Uitgelicht en gespot op internet (week 5, 2022)

Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet. Er zijn ook weer nieuwe bijeenkomsten en publieke consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.

‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

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Clinical trials, Clinical research, Platform trials

• Reporting of trials with possible detrimental overall survival: a patient advocate perspective )februari 2022). The Lancet Haematology.
• Choosing drugs for UK COVID-19 treatment trials (07-12-2021). Nature Reviews Drug Discovery.
• FDA Final Guidances Expand on Patient Advisers, PROs in Device Trials (31-01-2022). WCG CenterWatch.
• Institutions Still Sluggish to Report Clinical Trial Results, Analysis Finds (31-01-2022). WCG CenterWatch.
• Preprint: Transparency in conducting and reporting research: a survey of authors, reviewers, and editors across scholarly disciplines (26-01-2022). Research Square.
• Ben Goldacre: The use and safety of data (26-01-2022). Genomics England, via PodBean.
• Understanding Various Decentralized Terms in Research (26-01-2022). Advarra.
• Budgeting and Billing Compliance in Study Activation (18-01-2022). Advarra.
• Developing an Emergency Preparedness Plan for your HRPP (11-01-2022). Advarra.
• Considerations for Transitioning from Paper to eSource (10-01-2022). Advarra.

Clinical Trials Regulation (CTR) (aanpassing WMO, bestuursrechtelijke handhaving, fabrikantenvergunning, GMP-Z)

euclinicaltrials.eu

• Centrale Commissie Mensgebonden Onderzoek
  • Model naleving regels gebruik lichaamsmateriaal/Template biological samples, version 11 January 2022. Compliance with Member State applicable rules for the collection, storage and future use of human biological samples (Article 7.1h of EU Regulation 536/2014).
  • Model naleving regels dataprotectie/template (personal) data, version 13 January 2022. Compliance with Member State applicable rules for the collection, storage and future use of (personal) data (article 7 (1 d) of EU Regulation 536/2014).
• Dutch Clinical Research Foundation (DCRF)
  • Reflecties van de DCRF CTR Stuurgroep (31-01-2022).
  • Uit de praktijk: Hoe je als sponsor het VGO proces zo goed mogelijk kunt voorbereiden (31-01-2022).
  • Samenwerken om zo sneller patiënten te laten profiteren van nieuwe behandelingen: Vandaag is de nieuwe Europese Clinical Trial Regulation (CTR) live gegaan! (31-01-2022).
• EudraLex
  • Update – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials (04-02-2022).
  • Update – Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (04-02-2022).
  • Questions and Answers Document – Regulation (EU) 536/2014 – Version 5 (January 2022)
  • New template – Compliance with applicable rules for biological samples (01-02-2022).
• België: Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG)
  • Klinische proeven: nieuwe Europese verordening treedt in werking (31-01-2022).
  • Website sectie ‘Klinische proeven’ totaal vernieuwd.
• Inspectie Gezondheidszorg en Jeugd (IGJ)
  • Nieuwe regels voor onderzoek met geneesmiddelen van kracht (31-01-2022).
• EU Clinical Trials Regulation: Today is the Day! (31-01-2022). BioSlice Blog.
• Today publication of drug trial results becomes mandatory in 30 European countries. TranspariMED.
• EU wants to get back among the world leaders in clinical research (27-01-2022). EURACTIV.

Commissie Genetische Modificatie (COGEM)

• Signalerende brief bij onderzoeksrapport ‘On the nature of nature – A study on the use and meaning of nature and (un)naturalness in the literature on genetic modification’ (01-02-2022).
• Onderzoeksrapport: On the nature of nature – A study on the use and meaning of nature and (un)naturalness in the literature on genetic modification (01-02-2022).

Corrective (Actions) and Preventive Actions (CAPA)

• Praktische tips om snel de CAPA achterstand weg te werken (28-01-2022). Quality Business Support.

Data sharing, Genomic medicine

• The difficulties of broad data sharing in genomic medicine: Empirical evidence from diverse participants in prenatal and pediatric clinical genomics research (30-11-2021)> Genetics Medicine.

Enhancing the QUAlity and Transparency Of health Research (EQUATOR Network)

• EQUATOR Network Newsletter January 2022 (31-01-2022).
  • The EQUATOR Network Reporting Guideline database audit has preliminary findings
  • Methods Wizard: a new online tool to help with writing systematic review protocols
  • EQUATOR-UKRN webinar: enhance your writing and peer review in biomedical research with reporting guidelines
  • Questions answered: PRISMA authors clarify guidance for flow diagrams in systematic reviews
  • Guideline for reporting economic evaluations updated: CHEERS 2022
  • Sex and gender in reporting guidelines for health research: a systematic review

European Commission

• 2022 EU4Health Work Programme – Background document

Funding

• The Karikó problem: Lessons for funding basic research (01-02-2022). STAT.

