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.
Amsterdam UMC
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).
- 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)
EU Verordening klinische proeven met geneesmiddelen (ECTR), Clinical Trials Information System (CTIS)
EU Verordeningen medische hulpmiddelen (MDR) & in vitro diagnostiek (IVDR)
Participatiekompas
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.
- 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)
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)
- UK Research Integrity Office
Vereniging Innovatieve Geneesmiddelen
ZonMw
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.
Meer actueel nieuws, bijeenkomsten en publieke consultaties