Is someone’s phone ringing? Chances are you reached within arm’s length to grab for your device. This increased dependency on digital gadgets has skyrocketed in the previous years. This results in immense amounts of health-related data and information about human behavior. Learn more about this technological trend and how it can bridge the gap between clinical trials and real-world evidence.
Benefit of Digital Health Therapeutics
In 2019, the World Economic Forum reported that 55% of the world’s population is now online. This number is continually increasing as more markets are making the switch to digital offerings and situations such as pandemics require social distancing. This also means that medical and health services would benefit from making the shift.
When therapeutics are provided in a digital format, this offers the opportunity to collect data. This includes collecting patient habits, engagement numbers, and the benefit of different forms of care. This helps fill in the gaps between clinical evidence and real-world observation.
What is Real World Observational Evidence?
Real-world observational evidence is defined, just as it describes – evidence that is generated or that exists in the real world. It can be generated by different study designs such as randomized trials. The Food and Drug Administration (FDA) defines real-world data as data that relates to patient health status or the delivery of health care which is consistently gathered from different sources such as health records, data from home-use, and mobile devices.
Real-world evidence fills the gaps that a clinical trial can’t account for. It can help analyze the effects of treatments over a longer period of time. It helps increase understanding of patient lifestyle, behaviors, and demographics to ultimately improve customization of care while minimizing financial risk to both the patient and health care providers.
Real-World Evidence vs Real World Data – What is the Difference?
Real-world data can provide the information needed for real-world evidence. Real-world data is information that’s collected outside of a clinical trial. This includes medical records and patient statistics and biomarkers. This information gets de-identified in order to protect patient confidentiality and privacy. Analyzing this knowledge provides a bigger view of the population in terms of age, daily habits, environment, co-morbid conditions, and medical adherence.
Why is Real World Evidence Important?
When comparing randomized controlled trials (RCTs) to real-world studies, an RCT is considered to be higher in accordance. This is because it is conducted in a randomized, double-blind, and sometimes controlled setting. The problem is that it isn’t always relatable to real-life situations. In addition, RCT has limitations such as inclusion and exclusion criteria. The criteria ensure that a representative sample is collected. When considering in the context of the “real world”, it’s worth noting that any patient can be excluded.
This data provides the potential to help influence and design clinical trials and adds an element that would otherwise be lacking. For instance, measuring how often, and when, someone uses a digital health app with information linking their behaviors to their medication adherence can help improve clinical trial engagement.
Comparative research from real-world situations is helpful for efficiency studies and pharma related to economic impact studies. They can help doctors identify what clinical and environmental characteristics aid a patient in keeping to a drug regimen and ultimately making sure they are on the right medication and care path.
Real-world evidence helps supplement data from RCTs and can hopefully bridge the gap between a controlled RCT environment and real-world considerations. In real-world clinical practice, it’s about the individual patient. It’s also important to remember that every patient can be unique in the way that they respond to a drug or treatment.
Nori Health: Real-World Evidence
Nori Health has been conducting real-world evidence tests showing promising results*. Our overall aim is to help improve the quality of life and decrease symptoms. Nori continues to collect real-world evidence through anonymized PROMS answers and demographics.
A group of 85 randomized people living with Crohn’s Disease, ulcerative colitis, and IBS was included in a trial. These participants were sourced through hospitals and patient foundations. After completing the Nori Health program, patients showed promising results in the following:
- 35% average increase in score for daily management of the condition, which includes practical improvement in factors such as diet and exercise routines.
Daily management of a health condition such as IBD can empower the patient to identify and change problems that are contributing to the condition.
- 56% of participants that completed the 8-week program indicate that they missed key social activities before the program, but did not anymore in the final 2 weeks of the program.
Social life and quality connections enable humans to thrive, yet suffering from a chronic illness can make it difficult to access social networks. Using the Nori app helped patients improve social isolation.
- 44% of participants that completed the 8-week program believe that they have the right treatment for their condition, while they did not believe this before starting the program.
The main IBD patient struggles when it comes to caring to include a lack of multidisciplinary and psycho-social support and inability to communicate with health care providers. This results in a lack of confidence about their treatment.
- 75% of participants are actively referring friends or family members that live with the same condition to the Nori program, hoping that they will complete it too.
Research shows that the satisfaction perceived by patients with chronic diseases affects clinical outcomes and healthcare costs.
- 22% of participants that completed the 8-week program indicated extreme fatigue before the program, but no more after the program was completed.
Fatigue is reported to impact nearly 50% of patients in clinical remission and over 80% of those with active IBD. The result is a decrease in quality of life and productivity.
* Please note that all results published on this page are not scientific outcomes. We have completed these tests to establish the first results of the program, which will be followed by scientific research.
Nori Health: Utilizing Digital Health for Real-World Evidence
Nori Health offers an extension to treatment for a better quality of life. Our 8-week digital therapeutics program supports your medication and clinical trial adherence to gain better outcomes. With the proven increased daily management of the condition and engagement with social activities, this could promote the belief in current treatment.
This article has been written by Lisa Booth, registered dietitian and nutritionist, and co-founder of Nori Health. Content is based on her professional knowledge and our collection of 100+ scientific research study papers.