Nr. 148
27 mei 2022

Beste abonnee,

Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 27 mei 2022, met een overzicht van de laatste ontwikkelingen rond wet- en regelgeving en mensgebonden onderzoek.

Met vriendelijke groet,

Vincent Bontrop
www.bontrop.com

Inhoudsopgave

• Gereviseerde 'ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals' gepubliceerd
• De IVDR is van toepassing geworden
• Nieuw gepubliceerd: MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746
• EMA publiceert rapport met 'Key performance indicators (KPIs) to monitor the European clinical trials environment'
• 15 jaar oude 'annexes to procedures for conducting GCP inspections requested by the CHMP' bijgewerkt
• Publieke consulaties
• Proefschriften
• Overig nieuws
• Uitgelicht en gespot op internet

Gereviseerde 'ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals' gepubliceerd

Het International Committee of Medical Journal Editors (ICMJE) heeft op 20 mei 2022 een bijgewerkte versie van de 'Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals' gepubliceerd.

Bijgewerkt zijn de secties III.D.2. 'Duplicate and Prior Publications' en IV.A.3.d.i. 'Selection and Description of Participants'. Zoals we gewend zijn van het ICMJE is er ook een versie met gemarkeerde wijzigingen beschikbaar, klik hier om de geannoteerde PDF te raadplegen.

Lees verder

• ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (May 2022)
• ICMJE Nieuwsbericht Up-Dated ICMJE Recommendations (May 2022).
  

De IVDR is van toepassing geworden

Donderdag 26 mei 2022 is de EU verordening betreffende medische hulpmiddelen voor in-vitro diagnostiek (IVDR) van toepassing geworden.

Meer lezen

• CCMO themapagina 'Prestatiestudies naar in-vitro diagnostica (IVDR)'
• Public health: Stronger rules for placing medical tests on the market (25-05-2022). Press release European Commission.
• Happy IVDR day! (26-05-2022). Medicaldeviceslegal.
• The EU IVDR is here! (26-05-2022). BioSlice Blog, Arnold & Porter.
• Critical Implications of IVDR for Innovation in Diagnostics: Input From the BioMed Alliance Diagnostics Task Force. HemaSphere: June 2022 - Volume 6 - Issue 6 - p e724.

Nieuw gepubliceerd: MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746

De Medical Device Coordination Group (MDCG) heeft op 25 mei 2022 de 'MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746' gepubliceerd.

Lees verder

• MDCG 2022-10 - Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) - May 2022.

EMA publiceert rapport met 'Key performance indicators (KPIs) to monitor the European clinical trials environment'

Het eerste rapport met een overzicht van Key Performance Indicators (KPI's) gerelateerd aan de implementatie van de EU verordening betreffende klinische proeven (CTR) is op 20 mei 2022 door het European Medicines Agency (EMA) gepubliceerd.

Het rapport zal maandelijks worden gepubliceerd en is onderdeel van Accelerating Clinical Trials EU (ACT EU) programma.

"ACT EU seeks to transform how clinical trials are initiated, designed and run. One of the priority actions of ACT EU focusses on monitoring the implementation of the CTR. The metrics presented [in this report] reflect the status of applications in CTIS and EudraCT as of 2 May 2022 for Clinical Trial applications (CTA) submitted between 31 January 2022 and 30 April 2022."

bron: pagina 1, Key performance indicators (KPIs) to monitor the European clinical trials environment. Metrics on the Clinical Trials Regulation and Clinical Trials Directive d.d. 18-05-2022.

Lees verder

• Key performance indicators (KPIs) to monitor the European clinical trials environment. Metrics on the Clinical Trials Regulation and Clinical Trials Directive (18-05-2022).
• Website EMA 'Clinical Trials Regulation: progress on implementation'.
  

15 jaar oude 'annexes to procedures for conducting GCP inspections requested by the CHMP' bijgewerkt

Het European Medicines Agency (EMA) heeft op 5 mei 2022 de bijgewerkte 'Annexes to procedures for conducting GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP)' gepubliceerd.

De hieronder genoemde bijlagen zijn bijgewerkt:

• Annex I to procedure for conducting GCP inspections requested by the CHMP: Investigator site (updated 05-05-2022).
• Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories (updated 05-05-2022).
• Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO) (updated 05-05-2022).
• Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents (updated 05-05-2022).
• Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (updated 05-05-2022).

