Can we say something more around why we are focusing on collecting raw data from Wearables?
Wearables are being implemented in more and more clinical trials, and gaining steam in the healthcare world at-large. Deloitte predicts that 320 million consumer health and wellness wearable devices will ship worldwide in 2022.
These devices enable a clinical study team to monitor their patients’ various health metrics, like daily steps, sleep quality, and heart rate, increasing patient compliance and retention.
Delve Health offers a customizable technology solution to researchers and providers, opening up a whole new world of possibilities for data captured by wearable devices, that can be used to enhance patient outcomes and care delivery.
Over the next 25 years, wearables are expected to reduce healthcare costs by over 20 billion dollars, providing more accurate insights into patient activity. The quality data collected and analyzed by Clinical StudyPal can help researchers and providers gain a better perspective on why a certain implanted device might be acting a certain way, or whether a treatment has changed a patient’s daily activities.
While there are a lot of pros to using wearables, biosensors, and other devices in your upcoming clinical trial, we understand there some challenges that come with implementing new technologies. Collecting, standardizing, and validating the data, which are necessary precursors to data analytics, can be a challenge for many health systems. Delve Health can help!
Wearables in Clinical Research Today
In today’s complex and competitive marketplace, we at Delve Health remains focused on why we got into the clinical research enterprise in the first place—our patients.
We have the infrastructure in place to ship and deliver wearables (and more) for use in clinical trials around the globe. Our Clinical StudyPal app not only integrates with virtually any wearable, but we also:
- Procure devices;
- Collect the patient data;
- Reconcile and analyze the data, and;
- Report the analytics—in near real-time.
Our Clinical StudyPal app is tailored to streamline patients’ data collection in order to not only increase the amount of data received, but also increase the quality of data collected.
Using wearables to monitor a study’s patients in their homes allows clinical researchers a window into their day-to-day lives. It provides study teams a more complete, and therefore more accurate picture—gaining a more informed perspective which benefits the study’s results overall.
Imagine how clear the picture of a patient’s health would be without the guess work? Clinical researchers no longer have to estimate how many hours of quality sleep a patient got or how many times they dreamt that night. They no longer have to estimate how long a patient’s heart rate was elevated by exercise or for how long. They will know how many minutes a patient was active and even how wide their gait was while walking! This is not only fascinating—but it also provides clinical researchers with real-world data and evidence—that they can act on.
The Future of Clinical Research?
The use of home computers, mobile devices (e.g., smartphones and tablets), wearables, and biosensors to gather and store large amounts of health-related data has been prominent for years. However, the COVID-19 pandemic and the challenges it exposed regarding the lack of access to proper healthcare put the adoption and implementation of wearables on the fast-track within the field.
The passive, secure collection of patient data holds the key to leveraging previously untapped potential, allowing clinical study teams to better design and conduct clinical trials and to answer questions previously thought impossible! In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze patient participant data points and apply the results of our analyses to meet the needs of each unique clinical study (e.g., medical product development and approval, etc.).
What is Real-World Data (RWD)?
Real-world data is the data relating to a patients’ health status and/or the delivery of health care routinely collected from a variety of sources. RWD can also be collected from multiple devices for example:
- Electronic health records (EHRs)/Electronic Medical Records (EMRs)
- Product and disease registries
- Patient-generated data (e.g., from wearables, mobile devices, biosensors; including passive, in-home-use and active, like eDiary entries)
What is Real-World Evidence (RWE)?
The FDA defines real-world evidence as the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to: randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).
Delve Health Handles the Logistics, So You Can Focus on Patients
Are you getting the patient data you need when you need it? Are you keeping your studies on their timelines with no missed appointments?
We know your clinical study team’s daily task lists are detailed and therefore time-consuming. Delve Health’s Clinical StudyPal app can help! Leverage our in-depth, global reaching network to ship and deliver wearables (and other devices) directly to your study’s patients.
Once they receive the device, Clinical StudyPal will already be integrated and ready to assist everyone involved. Its reminders will help automate many daily tasks, alleviating your study team’s workload, but also increasing patient monitoring, compliance, and retention.
Delve Health’s app also has the capability to gather clean data sets from patients, whether they are wearing one device or multiple wearables in a single trial. The more quality data we can safely and securely collect, the higher the chance of the study’s overall success.
- Guidance: Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
- Guidance: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
- Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
- Guidance: Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
- Guidance: Use of Electronic Health Records in Clinical Investigations
- Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices