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.     

Best practices for online Canadian prenatal health promotion: A public health approach

Background

Prenatal health promotion provides information regarding pregnancy risks, protective behaviours and clinical and community resources. Typically, women obtain prenatal health information from health care providers, prenatal classes, peers/family, media and increasingly, Internet sites and mobile apps. Barriers to prenatal health promotion and related services include language, rural/remote location, citizenship and disability. Online public health platforms represent the capacity to reach underserved women and can be customised to address the needs of a heterogeneous population of pregnant women.

Truth® ads,receptivity, and motivation to use or quit tobacco among college students

Abstract

Objective: Examine receptivity and motivation to use/quit tobacco among college students after viewing Truth ads. Participants: Random sample of 10,000 college students invited to complete online survey February 2016 (8.5% response rate). Methods: Quasi-experimental. Participants (N?=?854) watched four ads and answered survey items for each ad. Results: Students rated ad receptivity and decreased motivation to use tobacco higher for the Catmageddon ad than the others. Regardless of ad, men and current cigarette smokers reported lower receptivity. Younger age was associated with lower motivation to use tobacco for all ads. Tobacco users reported greater motivation to quit with the Catmageddon ad. Conclusions: College students were receptive to the Truth ads, and many indicated lower motivation to use tobacco. Men, older college students, and current cigarette smokers were less receptive to the ads, reinforcing the need to develop tailored campaigns to reach these subgroups.     

Digital learning across cultures: an account of activity theory

ABSTRACT

This paper explores a teaching and learning process as it unfolds in an online offshore classroom. The paper reports on teaching and learning narratives distilled from different cultures, namely the cultures of educators and students in the context of digital learning environments. Drawing on activity theory as a conceptual framework to analyse the narrative, we employ self-study as a methodological tool for capturing the dynamism and complexities that unravel in intercultural and technology-enabled teaching activities. The framework explores the relationships, tensions and opportunities of diverse activity elements that constitute the design and delivery of digital pedagogies. In the networked intercultural system, sustaining the position of activity elements and the specific relational circuit that they institutionalise is a key task for understanding digital technologies as an influential tool for effective learning and teaching practices. We argue that seeing the digital platform from the perspective of its role in creating dynamic interrelationships in a complex activity system is one way to move beyond the cultural confines of any particular element in the system.     

What about Rural Blight? Housing and Neighborhood Conditions in Southeastern Small Towns

Though the concept of blight clarifies housing and neighborhood changes in rural and small towns experiencing disinvestment and decline, the term is rarely examined outside of urban discourse. This study explores the extent of rural blight and its relationship to community characteristics using survey results from elected officials and staff members of small towns in one southeastern state. We examine the historical background of blight, including its connections to urban renewal, racial bias and stereotyping, and the broken windows theory. Among the small towns in the study, economic blight, particularly dilapidated housing, was prevalent. Social blight, which includes behaviors that are thought to be threatening or criminal in nature, was less common but correlated moderately with economic forms of blight. While social disorganization and collective efficacy theories link a range of demographic characteristics to physical and social disorder, our findings pointed only to a significant relationship between communities with a higher portion of the population who are black and multiple forms of extensive blight. More research is needed to understand the relationship, both observed and perceived, between economic and social blight in rural small towns and how these issues may be remediated through local collective action.     

International Adaptation of a Treatment Program for Situational Couple Violence

Intimate Partner Violence (IPV) is a serious international problem. Stith, S. M., McCollum, E. E., and Rosen, K. H. received funding from the US National Institute of Mental Health to develop and test a program for couples experiencing IPV: Domestic Violence Focused Couples Treatment (DVFCT). This article provides an overview of DVFCT, and presents three case studies illustrating how DVFCT has been adapted for use in Colombia, Iran, and Finland. This article emphasizes the need for adapting treatment models to be culturally informed, provides practice-based evidence for DVFCT as a treatment model, and highlights the importance of careful screening and assessment when working with couples who have experienced violence, no matter the country or location where treatment is being conducted.     

Adverse childhood experiences,post-traumatic stress disorder symptoms,and self-reported stress among traditional and nontraditional college students

Abstract

Objective: To investigate the relationships between adverse childhood experiences (ACEs), post-traumatic stress disorder symptoms (PTSD-S), and self-reported stress among college students. Participants: A total of 236 undergraduate students enrolled in nursing courses participated. Method: Using a correlational design, participants completed questionnaires online. To examine PTSD moderation between ACE and self-reported stress, multiple regression was employed. Stress outcomes were examined using a 4-group variable. Mean differences in stress response between these four groups were examined. Differences in ACE, PTSD-S, and stress response between traditional and nontraditional students were also examined. Results: PTSD-S moderated the relationship between ACEs, and self-reported stress. This indicates that students who report PTSD-S following childhood adversity perceive higher levels of stress. Nontraditional and traditional students differed in their responses to the ICLRE scale. Conclusion: Individuals who report PTSD-S following childhood adversity perceive higher levels of stress later in life. Stress reduction programs may be beneficial for students.     

What you say,and how you say it: Preschoolers' growth in vocabulary and communication skills differentially predict kindergarten academic achievement and self‐regulation

The idea that language skills support school readiness, predicting later self‐regulation and academic success, is widely accepted. Although vocabulary is often emphasized in the developmental literature, the ability to use language appropriately in the classroom, or social communication skills, may also be critical. This article examined longitudinal contributions of children's vocabulary and social communication skills, from preschool to kindergarten, to kindergarten academic achievement (reading and math) and self‐regulation (executive functions and learning behaviors). Participants were 164 children (14% Latinx, 30% Black, 56% White; 57% girls) enrolled in Head Start programs. Results revealed that initial levels and growth in vocabulary and communication skills predicted better academic achievement. Social communication skills uniquely predicted self‐regulation, after accounting for vocabulary. We discuss potential mechanisms for these links and recommend that strategies to build social communication skills be incorporated in preschool interventions promoting school readiness.