Uitgelicht en gespot op internet (week 42, 43, 44, 45 & 46, 2023)
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
Accelerating Clinical Trials in the EU (ACT EU)
Associatie van Contract Research Organisaties in Nederland (ACRON)
All European Academies, European Federation of Academies of Sciences and Humanities (ALLEA)
- ALLEA Statement on Curbing Predatory Practices in Open Access Scholarly Publishing.
- ALLEA Addresses Dangerous and Exploitative Predatory Publishing Practices during International Open Access Week (23-10-2023).
- European Code of Conduct for Research Integrity, 2023 Revised Edition (23-06-2023).
Biobank
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trial results reporting
- Klinisch geneesmiddelenonderzoek. Van wie zijn de gegevens? (23-10-2023). NTvG.
- New study suggests that simple nudges could improve clinical trial registration and reporting (17-10-2023). TranspariMED.
Clinical Trials Coordination and Advisory Group (CTAG)
Clinical Trials Transformation Initiative (CTTI)
CROMSOURCE
Data delen
Diversiteit, Inclusiviteit, Representativiteit, Recruitment, Retention
- Conditional versus non-conditional incentives to maximise return of participant completed questionnaires in clinical trials: a cluster randomised study within a trial (07-11-2023). Trials.
- Alzheimer’s Trials Need Rethinking to Broaden Participation, Expert Says (06-11-2023). CenterWatch.
- Diversifying clinical trials isn’t enough to close racial gaps: study (25-10-2023). STAT.
- Study designs should be tailored to encourage disabled people to take part, says study (20-10-2023). Clinical Insider.
- Precision medicine in regulatory decision making: Biomarkers used for patient selection in European Public Assessment Reports from 2018 to 2020 (18-10-2023). Clinical and Translational Science.
- Studies point to risks of excluding people with obesity from drug trials (16-10-2023). STAT.
- Recruiting women with ductal carcinoma in situ to a randomised controlled trial: lessons from the LORIS study (14-10-2023). Trials.
Dutch Clinical Research Foundation (DCRF)
- DCRF-symposium: Nationale Dialoog Klinisch Onderzoek (13-11-2023).
- Een uniform toetsingskader voor nWMO onderzoek: “een zegen!” (26-10-2023).
- Uitdagingen en ervaringen op de werkvloer met de invoering van de CTR vanuit het Erasmus Medisch Centrum (25-10-2023).
Embryo-onderzoek
Ethiek
- Developing ethical standards for dissemination and implementation research: a roadmap for consensus and guidance (06-11-2023). Implementation Science Communications.
- Ethical challenges in first-in-human trials of the artificial placenta and artificial womb: not all technologies are created equally, ethically (03-07-2023). Journal of Perinatology.
EUDAMED
European Advanced Translational Research Infrastructure in Medicine
European Commission, COMBINE project
European Medicines Agency (EMA)
- CTIS newsflash – 10 November 2023
- Clinical Trial Information System (CTIS) – Sponsor handbook (updated 10-11-2023).
- Quick guide: Clinical Study Reports submission – CTIS Training Programme – Module 13 (updated 07-11-2023).
- CTIS newsflash – 27 October 2023
- CTIS newsflash – 13 October 2023
Genetisch gemodificeerd organisme (GMO)
Informed consent
- SWAT 84: effects of same-day consent vs delayed consent on the recruitment and retention of trial participants—an observational SWAT (25-10-2023). Trials.
- Specific measures for data-intensive health research without consent: a systematic review of soft law instruments and academic literature (17-10-2023). European Journal of Human Genetics.
- e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence (10-10-2023). Trials.
- Opt‐out, mandated choice and informed consent (04-10-2023). Bioethics.
Integraal Kankercentrum Nederland (IKNL)
Keuringsraad
Kunstmatige Intelligentie (KI)
- Worldwide AI ethics: A review of 200 guidelines and recommendations for AI governance: Patterns (13-11-2023). Patterns.
- Garbage in, garbage out: mitigating risks and maximizing benefits of AI in research (31-10-2023). Nature.
- Five critical quality criteria for artificial intelligence-based prediction models (28-10-2023). European Heart Journal.
- EU model contractual AI clauses to pilot in procurements of AI (29-09-2023). European Commission.
Medicines and Healthcare products Regulatory Agency (MHRA)
- Transparency data: MHRA performance data for assessment of clinical trials and established medicines (updated 15-11-2023).
- Guidance: Common issues identified during clinical trial applications (updated 06-11-2023).
- Software and Artificial Intelligence (AI) as a Medical Device (updated 25-10-2023).
- MHRA and international partners publish five guiding principles for machine learning-enabled medical devices (24-10-2023).
Methodologie
- A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials (november 2023). eClinicalMedicine.
- Enhancing open clinical trials through blinded evaluations: an exploration with diabetic foot infections (09-11-2023). Trials.
- How is overall survival assessed in randomised clinical trials in cancer and are subsequent treatment lines considered? A systematic review (06-11-2023). Trials.
- Explaining an after-the-fact subgroup analysis in a failed clinical trial (31-10-2023). STAT.
- Bad research is not all bad (20-10-2023). Trials.
- Letter in response to: “The importance of clinical importance when determining the target difference in sample size calculations” (12-10-2023). Trials.
- The Use of Historical Controls in Clinical Trials (28-09-2023). JAMA Guide to Statistics and Methods.
Nederlandse Vereniging van METC’s (NVMETC)
NHS Health Research Authority (HRA)
- Blog: Consent, capacity and long-term research – Health Research Authority (25-10-2023).
- Frequently Asked Questions: Quality Standards and Design and Review Principles – Health Research Authority (updated 24-10-2023).
