Browse views: by Year, by Function, by GLF, by Subfunction, by Conference, by Journal

Evaluation of Therapeutics for Severely Debilitating or Life-Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development

Liu, MM and Fields, FO and Prescott, JS and Bello, A and Bower, N and Hartke, J and Kadambi, V and Lapadula, Daniel and Stoch, A and Derzi, M (2020) Evaluation of Therapeutics for Severely Debilitating or Life-Threatening Diseases or Conditions: Defining Scope to Enable Global Guidance Development. Clinical Pharmacology and Therapeutics, 107 (3). pp. 514-520. ISSN 15326535

Abstract

A significant regulatory gap exists to facilitate global development of therapeutics for nononcology severely debilitating or life-threatening diseases or conditions (SDLTs). In a 2017 publication, a streamlined approach to the development of treatments for SDLTs was proposed to facilitate earlier and continued patient access to new, potentially beneficial therapeutics.1 However, a major hindrance to broad adoption of this streamlined approach has been the lack of universally accepted, objective criteria to define SDLTs. This article serves to extend the 2017 publication by further addressing the challenge of defining SDLT scope in order to stimulate broader discussion and facilitate development of regional and ultimately international guidelines on the development of therapeutics for SDLTs. Using case examples, we describe key attributes of SDLTs and provide criteria for consideration of an SDLT scope definition.

Item Type: Article
Date Deposited: 10 Mar 2020 00:45
Last Modified: 10 Mar 2020 00:45
URI: https://oak.novartis.com/id/eprint/39672

Search

Email Alerts

Register with OAK to receive email alerts for saved searches.