Clinical Research Task

A Clinical Research Task is a domain-specific research task that determines the safety and efficacy of clinical therapies while investigating medical questions and health-related issues through structured scientific methods to improve patient care, develop new treatment options, and enhance healthcare outcomes.

• Context:
  • input: Clinical Questions, Research Hypothesis, Patient Data, Medical Records, Biological Samples.
  • output: Clinical Findings, Research Reports, Clinical Trial Results, Medical Publications.
  • It can (typically) evaluate the Clinical Safety and Clinical Efficacy of new clinical therapies in humans.
  • It can (typically) be performed by Clinical Researchers.
  • It can (typically) involve Clinical Research Concepts, instantiated in clinical research terms.
  • It can (typically) be associated with Clinical Research Data.
  • It can (often) involve a Clinical Research Study, such as a clinical intervention trial.
  • It can (often) include Clinical Study Design, such as: clinical trial design.
  • It can (often) involve Clinical Study Analysis.
  • It can (often) involve Clinical Study Reporting.
  • It can be supported by a Clinical Research Supporting Organization.
  • It can be the study area of a Clinical Research Discipline.
  • It can involve the use of specialized Medical Databases, Clinical Trial Registrys, Biostatistics Tools, and Laboratory Equipment.
  • It can precede Clinical Decision-Making and the development of Medical Guidelines.
  • It can be carried out by Clinical Researchers, Medical Professionals, and Healthcare Scientists.
  • It can support Clinical Practice, Drug Development, Public Health Policy, and Medical Education.
  • It can be supported by Clinical Research Software, Data Analysis Tools, and Laboratory Information Management Systems (LIMS).
  • It can range from being Observational Studies to Experimental Studies, including Randomized Controlled Trials (RCTs) and Cohort Studies.
  • It can involve Ethical Considerations, Regulatory Compliance, and Informed Consent processes specific to clinical research.
  • It can involve Critical Thinking, Analytical Skills, and Attention to Detail specific to clinical and medical contexts.
  • ...
• Example(s):
  • Clinical Trial Research: Conducting clinical trials to evaluate the effectiveness and safety of medical treatments, drugs, or devices.
  • Epidemiological Research: Investigating the distribution and determinants of health and diseases in populations to inform public health interventions.
  • Health Services Research: Analyzing the organization, delivery, and outcomes of healthcare services to improve quality and efficiency.
  • Translational Research: Bridging the gap between laboratory research and clinical practice to develop new therapies and diagnostics.
  • Genetic Research: Studying genetic factors that influence health and disease to develop personalized medicine approaches.
  • Behavioral Research: Examining the impact of behavior and lifestyle on health outcomes to develop preventive strategies.
  • Pharmacovigilance Research: Monitoring and evaluating the safety of pharmaceutical products to detect and prevent adverse effects.
  • Nutritional Research: Investigating the role of diet and nutrition in health and disease prevention.
  • Pediatric Research: Focusing on health issues affecting children and developing age-appropriate treatments and interventions.
  • Geriatric Research: Studying health challenges faced by the elderly to improve quality of life and care for aging populations.
  • …
• Counter-Example(s):
  • A General Medical Research Task, which does not involve the specific regulatory and ethical considerations unique to clinical research.
  • A Laboratory Research Task, which focuses solely on bench research without direct clinical application.
  • An Exploratory Research Task, which may not have the structured methodology required for clinical research.
  • Pre-Clinical Research.
  • New Manufacturing System R&D.
  • Clinical Care, such as medical diagnosis.
• See: Clinical Trial, Medical Treatment, Healthcare Science, Efficacy, Medications, Medical Device, Diagnostics.

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References

2023

• (Subbiah, 2023) ⇒ Vivek Subbiah. (2023). “The Next Generation of Evidence-based Medicine.” In: Nature Medicine. https://doi.org/10.1038/s41591-022-02160-z
  • 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. ...

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_research Retrieved:2021-11-3.
  • Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

2017

• (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. ...

2016

• (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.

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