Considerations for a digital-first approach to data collection
In recent years, digital health technologies (DHT) have dramatically changed the way we collect data in clinical trials. This is partly due to the overall industry shift towards a patient-centric approach, but in some cases it is also due to the commercial availability of powerful technological solutions that were not previously feasible for use in medical devices. In the past, almost all patient data was traditionally acquired by purpose-built machines made by relatively small-scale manufacturers for use in hospitals. Today, some of the largest consumer electronics producers use sensors that can measure many of these same patient data. Built-in watches, phones, rings, or other convenient options allow patients to go about their daily lives while collecting data that can serve as the basis for understanding the value of treatment. Through the use of connected devices and wearables, study teams can track large amounts of datasets regarding patient behaviors, early detection of adverse events, and more.
This exponential growth of potential data sources in clinical studies requires careful consideration of many factors that impact connected device(s) that may optimize study protocol, improve data quality, and/or speed up data collection and trial times. When determining which devices, if any, to incorporate into trial design and use, sponsors should keep a few key aspects in mind.
Given the nuances of digital data collection as well as the sheer volume of information, many DHTs require multiple medical, regulatory, operational, and technology specialists to ensure trial strategy, design, and execution are optimized and compliant with guidelines. For instance, Those working in drug development rely on therapeutic experts and medical specialists to know precisely what patient safety issues we need to be concerned about and how to effectively monitor them.
These specialists must also intimately understand the desired effects of the treatment from both the perspective of the sponsor and the patient. And, they must understand the most effective ways to demonstrate these desired effects both objectively with device data and subjectively by helping to ensure that the patient’s perception of any changes in their mental or physical state is fully understood.
It is imperative to consult with individuals/organizations who have experience in safety and efficacy in a therapeutic area to guide a data collection strategy. Presumably, these same resources will include the latest regulatory guidelines and strategies/best practices employed to meet these requirements, as well as data privacy, country approval status, and logistical and regional nuances associated with collection and processing. transmission of the desired electronic data from the clinic or in -home.
Additionally, patients often note the need for easy-to-use, intuitive devices to ensure they are used as intended. Technologists are able to help refine devices based on participant/user feedback, allowing for improved usability to improve data quality. Given the scope of data collected and analyzed from the growing integration of connected devices into clinical trials and other forms of data capture, sponsors also need expertise and services to collate data. disparate in meaningful ways in order to gain deeper insights that guide their trials. The use of artificial intelligence/machine learning and advanced, predictive analytics can help predict and even prevent trial risks and provide real-time actionable insights, which also makes these experts essential .
Informed device selection
In combining the scientific, medical, technical and operational objectives of a study, trial sponsors, study teams and their service partners, including clinical research organizations (CROs), should consider whether they have addressed the questions below to fully inform the data collection and analysis strategy. To ensure that they know why they are collecting data and have selected the optimal means to provide regulators with the desired electronic data to support safety and efficacy claims made in approval applications , sponsors may need to ask themselves the following questions:
1. Are there any patient safety issues with the proposed treatment?
2. Is security established with one or more parameters?
3. Is there a single numerical criterion for establishing effectiveness? If not, what combination will?
4. Does the frequency of data collection matter? Continued? Dot in time?
5. Is the sampling rate/resolution of the data important?
6. Does the form factor of the device matter to patient compliance?
7. Will patient/caregiver/clinician impressions be included in the efficacy record?
8. Will real-time clinical decisions/protocol updates be made based on the data collected?
9. Will the data be collected in the clinic, or will it be outpatient/home based?
10. If several parameters are required, which ones take precedence?
11. Do the devices require support for 21 CFR Part 11 regulatory requirements?
12. What is the data transmission strategy (eg, in clinic, mobile phone, etc.)?
13. Will the patient population be able to perform any necessary data entry or transmission activities?
14. What are the data format requirements?
15. Will Electronic Data Capture (EDC) integration be required?
16. Which countries will the devices be shipped to?
17. What are the specific data privacy rules in each region?
18. What regulatory authorizations are required for import?
19. Will centralized electronic analysis and reporting of data be required?
20. What will be included in the final expert report/submission requirements?
These basic questions and details about other study-specific requirements will help sponsors avoid the pitfalls of selecting new and interesting technologies that are not useful and do not produce the data required for approval. regulatory.
The majority of modern devices and technologies used in clinical trials have evolved from stand-alone devices without any electronic connection to external systems to an application programming interface or API-driven devices that can provide two-way communication of test data. registration, visit times and results. As important as the choice of technology is, it is also essential to consider using an eSource platform that manages all required activities around patients and visit schedules. This can mean that the patient, site and sponsor workflow and experience are consistent regardless of the technology chosen.
An added benefit is that the direct integration with eSource technology also manages the workflow associated with remote patient data capture and enables continuous passive collection of subject data directly into the central database without the patient having to need to know anything about how to transmit data to a lab. or caregiver. As data is continuously transmitted from the device to the laboratory, reports are updated so that measurements and compliance values can be assessed during the study and protocol or treatment adjustments can be made.
As connected digital medical devices play a more critical role in sponsors’ goals of bringing new treatments to market faster and with quality, it will be essential to ensure that the optimal device(s) are selected for the needs of the individual test program. By pairing the right device with the right expertise and services, you ensure that sponsors get the information they need to accelerate trial times and efficiency. To make every data connection point count, sponsors must also go beyond device selection to ensure the data collection strategy is effective. In some cases, this may mean relying on a trusted partner with deep expertise in the scientific, medical, technical, and logistical aspects of data collection and analysis to ensure study success.
About Mark Mentzer
In his current role at IQVIA, Mark is responsible for data-driven strategy development and operational implementation of IQVIA Connected Devices strategy and solutions. Mark draws on his 20 years of experience in the clinical research industry, specializing in innovation technologies and data collection in the areas of data science, connected devices, patient engagement patients and the operational integration of IQVIA strategies, products and services into global multidisciplinary teams. , sites and with customers who take advantage of IQVIA solutions.