Uitgelicht en gespot op internet (week 44, 2021)

Hierbij een overzicht van actualiteiten en nieuwsberichten die de afgelopen periode zijn gespot op het internet.

Ook zijn er weer nieuwe events en publieke consultaties toegevoegd aan de ‘Events‘ pagina en de ‘Consultations‘-pagina.

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Biobanken

• Allocation of scarce biospecimens for use in research (27 oktober 2021). Journal of Medical Ethics.

Clinical Data Interchange Standards Consortium

• CDISC and REDCap Work Together to Foster More Meaningful Clinical Research for Academics (21 oktober 2021).
• CDISC and OpenClinica Collaborate to Drive Academic Clinical Research Forward (19 oktober 2021).

Clinical trials

• New Trial Approaches Have Strong Benefits, but Industry Worries about Complexities (1 november 2021). WCG CenterWatch.
• Riding the Wave: Key Site Considerations for Cell and Gene Therapy Research (1 november 2021). WCG CenterWatch.

Clinical trials, Genetically Modified Organisms (GMO), EudraLex

• Good Practice on the assessment of GMO-related aspects in the context of clinical trials with human cells genetically modified, version 5 (November 2021).
• Common Application form for clinical research with human cells genetically modifiedSearch for available translations of the preceding, version 5 (November 2021).

Clinical trial results reporting & data sharing

• Medical journal requirements for clinical trial data sharing: Ripe for improvement (25 oktober 2021). PLOS Medicine 18(10): e1003844.

• UK clinical trial transparency system to go live in 2022 (oktober 2021). TranspariMED.

Data management

• The Role of Human Fallibility in Psychological Research: A Survey of Mistakes in Data Management (21 oktober 2021). Advances in Methods and Practices in Psychological Science.

Dierproeven

• Lancering Transparantieovereenkomst Dierproeven (2 november 2021). Stichting Informatie Dierproeven.

Dutch Association of Research Quality Assurance (DARQA)

• DARQA webinar Post-Authorization (Safety) (PASS) Studies, 8 oktober 2021 (3 november 2021).

European Medicines Agency (EMA)

• EMA Offers Guidelines for Registry-Based Trials (1 november 2021). WCG CenterWatch.
• Repurposing of authorised medicines: pilot to support not-for-profit organisations and academia (28 oktober 2021).
• Generating high-quality evidence from registry-based studies (26 oktober 2021).

Federatie Medisch Specialisten (FMS)

• De Richtlijnendatabase app: heb jij ‘m al? (4 november 2021).

ICH E6 (R3) Good Clinical Practice

• The Proactive Benefits of Early Adoption of ICH E6 (R3) (1 november 2021). WCG CenterWatch.

Integrity

• Does the World Need an Academic Integrity Awareness Index? An Interview with Helen Zhang (2 november 2021). The Scholary Kitchen.
• Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial (2 november 2021). BMJ.
• CHECK – Nee, “Pfizergate” betekent niet dat Pfizer studieresultaten over het coronavaccin heeft vervalst (6 november 2021). VRT NWS.

Good Lay Summary Practice (GLSP)

• The Importance of Plain Language Communication in Clinical Research. A Q&A session with EFGCP Chairman of the Board, Ingrid Klingmann (8 oktober 2021). Lionbridge.

Health Data Research UK (HDR UK)

• Health Data Research UK releases new tool to improve dataset discovery  (18 oktober 2021).

Inspectie Gezondheidszorg en Jeugd (IGJ)

• Poliovirus gevonden in riool Utrecht Science Park Bilthoven (1 november 2021).
• Erkenning Stamcelbank Nederland ingetrokken (1 november 2021).

National Health and Medical Research Council (Australie)

• Report on the Activity of Human Research Ethics Committees and Certified Institutions for the period: 1 January 2020 to 31 December 2020 (oktober 2021).

Nederlandse Kankerregistratie (NKR)

• Synthetische dataset NKR beschikbaar voor onderzoekers (8 oktober 2021).
• Real-world data waardevol, maar niet voor elk doel (29 oktober 2021). Oncologie Vandaag.

Patient-Centered Outcomes Research

• Building Data Capacity for Patient-Centered Outcomes Research: Interim Report Two – Data Standards, Methods, and Policy. Washington, DC: The National Academies Press.

Predatory publishers

• Questionable and Predatory journals: How to spot and avoid them (28 oktober 2021). Digital Scholarschip@Leiden.

Quality

• Methodology over metrics: current scientific standards are a disservice to patients and society (oktober 2021). Journal of Clinical Epidemiology.

Research ethics

• Invasive experimental brain surgery for dementia: Ethical shifts in clinical research practices? (21 oktober 2021). Bioethics.

Society for Clinical Data Management (SCDM)

• Leadership Forum: The Evolution of Clinical Data Management in the Today’s Changing Landscape of R&D (2 november 2021).

TransCelerate BioPharma

• TransCelerate BioPharma Commences Collaborative Development of a Novel Digital Data Flow Solution for Study Start-Up [standards-based study definitions repository] (9 september 2021). Businesswire.

Overige

• ‘Pure’ ellende: hoe Open Access ons afhankelijker maakt van grote uitgevers (3 november 2021). Univers.
• Portal Helps Researchers Screen COVID-19 Drug Candidates (2 november 2021). Technology Networks.
• How conspiracists exploited COVID-19 science (1 november 2021). Nature Human Behavior.
• Combine Compensation Models for More Precise Investigator Payments (1 november 2021). WCG CenterWatch.
• The Metascience Movement Needs to be More Self-Critical (31 oktober 2021). PLOS Blogs.
• Open Science verbetert de kwaliteit van de wetenschap (29 oktober 2021). ScienceGuide.
• Comparing regulatory transparency in Europe, the United States and Canada (oktober 2021). TranspariMED.
• Improving transparency of regulatory data at EMA, Health Canada, FDA (29 oktober 2021). Regulatory Focus.
• All in the mind: what the placebo effect looks like in the brain (29 oktober 2021).
• How faculty define quality, prestige, and impact of academic journals. PLoS ONE 16(10): e0257340.
• How Pseudoscience Generated US Material and Device Regulations (september 2021). AMA Journal of Ethics.

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Meer actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com

consultations.bontrop.com

events.bontrop.com