Uitgelicht en gespot op internet (week 27, 28 & 29, 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.

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

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Advarra (Verenigde Staten)

• What is an sIRB and Why Does my Study Need One? (21-07-2022).
• Short Form Consents and the Unexpected Non-English Speaking Participant (19-07-2022).
• Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents (18-07-2022).
• Return of Research Results to Study Participants (05-07-2022).
• Common Pitfalls in Preparing an IND Application (28-06-2022).
• A Checklist for Optimizing Clinical Trial Study Startup Activities (16-06-2022).
• Common Elements of IRB Assessments (14-06-2022).
• Why do Funding and Legal Structure Matter in Decentralized Clinical Trials? (09-06-2022).

Biobanking, Embryoonderzoek, Organoids

• Building a baby: are stem cell-based, embryo-like models the key to unlocking the secrets of human development? (16-07-2022). BioTechniques.
• Ethics Considerations Regarding Donors’ and Patients’ Consent (10-07-2022). Brain Organoids in Research and Therapy.
• The death of Roe and the future of ex vivo embryos (03-07-2022). Journal of Law and the Biosciences.
• Data solidarity for machine learning for embryo selection: a call for the creation of an open access repository of embryo data (22-03-2022). RBMO.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Template onderzoeksprotocol voor CTR-studies beschikbaar op CCMO-website (21-07-2022).
  • Download: Template protocol [CCMO protocol template CTR Version 2.0, July 2022] (25-05-2022).
• Nieuw model Proefpersoneninformatie (PIF) voor volwassenen beschikbaar op de CCMO-website (15-07-2022).
  • Download: Model proefpersoneninformatie voor proefpersonen van 16 jaar en ouder (volwassenen) versie juli 2022
• Bijgewerkte (model) documenten:
  • A1. Model aanbiedingsbrief (update 18-07-2022)
  • A1. Model aanbiedingsbrief bevoegde instantie (update 14-07-2022)
  • A1. Model aanbiedingsbrief amendement bevoegde instantie (update 14-07-2022)
  • Standaardonderzoeksdossier Toelichting & Codering (update 14-07-2022)
  • Erkende METC’s met code (update 19-07-2022)

Clinical research, Clinical trials

• Where’s the demand in human challenge clinical trials? (22-07-2022). Clinical Trials Arena.
• Phase 0 clinical trials: what you need to know (21 July 2022). Clinical Trials Arena.
• Glioblastoma: are Phase 0 trials a window of opportunity in drug development? (21 July 2022). Clinical Trials Arena.
• 5 Reasons Your TMF Isn’t Inspection-Ready (20 July 2022). Applied Clinical Trials.
• Are You a Victim of Clinical Trial Fraud? If So, What Are Your Rights and Obligations? (19 July 2022). Applied Clinical Trials.
• No time to delay: sponsors need to act fast ahead of CTIS deadline (14-07-2022). Clinical Trials Arena.
• How CROs are Uniquely Positioned to Drive Adoption of the TMF Exchange Mechanism (14 July 2022). Applied Clinical Trials.
• Data Linking in Clinical Trials (14 July 2022). Applied Clinical Trials.
• 10 Questions to Consider With eTMF Vendor Selection (13 July 2022). Applied Clinical Trials.
• Understanding Project Optimus (13 July 2022). Applied Clinical Trials.
• Signant Health Enhances Randomization and Trial Supply Management (RTSM) Platform (13 July 2022). Applied Clinical Trials.
• Clinical trials for pig-to-human organ transplants inch closer (06-07-2022). Nature.
• Reinterpreting Clinical Trials in Children With Multiple Sclerosis Using a Bayesian Approach. JAMA Neurol. Published online July 05, 2022.
• Statistical robustness of RCTs in high-impact journals has improved, but was low across medical specialties, Journal of Clinical Epidemiology (2022).

Clinical trial registries

Het Nederlands Trial Register is niet meer…. En een paar tips

Stand van zaken rond openbaarmaking resultaten geneesmiddelenonderzoek 2 jaar na rapport HAI

Decentralized clinical trials (DCT), Remote clinical trial monitoring

• Ethics review of decentralized clinical trials (DCTs): results of a mock ethics review (20-07-2022). Drug Discovery Today.
• People more likely to take part in trials that use decentralized tech: study (15-07-2022). Fierce Biotech.
• Decentralised paediatric clinical trials trending up but study execution critical (08-07-2022). Clinical Trials Arena.
• Wearable smart devices in cancer diagnosis and remote clinical trial monitoring: Transforming the healthcare applications (04-07-2022). Drug Discovery Today.

Diversity, Engagement, Inclusiveness, Representative

• Apgar scores are less predictive of infant mortality for Black babies than white ones, study finds (12-07-2022). STAT.
• Improving Diversity in Clinical Trial Volunteer Participation by Addressing Racial and Ethnic Representation Among the Clinical Research Workforce. Applied Clinical Trials.
• Global Investigative Site Personnel Diversity and Its Relationship with Study Participant Diversity. TIRS. 2022. Doi.org/10.1007/243441-022-00418-9.
• Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe. TIRS. 2022. Doi.org/10.1007/s43441-022-00421-0.
• Protocol Design Variables Highly Correlated with, and Predictive of, Clinical Trial Performance. Ther Innov Regul Sci. 2022 Jan 30. doi: 10.1007/s43441-021-00370-0. Epub ahead of print. PMID: 35094369.
• Patient Voices in Protocol Design. Applied Clinical Trials. Sept 2021; 30:9.

