More evidence of the growing acceptance of medication adherence solutions as FDA issues grant to advance sensor-based digital health technologies
AARDEX Group
AI-powered SaaS Platform Revolutionizing Clinical Trials Through Better Drug Exposure
For too long clinical trials have been failed by suboptimal methods of measuring patient adherence, leading to unreliable data and incorrect conclusions regarding efficacy and safety. And for far too long, digital medication adherence solutions have been largely ignored partly because of the lack of regulatory imperative and clarity in ROI for such options.
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However, this indifference is now being challenged at the very highest level. A paper recently issued by the World Health Organisation has provided the clearest direction yet that medication adherence solutions should be implemented to ensure optimised clinical trial outcomes, stipulating that ‘Automated and digital processes should be encouraged and supported globally to increase clinical trial speed, efficiency and transparency.’[1]
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And just last month the Digital Health Measurement Collaborative Community (DATAcc) announced it had been awarded a grant from the U.S. Food and Drug Administration (FDA) to develop a comprehensive ‘How-To Guide’ for those seeking to advance the broad use of sensor-based digital health technologies (sDHTs) to develop digitally-derived endpoints in clinical trials.
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This initiative was in part, sparked by the publication of a white paper entitled ‘ASSESSING THE NET FINANCIAL BENEFITS OF EMPLOYING DIGITAL ENDPOINTS IN CLINICAL TRIALS’[2].
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In this collaborative study, the research team developed an expected net present value (eNPV) model of the cash flows for new drug development and commercialisation to assess financial value. They also built a return on investment (ROI) ratio of the estimated increment in eNPV versus the digital endpoint implementation cost.? The conclusion was stark: the use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs.
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Indeed, for phase 2 trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% to 48% per indication.? For phase 3 trials, the returns were even more substantial with the increase in eNPV varying from $27 million to $48 million, with and ROI ration of four to seven times the investment.
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The ambition for the guide is to integrate all the existing regulatory guidelines, scientific resources industry case studies into an interactive platform that provides a one-stop resource for developers and clinical trial teams. It aims to address the key challenges such as the consolidation of references, provide clear instruction on how to select, build and validate digital endpoints and provide a platform that supports faster, more inclusive trials.
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The Digital Health Measurement Collaborative Community (DATAcc) is part of the wider The Digital Medicine Society (DiMe) co-operative, a global non-profit organisation driven by the objective to ensure the broad adoption of digital approaches to advance the practice of medicine to enhance public health.
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CEO & Scientific lead at AARDEX, Bernard Vrijens, PhD has been part of the team that developed the DIME V3+ framework development, an extension to the V3 framework to ensure user-centricity and scalability of sensor-based digital health technologies. It is therefore with great excitement and anticipation that the FDA has officially acknowledged, and is now supporting the importance of digital medication adherence solutions.
Establishing hard evidence for your trial…?
AARDEX has a best practice methodology, independent of any device package or software platform. Utilising our expertise and experience in medication adherence and patient compliance we acquire, monitor, analyse, guide and interpret data to deliver absolute clarity and bring confidence to sponsors, trialists, and ultimately, patients.??
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AARDEX is the only mature, robust and proven adherence solution on the market today, one that maximises the reward, mitigates the risk and delivers resolution for your clinical trial. All delivered with the clarity, integrity and certainty you need to proceed with complete confidence in the exposure-response.??