Uitgelicht en gespot op internet (week 36, 2021)

Ook deze week is er weer een nieuw overzicht van actualiteiten en andere nieuwsberichten de zijn gespot op het internet.

Vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen. Er zijn weer een flink aantal nieuwe events toegevoegd waaronder het EMA ‘Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)‘.

Heeft u zelf nieuws, een evenement of enquête/consultatie gespot? Geef ze aan mij door via het contact formulier hier op mijn weblog.

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Amsterdam UMC

• Kwaliteit wetenschappelijk onderzoek onder druk (11 september 2021).

Biobanking, Organoids, Germline editing

• How personalized brain organoids could help us demystify disorders (3 september 2021). ScienceNews.
• Microsatellite Markers in Biobanking: A New Multiplexed Assay (1 september 2021). Biopreservation and Biobanking.
• Governing Human Germline Editing Through Patent Law. JAMA. Published online August 30, 2021.
• The Dutch National TissueArchive Portal enables efficient, consistent, and transparent procurement of diagnostic tissue samples for scientific use (25 augustus 2021). Cell Tissue Bank.
• Response by BBMRI-ERIC to “EUROPEAN HEALTH DATA SPACE” (EHDS) Questionnaire (Public Consultation). BBMRI-ERIC.

Clinical trials, Clinical trial results reporting, Informed consent

• In a first, FDA warns a researcher for failing to submit data 3 years after trial completion (10 september 2021). Endpoints News.
• FDA now chasing up missing academic trial results – with immediate success (9 september 2021). TranspariMED.
• Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (9 september 2021). BMJ.
• Sponsors running multi country trials must guard against bribery (8 september 2021). Clinical Leader.
• ACRO launches remote study toolkit to help CROs secure data (8 september 2021). Clinical Leader.
• Analyses reveal wide variation in PRO measures in cancer trials (7 september 2021). Regulatory Focus.
• European Trials Lag Behind U.S. in Decentralization, Survey Finds (6 september 2021). WCG CenterWatch.
• Decision to Review On-site Data that Was Remotely Monitored Up to Sponsors, FDA Says (6 september 2021). WCG CenterWatch.
• Cancer Patients Believe Trials Are Moving Far Too Slowly, Survey Finds (6 september 2021). WCG CenterWatch.
• Clinical trial transparency: new publications and tools (summer 2021) (4 september 2021). TranspariMED.
• EUCROF Podcast n. 3 – “eConsent” (3 september 2021). EUCROF.
• Clinical Research in Neonates: Redesigning the Informed Consent Process in the Digital Era (1 september 2021). Front. Pediatr.
• Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics  (30 augustus 2021). Therapeutic Innovation & Regulatory Science.

Databases, Persoonsgegevens, Gegevensuitwisseling, Kwaliteitsregistraties, Patiëntdata

• Bewaartermijnen gegevens medisch-wetenschappelijk onderzoek (z.d.). CCMO.
• Replication Studies for Database Research. JAMA Surg. Published online September 01, 2021.
• Nóg een wet over de uitwisseling van patiëntgegevens (30 augustus 2021). ICT Recht.
• Causal analyses of existing databases: no power calculations required (27 augustus 2021). Journal of Clinical Epidemiology.
• De Personal Health Train kan data ontsluiten om de geheimen van kanker verder te ontrafelen (19 augustus 2021). IKNL.
• Data sharing practices and data availability upon request differ across scientific disciplines (27 juli 2021). Scientific Data.

Dierexperimenteel onderzoek

• Microphysiological Systems: Bridging Human and Animal Research: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press.
• Rapid Response by Laboratory Animal Research Institutions During the COVID-19 Pandemic: Lessons Learned: Proceedings of a Workshop–in Brief. Washington, DC: The National Academies Press.

Dutch Oncology Research Platform (DORP)

• Het rapport van de enquête Laagdrempelig PIF is beschikbaar! (10 september 2021).
  • Rapportage Enquête Laagdrempelig PIF, Versie 3.0 03-09-2021.
• DORP draagt bij aan Programma Regeldruk en Programma ZE&GG (8 september 2021).
• Meer trials aangemeld bij Onderzoekbijkanker.nl (7 september 2021).
• DSMB(-statisticus) nodig? (6 september 2021).

