What is the main challenge in the determination of efficacy? What is the main challenge in the determination of efficacy?
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Efficacy, in a general sense, refers to the ability to produce a desired or intended result. In different fields, the challenges to determining efficacy can vary. Show more…
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1. On average the percentage of successful trials (from phase one to approval) is: a. Around 25% b. Around 10% c. Around 50% d. Around 75% 2. A new product has of relative risk of 0.8 compared to the gold standard. This means that the new product. a. Is not effective. b. Is 80% better. c. Is 20% worse. d. Is 20% better. 3. A study that compares a new branded product with a placebo should be. a. Non-inferiority b. Intention-to-treat. c. Superiority d. Equivalent 4. A product costs 50 000 while its competitor costs 30 000. In order for the product to be cost-effective the marginal superiority in terms if QALY- under a 100 000 willingness to pay threshold to its competitor... a. Should be 0.5. b. Should be 0.44. c. Should be 0.2. d. Should be 0.7. 5. What is a phase III clinical vaccine trial? a. A vaccine tested on animals. b. A vaccine tested on thousands of people to determine efficacy and safety. c. A vaccine tested after the authorization/approval to the market d. A vaccine tested to a small group of people (e.g. 10-50) 6. A product demonstrated a 30% statistically superior efficacy compared to its comparative. Which of the following relative risk matches this statement? a. RR0.7(CI95%0.6-0.9] b. RR 1.3 [CI 95% 1.1-1.4] c. RR 1.3 [CI 95% 0.7-1.3] d. RR 0.7 [CI 95% 0.7-1.1]
Keondre P.
Farhan A.
The Ebola virus disease outbreak, which began in Western Africa in 2013, was unparalleled in scope and spread, and the global response was far slower and less coherent than was optimal given the scale and pace of the epidemic. Past experience with limited localized outbreaks, lack of licensed medical countermeasures, reluctance by first responders to direct scarce resources to clinical research, community resistance to outside interventions, and lack of local infrastructure were among the factors delaying clinical research during the outbreak. Despite these hurdles, the global health community succeeded in accelerating Ebola virus vaccine development, in a 5-month interval initiating phase I trials in humans in September 2014 and initiating phase II/III trials in February 2015. Each of the three Ebola virus disease-affected countries conducted phase II/III Ebola virus vaccine trials. Only one of these trials, evaluating recombinant vesicular stomatitis virus expressing Ebola virus glycoprotein, demonstrated vaccine efficacy using an innovative mobile ring vaccination trial design based on a ring vaccination strategy responsible for eradicating smallpox that reached areas of new outbreaks. Thoughtful and intensive community engagement in each country enabled the critical community partnership and acceptance of the phase II/III in each country. Due to the delayed clinical trial initiation, relative to the epidemiologic peak of the outbreak in the three countries, vaccine interventions may or may not have played a major role in bringing the epidemic under control. Having demonstrated that clinical trials can be performed during a large outbreak, the global research community can now build on the experience to implement trials more rapidly and efficiently in future outbreaks. Incorporating clinical research needs into planning for future health emergencies and understanding what kind of trial designs are needed for reliable results in an epidemic of limited duration should improve the global response to future infectious disease outbreaks. Your company, EbVac, has developed a novel engineered humanized trispecific antibody targeting the Ebola virus, and you need to conduct a phase II/III trial. You are leading the regulatory strategy team and have been asked to describe the path to approval. Please discuss the following: (1) Which agency or agencies will be responsible for approving/reviewing your EbVac Trispecific: (a) before commercial introduction, and (b) after approval for commercialization/sale. Specifically cite any relevant Federal Statutes and standards that must be met (HINT: I would consult and cite the Coordinated Framework to start!), and (2) Provide an analysis of the potential risks you see with going before a particular agency (agency expertise, complexity of rules, history, etc.) under the particular regulations identified. Two typed pages, 12pt font, and proper citations.
Adi S.
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