Medical devices, often referred to as med devices in day-to-day vernacular, are applicable across a variety of different therapeutic areas (TAs) and functionalities including diagnostics, biometric monitoring, treatment, and more. This wide range of use cases requires every medical device trial to be intentionally designed so that patient burden for data collection is reduced, resulting in cleaner data and reporting at every stage of the trial.
To understand the impact DCT elements have on data collection within medical device studies, we must first align on what determines a medical device classification, when clinical trials are required for med devices, and finally, for those devices that must go through trial testing, how decentralized elements can aid in data capture and reporting cleanliness.
According to the FDA, medical devices are defined as, “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions.”
Most medical devices will need to be properly researched in clinical trials before they are adopted into patient care. The FDA’s frequently asked questions about medical devices covers many of the requirements, regulations, and exemptions for med device clinical trials. Medical devices are also further regulated by the FDA's Center for Devices and Radiological Health (CDRH) which classifies regulatory control and requirements for firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. Due to the strict regulation of the industry, the demonstrated need for data that can accurately represent the effectiveness of each device is clear.
When it comes to collecting quality data for medical devices, there are several types of data needed. Not only do devices need to be tested for safety, effectiveness, accuracy, etc., but many also need research on patient usage and understanding. Yet historically, it can be difficult to collect quality patient experience data in a traditional clinical trial setting.
In traditional trial settings, it often becomes the responsibility of site staff, physicians, and principal investigators (PIs) to collect patient experience data. This typically means asking them to fill out a survey or two and then having to return these completed surveys to the sponsor somehow. In this process there is a large potential for data loss and the process can be burdensome for those having to administer the reports.
Site staff, physicians, and PIs are typically focused on much more pressing patient matters and are burdened with extra workloads like trying to collect patient experience reports. Thus, it is crucial medical device clinical trials have a means of collecting high-quality data that doesn’t rely on putting extra workloads on site staff and others who should be focused on patient care.
According to the World Health Organization (WHO), “Medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians and dentists and by health-care professionals in advanced medical facilities, for prevention and screening and in palliative care.”
Because of the wide range in use and intended setting, not all med devices are best suited for incorporating decentralized clinical trial elements. In order for DCTs to be a fit for a med device study, the device will likely need to be used in a physician’s office, local health clinic, or patient's home with little to no significant patient risk. Examples of this type of med device can include a pregnancy test kit, an STI at-home kit, a blood glucose monitor, etc.
One of the most beneficial aspects of using a DCT model for a medical device clinical trial is that sponsors are able to control and monitor the setting in which patients interact with the med device and can therefore have the trial setting mimic the real-world use setting. This benefit can offer much more accurate data on how patients use and interact with these med devices.
For example, a medical device for testing an at-home pregnancy test may traditionally be administered by a patient with the guidance and assistance of an on-site staff or clinician staff. However, results on how comfortable patients feel administering their test and how well they understand the instructions may be skewed by the presence and assistance of site staff and physicians. By using a full-service DCT vendor, the at-home pregnancy tests can be sent directly to the patient’s homes along with the intended directions. The sample can be collected and tested against an on-site pregnancy test for effectiveness while also being able to collect accurate ePROs on how patients felt taking the test.
This type of decentralized model for medical devices allows sponsors to collect the type of ePROs and eCOAs they need through a comprehensive, patient-friendly, DCT platform without burdening site staff, PIs, or clinicians. Furthermore, sponsors are able to see patient feedback in real-time and compare intended use and device feasibility with real-world data in a desired setting.
Quality data capture and reporting is imperative for any clinical study, however, medical device trials present a unique set of challenges that have specific data needs that can be properly addressed through a decentralized trial model. DCTs can bring high-performing data capture capabilities without relying on site staff or PIs or adding to their workload. Furthermore, DCTs give sponsors the crucial ability to collect data from settings that mimic real-world usage to deliver accurate and comprehensive data.
Learn more about the software used for electronic data capture in DCTs in this blog: The “E’s” of eClinical Software: Understanding and defining technology elements of decentralized trials
Aug 25, 2022
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