Nieuwsbrief voor Goede Onderzoekspraktijken

Nr. 156
15 november 2022

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 15 november 2022, met een overzicht van de laatste ontwikkelingen rond wet- en regelgeving en mensgebonden onderzoek.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

U kunt met mij linken via LinkedIn en met Mastodon.

Associatie van Contract Research Organisaties in Nederland (ACRON)

• Presentaties ACRON Symposium “Digitalisering in de Zorg” (07-11-2022).

Dutch Clinical Research Foundation (DCRF)

• Dineke Amsing: ‘Stevig fundament voor nieuwe DCRF’ (01-11-2022). Vereniging Innovatieve Geneesmiddelen.
• De DCRF volgt een nieuwe koers – een interview met DCRF-bestuurslid Bart Scheerder (29-10-2022).
• Vernieuwde examens GCP-WMO (24-10-2022).

Dutch Oncology Research Platform (DORP)

• Systematic review over alternatieve RCT designs in chirurgische trials (07-11-2022).

Loket Gentherapie

• Wijziging werkwijze indienen SNIF (03-11-2022).

Vereniging Innovatieve Geneesmiddelen

• Nieuwe samenwerkingen tussen Zweden en Nederland op vlak klinisch onderzoek (25-10-2022).

Publieke consultatie geopend voor 'EMA Concept paper on platform trials'

Het European Medicines Agency (EMA) heeft vorige week de publieke consultatie geopend voor het "concept paper on platform trials":

"Platform trials have become more common in the recent years. Currently, they are frequently seen in Scientific Advice and more rarely as part of Marketing Authorisation Applications. This is, however, likely to change during the coming years. They contain some unique, mostly methodological, aspects and it has become apparent that a reflection paper is needed to enable adequate planning of platform trials such that they can be used as pivotal trials. The aim of the reflection paper is to complement existing guidance documents, e.g. on multiplicity and adaptive design, and not to replace or revise them."

bron: Concept paper on platform trials, pagina 2.

De deadline voor het aanleveren van commentaar op het concept paper on platform trials is 31 januari 2023.

Publieke consultatie geopend voor ICH M11 guideline, clinical study protocol template and technical specifications

Het European Medicines Agency (EMA) heeft de publieke consultatie geopend voor de ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), het clinical study protocol template en de Technical Specifications.

"The purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory authorities. The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardized content with both required and optional components. The Technical Specification that are acceptable to all regulatory authorities of the ICH regions presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content with a view to develop an open, non-proprietary standard to enable electronic exchange of clinical protocol information."

bron: EMA website 'ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline'

De deadline voor het aanleveren van commentaar op de documenten is 10 februari 2023.

Lees verder

• ICH M11 guideline, clinical study protocol template and technical specifications – Step 2b
• ICH M11 technical specification – Step 2b
• ICH M11 clinical study protocol template – Step 2b

Gerelateerd

• ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers (06-11-2022). Regulatory Focus.

European Clinical Research Infrastructrure Network (ECRIN) 

• Public database inventorying the national health databases and registries (09-11-2022).

European Medicines Agency (EMA)

• Presentations – ACT EU multi-stakeholder meeting on decentralised clinical trials (08-11-2022).
• Terugkijken: ACT EU multi stakeholder workshop on Decentralised Clinical Trials. via YouTube.

Sample Size Justification

• Shiny app for Sample Size Justification
  This Shiny app accompanies the paper ‘Sample Size Justification’ by Daniël Lakens. … The main goal of this app and the accompanying paper is to guide you through an evaluation of the informational value of a planned study. After filling out this form you can download a report of your sample size justification.

Trial Master File Reference Model (TMF RM)

• The Impact of the EU CTR on the TMF Content and Process (02-11-2022).
• TMF Reference Model White Paper on the Impact of the EU CTR on TMF Content April 7, 2022.
• CDISC TMF Plan Template v2 Available (02-11-2022).

Weesgeneesmiddelen, Orphan medicines

• The Revision of the Orphan Medicines Regulation Is an Opportunity. Will Europe Seize it? (11-11-2022). EuropeBio
• ‘Dogma’ About Innovation vs. Access Impeding EU Fixes for Rare Diseases (10-11-2022). Applied Clinical Trials.
• Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases (15-09-2022). Trials.

Overige berichten

• Consent is a confounding factor in a prospective observational study of critically ill elderly patients (27-10-2022). PLOS ONE 17(10): e0276386.
• The Netherlands is good at collecting data but not at (re)using it (9 November 2022).
• Participants’ Perspectives on Payment for Research Participation: A Qualitative Study (01-11-2022). Ethics & Human Research.
• Challenges and Possible Solutions to Adapting to Virtual Recruitment: Lessons Learned from a Survey Study during the Covid‐19 Pandemic (01-11-2022). Ethics & Human Research.
• A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial (27-10-2022). Trials.
• Pushing and Dragging the New European Clinical Trials Rules into Shape (26-10-2022). Applied Clinical Trials.