By Tom Rhoads, Founder & CEO, Spencer Health Solutions
It wasn’t a mystery that clinical trial sponsors were in the process of transforming their protocol design for the past five to ten years. And I think it’s fair to say that the COVID-19 pandemic put that transformation into overdrive.
Little did we know back in February 2020 that pharmaceutical manufacturers — who had already been looking at decentralizing the clinical trial process — would need to radically rethink how they engaged and interacted with patients…fast.
While this seismic shift has surely presented many challenges, it has also brought tremendous opportunities to improve the speed and efficiency by which therapies are approved and brought to market. Clinical trial sponsors can achieve this by taking advantage of technology to capture real-world data, in near real-time, from patients participating in their programs.
Real-world data are just that…routinely collected patient-level information relating to a patient’s health status.
Real-world evidence has been defined by the EMA as the information derived from analysis of routinely collected real-world data relating to a patient’s health status or the delivery of health care from a variety of sources.
Practitioners involved in clinical trials have already found real-world data as an increasingly important method of supporting the evidence gathered in traditional, randomized controlled trials. This is especially true now that decentralized clinical trials are becoming more common and greater emphasis is placed on making trial participation more inclusive and representative of the total population.
Real-world data (RWD) and real-world evidence (RWE) have already been widely used in the regulation of the development, authorization, and supervision of medicines in the European Union. One clear example of this can be found by examining new marketing authorization applications (MAAs) and extensions of indication (EOIs) for already authorized products submitted to the EMA in 2018 and 2019. RWE was included to support safety in 82% of the submitted applications, and nearly half of all the applications included RWE in support of efficacy.
In addition, the regulatory strategy set forth by the European Medicines Regulatory Network is that by 2025, “the use of RWE will have been enabled and the value will have been established across the spectrum of regulatory use cases.”
The bottom line? Collecting real-world data and real-world evidence will be necessary components of successful clinical trial programs.
In most cases, researchers, trial sponsors, and clinical teams have many options to gather RWD, including data collection from wearables (e.g., Apple watch), in-home diagnostic devices (e.g., blood pressure devices, pulse oximeters), smartphone apps, and electronic surveys. Unfortunately, each of these technologies brings its own set of challenges and considerations, including:
- Data quality – How valid is the data being collected? What measures are being used to ensure the timeliness and validity of the information?
- Data monitoring – Are clinical teams sufficiently staffed and trained to collect, analyze, and use the data to better manage patient care?
- Privacy – How secure is the data being collected? What safeguards are in place to ensure that protected health information is secure?
- Patient hesitancy – How comfortable are patients with being monitored outside the confines of a formal clinical trial site or clinic? How comfortable or tech-savvy are they using in-home devices, wearables, and apps?
Before clinical teams select a technology — and design their protocols around it — they need to be certain that these concerns are addressed.
The team at Spencer Health Solutions has developed a platform that addresses all the natural concerns surrounding data collection, while also delivering near real-time data that can be used to take actionable measures that benefit clinical trial participants.
Measuring Quality of Life – A Case Study
Spencer Health Solutions was founded on the notion that there had to be a better way to engage patients, alleviate the burden on caregivers, and effortlessly collect important health information that would move the needle on patient health. Fortunately, we were able to work with some of the most knowledgeable and experienced health data analysts in the industry to develop robust data modeling technology to support our solution and make a meaningful difference in patients’ lives…right in their own homes.
With a wealth of industry experience between them, Spencer’s data team concluded that one of the most critical things to know about a patient is their quality of life, with the challenge being how to design and capture meaningful quality of life measures. Utilising our existing patient population, the Spencer team was able to draw some striking conclusions about QoL data points using the spencer® smart hub device.
The spencer device was already in the homes of a large cohort of patients, and was being used to dispense medication pouches, monitor patient adherence, support via telehealth, and collect responses to quality-of-life questions. During the early days of the pandemic, the Spencer team added questions related to COVID-19 symptoms and how patients were feeling.
The surprising result was that, while no COVID cases were identified, the resulting data revealed a more complete picture of the patient’s health and ultimately identified patients with other lung and heart conditions. These patients were then able to benefit from timely outreach and additional support.
It was clear that the spencer smart hub was not only an acceptable tool for improving medication management and adherence, but it could also lead to significant patient and system-level benefits.
Click here to read the white paper about this study.
Data – Putting It All Together
As was shown in the aforementioned program, using real-world data provides a more complete picture of the patient’s condition and their quality of life. Seeing what a powerful tool this collection mechanism can be, it’s imperative that researchers and trial sponsors use what the data show – the real-world evidence – in clinical decision-making so that patients remain on their medication protocol and successfully complete trial programs.
And as we make more progress using real-world data, we’re going to adopt better, more efficient ways to capture it and determine what’s meaningful.
It’s safe to say that we’re headed toward a day when real-world data is more than just a snapshot of how the patient is doing at a moment in time. The exciting part is that we can now chart the data over a longer period of time, giving caregivers and researchers the ability to see changes in the patient’s condition longitudinally and design interventions for each patient, as needed.
It’s an exciting time for companies that wish to provide next-level care to support a patient’s health journey. Let’s make the most of this opportunity to increase the success of our investment in clinical trials by using technology and the real-world evidence it provides.
If you’d like to know more about collecting real-world data with spencer, feel free to reach out to us directly, and let’s have a conversation.