Clinical Trial & Best Clinical Research Training - PowerPoint PPT Presentation

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Clinical Trial & Best Clinical Research Training

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Clinical trials are a type of research conducted to study new tests, treatments, and drugs and evaluate their outcomes, side effects, and efficacy on human health. – PowerPoint PPT presentation

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Title: Clinical Trial & Best Clinical Research Training


1
Clinical Trial Clinical Training
  • By-
  • Shreya Gupta,
  • Clariwell Global Services.
  • Magarpatta, Pune.

2
Clinical trials
  • Are a type of research conducted to study new
    tests, treatments, and drugs and evaluate their
    outcomes, side effects, and efficacy on human
    health. There are various medical interventions,
    including drugs, biological products,
    radiological procedures, devices, behavioral
    treatments, surgical procedures, and preventive
    care in which people volunteer to take part.
    Learn Best Clinical Research Course.

3
WHOs International Clinical Trials Registry
Platform (ICTRP)
  • People from more than one country and one medical
    or research institution can participate in a
    clinical trial. Different countries have
    different clinical research requirements, so one
    clinical trial may be enlisted on more than one
    registry. That clinical trial shall appear on the
    database of more than one registry. However, data
    on various clinical trial registries varies.
  •  
  • The International Clinical Trials Registry
    Platform (ICTRP) is a global initiative by WHO,
    responsible for linking clinical trial registers
    worldwide for ensuring a single point of access
    and the apparent identification of clinical
    trials. This was done with the view that
    participants, patients, families, and patient
    groups have easy access to information

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  • The ICTRP was established with the aim to make
    information about all clinical trials that
    involve humans publicly available. It also aims
    to achieve the following 
  • Improving the comprehensiveness, completeness,
    and accuracy of registered clinical trials data
  • Communicating and raising awareness of the need
    for registering clinical trials
  • Ensuring the accessibility of registered data
  • Building capacity for clinical trial
    registration
  • Encouraging the utilization of registered data
    and
  • Ensuring the sustainability of the ICTRP.

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The Secretariat of the ICTRP is housed by the
World Health Organization in its headquartersin
Geneva and is responsible for the following
  •  
  • Publishes the ICTRP search portal A database and
    website that makes it possible for every person
    in the world to search for free data provided by
    clinical trial registries around the world. The
    data is updated weekly and meets WHOs criteria
    for content and quality.
  • Supports the WHO registry network A forum
    created to establish and work together for the
    purpose of clinical trial registries. It aims to
    establish best practices for clinical trial
    registration and the collection of high-quality,
    accurate data.
  • Supports different countries and regions It aims
    to establish clinical trial registries or
    policies on trial registration.

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Clinical research training
  • Clinical research training programs are designed
    for clinicians and scientists around the world.
    These research training programs provide advanced
    training in healthcare methods and research. The
    training often incorporates in-person seminars
    and dynamic workshops. It focuses on enhancing
    clinicians and staff skills, knowledge, and
    ability at every phase of the research,
    particularly for pre-clinical research phases.
    The training includes writing grant proposals and
    launching new projects for analyzing data and
    presenting their clinical results. Take Clinical
    Research Training from the Best Provider.

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Principles regulating clinical trials worldwide
  • Clinical trials are required to follow the
    following guidelines and more to ensure the
    safety of patients and efficacy of tests and
    treatments. However, stringent requirements may
    force clinical trials to shift to low-income and
    middle-income countries depriving the local
    population of the opportunity to benefit from
    international clinical research. 
  • Obtaining clear, transparent, and informed
    consent from participants.
  • Allowing participants to withdraw at any point of
    time from a clinical trial.
  • The outcome of the clinical research should
    provide benefits to society without doing any
    harm to the participants who volunteered to
    participate in the clinical trial.
  • Any unintended response to a drug or medical
    product should be considered an adverse reaction.

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  • A declaration of confirmation by the auditor that
    an audit has been conducted.
  • The auditor should provide a written evaluation
    of the results of the audit.
  • A written description of a clinical trial or
    study.
  • Report of placebo or any investigational product
    if used in the clinical trial.
  • The ethical and moral obligation to protect
    patients and reap clinical research benefits.
  • The conclusions derived from the results of a
    clinical trial conducted worldwide generally
    apply to all study centers and countries. It
    increases the pace of drug development and
    facilitates the approval process of the tests and
    treatments in foreign markets. However, clinical
    trials face several challenges that they should
    overcome to ensure optimal conduct and coordinate
    clinical trial sites that operate under different
    regulations, technical, cultural, and political
    conditions
  • Clinical trial sponsors are responsible for
    obtaining consensus among clinical experts and
    regulatory agencies regarding fundamental
    questions that include a consistent diagnosis

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