Therapeutic area being studied as well as number and types of clinical procedures involved were the key drivers of direct costs in Phase 1 through Phase 3 studies. Research shows that strategies exist for reducing the price tag of some of these major direct cost components. Therefore, to increase clinical trial efficiency and reduce costs, gaining a better understanding of the key direct cost drivers is an important step.

Introduction The US FDA announced its intention to ban menthol in cigarettes. However, information is needed on how a federal ban would affect population health. We conducted an expert elicitation to gauge the impact of a menthol cigarette and cigar ban in the US. Methods We developed and pilot tested a questionnaire that focused on tobacco use transitions of current smokers (age 18-24 menthol, age 35-54 menthol, and age 35-54 non-menthol) and potential menthol smokers (age 12-24). Using a structured expert elicitation, we estimated mean net transitions under a ban from cigarette use to combustible tobacco product, smokeless tobacco, novel nicotine delivery product (NNDPs, such as e-cigarettes) use, or no tobacco use. Results Eleven experts provided responses. Of those ages 12-24 who would have initiated menthol cigarette use in the absence of a ban, the experts estimated that 41% would still initiate combustible products under a ban, while 18% would initiate with NNDPs and 39% would not initiate regular tobacco use. Combustible use by menthol smokers ages 35-54 was expected to decline by 20% post-ban relative to pre-ban rates, half switching to NNDPs and half quitting all tobacco use. Menthol smokers ages 18-24 were expected to reduce combustible use by 30%, with 16% switching to NNDPs. Greater reductions in combustible use were estimated for African-Americans across the three age groups. Negligible impacts were expected for current adult non-menthol smokers. Conclusions According to expert opinion, a menthol ban is expected to substantially reduce smoking initiation and combustible tobacco product use among current menthol smokers.

IMPORTANCEThe US medical device market is the world's largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation. OBJECTIVE To estimate the mean expected capitalized cost of developing a novel therapeutic complex medical device. DESIGN, SETTING, AND PARTICIPANTSIn this economic evaluation, an analytical model of novel therapeutic complex medical device development using data from public and proprietary sources with coverage from 2000 through 2018 was used to estimate the cost, duration, and phase transition success probability associated with each stage of development. Data analysis was completed in September 2021.

Optimal policies should maximize the difference between societal benefit, primarily measured as the reduction in public health burden from the development of a new antibacterial drug that treats an infectious disease while ensuring prudent use, and social cost. Here, we show that the two types of policies examined under-incentivize early-stage developers (i.e., do not achieve the desired outcome) and over-incentivize late-stage developers (i.e., achieve the desired outcome but at a cost that is higher than needed) ceteris paribus.

Reliable quantitative data are lacking that document the prevalence of ingestion of soil and other "non-food" substances among U.S. children and adults. This article explores the proportion of the U.S. population that ingests substances such as soil, clay, starch, paint, or plaster. We compiled data from the National Health and Nutrition Examination Survey (NHANES) collected from years 1971-1975 (NHANES I) and 1976-1980 (NHANES II) because these particular surveys asked participants specific questions about non-food ingestion practices. We examined the prevalence of the behavior across multiple demographic variables, such as age, gender, education, and income level. Approximately 1% (NHANES II) to 2.5% (NHANES I) of the U.S. population ingests some type of non-food substance. The most notable variation across the demographic subgroups studied was the difference in estimated prevalence among young children (1 to <3 years) compared to older children and adults. Estimated prevalence was also higher among blacks compared to whites and within lower compared to higher socioeconomic groups. This analysis helps fill data gaps on the relative pattern of non-food ingestion practices on a national scale. This information provides perspective for risk assessors when evaluating exposure variables and for risk managers when weighing risk management alternatives.