European Patients’ Academy on Therapeutic Innovation (EUPATI)

• Terugkijken: The role of patients in Ethics Committees: Interview with the EC Chair (27 januari 2021), via YouTube.

EU Verordening klinische proeven met geneesmiddelen (ECTR), Clinical Trials Information System (CTIS)

• Clinical Trials Information System (CTIS): online modular training programme (updated)
  • Quick guide – Introduction: CTIS for SMEs and Academia – CTIS Training Programme – Module 19

EU Verordeningen medische hulpmiddelen (MDR) & in vitro diagnostiek (IVDR)

• Webinars over nieuwe Europese wetgeving voor medische technologie (10 september 2021). NFU.

Participatiekompas

• Praktijkvoorbeeld –  Clinical mock trial: droog oefenen met de patiënt.

Remote source data verificatie (rSDV), Access to Electronic Health Records

• Euro Roundup: MHRA revises guidance on remote clinical trial monitoring, EHR access (9 september 2021). Regulatory Focus.
• Verenigd Koninkrijk: Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials(updated 8 september 2021). HRA & MHRA. Updated guidance for viewing Electronic Health Records (EHR) remotely

Research integrity, Misconduct, Questionable practices

• Two Scientific Journals Retract Articles Involving Chinese DNA Research (9 september 2021). The New York Times.
  • Omstreden studies van Erasmus MC-onderzoeker met dna Oeigoeren worden teruggetrokken (8 september 2021). Follow the Money.
  • Study of China’s ethnic minorities retracted as dozens of papers come under scrutiny for ethical violations (6 augustus 2021). Retraction Watch.
• When organisations’ behaviours betray their value statements (8 september 2021). BMJ.
• How misconduct helped psychological science to thrive (7 september 2021). Nature.
• How can institutions and funders help to police questionable research practices? (7 september 2021). Nature Index.
• An unpublished COVID-19 paper alarmed this scientist—but he had to keep silent (3 september 2021). Science.
• Systemic Obstacles to Addressing Research Misconduct in Higher Education: A Case Study (29 augustus 2021). Journal of Academic Ethics.

U.S. Food and Drug Administration (FDA)

• Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry. Final guidance (8 september 2021).

Verenigd Koninkrijk

• Medicines and Healthcare products Regulatory Agency (MHRA)
  • Guidance Managing clinical trials during Coronavirus (COVID-19) (updated 8 september 2021). Updated guidance for remote monitoring for trials.
• National Institute for Health Research (NIHR)
  • A strategy for impact 2020 – 2022. Building the evidence base to support cost effective public health practice.
• UK Research Integrity Office
  • Concordat Self-Assessment Tool
    • UKRIO’s Self-Assessment Tool for the Concordat: second edition

Vereniging Innovatieve Geneesmiddelen

• Dutch Medicine Days in teken innovatieve geneesmiddelenontwikkeling (7 september 2021).

ZonMw

• Meer dan 80% publicaties NWO en ZonMw Open Acces (7 september 2021).

Overige

• Weekend reads: A ‘hoax paper’ author resigns; Uyghur DNA papers retracted; a year without p values (11 september 2021). Retraction Watch.
• Biogen trials for Alzheimer’s drug excluded much of the targeted patient pool, study finds (10 september 2021). STAT+.
• How to Address the Undermining of Drug Regulators by Pharma (8 september 2012). Mad in America.
• New details emerge about coronavirus research at Chinese lab (7 september 2021). The Intercept.
• Language in Patient Records Can Convey More Than Medical History (7 september 2021). Renal & Urology News.
• Crossing disciplines to answer complex research questions (6 september 2021). National Health and Medical Research Council.
• New ICH Standards Will Require Shift in Industry Thinking, Experts Say (6 september 2021). WCG CenterWatch.
• Personalized profiles for disease risk must capture all facets of health (6 september 2021). Nature.
• Post-Authorization Monitoring of Vaccine Safety (z.d.). Modis.

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