Clinical Trials: SAQ Solutions

Below are the solutions to the Clinical Trials Self-Assessment Questions:

  1. Low and Middle Income Countries
    These countries are also referred to as low-resource settings in the video. Clinical trials in these settings are sometimes taken advantage of in the clinical trial process.
  2. Clinical trials are studies for medical drugs, devices, or therapies that target a specific disease, condition, or health outcome. Participants are assigned to groups and of one or more treatments and their responses are evaluated to determine treatment efficacy. This is the main way for researchers to determine if a certain intervention is safe and effective in humans.
  3. Samples solutions include:
    Pros: boost local infrastructure, train workers, save time and money, represent underrepresented populations in research when lower resource settings have higher disease burden.
    Cons: Benefits mainly go to high-resource settings, companies come and leave leaving drug-resistant strains, illiteracy and lack of background knowledge leaves informed consent unclear, lack of access to medical care incentivizes people to take part in potentially unsafe studies.
    Although the inclusion of low-resource settings in clinical trials can help bring these settings with higher disease burdens more treatment access, the desperation for treatment in these settings can be taken advantage of by drug manufacturers that are intent of getting participants for a clinical trial quickly and cheaply. Ethical constraints are not always well enforced in trials in these settings.

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