Inference and Decision Making for 21st-Century Drug Development and Approval

ABSTRACT

The cost and time of pharmaceutical drug development continue to grow at rates that many say are unsustainable. These trends have enormous impact on what treatments get to patients, when they get them and how they are used. The statistical framework for supporting decisions in regulated clinical development of new medicines has followed a traditional path of frequentist methodology. Trials using hypothesis tests of “no treatment effect” are done routinely, and the p-value < 0.05 is often the determinant of what constitutes a “successful” trial. Many drugs fail in clinical development, adding to the cost of new medicines, and some evidence points blame at the deficiencies of the frequentist paradigm. An unknown number effective medicines may have been abandoned because trials were declared “unsuccessful” due to a p-value exceeding 0.05. Recently, the Bayesian paradigm has shown utility in the clinical drug development process for its probability-based inference. We argue for a Bayesian approach that employs data from other trials as a “prior” for Phase 3 trials so that synthesized evidence across trials can be utilized to compute probability statements that are valuable for understanding the magnitude of treatment effect. Such a Bayesian paradigm provides a promising framework for improving statistical inference and regulatory decision making.     

Big lie, small world: what e. Lynn harris wanted readers to understand about the struggle for african american, homosexual males seeking to attain the american dream

This article will examine the social implications for African American homosexual males seeking to achieve the American Dream. Invisible Life and Just as I Am-the first two novels in a trilogy by the late E. Lynn Harris writing from a semi-autobiographical perspective in late-twentieth century America-will serve as the texts that drive this research topic. Careful analysis of these works will substantiate the assertion that the American Dream, even on the cusp of the new millennium, is just beyond the grasp of this specific subpopulation.     

A perfect storm: Challenges encountered by family caregivers of persons with Alzheimer’s disease during natural disasters

ABSTRACT

Since Hurricane Katrina there has been a movement across the U.S. to examine best practice for disaster response within the aging population. However, little is known about the experience of natural disasters from the perspective of family caregivers of persons with Alzheimer’s disease and related dementia (ADRD). In this exploratory, qualitative study, family caregivers (n=27) were interviewed about their experience with the historic 2015 South Carolina flood. By using thematic analysis, themes were identified to better understand what unique challenges caregivers of person with ADRD experienced. While many caregivers stated they had experienced a natural disaster previously, none had ever done so in their current caregiving role. The caregiving role affected their ability to prepare for the storm and influenced their decision-making regarding evacuation and utilization of recovery resources. Thus, caregivers were confronted by a “perfect storm” of circumstances and uncertainty. Family caregivers need to have actionable emergency plans for disasters that are specific to their role as caregivers of persons with ADRD. Study implications also suggest the role social work professionals can have in educating, advocating, evaluating, and coordinating support to assist caregivers of persons with ADRD as a potentially vulnerable and at-risk population during all phases of disaster.     

Use of Contemporary Film as a Medium for Teaching an Online Death and Grief Course

Online education is becoming commonplace in the academic world. Schools now offer totally online degree programs or provide a hybrid of face-to-face and online courses for fulfilling academic requirements. Developing courses and teaching online requires instructors to rethink the educational paradigms they have relied upon in the past. The Net Generation of learners brings a different set of expectations, styles, and needs to the classroom than those of previous generations; this mandates that instructors redesign courses and use contemporary teaching modalities. This article describes how film was successfully used as the primary medium to teach a graduate online Social Work course, Death and Grief.     

Women's perceptions of their healthcare experience when they choose not to breastfeed

Research questionHow do women who choose not to breastfeed perceive their healthcare experience?MethodThis qualitative research study used a phenomenographic approach to explore the healthcare experience of women who do not breastfeed. Seven women were interviewed about their healthcare experience relating to their choice of feeding, approximately 4 weeks after giving birth. Six conceptions were identified and an outcome space was developed to demonstrate the relationships and meaning of the conceptions in a visual format.FindingsThere were five unmet needs identified by the participants during this study. These needs included equity, self sufficiency, support, education and the need not to feel pressured.ConclusionWomen in this study who chose not to breastfeed identified important areas where they felt that their needs were not met. In keeping with the Code of Ethics for Nurses and Midwives, the identified needs of women who do not breastfeed must be addressed in a caring, compassionate and just manner. The care and education of women who formula feed should be of the highest standard possible, even if the choice not to breastfeed is not the preferred choice of healthcare professionals.     

The Status of Nutrition Education in ACHA College and University Health Centers

Abstract

An assessment of the prevalence and scope of nutrition services offered through 208 randomly selected American College Health Association member student health centers revealed that 79% of the 160 respondents provided some type of nutrition education for students. One-to-one counseling, available at 96% of the institutions, was the most common approach. The larger the school's enrollment, the more likely it was to provide programs in nutrition. All of the institutions with student populations of more than 35,000 offered some type of nutrition service, as did 52% of the 19 schools with enrollments between 2,000 and 5,000. Health educators, nurses, doctors, dietitians, and trained peer educators provided the services, with registered dietitians the most common providers and often coordinators of the programs. Costs to students for nutrition interventions were nominal; weightmanagement programs were the most expensive and showed the greatest variation in content.