Uitgelicht en gespot op internet (week 38, 2021)

Hierbij een nieuw overzicht van actualiteiten en nieuwsberichten de de afgelopen week zijn gespot op het internet.

Er zijn ook weer nieuwe evenementen en consultaties toegevoegd aan de ‘Events‘ pagina en de ‘Consultations‘-pagina.

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

---

Biobanken, Persoonsgegevens, Wet zeggenschap lichaamsmateriaal

• Zorgen om versnipperd juridisch kader (her)gebruik lichaamsmateriaal (24 september 2021). Federatie Medisch Specialisten, NFU, COREON & Health-RI.
• HIPAA and the Leak of “Deidentified” EHR Data (16 september 2021). NEJM.
• Privacy and artificial intelligence: challenges for protecting health information in a new era (15 september 2021). BMC Medical Ethics.
• Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting. Practical and Ethical Considerations 14 september 2021). Academic Medicine.
• The Dutch National TissueArchive Portal enables efficient, consistent, and transparent procurement of diagnostic tissue samples for scientific use. Cell Tissue Bank. 2021 Aug 25.

Clinical trials

• Vaccine trials during a pandemic: potential approaches to ethical dilemmas (15 september 2021). Trials.
• US Food and Drug Administration Approval of Aducanumab—Is Amyloid Load a Valid Surrogate End Point for Alzheimer Disease Clinical Trials? JAMA Neurol. Published online September 13, 2021.
• COVID-19: release approved vaccines for trials of new ones (7 september 2021). Nature.

Clinical trials registers

• Significant Overhauls Are on the Horizon for ClinicalTrials.gov with Beta Test This Year (20 september 2021). WCG CenterWatch.

Data research, Databases

• Causal analyses of existing databases: The importance of understanding what can be achieved with your data before analysis (commentary on Hernán) (21 september 2021). Journal of Clinical Epidemiology.
• Letter to the editor: Sample size considerations are needed for the causal analyses of existing databases (20 september 2021). Journal of Clinical Epidemiology.

Drug discovery

• Computational resources in the management of antibiotic resistance: Speeding up drug discovery (september 2021). Drug Discovery Today.

European Clinical Research Infrastructrure Network (ECRIN)

• NIH’s Introduction to the Principles and Practice of Clinical Research (IPPCR) course registration is now open (20 september 2021).

European CRO Federation (EUCROF)

• Artificial Intelligence (AI) in Pharmacovigilance: do we really need it…? (24 september 2021).
• EUCROF/eClinical Forum’s eConsent Implementation Guide – TOPRA Awards Finalist 2021 (22 september 2021).
• EUCROF presented at EMA/GCP IWG workshop on AI in Clinical Research (22 september 2021).

Gentherapie, genetisch gemodificeerde organismen (ggo)

Informed consent

• Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors (22 september 2021). BMJ Open.
• Reshaping the review of consent so we might improve participant choice (15 september 2021). Research Ethics.

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

• No. 22: GLP Data Integrity (20 september 2021).

Research integrity

• “Fabulous document”, “very helpful guidance”: Sleuths react to recommendations for handling image integrity issues (21 september 2021). Retraction Watch.

Quality systems

• Quality, Quality, Quality: FDA Official Outlines the Quality Systems It Wants to See in Trials (20 september 2021). WCG CenterWatch.

Overige

• Weekend reads: Vaccine-myocarditis preprint withdrawn; are citations worth $100,000 each?; the lesson of ivermectin (25 september 2021). Retraction Watch.
• How can we support reviewer diversity? (23 september 2021). On Medicine, BMC Blog Network.

• “Why Is the Statistical Revolution Not Progressing? Vicious Cycle of the Scientific Reform.” OSF Preprints, 23 Sept. 2021. Web.
• “Justify Your Alpha: A Primer on Two Practical Approaches.” PsyArXiv, 14 June 2021. Web.
• The lesson of ivermectin: meta-analyses based on summary data alone are inherently unreliable (22 september 2021). Nature Medicine.
• Consultation on framework for medical devices in UK (21 september 2021). BioSlice Blog, Arnold & Porter.
• ICH survey shows strong level of guideline implementation (20 september 2021). Regulatory Focus.
• TransCelerate Begins Work on Solution to Speed Trial Startup (20 september 2021). WCG CenterWatch.
• FDA finalizes more Q&As on biosimilar development (20 september 2021). Regulatory Focus.
• Toward Open Research: A Narrative Review of the Challenges and Opportunities for Open Humanities (18 september 2021). Journal of Communication.
• Experimentation and Manipulation with Preregistration (15 september 2021). Games and Economic Behavior.
• Correlation Between National Institutes of Health Funding for Pediatric Research and Pediatric Disease Burden in the US. JAMA Pediatr. Published online September 13, 2021.
• No, the Tuskegee Study Is Not the Top Reason Some Black Americans Question the COVID-19 Vaccine (25 februari 2021). KQED.

---

Meer actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com

consultations.bontrop.com

events.bontrop.com