Essay Instructions: I want a very crisp and Nicely written information on Clinical trial phases. All three phases should be explained for a high level audience and also what regulatory procedures are involved by the FDA.
Clinical Development is a part of drug development program where Clinical trials are run before the drug is launched in the market on human subjects.
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Total Pages: 2 Words: 572 Sources: 4 Citation Style: MLA Document Type: Research Paper
Essay Instructions: Application: Outsourcing and Associated Contracts
You learned in a previous course that outsourcing is a growing trend in the administration of clinical trials. This week you will examine a hypothetical situation in which a new biotech firm outsources its trial to another firm in Central Africa. The clinical trial administrators will be faced with a number of contractual issues.
To prepare for this Application Assignment, consider the following scenario:
You and a colleague, who own the patent rights to a compound that is potentially efficacious in the treatment of Alzheimer?s disease, have decided to form a new pharmaceutical company. Your colleague has the rights to the patent on the potential product, and you and your colleagues have the skills to do the research.
To complete this assignment, write a 1- to 2-page paper about the contracts associated with outsourcing this trial. Be sure to include your response to the following questions in your paper.
What services will you need to continue development?
What kinds of organizations will you need to contract with in order to succeed in your developmental activities?
Submit your Application Assignment to the Dropbox by Day 6.
Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week?s Learning Resources and additional scholarly sources as appropriate. Refer to the Pocket Guide to APA Style to ensure your in-text citations and reference list are correct.
Save your Application as a ".doc" or ".rtf" file with the filename "APP4+last name+your first initial." For example, Sally Ride?s assignment filename would be "APP4RideS". Use the Submit an Assignment link, choose the Week 4: Application basket, and then add your Application as an attachment.
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Essay Instructions: Answer the appropriate question that will follow this quantitative research study example on health promotion. STUDY: Clinical trial of tailored activity and eating newslette with older rural women. STATEMENT OF THE PURPOSE: The purpose of the study was to evluate the effects of a tailored intervention, based on Pender's health promotion model, on such health outcomes as physical activity and healthy eating among older rural women. the intervention involved a series of newsletters. THEORETICAL FRAMEWORK: The HPM was used as the framework for the intervention because midlife and older women may be more interested in enhancing health to maintain independence than in avoiding specfic disease as they age. In designing the tailored interventions, the researchers selected 4 behavior-specific cognitions from the HPM-perceived benefits, barriers, self-efficacy, and interpersonal influences. These cognitions are viewed in the model as determinants of behavior, and have been found to be modifiable. The intervention targeted change on health behaviors themselves, and also on these known influences on the behaviors. METHOD: In this community-based study, 2 similar rural sites were assigned, at random, to either the tailored intervention protocal or to a generic intervention. A sample of 225 women aged 50-69 years old were recruited to participate. Over a 12 month period, the women recived by mail either 18 generic newslettes tailored on the 4 HPM behavior specific cognitions, as welll as on the behavior of interest-activity and diet. Tailored newslettes included content relevant to individual recipients, as suggested in their assessment responses. Newsletters also included information about HPM determinants-that is, the benefits of healthy eating and activity, overcoming barriers to change, building confidence in the ability to change, and obtaining social support from friends and family. Outcome data were collected at 6 and 12 months after the start of the intervention. Assessments of the HPM beahvioral determinants for tailoring purposes were completed at the outset and at 3, 6, and 9 months later. Outcomes focused on physical activity and eating, and included behavior markers (e.g. self-reported daily servings of fruits and vegetables, time engaged daily in moderate or high intensity activity) and biomarkers (e.g. serum lipid levels, percentage of body fat). KEY FINDINGS: Women in both gropus showed improvement in certain outcomes over the course of the study, such as increased fruit and vegetables servings and decreased percentage of calories and fat. Improvement in other outcomes, however, were only observed in the tailored intervention group, including increased moderate or high intensity activity and decreased blood pressure. The researchers concluded that the theory-based tailored news letters were more effective than generic newsletters in facilitating behavior change over the 12 month period.These questions need to be answered concerning the research study 1) Does the report describe an explicit theoretical or conceptual framework for the study? If not, does the absence of a framework detract from the usefulness or significance of the research. 2) Does the report adequately describe the major features of the theory or model so that readers can understand the conceptual basis of the study? 3) Is the theory or model appropriate for the research problem? Would a different framework have been more fitting? 4) If there is an intervention, wass there a cogent theoretical basis or rationale for the intervention? 5) Was the theory or model used as the basis for generating hypothesis, or was it used as an organizational or interpretive framework? Was this appropriate? 6) Do the research problem and hypothesis if any naturally flow from the framework, or does the purported link between the problem and the framework seem contrived? are deductions from the theory logical? 7) Are the concepts adequately defined in a way that is consistent with the theory? If there is an intervention, are intervention components consistent with the theory? 8) Is the framework based on conceptual model of nursing or an a model developed by nurses? If it is borrowed from another disciplined, is there adequate justification of its use? 9) Did the frame work guide the study methods? Do the operational definitions correspond to the conceptual definitions. 10) Does the researcher tie the study findings to the framework in the discussion section? Do the findings support or challenge the framework? Are the findings interpreted within the context of the framework? 11) What is the implications of the study in terms of the health promotion model. Please nuber each answer, and answers cannot be a simply yes or no, have to be supported, this is an assignment on research which I no nothing about.
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Essay Instructions: The Oversight of Clinical Trials
There are many ethical concerns relating to the conduct of clinical trials. Institutional review boards (IRBs) and institutional ethics committees (IECs) have proven essential for maintaining ethical standards in research enterprises. In this week's Discussion, you will analyze the contribution IRBs provide and the obstacles they face.
To prepare for this Discussion, review this week?s Learning Resources relating to IRBs/IECs.
Post by Day 4 an evaluation of the how IRBs and IECs maintain the ethical treatment of research patients, particularly in developing countries.
? What are the obstacles involved with instituting institutional oversight in developing countries?
? How do you think the obstacles can be overcome?
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