A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial

The need for proportionate regulation of clinical trials

(2013) Pamela Kearns   LANCET ONCOLOGY

Randomized Clinical Trials — Removing Unnecessary Obstacles

(2013) Christina Reith et al.   NEW ENGLAND JOURNAL OF MEDICINE

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

(2012) Christian Gluud et al.   Trials

Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

(2012) Markus Hartmann   Trials

Reforming the Regulations Governing Research with Human Subjects

(2011) Ezekiel J. Emanuel et al.   NEW ENGLAND JOURNAL OF MEDICINE

Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies — The Pre-Optimon study

(2010) Valérie Journot et al.   Contemporary Clinical Trials

Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials

(2009) Oana Brosteanu et al.   Clinical Trials

Ethical and Scientific Implications of the Globalization of Clinical Research

(2009) Seth W. Glickman et al.   NEW ENGLAND JOURNAL OF MEDICINE

The Unintended Consequences of Clinical Trials Regulations

(2009) Alex D. McMahon et al.   PLOS MEDICINE

Does the European Clinical Trials Directive really improve clinical trial approval time?

(2008) Hiddo J. Lambers Heerspink et al.   BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Globalization of sponsored clinical trials

(2008) Johan P. E. Karlberg   NATURE REVIEWS DRUG DISCOVERY

Trends in the globalization of clinical trials

(2007) Fabio A. Thiers et al.   NATURE REVIEWS DRUG DISCOVERY