Industry-sponsored clinical trials are legally required to only use clinical outcome measures that have been prospectively validated. True or false?

The Physicians' Health Study was a randomized, double-blind, placebo-controlled trial of 22,071 apparently healthy male physicians.  Subjects were randomized into two groups: one group took a buffered aspirin every other day and the other was given a placebo. The average follow-up during the aspirin component of the trial was 60.2 months. Baseline cardiovascular risk factors and adherence to therapy during the trial were assessed by questionnaire. Cardiovascular outcomes were reported by questionnaire and confirmed by record review by an Endpoints Committee. Among those taking the aspirin, 104 heart attacks (with five deaths) occurred compared to 189 heart attacks ­18 of them fatal ­ among those taking the placebo. The study was terminated early, due principally to a 44% reduction in the risk of a first myocardial infarction (MI). Which of the following are NOT a reason(s) to use a placebo in this trial? Select all that apply. To ensure the ethical review board will approve the…

1) What are the physiological criteria for having attained VO2max? 2) In the VO2max protocol, it is stated that the subject is to communicate during the test using hand signals. Why is it so important that the subject only uses hand signals during a VO2max test? 3) A scale is referenced multiple times through the VO2max protocol. What is the name of this scale and what is its purpose? 4) What is another equation that can be used to calculate VO2max? Define the variables of this equation (using proper units).    ( explain all  question with proper address )

By convention, when the difference between the observed experimental outcome and the expected outcome is less than 5 percent (< 0.05), the experimental results are considered to be Group of answer choices a)less than one standard deviation from the mean. b)within the normal range. c)not significant. d)statistically significant and different from the expected outcome.

Why is a therapeutic, cost-effective, and informative formulary system valuable or beneficial to a hospital and its patients? Please explain further your opinions or insights. • If you were to critique the stages of clinical trials, what would you modify and advocate for the system's improvement? Please explain further your opinions or insights.

What risk and quality management tools do you use to interpret or present the data for long wait times for patients to see their healthcare providers?

Describe the role of the “surprise” protocol in the experimentaldesign.

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.

What are some challenges that you foresee when implementing Precision Medicine (which includes Pharmacogenomics and Immunogenomics as well as Risk Screenings for certain cancers)?  This can include ethical, financial, social, legal, etc. challenges.  Please provide some examples when discussing your identified challenges.  How might you tackle these challenges you comment on above?  How might your solutions influence/impact the patient when utilizing Precision Medicine?

You have been assigned by your supervisor to develop a handbook for ethical research standards. Within your department you have a wide range of research areas involving both human and animal subjects. What values and issues should this handbook address? What steps can be taken to ensure ethical research is being conducted within the department by both faculty and students?