Inclusiviteit, Diversiteit, Representativiteit

• Meer diversiteit nodig bij geneesmiddelenstudies migraine (28-01-2022). Amazing Eramus MC.
• Calcitonin gene-related peptide-targeting drugs for migraine: how pharmacology might inform treatment decisions (27-01-2022). The Lancet Neurology.
• Improving Patient Centricity and Research Access (04-01-2022). Advarra.
• Verenigde Staten: Eshoo, Kelly, and Fitzpatrick Introduce Bill to Strengthen Diversity in Clinical Trials (03-02-2022). Congresswoman Anna G. Eshoo.

Provides FDA with the authority to mandate post-market studies when sponsors fail to meet diversity enrollment targets and do not provide a sufficient justification.

bron: Eshoo, Kelly, and Fitzpatrick Introduce Bill to Strengthen Diversity in Clinical Trials (03-02-2022). Congresswoman Anna G. Eshoo.

Integraal Kankercentrum Nederland (IKNL)

• Eenheid van taal.
• NKR symposium 2021: Myriam Koopman – Eenheid van taal voor betere zorg en onderzoek, via YouTube.

International Council for Harmonization (ICH) 

• ICH guide provides clarity on estimands, sensitivity analyses (31-01-2022). Regulatory Focus.

Medical Device Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR)

• Update on the MDR and IVDR in the EU (28-01-2022). BioSlice Blog, Arnold & Porter.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Public Consultation on new Clinical Trials Legislation (01-02-2022). Blog MHRA Inspectorate.
• Guidance Oversight and monitoring of investigational medical product trials (28-01-2022).
• Guidance Risk-Adapted Approach to clinical trials and Risk Assessments (28-01-2022).

Nederlandse Federatie van Universitair Medische Centra (NFU)

• Randvoorwaarden wetenschappelijk onderzoek: Nationale Leidraad Kennisveiligheid gepubliceerd (31-01-2022).
• Kabinet komt kennisinstellingen te hulp met nieuw Loket Kennisveiligheid (31-01-2022). Ministerie van OCW.
• Rijksbreed loket kennisveiligheid.
• Nationale Leidraad Kennisveiligheid (januari 2022). VH, UNL, KNAW, NWO, NFU, TO2-federatie & Rijksoverheid.

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 143 (31-01-2022).
  Nog geen abonnee? Klik hier om u te abonneren op de nieuwsbrief.

Nuffield Council on Bioethics

• Exploring the UK bioethics landscape – how do we embed bioethics thinking in research culture and policy making? (03-02-2022).

Pharmaceutical Inspection Co-operation Scheme (PIC/S), Good Manufacturing Practice

• Revision of PIC/S GMP Guide (PE 009-16) (februari 2022).
  • PIC/S GMP Guide (introduction)
  • PIC/S GMP Guide (Part I)
  • PIC/S GMP Guide (Part II)
  • PIC/S GMP Guide (Annexes)
  • PIC/S GMP Guide (ZIP)
• PIC/S revises GMP guide to reflect new EU clinical trials regulation (01-02-2022). Regulatory Focus.

De RSS feed van deze instantie/organisatie is toegevoegd aan de ‘Nieuws’ overzichtspagina van dit weblog, zie news.bontrop.com

Preklinisch onderzoek

• Preclinical cancer research suffers another reproducibility blow (13-01-2022). Nature Reviews Drug Discovery.

TransCelerate BioPharma Inc.

• Diversity Roundtable Reference Table and Visual Landscape of Available Resources (januari 2022).

Verenigde Staten, Clinical Trial Fraud

• DOJ Increases Focus on Clinical Trial Fraud (01-02-2022). Ropes & Gray.
• Fake Histories, Calls by Staff Impersonating Subjects: A Look Inside Two Trial Fraud Cases (28-01-2022). JD Supra.
• Phantom Participants with Real-World Ramifications: Clinical Drug Trial Data Falsification (25-01-2022). The National Law Review.

Overige berichten

• Weekend reads: ‘Death threats, ghost researchers and sock puppets’; high levels of duplication in Russian science; DNA barcoding fraud? (05-02-2022). Retraction Watch.
• Weekend reads: Academia with and without peer review; bogus journals; rector found guilty of misconduct (29-01-2022). Retraction Watch.
• Australia needs an Office for Research Integrity to catch up with the rest of the world (02-02-2022). The Conversation.
• Researchers label early CAR-T therapy patient ‘cured’ after living a decade without cancer (02-02-2022). STAT.
• ECRIN and EUPATI set up strategic partnership (01-02-2022). ECRIN.
• Blog Dorota Mazurkiewicz: Boston aan de Thames? (01-02-2022). Vereniging Innovatieve Geneesmiddelen.
• Academic Journal Claims it Fingerprints PDFs for ‘Ransomware,’ Not Surveillance (31-01-2022). Vice.
• Ruggengraat van de zorg (31-01-2022). NTvG.
• Responding to Real-World Data Guidance, Industry Calls for Flexibility and Further Clarity (31-01-2022). WCG CenterWatch.
• EU Launches Long-Awaited Clinical Trials Regulation and CTIS Database (31-01-2022). WCG CenterWatch.
• Death threats, ghost researchers and sock puppets: Inside the weird, wild world of dodgy academic research (30-01-2022). ABC News.
• The Rise of Science-Based Investigative Journalism (25-01-2022). Global Investigative Journalism Network.

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