Uitgelicht en gespot op internet (week 37, 2021)
Hierbij weer een nieuw overzicht van actualiteiten en andere nieuwsberichten de zijn gespot op het internet. Ook de ‘Events‘ pagina is bijgewerkt en vergeet niet om de ‘Consultations‘-pagina te bezoeken.
Heeft u zelf nieuws, een evenement of enquête/consultatie gespot? Geef ze aan mij door via het contact formulier hier op mijn weblog.
Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG)
BBMRI.nl & Health-RI
- Terugkijken en slides beschikbaar: Making health data available for research. The next step #1 (15 september 2021).
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trials
- Towards Pharma 4.0 in clinical trials: a future-orientated perspective (16 september 2021). Drug Discovery Today.
- Striving for Diversity in Research Studies (13 september 2021). NEJM.
- Black Adults Are Still Underrepresented in Federally Funded Cardiovascular Trials (13 september 2021). WCG CenterWatch.
- CDER Finds Broad Variations Among PROs in Multiple Myeloma Trials (13 september 2021). WCG CenterWatch.
- Ask the Experts: Questions about Advertising for Clinical Trials (13 september 2021). WCG CenterWatch.
- Sites Face Tighter Imaging Needs for Certain Trials as Use of Imaging Keeps Climbing (13 september 2021). WCG CenterWatch.
- Journal of Clinical Research Best Practices, September 2021.
- Building Data Capacity for Patient-Centered Outcomes Research: Interim Report One – Looking Ahead at Data Needs. Washington, DC: The National Academies Press.
Clinical trials results reporting
- World first: UK starts monitoring all clinical trials to check if they report results (18 september 2021). TranspariMED.
- EU Trials Tracker — Who’s not sharing clinical trial results?
Data management, Data research, Databases
- Ethical requirements for responsible research with hacked data (16 september 2021). Nature Machine Intelligence.
- Data Integrity – It’s All About the Data! (15 september 2021). Advarra.
- After Covid-19 Data Is Deleted, NIH Reviews How Its Gene Archive Is Handled (13 september 2021). The Wall Street Journal.
- Causal analyses of existing databases: no power calculations required (27 augustus 2021). JCE.
- Data sharing practices and data availability upon request differ across scientific disciplines (27 juli 2021). Scientific Data.
Dierexperimenteel onderzoek
Drug development, Drug approval
- Should regulatory authorities approve drugs based on surrogate endpoints? (16 september 2021). BMJ.
- EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines (16 september 2021). EMA.
- Aduhelm backlash threatens to reverse progress in FDA’s reviews of rare and ultra-rare disease drugs (14 september 2021). STAT.
- Convergence: EMA study reveals need for RWE framework, submission structure (14 september 2021). Regulatory Focus.
- Tips for avoiding regulatory pitfalls in pediatric drug development (14 september 2021). Regulatory Focus.
- Convergence: Regulatory considerations in advancing gene and cellular therapies (13 september 2021). Regulatory Focus.
- Amsterdam UMC maakt zelf een ‘gekaapt’ medicijn (13 september 2021). NTvG.
- Identifying adverse drug reactions from free- text electronic hospital health record notes (1 september 2021). British Journal of Clinical Pharmacology.
- Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator’s Perspective (27 augustus 2021). Front. Med.
Dutch Clinical Research Foundation (DCRF)
Dutch Oncology Research Platform (DORP)
Europese Commissie
Medicines and Healthcare products Regulatory Agency (MHRA)
- Decision – Access Consortium: Alignment with ICMRA consensus on immunobridging for authorising new COVID-19 vaccines d.d. 15 september 2021.
- MHRA Sets Data Security Requirements for Remote Monitoring (13 september 2021). WCG CenterWatch.
- Transforming the regulation of software and artificial intelligence as a medical device (16 september 2021).
Nederlandse Organisatie voor toegepast-natuurwetenschappelijk onderzoek (TNO)
- Praktijktest succesvol: Gemeenschappelijke analyse zonder onderlinge datadeling (17 september 2021).
Paediatric Clinical Research Infrastructure Network (PedCRIN)
Publications, Reproduceerbaarheid, Open Science
- Reproducibility: expect less of the scientific paper (15 september 2021). Nature.
- A Surge in Pandemic Research Shines a Spotlight on Preprints (10 september 2021). The Scientist.
- Germline genome modification through novel political, ethical, and social lenses. PLOS Genetics 17(9): e1009741.
- Open science practices in different disciplines – An interview with Prof. Peter de Jonge and Prof. Casper Albers, Faculty of Behavioural and Social Sciences (9 september 2021). Open Science Blog, Rijksuniversiteit Groningen.
- Medical publishing: a flawed model in dire need of reform (6 september 2021). The European Journal of Psychiatry.
Research ethics, Research integrity, Informed consent
- Authors who don’t disclose conflicts of interest? “[W]e cannot force them to do so,” says editor (15 september 2021). Retraction Watch.
- Reshaping the review of consent so we might improve participant choice (15 september 2021). Research Ethics.
- Preprint advocates must also fight for research integrity (13 september 2021). Nature.
- Creating a Research Ethics Consultation Service: Issues to Consider (8 september 2021). Ethics & Human Research.
- A phenomenographic study of scientists’ beliefs about the causes of scientists’ research misconduct (1 september 2021). Research Ethics.
TransCelerate BioPharma Inc.
- Patient Technology: Innovating Clinical Trials with Novel Digital Endpoints (13 september 2021).
- TransCelerate BioPharma Commences Collaborative Development of a Novel Digital Data Flow Solution for Study Start-Up (9 september 2021).
Overige
- Weekend reads: The ‘plagiarism hunter’; targeting academics over grant fraud; data manipulation at the World Bank (18 september 2021). Retraction Watch.
- Speculatie zonder weegschaal (17 september 2021). NRC.
- Remote working has not hurt clinical trial sector productivity, Tufts (15 september 2021). Clinical Insider.
- The impact of the COVID-19 pandemic on academic productivity (14 september 2021). arXiv.
- Wim de Haart: Betrek artsen vroegtijdig bij innovaties (14 september 2021). Vereniging Innovatieve Geneesmiddelen.
- Neurofeedback as placebo: a case of unintentional deception? Journal of Medical Ethics Published Online First: 14 September 2021.
- Het heldere verhaal over placebo’s (13 september 2021). Universiteit Leiden.
- Germline genome modification through novel political, ethical, and social lenses. PLOS Genetics 17(9): e1009741.
Meer actueel nieuws, bijeenkomsten en publieke consultaties