You Are Not an Aggregate

What Biomarker Labs Studies Are and Aren’t

 
Photo by  Tom Plouff

Photo by Tom Plouff

When it comes to wellness, the word “study” often evokes the scientific rigor associated with drug trials, where researchers design and execute highly structured experiments to test whether a certain drug is a safe and effective treatment for a given condition. In fact, the term “study” actually encompasses many kinds of research, not just trials. Studies range in formality from highly structured, like data-intensive meta-analysis of other studies, to loosely structured based on anecdotal evidence alone.

In the world of scientific and medical research, Biomarker studies are N-of-1 experiments. Quite simply the N refers to the number of people in the study. In this case N equals 1, so it’s a study with only one participant: you. Many other people may take the study but each time it’s an N of 1. Many have written about the use of N-of-1 studies as the most scalable, cost-effective way to find the best option for an individual and offer personalized wellness to a broad swath of the population. Indeed, some advocate N-of-1 studies as an alternative to both randomized clinical trials (RCT) and standard practice where patients try therapies concurrently or sequentially without using objective measures of effectiveness.

 
n-of-1-studies-on-biomarker
 

The Biomarker App and the N of 1

The Biomarker app comes from Biomarker Labs, a San Francisco-based, venture-backed company advised by world-renowned doctors, researchers, medical advisors, and data scientists.

The app marries individual wellness choices with data science and AI. Users track what they’re doing and the app tells them what’s happening to them in relation to the wellness choice. People can see their own responses to a wide variety of practices by taking studies in sleep, diet, fitness, and other wellness areas by conducting an N-of-1 experiment on themselves.

To get insights into what works, users start by connecting their wearables, smart devices, and even lab results to the Biomarker app. We integrate with hundreds of applications already and are adding more connection options every day. Then, the user chooses a study to join. Options vary widely, covering nootropics to weight lifting regimens to over-the-counter sleep aids. Each study has a pre-set hypothesis, baseline, control period, and data collection protocol. At the end of the study, Biomarker shows users their results. And users find out conclusively and objectively whether it worked, for them.

Why Did Biomarker Choose N of 1 Over Other Study Methodologies?

 

What is an N-of-1 study?

 

Time and Cost

Biomarker seeks to help individuals use their own health data to further their wellness goals. While the meta-analysis of peer-reviewed double-blind clinical randomized clinical trials (RCT) may be the gold-standard in patient research, these hugely expensive studies often take months or years to complete and more time to analyze. Biomarker makes it possible to conduct unlimited, simultaneous, legitimate studies as Ns of 1 and deliver their results quickly and at no cost to study takers.

Personal Results Matter

RCTs and similar studies focus on finding outcomes that serve the largest population groups with a given health condition or need. As such, they rarely uncover interventions that work better or worse for certain groups and they never analyze whether an intervention works better or worse for an individual. This is a large and costly problem. According to Nicholas J. Schork, Director of Human Biology at the J. Craig Venter Institute and Professor at the Translational Genomics Research Institute, the US’s top ten highest-grossing drugs only help at most one quarter of the people who take them. Some top-selling drugs help just one in 25. Similarly, Americans consume more than $30 billion in nutritional and dietary supplements every year, even though most experts believe many have no effect on the average person’s health. Biomarker helps individuals discover what works for them and what doesn’t.

The N-of-1 trial could provide the strongest evidence for individual treatment decisions and “should therefore occupy the pinnacle of the evidence pyramid,” according to the Agency for Healthcare Research and Quality’s (AHRQ) Effective Health Care Program.

Greater Engagement

N-of-1 trials typically require significantly more patient engagement than standard practice or cohort studies. A typical Biomarker study includes a recipe: the therapy to evaluate, biomarkers to track, devices and apps to use to collect data, and the outcomes to measure. Devices and apps record most of this data passively. However, users also record objective and subjective measures of effectiveness, sometimes several times a day. Choosing which studies to join and journaling gives people a sense of investment and ownership, which improves study compliance. The AHRQ states, “N-of-1 trials can awaken patients’ ‘inner scientist’ and give them a greater stake in the process of clinical care.” Further, their research shows that patients with chronic illness enjoy better outcomes when they’re more engaged in their own care. In at least one study, patients who had completed an N-of-1 trial understood their condition better and felt more in control of their healthcare decisions. We hope to see this effect with people with much less severe health needs, too.

 
 

What Biomarker Is Not

Biomarker studies are not clinical trials or RCTs. No definitions, analogies, or descriptions related to clinical research are applicable to Biomarker studies. Biomarker is in no way, shape, or form a platform for running studies or trials of any kind. We’re a tool for consumers who are already buying products and measuring results to leverage the information they’re already generating to understand better the impacts of their choices.

Biomarker provides user report data from the information the user provides.

Once we have a sufficient number of N-of-1 results on a particular product or service we can reach a confidence score to provide data on impact.

Statistical significance is defined in medical research as the likelihood that a study’s results aren’t merely chance findings, and if researchers re-did the study they’d get the same results. Given enough data, an N-of-1 study can even provide statistically significant results for individual; however, these results don’t carry over to others. One can’t conclude from an N of 1 that what worked for Person A will also work for Persons B and C. If many individuals get the same results from their N-of-1 studies that may indicate a wider pattern. In this way, groups of N-of-1 results can be used similarly to RCTs.

Going forward

A “study” can be one of many kinds of research. RCTs rarely uncover what works better or worse for certain groups and never uncover what works better or worse for a particular person. An N-of-1 study is a scalable, cost-effective way to find the best option for an individual. The more engaged people are, the better their outcomes. N-of-1 requires a lot of involvement and investment from their takers. They also provide perhaps the strongest evidence for individual wellness decisions.

The Biomarker app makes N-of-1 experiments widely accessible and easy to run. Biomarker doesn’t run clinical trials or RCTs. Rather, we enables users to perform informal N-of-1 experiments on themselves. Once we have a sufficient number of N-of-1 results on a particular product or service we can reach a confidence score to provide data on impact.


See for yourself

Would you like to assess the effect of Dream Water or any other wellness improvement on your self? Sign up to beta test Biomarker.io below - it’s an app that connects with your wearables to let you know how well your wellness choices are working for you. Or email us at hello@biomarker.io. We’d love to talk.