Economics of new oncology drug development.

PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

Making Young Voters: The Impact of Preregistration on Youth Turnout

© 2016 by the Midwest Political Science Association.Recent research has cast doubt on the potential for various electoral reforms to increase voter turnout. In this article, we examine the effectiveness of preregistration laws, which allow young citizens to register before being eligible to vote. We use two empirical approaches to evaluate the impact of preregistration on youth turnout. First, we implement difference-in-difference and lag models to bracket the causal effect of preregistration implementation using the 2000-2012 Current Population Survey. Second, focusing on the state of Florida, we leverage a discontinuity based on date of birth to estimate the effect of increased preregistration exposure on the turnout of young registrants. In both approaches, we find preregistration increases voter turnout, with equal effectiveness for various subgroups in the electorate. More broadly, observed patterns suggest that campaign context and supporting institutions may help to determine when and if electoral reforms are effective.