{"id":30082,"date":"2024-09-27T19:11:48","date_gmt":"2024-09-27T13:41:48","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=30082"},"modified":"2024-09-27T19:11:49","modified_gmt":"2024-09-27T13:41:49","slug":"global-guidance-for-more-effective-and-equitable-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/27-09-2024\/global-guidance-for-more-effective-and-equitable-clinical-trials","title":{"rendered":"Global Guidance for More Effective and Equitable Clinical Trials"},"content":{"rendered":"\n

Syllabus :GS2\/Health<\/strong> <\/p>\n\n\n\n

In News\u00a0<\/strong><\/h2>\n\n\n\n
    \n
  • WHO released new guidance to improve clinical trial design, conduct, and oversight globally, targeting all income levels.<\/li>\n<\/ul>\n\n\n\n

    About<\/strong>\u00a0<\/h2>\n\n\n\n
      \n
    • The guidance was developed based on World Health Assembly resolution WHA 75.8, with input from nearly 3,000 stakeholders across 48 countries.<\/li>\n\n\n\n
    • Scope<\/strong> :The guidance covers trials for a wide range of health interventions, including medicines, vaccines, diagnostics, preventive care, digital health, and traditional or herbal measures.\u00a0<\/li>\n\n\n\n
    • It aims to strengthen country-led research and development (R&D) to accelerate access to safe and effective health interventions worldwide.<\/li>\n<\/ul>\n\n\n\n

      Key Findings\u00a0<\/strong><\/h2>\n\n\n\n
        \n
      • Global Inequities in Clinical <\/strong>Trials:There is a divide between high-income countries (HICs) and low- and middle-income countries (LMICs) in trial numbers (27,133 in HICs vs. 24,791 in LMICs in 2022).\n
          \n
        • LMICs are often included in trials due to disease burden, but results are mainly used for approvals in HICs, leaving LMICs behind.<\/strong><\/li>\n<\/ul>\n<\/li>\n\n\n\n
        • Limited Representation of Vulnerable Groups:<\/strong>Pregnant women participated in less than 5% of trials, and only 13% of trials included children in 2022, lowering the quality of evidence and reducing access to interventions for these groups.\n
            \n
          • The lack of inclusion of vulnerable populations limits treatment options for them and erodes their trust in health recommendations.<\/strong><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n

            Recommendations<\/strong><\/h2>\n\n\n\n
              \n
            • National Authorities: <\/strong>For the first time, WHO offers recommendations for health authorities, regulators, and funders to facilitate better clinical trials.\n
                \n
              • It addresses challenges like poor trial design, limited participant diversity, infrastructure gaps, and bureaucratic inefficiencies.<\/li>\n<\/ul>\n<\/li>\n\n\n\n
              • Need for Participant Diversity:<\/strong>WHO emphasizes including diverse participants, particularly underrepresented groups such as pregnant women (less than 5% in trials) and children (13% in trials), to improve the quality and applicability of evidence.<\/li>\n\n\n\n
              • Focus on Vulnerable Groups:<\/strong>Special guidance for including pregnant, lactating women, and at-risk populations in trials, with safety prioritized early in the process.\n
                  \n
                • Appropriate procedures for consent and assent, especially for children, are stressed.<\/li>\n<\/ul>\n<\/li>\n\n\n\n
                • Community Engagement:<\/strong>WHO recommends centering patient and community engagement in trials to ensure research aligns with public needs and maintains trust.<\/li>\n\n\n\n
                • Strengthening National R&D Ecosystems<\/strong>:The guidance calls for sustainable financing to strengthen national R&D ecosystems, improve decision-making, and accelerate access to health innovations.<\/li>\n<\/ul>\n\n\n\n

                  Source : DTE<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"

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