Dutch Oncology Research Platform (DORP)

• Korte video’s om patiënten te informeren over klinisch onderzoek (14-07-2022).

European Health Data Space (EHDS)

• EHDS-webinar gemist? Geen nood, kijk hem hier terug (22-07-2022). Ministerie van VWS.
• Minister Kuipers bij EHDS-debat: Burgers bepalen zelf welke gezondheidsgegevens ze willen delen (19-07-2022). Ministerie van VWS.
• European Health Data Space must ensure strong protection for electronic health data (14-07-2022). EDPB.

European Medicines Agency (EMA)

• Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making (22-07-2022).
• EMA joins regulatory coalition in calling for RWE to be integrated into regulatory decisions (22-07-2022). Endpoints News.
• Scientific guideline: Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies (12-07-2022).
• EMA launches pilot project on analysis of raw data from clinical trials (12-07-2022).
  • Information about the raw data proof-of-concept pilot for industry. Access to raw data for marketing authorisation and post-authorisation applications submitted to the EMA (12-07-2022).
• EMA to explore reviewing raw data from clinical trials in applications (12-07-2022). Regulatory Focus.
• EMA: Pilot bringing ex-EU regulators to COVID product meetings was a success (12-07-2022). Regulatory Focus.

Europese Commissie

• Blood, tissue and cell therapies save countless lives each year – now, with even greater safety and quality (20-07-2022).
• European Health Union: Stronger rules for greater safety and quality of blood, tissues, and cells (14-07-2022).
• European Commission proposes overhaul of blood, tissues and cells regulation (18-07-2022). Regulatory Focus.

Fraude, Integriteit

• In de strijd tegen corruptie kijkt de FIOD ook naar de medische wereld (20-07-2022). Medisch Contact.
• Experts identified warning signs of fraudulent research: a qualitative study to inform a screening tool (15-07-2022). Journal of Clinical Epidemiology.

Gen- & Celtherapie, Genetically modified organism (GMO)

• Impact of genetically modified organism requirements on gene therapy development in the EU, Japan, and the US (08-09-2022). Molecular Therapy: Methods & Clinical Development.
• Manifest van het Patientenplatform. VSOP, Patientenfederatie Nederland, Nederlandse Federatie van Kankerpatiënten organisaties, Spierziekten Nederland & Hematon.
  • Patiëntenplatform Gen- en Celtherapie
• Evolution to a New Clinical Research Environment for Cellular Therapies (02-07-2022). BioPharm International.

Health-RI

• ‘We willen onderzoekers een soort Spotify voor gezondheidsdata bieden’ (05-07-2022).
• Gedragscode Gezondheidsonderzoek van COREON herzien (04-07-2022).
• Toestemming voor ieder buisje bloed? (04-07-2022).

In Vitro Diagnostic Regulation (IVDR)

• Leidraad IVDR: Review of a performance study with in-vitro diagnostics or companion diagnostics – guidance document for MRECs (Version June 3, 2022) (19-07-2022). CCMO.
• MDCG 2022-12: Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) (13-07-2022).
• MDCG offers guidance on Eudamed workarounds for IVDR (13-07-2022). Regulatory Focus.

Integraal Kankercentrum Nederland (IKNL)

• Meerderheid darmkankerpatiënten wil terugkoppeling PROM-data (04-07-2022).
• DGOG-website toont overzicht trials van Onderzoekbijkanker.nl  (28-06-2022).
• Verschillen in de registratie van hersentumoren kunnen leiden tot vertekende schattingen van de overleving (23-06-2022).

International Council for Harmonisation (ICH)

• The ICH M12 draft Guideline presentation available now on the ICH website (15-07-2022).

Medicinal Products, Medical Devices

• Medicinal products meet medical devices: classification and nomenclature issues arising from their combined use (22-07-2022). Drug Discovery Today.

Medicines and Healthcare products Regulatory Agency (MHRA) (Verenigd Koninkrijk)

• Guidance: Clinical trials for medicines: apply for authorisation in the UK (updated 18-07-2022: Added information on ‘Requesting approval of trials with complex innovative designs’)

MRC Clinical Trials Unit UCL

• Data provenance and integrity of health-care systems data for clinical trials (augustus 2022). The Lancet Digital Health.
• Assessing the provenance and integrity of routinely collected healthcare systems data for clinical trials (20-07-2022).
• Use of NHS Digital datasets as trial data in the UK: a position paper (2.0) (2022). Zenodo.

MLCF

• Presentations from the symposium “Data For a Learning Healthcare System” (20-07-2022).

