[Innovative drug development: ethical and regulatory challenges].

Authors

Thomas D Szucs

Published in

Therapeutische Umschau. Revue therapeutique. Volume 83. Issue 4. Pages 151-156.

Abstract

Drug development is undergoing profound change. Accelerated regulatory processes, gene and cell therapies, the use of artificial intelligence, and the increasing use of real-world evidence are fundamentally transforming the pharmaceutical innovation system. These developments offer patients faster access to effective therapies, but at the same time raise significant ethical and regulatory questions: How can the protection of trial participants be reconciled with the desire for rapid innovation transfer? How can an evidence-based risk-benefit assessment be successful when pivotal trials are small and short? What mechanisms ensure the equitable distribution of high-cost therapies in a solidarity-based healthcare system such as Switzerland's? This overview outlines the key trends and provides guidance for practising doctors on the use of innovative medicines.

PMID:
42678140
Bibliographic data and abstract were imported from PubMed on 01 Sep 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.