Clinical trials can be designed to demonstrate that a new technology offers measurable, relevant benefits, in terms of safety, clinical effectiveness, and in some instances, cost-effectiveness
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Clinical trial or often termed "medical trials" are research designs aimed to evaluate the efficiency, safety, and outcomes of new medical approaches.
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- BENEFIT: advantages, good effects/impacts, profit COST: disadvantages, negative effects/impacts, drawbacks Scenario Benefits (List 3 possible benefits) Costs (List 3 possible costs) Assessment Which do you think is more equitable in its impact? (benefit or cost) Why? 1. Nanotechnology can provide alternatives to early detection of cancer cells, drug delivery, and injectable vaccines that to this day rely on healthcare professionals to administer. 2. Nanotechnology can be used to reduce pollutants in the environment such as radioactive wastes, oil spill, and propylene oxide, the raw material for making plastics. 3. Nanotechnology can be incorporated into solar panels to convert sunlight to electricity more efficiently and helps in cleaner production of alternative and renewable energy sources.True or False? An active-control trial is the best option for researchers hoping to test a newly devised therapy for a life-threatening illness among individuals with the illness, when a previously devised treatment is available for the illness.Description of clinical trial process for the Pfizer-BioNTech. Incorporate the following key words: Length of trial; population diversity; efficacy; side effects Pfizer-BioNTech
- Identify potential barriers to inspection readiness in relation to site inspections in clinical trials.Injection safety, or safe injection practices, is a set of measures taken to perform injections in an optimally safe manner for patients, healthcare personnel, and others. Question options: A) True B) FalseWhich of the following is an important ethical considerations to keep in mind that can be compromised when using the RCT design? Group of answer choices: 1. Withholding treatment known to be effective 2. Deciding when to withdraw a patient from a study 3. Informing a patient of all of the potential side effects and toxic effects of a treatment 4. All of the above
- Explain how the design and implementation of a pharmacist-directed preventive care program case study article considers a systems-thinking approach in program planningWhy would ALS patients and their families want to participate in a clinical trial.Match the following terms/acronyms to their definition below: clinical event committee (CEC), core laboratory, contract research organization (CRO), data safety and monitoring board (DSMB), endpoints, inclusion criteria, power. Characteristics or indications that subjects must have in order to participate in the clinical trial A. DSMB The probability of detecting a meaningful difference, or effect, if one were to occur B. CRO Prospectively identified and quantifiable parameters that a study is designed to meet C. Inclusion criteria An independent organization that provides management services for clinical trials D. CEC An independent body that periodically reviews the results of clinical trials in the US to ensure that patients are not being inadvertently harmed by the study E. Endpoints An independent body that adjudicates clinical events and reports the results to both the trial investigators and the study sponsor F. Power An independent body that…
- Which statements regarding the preclinical research stage of drug development are true? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Select all that apply. Group of answer choices Most drugs do not proceed past the preclinical stage because they are found to be too toxic or just ineffective. Client variability is determined and potential drug—drug interactions are examined during pre-clinical testing.. The preclinical stage of research involves extensive testing on animals in the laboratory to determine if the drug will cause harm to humans. The Food and Drug Administration (FDA) is responsible for extensive testing for safety before the pharmaceutical company can begin the preclinical research stage of development.Identify potential barriers to inspection readiness in relation to resourcing in clinical trials. FYI: The course is clinical research.True positive and true negative are determined using a gold standard, such as an established reference assay or a definitive clinical diagnosis. TrueFalse When FDA-approved or FDA-cleared methods are incorporated, the test performance is verified by using the purchased reagent sets to test validation specimens. This verification establishes that the results of the commercial test performed in the individual laboratory are as predicted by the developer. TrueFalse The negative predictive value is the degree that a particular test result corresponds with the presence of a clinical state, such as disease symptoms or response to therapeutic agent. TrueFalse The positive predictive value is the clinical specificity of the test, that is, the absence of that test result in the absence of the disease state or response. TrueFalse Answ
