Uitgelicht en gespot op internet (week 6, 2022)
Hierbij een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet. Er zijn ook weer nieuwe bijeenkomsten en publieke consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Biobanking, Organoiden
Clinical trials, Clinical research
- Trends and variation in data quality and availability on the European Union Clinical Trials Register: A cross-sectional study (11-02-2022). Clinical Trials.
- Covid-19 challenge trial results are (finally) in: Here’s what should happen next (09-02-2022). STAT.
- CROs need to make knowledge management a focus say researchers (08-02-2022). Clinical Insider.
- Registered Reports: A new way to publish medical research (10-02-2022). TranspariMED.
- Trial Complexity Adds Hidden Costs Sites Must Learn to Look For (07-02-2022). WCG CenterWatch.
- Advocacy Groups Call for Transparency on Costs of Federally Funded Clinical Trials (07-02-2022). WCG CenterWatch.
- European Coalition Issues Recommendations for Improving Clinical Trials (07-02-2022). WCG CenterWatch.
- Sites Offer Flexibility, Combat Headhunters as Staffing Shortages Continue (07-02-2022). WCG CenterWatch.
- Registration and primary outcome reporting in behavioral health trials (06-02-2022). BMC Medical Research Methodology.
- Payment is a benefit and why it matters for pediatric trials (05-02-2022). Bioethics.
- Return of genomic results does not motivate intent to participate in research for all: Perspectives across 22 countries (03-02-2022). Genetics in Medicine.
- Noninferiority Margins in Clinical Trials—A Moving Target? JAMA Cardiol. Published online February 02, 2022.
- How To Use Plain Language in Clinical Research Communications (31-01-2022). Health Literacy Solutions Center.
- The PROTEUS-Trials Consortium: Optimizing the use of patient-reported outcomes in clinical trials (31-01-2022). Clinical Trials.
- Blinded interpretation of study results can feasibly and effectively diminish interpretation bias (juli 2014). Journal of Clinical Epidemiology.
Clinical trials Regulation (CTR), Clinical Trials Information System (CTIS)
- Terugkijken: Clinical Trials Information System (CTIS) demonstration for stakeholders (20-01-2022). EMA.
- CTIS newsflash – February 2022 (07-02-2022). EMA.
Key metrics
Metrics reported cover the period 31/01/2022-03/02/2022.
- Total number of logins to CTIS: 1,260
- This metric represents the sum of unique logins by individual users per day
- Number of draft applications in CTIS: 53
- This metric counts the number of applications with status: Draft in CTIS
- Number of submitted applications in CTIS: 1
Clinical trials in the European Union: euclinicaltrials.eu
Clinical Trials Transformation Initiative (CTTI)
European Medicines Agency (EMA)
- Scientific recommendations on classification of advanced therapy medicinal products (updated 11-02-2022).
- Annual Report of the Good Clinical Practice Inspectors Working Group 2019 (10-02-2022).
- Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU (09-02-2022).
- EMA medical terms simplifier (updated 09-02-2022).
Kunstmatige Intelligentie
Medicines and Healthcare products Regulatory Agency (MHRA)
- New year, new standards for investigational medicines (10-02-2022).
- Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response (08-02-2022).
- UK regulatory overhaul aims to make publication of clinical trial results a legal requirement (10-02-2022). TranspariMED.
U.S. Food and Drug Administration (FDA)
- Draft guidance: Development of Non-Opioid Analgesics for Acute Pain (09-02-2022).
- Draft guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry (07-02-2022).
- Industry cites outdated standards as flaw in FDA’s real-world data draft guidance (11-02-2022). Regulatory Focus.
- FDA officials, advisors cast doubt on foreign-only clinical strategy (10-02-2022). Regulatory Focus.
- FDA offers insights on blood pressure studies, immunogenicity labeling (09-02-2022). Regulatory Focus.
- FDA urges sponsors to find alternatives to nonhuman primates for toxicity studies (08-02-2022). Regulatory Focus.
World Health Organization (WHO)
Overige berichten
- Weekend reads: Weaponizing doubt; pharma’s lawsuit against journal dismissed; ‘misconstrued misinformation’ (13-02-2022). Retraction Watch.
- Pharma R&D Pipeline and New Product Launches Reach Record Levels in 2021 According to New IQVIA Institute for Human Data Science Report (10-02-2022).
- Reboot biomedical R&D in the global public interest (09-02-2022). Nature.
- Researchers use ultrasound to precisely and safely activate brain cells in mice (09-02-2022). STAT.
- Making Sure Open Science Stays Open: 10 Years of Advocating Open Science Policy (07-02-2022). Frontiers.
- ICH Q9: Quality Risk Management Revision Focuses on Six Topic Areas (03-02-2022). REDICA Systems.
- Traumatic Brain Injury Categories Should Be Updated and Personalized to Better Guide Patient Care, Says New Report (01-02-2022). National Academies of Sciences, Engineering, and Medicine.
- The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study (20-01-2022). Frontiers in Medicine.
- The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions, Drug Saf 45, 83–95 (2022).
- Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey. Wurst B.JMIR Med Inform. 2022 Jan 27;10(1):e30363.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties