How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.

Purpose: A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator's Brochure (IB) for meaningful risk assessment of early clinical trials.

Unintended drug exposure during pregnancy in clinical trials - a survey in early drug development.

Purpose: To collect information on unintended drug exposure during pregnancy in early clinical drug development.

Materials And Methods: Questionnaire mailed in autumn 2015 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey.

Results: 53 of the ~ 700 addressees participated in the survey.

Use of integrated clinical trial protocols - A survey in early medicines development .

Purpose: To collect information on the use of integrated protocols in early clinical medicines development.

Materials And Methods: The questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey.

Results: 97 respondents reported on 164 integrated protocols overall.

Who is a 'healthy subject'?-consensus results on pivotal eligibility criteria for clinical trials.

Introduction/methods: A discussion forum was hosted by the German not-for-profit Association for Applied Human Pharmacology (AGAH e.V.) to critically review key eligibility criteria and stopping rules for clinical trials with healthy subjects, enrolling stakeholders from the pharmaceutical industry, contract research organisations, academia, ethics committees and competent authority.

The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study.

Background: Empagliflozin is a potent, selective sodium glucose cotransporter 2 (SGLT2) inhibitor in development as an oral antidiabetic treatment. This QT interval study assessed potential effects of empagliflozin on ventricular repolarisation and other electrocardiogram (ECG) parameters.

Methods: A randomised, placebo-controlled, single-dose, double-blind, five-period crossover study incorporating a novel double-placebo period design to reduce sample size, while maintaining full statistical power.