Age Is But a Number? An Exploration of Age Differences in Episodic Volunteering

VOLUNTAS: International Journal of Voluntary and Nonprofit Organizations - Age has long been understood as a strong demographic determinant of volunteering. However, to date, limited literature...     

A new long-term survival model with dispersion induced by discrete frailty

Lifetime Data Analysis - Frailty models are generally used to model heterogeneity between the individuals. The distribution of the frailty variable is often assumed to be continuous. However, there...     

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.     

The evolution of intellectual property strategy in innovation ecosystems: Uncovering complementary and substitute appropriability regimes

In this article, we attempt to extend and nuance the debate on intellectual property (IP) strategy, appropriation, and open innovation in dynamic and systemic innovation contexts. We present the case of four generations of mobile telecommunications systems (covering the period 1980–2015), and describe and analyze the co-evolution of strategic IP management and innovation ecosystems. Throughout this development, technologies and technological relationships were governed with different and shifting degrees of formality. Simultaneously, firms differentiated technology accessibility across actors and technologies to benefit from openness and appropriation of innovation. Our analysis shows that the discussion of competitiveness and appropriability needs to be expanded from the focal appropriability regime and complementary assets to the larger context of the innovation ecosystem and its cooperative and competitive actor relations, with dispersed complementary and substitute assets and technologies. Consequently, the shaping of complementary and substitute appropriability regimes is central when strategizing in dynamic and systemic innovation contexts. This holds important implications for the management of open innovation, innovation ecosystems, platforms, and coopetition.     

Frustration in Infancy: Implications for Emotion Regulation,Physiological Processes,and Temperament

A study sample of 162 six‐month‐old children was selected from a larger sample of 346 infants on the basis of parents' report of their infants' temperament and a laboratory assessment of temperament. Infants were classified as easily frustrated and less easily frustrated and compared on a number of emotion regulation, physiology, and temperament measures. Results indicated that male and female infants were equally likely to be classified as frustrated and less easily frustrated; however, male infants were less able to regulate physiologically. Easily frustrated infants used different emotion regulation strategies and were observed to be less attentive and more active than less easily frustrated infants when observed in the laboratory. These infants were also characterized by their parents as more active, less attentive, and more distressed to novelty. Infants classified as easily frustrated were more reactive physiologically and less able to regulate physiological reactivity than their less easily frustrated counterparts. It is hypothesized that this cluster of characteristics may constitute a unique temperamental type that may have implications for other types of behavioral functioning. Limitations of the study are that observations are based on a single brief assessment of the infant, modest effect sizes were found, and the study is cross‐sectional.