This study evaluates whether an adaptive development and licensing approach to drug development, compared with approaches widely used today, might have tangible advantages across stakeholder groups, thereby facilitating the future adoption. Details involving actual and modeled clinical development and licensing programs for 3 case studies were used as inputs into a discounted cash flow spreadsheet model. Outputs included net present value and expected net present value, which are metrics considered as key incentives for pharmaceutical developers, and change in patient access over the product life and numbers of appropriately and inappropriately treated patients, which are metrics considered as key incentives for regulators, patients, and prescribers. Actual and modeled development programs were compared using an "adaptiveness" scoring algorithm. Generally, the more adaptive programs correlated with more favorable stakeholder outcomes. However, favorable outcomes may be overwhelmed in some cases, and the causative conditions and stakeholder reactions need to be defined.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1177/2168479013487355 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Informal care for people with dementia in Europe.
J Prev Alzheimers Dis
January 2025
Division of Neurogeriatrics, Department of Neurobiology Care Sciences and Society; Karolinska Institutet; Sweden; BioClinicum J9:20, Akademiska stråket, 171 64 Solna, Sweden.
Introduction: Informal care estimates for use in health-economic models are lacking. We aimed to estimate the association between informal care time and dementia symptoms across Europe.
Methods: A secondary analysis was performed on 13,529 observations in 5,369 persons from 9 European pooled cohort or trial studies in community-dwelling persons with dementia.
Proton radiotherapy significantly reduces pneumonia in oesophageal cancer patients.
Int J Radiat Oncol Biol Phys
January 2025
Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address:
Background: Neoadjuvant chemoradiotherapy (nCRT) followed by surgical resection is the current standard of care for oesophageal cancer (EC) patients. This treatment is associated with a variety of complications, with pneumonia being the most common. We hypothesize that proton radiotherapy (PRT) can significantly reduce the incidence of pneumonia compared to photon radiotherapy (PhRT).
View Article and Find Full Text PDFMeasuring the impact of a catchment area surveillance tool on cancer center adopters.
Cancer
January 2025
Markey Cancer Center, University of Kentucky, Lexington, Kentucky, USA.
Background: The University of Kentucky Markey Cancer Center developed the data gathering and visualization platform Cancer InFocus (CIF) as a solution for cancer center catchment area surveillance. CIF was released in June 2022 and made available for use to other institutions through a no-cost licensing agreement. The purpose of this study was to evaluate the impact CIF has had on cancer centers since its release.
View Article and Find Full Text PDFResults from the PROmoting Early Childhood Outside cluster randomized trial evaluating an outdoor play intervention in early childhood education centres.
Sci Rep
January 2025
Department of Pediatrics, University of British Columbia, British Columbia Children's Hospital Research Institute, F508 - 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
Article Synopsis
- Outdoor play is crucial for children's health and development, and ECECs can help provide this access.
- The PRO-ECO study tested an intervention designed to increase outdoor play in children aged 2.5 to 6 years across eight ECECs in Vancouver.
- Although the initial results showed no significant overall changes in outdoor play participation, there was a slight positive trend in the intervention group 6 months post-implementation, suggesting further research is needed to evaluate the intervention's effectiveness fully.
Protocol to study inter-tissue communication between the hypothalamus and white adipose tissue and lifespan using a chemogenetic approach in aged mice.
STAR Protoc
January 2025
Department of Developmental Biology, Washington University School of Medicine, St. Louis, MO 63110, USA; Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA. Electronic address:
Here, we present a protocol for assessing the impact of a chemogenetic manipulation in a subpopulation of the hypothalamic neurons on aging and lifespan control using a mouse model developed specifically for this purpose. We describe steps for stereotaxic viral injection and assess inter-tissue communication between protein phosphatase 1 regulatory subunit 17 (Ppp1r17)-expressing neurons in the dorsomedial hypothalamus and white adipose tissue. We then detail procedures for lifespan measurements following chemogenetic manipulation in aged mice.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!