Clinical Trial Adherence Intelligence
HITLAB Team • October 13, 2023
With 90% of clinical trials failing to meet FDA approval, researchers, regulators, sponsors and other stakeholders have worked tirelessly to identify causes of such high failure rates; many reasons are cited, including failure to meet statistical endpoints, insufficient patient enrollment, safety issues and failure to meet FDA protocols. Yet four contributing factors associated with existing trial design have material impacts as well: heterogeneity of trial populations, low patient compliance (50%) with protocols, analog monitoring tools (75% of trials use diaries) and cumbersome data management practices that make informed recommendations more difficult.
Serious examination of trial design throws a spotlight on a mission critical flaw that greatly undermines the efficacy of a clinical trial: research managers do not have real-time, objective knowledge of patient behavior. Latency of data access results in increased costs throughout all trial phases and compromises patient safety as well as data management that often produces false conclusions about the efficacy of a new drug.
Information Mediary Corporation has been a global leader in support of clinical trials for more than 20 years with its Smart Packaging technology that tracks real-time patient adherence. The devices are scalable and interoperable with other platforms; the tools have also supported many global trials. Its data capture system replaces subjective patient-reported outcomes with 100% objective data that can be used in many ways to improve the efficiency and efficacy of a trial, help trial managers engage patients with interventions that support adherence and trace each dose throughout the chain of custody, lowering patient recruitment costs, streamlining waste and
IMC’s CertiScan platform supports trial sites with real-time dashboards that follow every patient’s behavior throughout the trial and collaborates with other platforms to support data feeds when required. IMC transforms the management of a clinical trial by addressing the latency of a research team’s knowledge to mitigate cost and efficacy issues with current methods.
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