Dataset Information

Steering the Clinical Translation of Delivery Systems for Drugs and Health Products.

ABSTRACT: Besides the feasibility for industrial scale-up, accelerating the translation from bench to bedside of new technological strategies for controlled delivery and targeting of drugs and other actives relevant for health management, such as medical devices and nutraceuticals, would benefit from an even earlier evaluation in pre-clinical models and clinical settings. At the same time, translational medicine also performs in the opposite direction, incorporating clinical needs and observations into scientific hypotheses and innovative technological proposals. With these aims, the sessions proposed for the 2019 CRS Italy Chapter Workshop will introduce the experience of Italian and worldwide researchers on how to foster the actual work in controlled release and drug delivery towards a reliable pre-clinical and clinical assessment.

SUBMITTER: Pignatello R

PROVIDER: S-EPMC7238002 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Steering the Clinical Translation of Delivery Systems for Drugs and Health Products.

Pignatello Rosario R Matricardi Pietro P

Pharmaceutics 20200413 4

Besides the feasibility for industrial scale-up, accelerating the translation from bench to bedside of new technological strategies for controlled delivery and targeting of drugs and other actives relevant for health management, such as medical devices and nutraceuticals, would benefit from an even earlier evaluation in pre-clinical models and clinical settings. At the same time, translational medicine also performs in the opposite direction, incorporating clinical needs and observations into sc ...[more]

PMID: 32294939

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Project description:ObjectiveTo identify recurrent themes, insights, and process recommendations from stakeholders in US organizations during the health information technology (HIT) modernization of an existing electronic health record (EHR) to a commercial-off-the-shelf product in both resource-plentiful settings and in a resource-constrained environment, the US Indian Health Service.Materials and methodsThirteen qualitative interviews with stakeholders in various organizations were conducted about HIT modernization efforts. Using a Theory of Change framework, recurring themes were identified and analyzed.ResultsThe interviewees emphasized the importance of organizational and process revision during modernization, converting historical data, and clinical and leadership involvement. HIT implementation required technological and infrastructure redesign, additional training, and workflow reconfiguration. Motivations for modernization included EHR usability dissatisfaction, revenue enhancements, and improved clinical operations. Decision-making strategies, primarily during HIT selection, included meetings with stakeholders. Successful modernization resulted in improvements in clinical operations, patient experience, and financial outlay.DiscussionExisting implementation frameworks fail to provide experiential feedback, such as implementation challenges, like data conversion, regulatory, functionality, and interoperability requirements. Regardless of the healthcare environment, HIT modernization requires the engagement of leadership and end-users during HIT selection and through all stages of the implementation to prepare people, processes, and technology. Organizations must iteratively define the technological, infrastructure, organizational, and workflow changes required for a successful HIT modernization effort.ConclusionsHIT modernization is an opportunity for organizational and technological change. Successful modernization requires a comprehensive, intentional, well-communicated, and multidisciplinary approach. Resource-constrained environments have the additional challenges of financial burdens, limited staffing, and unstable infrastructure.

Dataset Information

Steering the Clinical Translation of Delivery Systems for Drugs and Health Products.

Publications

Steering the Clinical Translation of Delivery Systems for Drugs and Health Products.

Similar Datasets

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