Nationaal Comité advies dierproevenbeleid (NCad)

• NCad in Nieuwsuur: meer geld nodig voor proefdiervrije innovatie (18-07-2022).
• Harmonisatie ongeriefinschatting dierproeven door FELASA workshops (15-07-2022).

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 151 (20-07-2022).
  • CCMO publiceert ‘Leidraad IVDR: Review of a performance study with in-vitro diagnostics or companion diagnostics – guidance document for MRECs’
  • Model Proefpersoneninformatie (PIF) versie Juli 2022 gepubliceerd op CCMO website

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 150 (01-07-2022).

Organisation for Economic Co-operation and Development (OECD), Good Laboratory Practice (GLP)

• Latest news on OECD Chemical Safety. New reports on good laboratory practice (22-07-2022). DARQA.
• Advisory Document of the Working Party on Good Laboratory Practice on Quality Assurance and GLP, Number 23, (18-07-2022).
• Position Paper on Quality Improvement Tools and GLP, Number 24, (18-07-2022).

Podcast

• What We Are Missing by Not Including ”Who?” (30-06-2022). DIA: Driving Insights to Action.

Protocol violations

• Quantifying Protocol Deviation Experience by Clinical Phase. Applied Clinical Trials. 2022; volume 32, issue 6.
• Benchmarking Protocol Deviations and their Variation by Major Disease Category. TIRS 2022.

Rathenau Instituut

• Umc’s worden belangrijker als onderzoeksinstelling (07-07-2022).
• Meer aandacht voor twijfelachtige onderzoekspraktijken nodig (06-07-2022).

Regulatory Science Network Netherlands (RSNN)

• Report of RSNN session @ FIGON DMD/EUFEPS 2022 meeting now available (12-07-2022).

Research ethics

• Research bystanders, justice, and the state: Reframing the debate on third-party protections in health research (15-07-2022). Bioethics.
• Toward Meeting the Obligation of Respect for Persons in Pragmatic Clinical Trials (28-06-2022). Hastings Center Report.
• Learning Health Care and the Obligation to Participate in Research (28-06-2022). Hastings Center Report.

Stichting Code Geneesmiddelenreclame (CGR)

• Onderzoek en ontwikkeling (15-07-2022).
• Transparantieregister Zorg 2021 (15-07-2022).
• Financiële relaties binnen zorg stabiliseren in 2021 (15-07-2022). Vereniging Innovatieve Geneesmiddelen.

Universiteiten van Nederland

• Learning Community Research Support Offices (19-07-2022).

U.S. Food and Drug Administration (FDA)

• Draft guidance: Real-Time Oncology Review (RTOR) : Draft Guidance for Industry (22-07-2022).
• Draft guidance: Evaluation of Therapeutic Equivalence (21-07-2022).
• Draft guidance: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (29-06-2022).
• Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply (22-07-2022). Endpoints News.
• FDA offers new guidance on therapeutic equivalence evaluations (20-07-2022). Regulatory Focus.
• Industry asks FDA to expand scope of product quality assessment guidance (18-07-2022). Regulatory Focus.
• FDA finalizes instructions for use guidance for drugs, biologics (14-07-2022). Regulatory Focus.
• FDA cybersecurity draft guidance draws concern from patients, industry (13-07-2022). Regulatory Focus.
• Drugmakers seek details on use of ctDNA as a biomarker or early endpoint (07-07-2022). Regulatory Focus.
• PFDD: Draft guidance seeks to demystify clinical outcomes assessments (30-06-2022). Regulatory Focus.
• Should the Food and Drug Administration Limit Placebo-Controlled Trials? (08-07-2022). Voices in Bioethics.

Verklaring Geschiktheid Onderzoeksinstellingen (VGO)

• Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities (augustus 2022). Contemporary Clinical Trials Communications.

ZonMw

• NWO en ZonMw verdelen ruim zestig miljoen extra voor ongebonden onderzoek (12-07-2022).

Overig

• Potential fabrication in research images threatens key theory of Alzheimer’s disease (21-07-2022). Science.
• Weekend reads: Harvard sued over retracted paper; ‘retraction with honor’; critiquing our fake peer review coverage (23-07-2022). Retraction Watch.
• Weekend reads: How to fix peer review; a research ethics oath; papers become less readable (16-07-2022). Retraction Watch.
• Weekend reads: Retracted papers that keep getting cited; ivermectin retractions; publishing peer reviews (09-07-2022). Retraction Watch.
• CVS, Walgreens Take On Clinical Trials to Improve the Patient Experience. American Hospital Association.
• Groep psychiaters kritisch op aanleveren ggz-gegevens aan NZa (21-07-2022). Skipr.
• Scholarly Publishing, Boundary Processes, and the Problem of Fake Peer Reviews (17-07-2022). Science, Technology, & Human Values.
• Regionaal samenwerken goed voor wetenschapper en patiënt (12-07-2022). Amsterdam UMC.
• Personalized medicine growth hindered by outmoded drug development paradigm (11-07-2022). Regulatory Focus.
• Beyond a CRISPR treatment’s encouraging results, some scientists see a need for more data on risk (06-07-2022). STAT.

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