Daniel Strech

ORCID: 0000-0002-9153-079X · 2 papers in corpus · active 2018-2022
2022
Reporting of Retrospective Registration in Clinical Trial Publications: a Cross-Sectional Study of German Trials
·doi:10.1101/2022.10.09.22280784

Objective: Prospective registration has been widely implemented and accepted as a best practice in clinical research, but retrospective registration is still commonly found. We assessed to what extent retrospective registration is reported…

2018
Preclinical efficacy in therapeutic area guidelines from the U.S. Food and Drug Administration and the European Medicines Agency: a cross-sectional study.
British journal of pharmacology ·doi:10.1111/bph.14485

Background and purposeTherapeutic area guidelines (TAGs) published by the EMA and the FDA offer guidance in planning the launch of a trial in a certain indication. We assessed and compared the guidance on preclinical efficacy of all availab…