Pharma.be
Research integrity, Misconduct, Fraud
- Misconduct concerns, possible drug risks should stop major stroke trial, whistleblowers say (13-11-2023). Science.
- Research misconduct: Universities, scientists unite for first time on need for integrity body (11-11-2023). The Sydney Morning Herald.
- How big is science’s fake-paper problem? (06-11-2023). Nature.
- FDA Warns California PI Over Eligibility Criteria, Case History Maintenance (06-11-2023). CenterWatch.
- An analysis of functional relationships between systemic conditions and unethical behavior in German academia (05-11-2023). PsyArXiv Preprints
- Paper on homeopathy for ADHD retracted for ‘deficiencies’ (01-11-2023). Retraction Watch.
- Controversial French researcher loses two papers for ethics approval issues (31-10-2023). Retraction Watch.
- Research integrity during the COVID-19 pandemic: A book excerpt (30-10-2023). Retraction Watch.
- Are most published research findings false? Trends in statistical power, publication selection bias, and the false discovery rate in psychology (1975–2017) (17-10-2023). PLOS ONE.
- Druk op retractie sjoemelpublicaties opgevoerd (12-10-2023). Mare Online.
Replication crisis
- When Does Science Self-Correct? Lessons from a Replication Crisis in Early 20th Century Chemistry (14-11-2023). The Good Science Project.
- Preregistering, transparency, and large samples boost psychology studies’ replication rate to nearly 90% (09-11-2023). Science.
Springer Nature
Stichting Code Geneesmiddelen Reclame (CGR)
U.S. Food and Drug Administration, U.S. Public Health Service (USPHS), National Institutes of Health (NIH)
- Final guidance: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory (06-11-2023).
- Final guidance: Submitting Patient-Reported Outcome Data in Cancer Clinical Trials (06-11-2023).
- Final guidance: Benefit-Risk Assessment for New Drug and Biological Products (17-10-2023).
- Draft guidance: Diabetic Foot Infections: Developing Drugs for Treatment (17-10-2023).
- Two FDA Guidances Present Technical Specifications for Clinical Trial Data (13-11-2023). CenterWatch.
- FDA finalizes guidance on real-time review of oncology drugs (07-11-2023). Regulatory Focus.
- FDA publishes two guidances on collecting clinical outcomes data (06-11-2023). Regulatory Focus.
- Perspective: FDA moving in the right direction with psychedelic drug guidance (06-11-2023). Regulatory Focus.
- Comments on Draft NIH Scientific Integrity Policy (31-10-2023). The Good Science Project.
- Digitized Document Collection from USPHS Untreated Syphilis Study at Tuskegee Now Publicly Available Through NLM (19-10-2023).
- First detailed U.S. scientific integrity draft policies get mixed responses (23-10-2023). Science.
- FDA finalizes guidance on considerations for evaluating drug’s benefits and risks (20-10-2023). Regulatory Focus.
Verenigd Koninkrijk
- UK clinical trials – new notification scheme for lowest-risk clinical trials (19-10-2023). BioSlice Blog.
- Euro Roundup: MHRA aims to accelerate approval of lowest-risk clinical trials (19-10-2023). Regulatory Focus.
- UK rejigs rules and promises 14-day approvals for low-risk clinical trials (17-10-2023). Clinical Insider.
Overig
- Weekend reads: More Alzheimer’s misconduct?; AI bullshit; manipulating rankings (18-11-2023). Retraction Watch.
- Weekend reads: ‘What’s wrong with peer review?’; ‘how to catch a scientific fraud’; superconductor research falls apart (11-11-2023). Retraction Watch.
- Weekend reads: Why one chemist hasn’t made tenure; retractions in neuroscience; ‘pay to publish trash’ (04-11-2023). Retraction Watch.
- Weekend reads: UK shadow chancellor accused of plagiarism; eLife editor fired; Elsevier editor resigns because publisher ignored likely paper mill activity (28-10-2023). Retraction Watch.
- Weekend reads: A Nobelist earns an expression of concern; India’s fake universities; shaking things up in psychology (21-10-2023). Retraction Watch.
- 9 Compliance Issues That Are Putting Sponsor Studies at Risk (14-11-2023). Slope.
- Number of Phase 3 Biotech Trials Increases 400 Percent Over Decade, Study Finds (13-11-2023). CenterWatch.
- Preregistering, transparency, and large samples boost psychology studies’ replication rate to nearly 90% (09-11-2023). Science.
- CAR-T cancer therapy, in rare cases, can activate latent virus (08-11-2023). STAT.
- The “Free lunches” index for assessing academics: a not entirely serious proposal (06-11-2023). Scientometrics.
- Activities critical to success and growth of clinical trials networks. What is needed and how are we doing? An Australian and New Zealand perspective (04-11-2023). Trials.
- Conducting randomised controlled trials across countries with disparate levels of socio-economic development: The experience of the Asia-Pacific Hepatocellular Carcinoma Trials Group (november 2023). Contemporary Clinical Trials.
- The emerging transparency paradigm for clinical trials in Europe (31-10-2023). Regulatory Focus.
- Phesi sets out to rescue studies and help sponsors avoid amendments (31-10-2023). Clinical Insider.
- Microsoft fixes the Excel feature that was wrecking scientific data (21-10-2023). The Verge.
- ICH E6(R3): New Data Governance Insights for Clinical Trials (16-10-2023). Clinical Trials Vanguard.
- Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey (12-10-2023). Frontiers.
- The R&D landscape for infectious disease vaccines (20-07-2023). Nature Reviews Drug Discovery.
- Expanded access to investigational drugs in psychiatry: A systematic review (november 2023). Psychiatry Research.
- Unlocking the value of expanded access ethical, statistical, and policy considerations (10-10-2023). Erasmus Universiteit.
- Why Are So Many Studies Being Retracted? Mother Jones.