Uitgelicht en gespot op internet (week 48, 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)
- Revised CTIS transparency rules, interim period & historical trials: quick guide for users (01-12-2023).
- Q&A on the protection of commercially confidential information and personal data while using CTIS (29-11-2023).
- Accelerating Clinical Trials in the European Union (ACT EU). Concept paper: an EU multi-stakeholder platform for improving the EU clinical trials environment (11-10-2023).
BBMRI-ERIC
Clinical trials
- The movement towards trial transparency (01-12-2023). Clinical Trials Arena.
- Navigating affordable approaches to cell therapy clinical trials (01-12-2023). Clinical Trials Arena.
- Bayesian Adaptive Designs in Clinical Trials: Using Data Science To Optimize Investigational Product Supply (01-12-2023). Clinical Leader.
- BioVie reports protocol deviations in Phase III Alzheimer’s trial (30-11-2023). Clinical Trials Arena.
- Release Testing Of AAV Gene Therapies For Clinical Trials (29-11-2023). Clinical Leader.
- Study Examines Use of Optimal Control Groups in Randomized Clinical Trials for Systemic Rheumatic Diseases (28-11-2023). Applied Clinical Trials.
- These volunteers want to be infected with disease to aid research — will their altruism help? (28-11-2023). Nature.
- Attitudes and barriers to participation in window-of-opportunity trials reported by White and Asian/Asian British ethnicity patients who have undergone treatment for endometrial cancer (25-11-2023). Trials.
- Evaluating prospective study registration and result reporting of trials conducted in Canada from 2009 to 2019 (23-11-2023). FACETS.
- Medical research in Canada not meeting all criteria: report (23-11-2023). CTV News.
- With clinical trial data readouts, here’s how to spot spin (28-11-2023). STAT.
- Partnering with social service staff to implement pragmatic clinical trials: an interim analysis of implementation strategies (17-11-2023). Trials.
Clinical Trials Coordination Group (CTCG)
- CTCG Best Practice Guide for sponsors of multinational clinical trials with different Part I document versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 (Version 3 – November 2023)
- Cover letter template – Annex to the Best Practice Guide for sponsors of multinational clinical trials with different protocol versions approved in different Member States under the Directive 2001/20/EC that will transition to the Regulation (EU) No. 536/2014 (Version 3 – November 2023).
Clinical Trials Transformation Initiative (CTTI)
- CTTI Publication Explores Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards (28-11-2023).
- Stakeholder Reflections on Implementing the National Institutes of Health’s Policy on Single Institutional Review Boards (01-10-2023). Ethics & Human Research.
Coalition for Epidemic Preparedness Innovations (CEPI)
conect4children
Council for International Organizations of Medical Sciences (CIOMS)
Decentralized Trials & Research Alliance (DTRA)
Diversiteit, Inclusiviteit, Representativiteit, Recruitment, Retention
- Representation of older patients in the safety analysis of protein kinase inhibitor registration studies (november 2023). Journal of Geriatric Oncology.
- Rare Disease vs. Chronic Conditions: Recruitment And Engagement Strategies (02-12-2023). Clinical Leader.
- Study Finds Low Representation of Disabled Participants in Cardiac Clinical Trials (01-12-2023). Applied Clinical Trials.
- Increasing Clinical Trial Diversity Through Patient-First Payment Options (29-11-2023). Applied Clinical Trials.
- Addressing Barriers To Adolescent And Young Adult Participation In Cancer Trials (28-11-2023). Clinical Leader.
EQUATOR Network
Ethics committees
European Health Data Space (EHDS)
European Medicines Agency (EMA)
- EU medicines agencies reflect on lessons learned from COVID-19 (01-12-2023).
- COVID-19 lessons learned: Joint report on the response to the public health emergency (01-12-2023).
European Parliament
Medicines and Healthcare products Regulatory Agency (MHRA)
NHS Health Research Authority (HRA), National Institute for Health and Care Research (NIHR)
- Blog: Can we make it easier for people to hear about research that is relevant to them? (29-11-2023).
- New voluntary scheme for GPs to speed up commercial study set-up (27-11-2023).
- Making the UK one of the best places in the world for clinical trials – responding to Lord O’Shaughnessy’s review (22-11-2023).
