

One of our key goals at ProofPilot is to support organizations that already do research, while also providing the tools for organizations that haven’t been able to in the past.

So, well-known institutions and companies like Massachusetts General Hospital (a Harvard teaching Hospital) use ProofPilot. But, we’re also really pleased to see organizations like Thrive Market, an online grocery store, Withings, the connected health device company, and Lifesum, the digital health app, use ProofPilot to answer key health questions in conjunction with their customers. 

Joovv: Why is it necessary to expand beyond the current clinical trial model?

There’s this unspoken truth in healthcare right now. Most of what we know about human health comes from relatively small, flawed studies. In fact, the Institute of Medicine Round (a US Government non-partisan research service) suggested that only 30 percent of medical treatments conducted in hospitals had sufficient evidence of efficacy. 

And when we talk about things like health prevention and optimization, those stats are even more alarming because most of these activities happen outside a traditional healthcare or clinical setting. 

The studies Joovv will be running with ProofPilot are real-world trials. We’re generating scientific evidence with real people, like you, living your normal lives. Even though there is a robust amount of existing published clinical data on light therapy, it’s really exciting that we can fill some of these knowledge gaps, especially in emerging areas like sleep and hormone health.

Joovv: There has been some controversy with health and wellness companies running studies that misled participants. How do you make sure this doesn’t happen?

I’m glad you brought this up. ProofPilot has a strong policy. We do not insert our own judgments and biases on whether a study is worth doing. That would be counter to the spirit of scientific discovery. 

However, we are strict when it comes to ethics. We require the risks and benefits to be clearly laid out to anyone who joins the study. We require those sponsoring the study to disclose any conflicts of interest they may have. And, we don’t support organizations or individuals whom we are concerned won’t treat participants with the respect they deserve. There have been situations where we’ve turned away esteemed academic customers for these reasons.  

In addition, every study on ProofPilot gets a review by a third party ethics review board (often referred to as an “IRB”). Sometimes, the third-party reviewers may deem the study “exempt” meaning it does not need a review. Although the paperwork that goes along with these types of reviews is onerous, it’s important and protects everyone. 

As a participant, when reviewing any study you might want to join, if it’s not clear what the risks and benefits are for enrolling, and if you don’t see it’s been reviewed by a third-party for ethical compliance (or at least been deemed exempt), it’s not a real study and you probably shouldn’t join it. 

Rest assured that ProofPilot only runs real studies that meet all of the necessary regulatory and compliance guidelines.

Joovv: Why are you charging people to participate in studies? 

Participation in clinical studies are often (but not always) free, and there are even instances of compensation for participation. In some cases this is appropriate due to the study design. Many studies on ProofPilot are free to engage in. Some even provide financial compensation.

Reproducing research study results in 'the real world,' is a key goal for many studies on ProofPilot. Unfortunately, most healthcare and performance treatments are not free; presumably in the real world, you would pay for the product or service in the study.

So, there's an ongoing question. Are we creating trials in which we're testing things in an unrealistic environment? Is that unrealistic environment skewing results so they are not reproducible in real life?  ProofPilot is currently running a series of trials to help answer this question. 

A payment (or card hold) for a product or service can have a big impact on how much a person uses it. If they made a small payment, they’re more likely to follow the treatment directions. And treatment adherence has a massive impact on study outcomes. 

Only studies recruiting individuals testing health & wellness products are part of this experiment. And as always, every study on ProofPilot is also reviewed by a third-party ethics board. They too look closely at issues of payment and compensation. No study begins recruiting until the third party reviewers give us the green light.

Joovv: What’s a clinical area you’d like to explore in partnership with Joovv? 

Sometimes the questions are personal. I’m the CEO of a venture-backed company. It can be stressful. While I generally eat well, get good sleep, my blood pressure is creeping up. Nothing serious or medically treatable yet but something I’m keeping my eye on. 

I’ve recently been reading about the impact of natural sunlight on N02 (nitric oxide) levels. And, we know from other studies that increased levels of N02 helps reduce blood pressure. 

So, I’m very curious to learn more about Joovv’s effect on keeping blood pressure levels in check, low enough so pharmaceutical treatment isn’t necessary. I’m using Joovv every day to test it. Given that 1 in 3 Americans suffer from high blood pressure, this could be a major public health benefit as well. 

Joovv: Tell us about your hopes for other Joovv + ProofPilot studies we have planned.  

The World Health Organization has identified depression as the epidemic of our times. Depression is a complicated area, but we’ve known light is an important aspect for some time. I’m interested to see how Joovv impacts depression symptoms. 

We have several hormone-related studies planned with Joovv as well. Epidemiology studies are showing a general decline in testosterone levels among younger generations. There’s already anecdotal evidence and animal studies showing that Joovv increases testosterone. Replicating studies to see if you get the same results is a key part of the scientific process. I’m looking forward to doing this type of research with Joovv and seeing how red light therapy affects testosterone, thyroid conditions, and other hormonal health questions.

Joovv: How does someone get involved in a Joovv + ProofPilot study? 

It’s super easy. Once the studies are available, you can view them on Joovv's website and sign up for their email list. You’ll be taken to a page on ProofPilot where you can learn more about what’s involved in the study. Some studies will have some criteria you need to meet to be eligible to participate. If you’re a good match, you can manage your entire study experience right from your mobile phone or computer.

The whole reason we started ProofPilot is so that more people can see what treatment and therapy modalities work for them, and so we can get clinical trial data supporting their impact, faster. Like I mentioned before, there are many studies that need to be conducted and many people willing to participate. Here’s a way to make that happen, to make studies easy and accessible to anyone.

 

Joovv light therapy products are indicated for use in the relief of muscle and joint pain, including arthritis and muscle spasm pain, and increasing of blood circulation, and relaxation of muscles. The information provided in this article is for educational purposes only and is not intended to support the safety or effectiveness of Joovv devices, or diagnose, treat, cure, or prevent any disease. It's not a substitute for a face-to-face consultation with your healthcare provider, and should not be construed as medical advice.

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