Kommentare zu den "Scientific Guidelines for Human Medicinal Products" der European Medicines Agency
Die European Medicines Agency stellt ihre "Scientific Guidelines for Human Medicinal Products" vor Inkrafttreten zur allgemeinen Diskussion (Details). Die Deutsche Region der Biometrischen Gesellschaft nimmt dies in der Regel wahr und kommentiert die Entwürfe bei Bedarf. Wenn Guidelines zur Kommentierung anstehen, sind Mitglieder, die besondere Expertise auf dem jeweiligen Gebiet haben, aufgerufen, ihre Kommentare bis 4 Wochen vor Ablauf der Kommentierungsfrist an Antonia Zapf oder an Christoph Gerlinger zu senden. Die Kommentare werden dann zu einer Stellungnahme zusammengestellt und im Namen der Gesellschaft an die European Medicines Agency versendet.
Seit Mai 2004 wurden Stellungnahmen zu folgenden Entwürfen abgegeben:
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017, 7 May 2018)
- Guideline on multiplicity issues in clinical trials (EMA/CHMP/44762/2017, 27 June 2017)
- Guideline on multiplicity issues in clinical trials (EMA/CHMP/44762/2017, Draft 22 May 2017)
- ICH E17 General principles for planning and design of multi-regional clinical trials (Current Step 2 version, 6 May 2016)
- Guideline on the investigation of subgroups in confirmatory clinical trials (EMA/CHMP/539146/2013, Draft 23 January 2014)
- Guideline on missing data in confirmatory trials (CPMP/EWP/1776/99 Rev. 1 Corr, Draft 23 April 2009)
- Guideline on the use of statistical signal detection methods in the Eudravigilance Data Analysis System
- Reflection Paper on Methodological Issues in Confirmatory Clinical Trials with Flexible Design and Analysis Plan (CHMP/EWP/2459/02, Draft 23 March 2006)
- CCHMP Guideline on Clinical trials in Small Populations (CHMP/EWP/83561/2005, Draft, 17 March 2005)
- CHMP Guideline on the Evaluation of Anticancer Medicinal Products in Man(CHMP/EWP/205/95 Rev. 3, Draft, 17 March 2005)
- CHMP Guideline on Non-clinical and Clinical Development of Medicinal Products for the Treatment of Nausea and Vomiting associated with Cancer Chemotherapy(CPMP/EWP/4937/03, Draft, 17 February 2005)
- CHMP Guideline on Clinical Investigation of Medicinal Products for the Treatment of Hormone Replacement Therapy (CHMP/EWP/021/97, Rev. 1, Draft, 20 January 2005)
- CHMP Guideline on Clinical Investigation on Medicinal Treatment for the Treatment of Social Anxiety Disorder (SAD) (CHMP/EWP/3635/03, Draft, 18 November 2004)
- CHMP Guideline on Data Monitoring Committees (CHMP/EWP/5872/03, Draft, 18 November 2004)
- ICH E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (CHMP/ICH/2/04, ICH Step 2, 10 June 2004)
- CPMP Points to Consider on the Clinical Investigation of Medicinal Products for the Treatment of Neuropathic Pain (CPMP/EWP/252/03, Draft, 26 February 2004)
- CPMP Note for Guidance on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function (CPMP/EWP/2339/02, Draft, 26 February 2004)
- CPMP Points to Consider on the Choice of Non-Inferiority Margin (CPMP/EWP/2158/99, Draft, 26 February 2004)
- ICHE2E: Note for Guidance on Planning Pharmacovigilance Activities (CPMP/ICH/5716/03, Draft, 20 November 2003)
- CPMP Note for Guidance on Clinical Investigation of Medicinal Products Indicated for the Treatment of Psoriasis (CPMP/EWP/2454/02, Draft, 20 November 2003)
- Note for Guidance on Clinical Investigation of SteroidContraceptives (CHMP/EWP/519/98 Rev1, Draft, 23 June 2003)