How do clinical trials work and who can participate? PowerPoint PPT Presentation

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Title: How do clinical trials work and who can participate?


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How do clinical trials work and who can
participate?
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Clinical trials are done according to some
protocols. These protocols highlight those
patients who are eligible to take part in the
trials. There are different trials like
treatments, prevention trials, screening trials,
etc. Different institutions and labs
provide clinical research services at affordable
rates . 
  • How Clinical Trials Work? 
  •  
  • Clinical trials are executed in phases. Every
    phase is there to retrieve relevant information
    about the patient's history. To protect the
    safety of patients, good clinical practices are
    followed. Every study has its own rules, like
    deciding who can or can't participate. The
    eligibility of people depends upon some factors
    which include overall health, disease stage,
    treatment, and medical conditions. 

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  •  
  • What are the phases of clinical trials?
  • Clinical trials are conducted in the labs. The
    researchers here test the treatment on the
    animals before proceeding with that on
    humans. When these become promising for animals,
    then they move with humans. The following are the
    phases of research trials
  • Phase 1 -In this phase, the testing process
    ensures whether the clinical trials can be
    conducted on humans or not.
  • Phase 2- Here, how much the drug is effective is
    considered. Moreover, it takes several months to
    years. There are hundreds of participants here.

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  • Phase 3- There can be up to thousands of patients
    here. Here, in this, the trial side effects are
    depicted.
  • Phase 4- This phase is also called Post Marketing
    Surveillance Trials. It comes after the drug gets
    approval. Pharmaceutical companies monitor how
    effective the drugs are. Also, it gets compared
    with existing drugs in the market. Apart from
    that, the cost factor is also determined in this
    phase.
  •  
  • In a clinical trial, the following information is
    necessary
  • Total patients, who will be participating in the
    trial?
  • The number of eligible candidates
  • What kind of data is gathered?
  • How will the information be checked and measured?

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Who Can Participate?   There are specific
guidelines regarding who can participate in the
clinical trials. Some organizations only accept
candidates who are in good health. while the
other organization enrolls those who have minor
issues such as the common flu.  Before hiring the
right candidate for a clinical trial, the
organization uses inclusion as well as exclusion
criteria. Several factors are considered in this,
like gender, age, disease, medical conditions,
etc. The things which allow one to participate
are called inclusion criteria. Exclusion
criteria, on the other hand, are those that
prevent or disqualify someone from participating.
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What is Informed Consent and why it is needed to
get signed?    Informed consent is very much
needed when you are participating in a clinical
trial.  In this study, researchers inform you
about the benefits, alternatives, and risks
associated with the study. There are some verbal
instructions and printed materials, either in the
form of a questionnaire or something else. When
you are curious about the trial, you can ask
questions of the researchers.  After all, if you
still want to be a part of this trial, then you
need to sign a document. In this document, the
risks, benefits, etc are mentioned. This is just
a document, not any kind of bond or contract. The
main purpose of this consent is to protect your
information.  
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Thanks!
  • Any questions?
  • You can find me at
  • hello_at_vialtrials.com
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