Scientific advice is designed to improve the quality of evidence and approaches to evidence generation for future regulatory approval and HTA evaluation. Our experience to date suggests that payer requirements are inconsistently integrated in the clinical development programmes. More efforts should be dedicated to demonstrating the clinical value of new medicinal products to patients and key decision-makers.
The goal of this research was to investigate the effectiveness of the 10-week, University of Missouri (MU) Extension strength training program Advanced Stay Strong, Stay Healthy (ASSSH). It was hypothesized that the program can improve strength, balance, agility, and flexibility—all physical measures of falling among seniors. Matched pair t tests were used to compare differences in five physical measures of health, body composition, and percent body fat (%BF). Two-way ANOVA was conducted to examine the age effects on changes in physical health from the start and finish of the exercise program. Following programming, participants significantly improved strength, flexibility, and balance, and significantly reduced %BF (p < .05). Our data indicate that ASSSH can improve the physical health of senior citizens and can successfully be translated into community practice by MU Extension professionals.
OBJECTIVES:The NICE Scientific Advice (SA) programme was established in 2009. It provides written advice to pharmaceutical companies and device manufacturers about development plans for their products to ensure they produce relevant evidence for future submission to NICE. Herein we present a detailed analysis of the NICE SA programme over the past three years. METHODS: The NICE SA process involves assessment of the manufacturer's briefing book with input from external clinical experts, health economists and methodological experts. Following a faceto-face meeting between the manufacturer, the expert panel and the SA technical team, a formal written report summarising the advice is produced. In addition, NICE SA provides advice alongside the European Medicines Agency (EMA) and other Health Technology Assessment (HTA) agencies. Whilst such collaborations do not include a formal written report, advice is given verbally at joint meetings. Following these meetings, NICE SA provides a commentary on the manufacturer's minutes, clarifying the issues identified from the perspective of NICE. RESULTS: To date the programme has successfully completed 52 formal written advice projects. Requests for advice alongside the EMA and other HTA agencies have been steadily increasing with 13 projects completed since 2010. We produced detailed analyses of all requests to the NICE SA programme to date. Specifically, we will report on the types of questions posed in manufacturers' briefing books including questions on health economic evaluation. We will include a breakdown by therapeutic area, frequency of requests by company, type of company, profiles of participants at meetings, and trends over time. CONCLUSIONS: We will reflect on how the various models of advice projects differ, how manufacturers can get the most from the process, and how the NICE SA programme is expected to evolve.
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