Meer lezen

• Euro Roundup: EMA updates annexes on procedures for running GCP inspections (12-05-2022). Regulatory Focus.
• Website EMA 'Good clinical practice (GCP) inspection procedures'

Overig nieuws

Advanced therapy medicinal products (ATMP), Genetically modified organisms (GMO)

• Pandemic highlighted challenges of ATMP clinical trials in Europe (12-05-2022). Regulatory Focus.

Dutch Clinical Research Foundation (DCRF)

• EU CTR: Processen veranderen, maar METCs blijven toetsen op nut en noodzaak (18-05-2022).

European Medicines Agency (EMA)

• EMA Clinical Trials Highlights, Issue 9, May 2022.
• Synchron Research Service: suspension of medicines over flawed studies (20-05-2022).

International Council for Harmonization (ICH)

• ICH Plans Drug Development Guideline to Boost Trial Design (09-05-2022). WCG CenterWatch. 
• Pharmaceutical industry groups suggest ICH Q9 changes (06-05-2022). Regulatory Focus.

Er lopen momenteel een aantal interessante publieke consultaties:

• Draft ICH guideline E11A on pediatric extrapolation Step 2b
• Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes – Revision 2
• Draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)

Voor een volledig overzicht van publieke consultaties, surveys en enquêtes ga naar consultaties.bontrop.com of klik op de knop hieronder.

• Replication, bias, and meta-research in animal cognition research (11-05-2022). Farrar, Benjamin.
• Transforming the health research system: Embedding patient engagement in decision-making (17-12-2021). Lidewy Eva Vat.

• Clinical Trials Day: Celebrating 275 Years Since the First Controlled Trial (20-05-2022). Applied Clinical Trials.
• Blog Erwin Vermeulen: World Clinical Trial Day (17-05-2022). Vereniging Innovatieve Geneesmiddelen.
  
• Sofie Boutkan (NKI): ‘Passende behandeling voor elke patiënt’ (17-05-2022). Vereniging Innovatieve Geneesmiddelen.
  
• Drie insiders over belang klinisch onderzoek (17-05-2022). Vereniging Innovatieve Geneesmiddelen.

Commissie Regelgeving Onderzoek (COREON)

• COREON sessie op WEON 2022 (20-05-2022).

Dutch Oncology Research Platform (DORP)

• DORP draagt bij aan CCMO Project Patiëntenparticipatie in klinisch onderzoek – een update (13-05-2022).
• Terugblik op tweede werkconferentie Cohorten (12-05-2022).

Rathenau Instituut 

• Society and synthetic cells. A position paper by the Future Panel on Synthetic Life (26-04-2022).
• Society and synthetic cells – A position paper by the Future Panel on Synthetic Life. The Hague: Rathenau Instituut.

Real World Evidence (RWE)

• Use of Real-World Evidence in the UK (25-05-2022). BioSlice Blog, Arnold & Porter.
• Real world evidence: Lessons learned from an FDA pilot show the limits of emulating RCTs (16-05-2022). Endpoints News.

Representation in Clinical Trials

• Lack of Equitable Representation in Clinical Trials Compounds Disparities in Health and Will Cost U.S. Hundreds of Billions of Dollars; Urgent Actions Needed by NIH, FDA, Others to Boost Representation (17-05-2022). National Academies of Sciences, Engineering, and Medicine.
• Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups (2022). National Academies of Sciences, Engineering, and Medicine.
  • New report urges more clinical trial diversity, recommends incentives (18-05-2022). Regulatory Focus.
  • National Academies report cites ‘urgent’ need to recruit more diverse participants for clinical trials (17-05-2022). STAT.
• Nature journals raise the bar on sex and gender reporting in research (18-05-2022). Nature.

World Health Organization (WHO)

• Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination (24-05-2022). Draft resolution proposed by Argentina, Peru, United Kingdom of Great Britain and Northern Ireland.
• WHO member states pledge to tackle research waste (25-05-2022). TranspariMED.
• WHA clinical trial resolution: draft text now public (24-05-2022). TranspariMED.

Overige berichtgeving

• Evaluating the evaluators - Developing evidence of quality oversight effectiveness for clinical trial monitoring: Source data verification, source data review, statistical monitoring, key risk indicators, and direct measure of high risk errors (juni 2022). Contemporary Clinical Trials.
• Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes (16-05-2022). Trials.
• TMF Development Group Joins CDISC to Create Better Model (02-05-2022). WCG CenterWatch.

Actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com

events.bontrop.com

consultations.bontrop.com

Oude uitgaven van de nieuwsbrief zijn te vinden in het archief, klik hier.