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Khin, Ni A.; Grandinetti, Cheryl; Dixey, Hayley; Yu, Bei; Skeete, Rachel; Ayalew, Kassa; Budwal‐Jagait, Mandy; Cho, Seongeun‐Julia; Dasgupta, Arindam; Fisher, Andrew; Kleppinger, Cynthia; Kronstein, Phillip D.; Martin, Jennifer; McGuinness, Michael; Mulinde, Jean;
Wake, Dyson T.; Smith, D. Max; Kazi, Sadaf; Dunnenberger, Henry M.
doi: 10.1002/cpt.2387pmid: 34365648
Clinical decision support (CDS) is an essential part of any pharmacogenomics (PGx) implementation. Increasingly, institutions have implemented CDS tools in the clinical setting to bring PGx data into patient care, and several have published their experiences with these implementations. However, barriers remain that limit the ability of some programs to create CDS tools to fit their PGx needs. Therefore, the purpose of this review is to summarize the types, functions, and limitations of PGx CDS currently in practice. Then, we provide an approachable step‐by‐step how‐to guide with a case example to help implementers bring PGx to the front lines of care regardless of their setting. Particular focus is paid to the five “rights” of CDS as a core around designing PGx CDS tools. Finally, we conclude with a discussion of opportunities and areas of growth for PGx CDS.
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doi: 10.1002/cpt.2386pmid: 34358334
With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency provided the agencies’ perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records. This paper summarizes considerations of both agencies on these topics, along with case examples. This paper touches upon considerations when using real‐world data to support regulatory decisions. It also discusses the impact of the coronavirus disease 2019 (COVID‐19) pandemic on clinical trial conduct and underscores the importance of well‐designed, resilient, and adaptable systems for GCP compliance and data integrity.