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Safety studies

Oncologists’ reflections on patient rights and access to compassionate use drugs: A qualitative interview study from an academic cancer center

Jeremiah Stout, Cambray Smith, [ ... ], Zubin Master

Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

Corey A. Kalbaugh, Julianne M. Kalbaugh, Lisa McManus, Jill A. Fisher

Description of adverse events among adult men following voluntary medical male circumcision: Findings from a circumcision programme in two provinces of South Africa

Evans Muchiri, Salome Charalambous, [ ... ], Candice M. Chetty-Makkan

Understanding and predicting COVID-19 clinical trial completion vs. cessation

Magdalyn E. Elkin, Xingquan Zhu

The impact of COVID-19 on the clinical trial

Zhimin Chen, Liran Chen, Huafang Chen

Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study

Atul T. Patel, Mark F. Lew, [ ... ], Allison Brashear

On the coherence of model-based dose-finding designs for drug combination trials

Yeonhee Park, Suyu Liu

Efficacy, tolerability, and safety of an innovative medical device for improving oral accessibility during oral examination in special-needs patients: A multicentric clinical trial

Mathieu Mogenot, Laurence Hein-Halbgewachs, [ ... ], Daniel Anastasio

Institutional work to maintain, repair, and improve the regulatory regime: How actors respond to external challenges in the public supervision of ongoing clinical trials in the Netherlands

Jacqueline C. F. van Oijen, Iris Wallenburg, Roland Bal, Kor J. Grit

Lower-dose prescriptions in the post-marketing situation and the influencing factors thereon

Akiko Ogata, Masayuki Kaneko, Mamoru Narukawa

Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C in patients aged 65 years or older

Graham R. Foster, Tarik Asselah, [ ... ], Federico J. Mensa

Central adjudication of serious adverse events did not affect trial’s safety results: Data from the Efficacy of Nitric Oxide in Stroke (ENOS) trial

Peter J. Godolphin, Alan A. Montgomery, [ ... ], on behalf of the ENOS Investigators

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961–1990)

Rainer Erices, Andreas Frewer, Antje Gumz

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