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Tackling Challenging Data Integrity Topics in 2020: Update on Good Clinical Practice Perspectives from the US FDA and MHRA UK.
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; Vinter, Stephen; Wakelin-Smith, Jason; Walker, Paula; Francis, Gail.
  • Khin NA; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Grandinetti C; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Dixey H; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Yu B; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Skeete R; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Ayalew K; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Budwal-Jagait M; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Cho SJ; Division of Generic Drug Bioequivalence Evaluation, Office of Study Integrity and Surveillance (OSIS), Office of Translational Sciences (OTS), CDER, US FDA, Silver Spring, Maryland, USA.
  • Dasgupta A; Division of New Drug Bioequivalence Evaluation, OSIS, OTS, CDER, US FDA, Silver Spring, Maryland, USA.
  • Fisher A; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Kleppinger C; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Kronstein PD; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Martin J; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • McGuinness M; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Mulinde J; Division of Clinical Compliance Evaluation, Office of Scientific Investigations (OSI), Office of Compliance, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
  • Vinter S; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Wakelin-Smith J; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Walker P; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
  • Francis G; Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
Clin Pharmacol Ther ; 112(1): 31-43, 2022 07.
Article in English | MEDLINE | ID: covidwho-1344984
ABSTRACT
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: North America / Europa Language: English Journal: Clin Pharmacol Ther Year: 2022 Document Type: Article Affiliation country: Cpt.2386

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Country/Region as subject: North America / Europa Language: English Journal: Clin Pharmacol Ther Year: 2022 Document Type: Article Affiliation country: Cpt.2386