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By Vinita Kailasanath and Sora Park
The term “digital endpoints” is often used to describe clinical trial endpoints that use sensors like smartphone microphones, wearables, and digital pills to allow more frequent, objective remote monitoring of patients during clinical trials. In light of the recent increased interest in these novel endpoints, regulators, innovators, and investors should be aware of the key global trends with respect to the development and use of such endpoints, as well as the associated clinical, privacy, cybersecurity and other legal risks.
For a new drug to be approved in the U.S., the manufacturer must provide the Food and Drug Administration (FDA) with substantial evidence that the drug has a clinically meaningful effect. The National Medical Products Administration (NMPA) in China, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, and the European Medicines Agency (EMA) in the EU similarly evaluate the efficacy of a drug for its approval. In order to present evidence of a drug’s efficacy, the manufacturer provides data on endpoints, which are measurable outcomes used to address the objectives of a clinical trial.
Digital endpoints are a novel type of endpoint. Such endpoints are assessed using sensor-generated data that is often collected outside of a clinical setting, such as in a patient’s daily activities. Digital endpoints can capture pool of participants and real-world experiences. As noted in a recent FDA guidance, despite being disproportionately affected by certain diseases, racial and ethnic minority groups are frequently existing measurements in new ways, while also enabling the recording of new measurements that were not previously possible to access. Rather than relying on subjective assessments of the participant’s progress at intermittent appointments, researchers can record objective data throughout a participant’s daily life. In addition to providing more precise and accurate assessments, digital endpoints significantly reduce the time and costs associated with trial participation, particularly for those with physical or cognitive limitations or time constraints. This, in turn, allows manufacturers to open clinical trials to a more diverse and representative population hitherto underrepresented in clinical research. This has been true in part to the frequency of required study visits and other resource constraints. Using digital endpoints in clinical trials can relieve some of these burdens.
Current regulatory landscape affecting digital endpoints
Digital endpoints have not yet been accepted in support of new drug approvals in the U.S. However, in December 2021, the FDA published a draft guidance providing its recommendations on the use of digital health data acquisition in clinical investigations, signaling that regulatory acceptance of digital endpoints in support of drug approval may occur in the short-term.
Outside of the U.S., there appears to be a global regulatory consensus on the use of digital endpoints or—at least, digital tools—in clinical trials:
Regulators have also been collaborating with industry to help advance the acceptance of digital endpoints. The Digital Medicine Society and its partners from Anthem, Biogen, Eli Lilly, Evidation, Janssen, Merck, Pfizer, and Savvy Co-op recently launched a toolkit to facilitate the inclusion of digital endpoints as evidence for payers in reimbursement decisions for new drugs. The 3Ps of Digital Endpoint Value toolkit was developed following a series of workshops bringing together regulators, health technology assessment bodies, public and private payers, industry sponsors, health economists, and clinical and patient experts.
Legal challenges in the development and use of digital endpoints
As they develop digital endpoints, innovators are considering the associated risks to trial participants, including clinical, privacy, and safety risks:
Innovators, whether those creating or investing in DHTs or considering deploying DHTs in their clinical trials, should continue to evaluate and optimize their use of digital endpoints to minimize these risks, including by conducting safety testing of the DHT and implementing safeguards designed to secure the data collected and transmitted by the DHT.
As digital endpoints continue to undergo evaluation, innovators are working towards a future in which these outcomes can replace traditional in-clinic endpoints in regulatory approval and clearance submission and regulation.
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Vinita Kailasanath, a partner in the Silicon Valley office of Freshfields, has extensive experience in strategic intellectual property and data-driven transactions in life sciences and technology, and particularly at their intersection. She represents life sciences companies, technology companies, healthcare companies and providers, private equity firms and other investors in connection with the execution of their cutting-edge MedTech and digital health strategies in addition to their other complex licenses and collaborations, strategic investments, and R&D and supply agreements. Ms. Kailasanath has advised clients on transactions involving medical devices (including SaMD), wearables, mobile apps, telemedicine, artificial intelligence/machine learning, software, hardware, pharmaceutical products and biologics. Vinita also routinely advises on the intellectual property aspects of mergers, acquisitions and joint ventures. Vinita avidly tracks trends in MedTech and the associated legal considerations and publishes a quarterly MedTech Update.
Sora is an Associate at Freshfieldsand focuses her practice on a variety of life sciences and technology transactions. Her experience includes assisting clients in drafting and negotiating agreements involving the research, development and commercialization of new technologies and products, software licensing, and manufacturing and supply relationships. Sora also provides support on the intellectual property aspects of mergers and acquisitions.
This article is featured in the Healthcare Docket newsletter, a partnership between Breaking Media publications MedCity News and Above the Law.
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