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

4
Continue

• 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.

5
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.

6
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.

7
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.

8
Continue

• 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

9