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.     

Standing on Their Own Two Feet: How the New Public Charge Rules Could Impact Non-European LPR Applicants

Population Research and Policy Review - In February 2020, the U.S. government began to implement a new Public Charge rule that greatly expands the definition of “public charge” when...     

Changing Frameworks in Attitudes Toward Abortion

For more than two decades, legal abortion has been the subject of heated political debate and adversarial social movement activity; however, national polls have shown little change in aggregate levels of support for abortion. This analysis examines how the determinants of abortion attitudes have changed between 1977 and 1996, using data from the General Social Surveys. While in early time periods, whites were more approving of abortion than blacks, that pattern had reversed by the late 1980s. After controlling for other factors, older people are more accepting of abortion throughout the two decades, while gender is generally unrelated to abortion views. Catholic religion weakens slightly as a predictor of abortion attitudes, while religious fundamentalism and political liberalism increase in explanatory power. The associations between attitudinal correlates and abortion approval also change over this time period. Religiosity becomes a less powerful predictor of abortion attitudes, while respondents' attitude toward sexual freedom and belief in the sanctity of human life increase in their predictive power. Support for gender inequality remains a weak but stable predictor of abortion attitudes. This pattern of results suggests that the public is influenced more by the pro-life framework of viewing abortion than by the pro-choice perspective.     

Becoming Custodial Dads: Exploring Parenting Among Low‐Income and Working‐Class African American Fathers

The authors use an ecological framework and grounded theoretical analysis to explore the circumstances in which working‐class and low‐income custodial African American fathers gain custody of their children, their transition from part‐time to full‐time parents, and the role of support networks in enhancing or inhibiting these men's parenting. Twenty‐four men from an impoverished Midwestern urban area participated in the study. The findings suggest that these men, and perhaps others sharing their demographic profiles, generally become parents by default and are often reluctant to take on a full‐time, single parenting role. Adaptation to the role seems to be enhanced by these men's use of extended kin support networks and shared living arrangements. However, low wages, a lack of sufficient assistance from public assistance programs, and informal custody arrangements often inhibit their fathering.     

Secondary analysis of dangerousness among death sentenced capital murderers

The theory of incapacitation involves reducing an offender's ability or capacity to commit further crimes. Capital punishment accomplishes this goal. An executed murderer never murders again. However, we do not execute all murderers, only capital murderers. This policy produces several research questions. Do capital murderers present a special risk to society? Are capital murderers more likely to murder or commit other violent crimes again than other murderers or the average citizen? To answer these questions, many states require a prediction of future dangerousness of a newly convicted murderer. To what extent has the judgment of future dangerousness matched actuarial data of subsequent murders and serious crimes? Using a secondary analysis, this investigation attempted to assemble available data of postconviction dangerousness of death sentenced capital murderers to create a more comprehensive actuarial account of subsequent dangerousness and to present the data in a common format used by the Federal Bureau of Investigation and the Bureau of Justice Statistics. Across 14 studies identified with relevant data, there were 13 instances of subsequent murder and 462 serious crime or prison rule violations.     

Dependency—Bond as Construct

This article is a discussion of reality construction of dependency-bonds by oppressed groups with an oppressor. In this model of dependency-bond processes, it is suggested that oppressed people, when possible, attempt to translate the power-dependency equation from one of coercion and objectification into a less onerous, more agreeable bond; that is, subordinate people strive to establish and to reinforce dependency relationships as a strategy of control whereby the power of superiors is deflected from coercive measures against them into lines of obligation toward them. It is further proposed that the secondary effects of this process include the social construction of subordinate identity as dependent and of subordinate place as dependent place.     

Bankrupt Rhetoric: How Misleading Information Affects Knowledge about Social Security

Most citizens know little about politics. Scholars often attributepolitical ignorance to individual-level factors, but we concentrateon the quality of the information environment. Employing a combinationof experimental methods and content analysis, we code statementsfrom the 1998–99 debate over Social Security reform aseither misleading or not misleading. Then, using surveys conductedduring the debate, we examine the impact of individual- andenvironmental-level variables on political knowledge about theprogram’s future. We show that misleading statements aboutSocial Security’s future cause some citizens to get animportant fact about the program wrong. More precisely, manycitizens mistakenly believe that Social Security will run outof money because political elites occasionally use words thatlead to overly pessimistic assessments of the program’sfinancial future. Our findings have important implications forpolicymakers who are attempting to remake America’s largestfederal program, scholars who study citizen competence, andcitizens in a representative democracy.