Innovation in clinical trial methodologies : lessons learned during the Corona pandemic / edited by Peter Schüler, MD, Senior Vice President, Drug Development Services Neurosciences, ICON, Langen, Germany

Front Cover -- Innovation in Clinical Trial Methodologies -- Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic -- Copyright -- Contents -- Contributors -- Foreword -- REFERENCE -- 1 - Introduction -- 1 - Is the Covid pandemic an accelerator for digitalization in our industry? -- Reference -- 2 - Best practices for streamlining development -- The need -- The solution -- Social media -- Electronic health repositories -- Telehealth -- Wearable technologies -- SWOT analysis -- Outline placeholder -- Strengths -- Weaknesses -- Opportunities -- Threads -- Take-home message -- References -- 2 - Alternative study concepts requiring less patients -- 3 - Use of historic control data -- The need -- The solution -- Frequentist approach -- Bayesian approach -- How to incorporate historical data -- Evaluating and sourcing external data for historical controls -- Key concepts -- Resources for use in development of external controls -- Examples (Bayesian applications) -- Benlysta (belimumab) approval -- Phase-3 noninferiority study in a rare form of cancer -- Phase-3 equivalence study for a proposed biosimilar in patients with Diabetic Macular Edema (DME) -- Examples (frequentist applications) -- Brineura (cerliponase alfa) approval -- Exondys 51 (eteplirsen) approval -- Cystic fibrosis medication comparison with external control -- Applicable regulations -- Take-home message -- References -- 4 - Adaptive and platform trials -- The need -- The solution -- How does an adaptive design work? -- Platform trials -- Objections to adaptive designs -- Potential gains from adaptive designs -- SWOT analysis -- Applicable regulations -- Take-home message -- References -- 5 - A vision: in silico clinical trials without patients -- The need -- The solution -- SWOT analysis -- Outline placeholder -- Strengths -- Weaknesses -- Opportunities..

Medienart:	E-Book

Erscheinungsjahr:	[2021] ©2021
Erschienen:	London San Diego, CA Cambridge, MA Oxford: Elsevier, Academic Press ; 2021 ©2021

Weitere Ausgaben:	Erscheint auch als Druck-Ausgabe: Innovation in clinical trial methodologies

Sprache:	Englisch

Beteiligte Personen:	Schüler, Peter [VerfasserIn]

Links:	Volltext [lizenzpflichtig]

ISBN:	978-0-323-86006-2

Themen:	Clinical Trials as Topic Clinical trials Drugs Electronic books

RVK:	RVK Klassifikation XC 2011

Anmerkungen:	Description based on publisher supplied metadata and other sources

Umfang:	1 Online-Ressource (xvi, 185 Seiten)

Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1738840395