Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated. True or false?
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Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated.
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- 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.Manufacturers of self-contained test kits apply for and receive Food and Drug Administration (FDA) approval for their particular test to be on the Clinical Laboratory Improvement Amendment (CLIA) waived list. To find out if your particular brand of self-contained test kit is on the CLIA waived list, access an up-to-date listing at the FDA website(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm (Links to an external site.)) and use the key search term “Currently Waived Analytes” (be forewarned, though, that the list is very long) (Cited from Chap. 37). Research the link to the FDA to find your kit name on the list. Discuss the following questions: Why would it be important to have this kit listed here? Can a POL use kits that are not listed?Regulations/research help: True or false: Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated. Which of the following may be true for a significant risk (class III) medical device? (check all that apply) --Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject --Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject --Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject --Presents a potential for serious risk to the health, safety, or welfare of a subject
- 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 True FalseWhat are the shortcomings of randomized clinical trialsWhich of the following is a barrier to recruitment in a clinical trial? A. Investment in community education and outreach. B. Education about clinical trials early in a patient's diagnosis. C. Presentation of options for the patient. D. Strick protocols and narrow eligibility guidelines.
- A patient is being counseled for possible participation in a clinical trial for a new medication. After the patient meets with the physician, the nurse is asked to obtain the patient’s signature on the consent forms. The nurse knows that this “informed consent” indicates which of the following? a )Once therapy has begun, the patient cannot withdraw from the clinical trial. b) The patient has been informed of all potential hazards and benefits of the therapy. c )The patient has received only the information that will help to make the clinical trial a success. d )No matter what happens, the patient will not be able to sue the researchers for damages.The following case study is a paraphrase from "Good Clinical Practice. Standard Operating Procedures for Clinical Researchers" (Kolman, J., Meng, P. and Scott, G. editors; John Wiley and Sons publishers, 1998): “While a study subject and a relative were walking in town one day during the summer, a hanging flower basket fell on a study subjects head, resulting in the study subject falling down and becoming unconscious. The subject’s relative called for an ambulance. On arrival at a local hospital’s Emergency Department, in which the subject regained consciousness but could not recall the event, a x-ray revealed a fractured skull. The subject’s consciousness level at this point was deteriorating and after further tests a subdural hematoma was diagnosed, which was evacuated under general anesthesia. Postoperative recovery was uneventful and progressing well until day four, when the patient developed acute dyspnea (shortness of breath) at rest during visiting time. An emergency lung scan…In this assessment task, you will demonstrate your ability to identify a practice issue that requires an evidence-informed approach, develop a related clinical question, and search for evidence that may be used to answer this question. You will use this evidence, and the feedback from this assessment task, to inform and underpin the final assessment task, your research presentation. Instructions Identify an issue or situation from practice or in healthcare that requires an evidence-informed approach. Explain why this issue is important for a registered nurse to understand, drawing on the literature to support your argument. Develop a searchable question using an appropriate framework. Design a search strategy, including database choice, key terms, and Boolean operators to link these (tables may be used for this section Use this strategy to carry out your search, and identify four research articles that address your question, choosing these from the highest possible evidence sources…
- Outline the general steps from initial drug discovery to IND filing. Add as much detail as you need and feel free to use flow charts, graphics, visuals, as long as is made by you alone and not directly copied-pasted from another source. If an IND is cleared to proceed by the US-FDA, what is the single most important goal of a first-in-human (FIH) clinical trial?Outline an experimental approach using a dietary intervention for designing a novel supplement against a NCD of your choice. Describe your research hypothesis and what you are going to measure. (i) Phrase a specific health claim that can be used for this novel product.Do you think direct-to-consumer tests that provide information about the risk of developing medical conditions (such as breast cancer or Alzheimer disease) should be made available to the public? List some arguments for and against providing this service.