- Earning trust takes time, but we’re working to speed up progress. A blog by Director of Policy and Partnerships, Becky Purvis (22-11-2023).
- Strong public support for diversity in research (21-11-2023).
- Annual Report for Research Ethics Committees (RECs) in England 1 April 2022 to 31 March 2023 now published (30-10-2023).
- Introducing the hallmarks of People-Centred Clinical Research (29-10-2023).
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Research misconduct
- Factors related to the severity of research misconduct administrative actions: An analysis of office of research integrity case summaries from 1993 to 2023 (27-11-2023). Accountability in Research: Vol 0, No 0.
- Newly Released Documents from Untreated Syphilis Study: Ethical, Just, and Respectful Use of Archival Materials (27-11-2023). The Hastings Center.
U.S. Food and Drug Administration, U.S. Public Health Service (USPHS), National Institutes of Health (NIH)
- New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment – 10/15/2020 (30-11-2023).
- Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations (30-11-2023).
- Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (30-11-2023).
Wet medisch-wetenschappelijk onderzoek met mensen (WMO), Vierde evaluatieonderzoek van de Wet medisch-wetenschappelijk onderzoek met mensen (WMO) en de evaluatie van de Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Toekomstbestendig toetsingssysteem voor medisch-wetenschappelijk onderzoek met mensen is complex (29-11-2023).
- Vierde evaluatie Wet medisch-wetenschappelijk onderzoek met mensen en evaluatie Centrale Commissie Mensgebonden Onderzoek (2023) (november 2023).
- Vierde evaluatie Wet medisch-wetenschappelijk onderzoek met mensen en evaluatie Centrale Commissie Mensgebonden Onderzoek (31-10-2023). Rijksoverheid.
- Aanbiedingsbrief evaluatie Wet medisch-wetenschappelijk onderzoek met mensen en Centrale Commissie Mensgebonden Onderzoek (29-11-2023). VWS.
World Health Organization (WHO)
- First WHO Global Clinical Trials Forum puts forward a global vision for sustainable clinical research infrastructure (29-11-2023).
- WHO releases priorities for research and development of age-appropriate medicines for treatment of neglected tropical diseases (21-11-2023).
World Medical Association (WMA)
Overig nieuws
- Weekend reads: Hijacked journals polluting an index; special issues take a hit; a data breach at a megajournal (02-12-2023). Retraction Watch.
- Who Monitors the Monitors? CRA Evaluations Essential to Better Trials and Relationships (30-11-2023). Association of Clinical Research Professionals (ACRP).
- Some CAR-T may very rarely cause new cancers (30-11-2023). The Niche – Trusted stem cell blog & resources.
- FDA investigates risk of secondary malignancies with CAR T-cell therapy (30-11-2023). Regulatory Focus.
- Drug repurposing: een innovatieve wereld te winnen (28-11-2023). HollandBIO.
- World-class genomics laboratory to speed up drug discovery (28-11-2023). Medical Research Council (UK)
- Passive data collection on Reddit: a practical approach (28-11-2023). Research Ethics.
- Global Biodata Coalition Request Feedback on White Papers focused on Open Data Strategies (27-11-2023). Research Data Alliance (RDA).
- Factors related to the severity of research misconduct administrative actions: An analysis of office of research integrity case summaries from 1993 to 2023 (27-11-2023). Accountability in Research.
- Weekly reads: clonal expansion, Golden Retriever cancer, FTC hits genetics firm on testi-phony-als (26-11-2023). The Niche – Trusted stem cell blog & resources.
- Science is littered with zombie studies. Here’s how to stop their spread (26-11-2023). The Hill.
- Digital Therapeutic Clinical Trials: A Pioneering Approach to Better Treatments (22-11-2023). The Clinical Trial Vanguard.
- A flexible dose-response modeling framework based on continuous toxicity outcomes in phase I cancer clinical trials (21-11-2023). Trials.
- Poor statistical reporting, inadequate data… (20-11-2023). F1000Research.
- “Be sustainable”: EOSC‐Life recommendations for implementation of FAIR principles in life science data handling (15-11-2023). The EMBO Journal.
- IRDiRC Drug Repurposing Guidebook: making better use of existing drugs to tackle rare diseases (23-10-2023). Nature.