Clinical Research Task

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A Clinical Research Task is a research task that determines the safety and efficacy of clinical therapies intended to treat disease or health condition in humans.



  • (Subbiah, 2023) ⇒ Vivek Subbiah. (2023). “The Next Generation of Evidence-based Medicine.” In: Nature Medicine.
    • QUOTE: ... The success of future clinical trials requires a fundamental transformation in how trials are designed, conducted, monitored, adapted, reported and regulated to generate the best evidence. The status quo model is unsustainable. Instead, preventive, personalized, pragmatic and patient-participatory medicine is needed, and paradigm shifts are required to get there via sustainable growth. Silos need to be broken. Standards of care and clinical trials are currently viewed in different realms; however, the overarching goal of both is to improve health outcomes. The COVID-19 pandemic created an opportunity to observe how routine clinical care and clinical trials can work synergistically to generate evidence86. Pragmatic platform trials such as the RECOVERY trial should be a model and guide for trial efficiency and real-time impact.

      Current paradigms must be continuously challenged by emerging technology and by all stakeholders (the new generations of scientists, physicians, the pharma industry, regulatory authorities and, most importantly, patients). Disruptive innovation should lead to every clinical site being a research site, with all necessary quality checks and research as part of the standard of care. The healthcare system should be integrated into an intuitive RWE-generation system, with clinical research and clinical care going hand in hand. ...



  • (Friesen et al., 2017) ⇒ Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan. (2017). “Rethinking the Belmont Report?. ” The American Journal of Bioethics, 17(7).
    • QUOTE: ... Defining research and practice as interventions aimed at knowledge and interventions aimed at well-being is incompatible with Belmont’s own principles of respecting persons, maximizing beneficence, and ensuring justice. The boundaries around what requires oversight should be defined pragmatically, so that knowledge production and benefits to all communities are maximized and harms to participants are minimized. Oversight should be required for any research or intervention involving novel, significant risks that are not part of the standard of care. This would encourage low-risk data collection during routine practice and ensure that innovative therapies are regulated and their findings disseminated. Investigators ought to be permitted to engage in low-risk or minimally risky research with minimal oversight, while regulatory mechanisms for experiments with significant risks should be kept in place. Regulation ought to be proportionate to novelty and level of risk, rather than derived from intent. ...


  • (Krleža-Jerić et al, 2016) => Karmela Krleža-Jerić, Mirko Gabelica, Rita Banzi, Marina Krnić-Martinić, Bibiana Pulido, Mersiha Mahmić-Kaknjo, Ludovic Reveiz, Josip Šimić, Ana Utrobičić, and Irena Hrgović. "IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity." In: Biochemia Medica, 26(3).
    • ABSTRACT: ... The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. ...
    • QUOTE:

      Figure 1 Evidence pyramid.
 The hierarchy of evidence and the role of the individual participant data (IPD) meta-analysis in knowledge creation is presented. The reliability of evidence needed for evidence-informed decision-making in health increases as we move up the pyramid. It is expected that IPD meta-analysis would speed the knowledge creation.