Uitgelicht en gespot op internet (week 48, 2022)
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 en Mastodon.
Algemene verordening gegevensbescherming (AVG)
- Blijf van mijn dossier af! – over privacy (03-12-2022). PsychoseNet.
- Nieuwe EDPB-aanbevelingen voor binding corporate rules (BCR) (01-12-2022).
Biobanken
- The Bordet Institute’s tumour bank opens its doors to patients associations (01-12-2022). Institut Jules Bordet.
- Organoids. Nat Rev Methods Primers 2, 94 (2022).
- Een biobank moet geen biokluis zijn (25-11-2022). Medische Oncologie.
Clinical trials
- Applied Clinical Trials December 2022 Issue (PDF) (02-12-2022). Applied Clinical Trials.
- ACRP Offers DCT Insights (02-12-2022). Applied Clinical Trials.
- Identifying Important Risk Indicators in Clinical Development (02-12-2022). Applied Clinical Trials.
- Using Solid Endpoint Strategies for Successful Cancer Trials (02-12-2022). Applied Clinical Trials.
- FDA rejects Y-mAbs’ neuroblastoma drug after taking issue with clinical trial design (02-12-2022). Endpoints News.
- Clinical Trials: Have We Finally Reached The New Normal? (o1-12-2022). In Vivo Pharma Intelligence.
- What if Clinical Trials Deliver Results Too Late for an Emergency? (30-11-2022). Applied Clinical Trials.
- Cancer Research UK and Stitch to pilot app for patients in trials (29-11-2022). Clinical Trials Arena.
- Advancing cluster randomised trials in children’s therapy: a survey of the acceptability of trial behaviours to therapists and parents. Trials 23, 958 (2022).
Clinical Trials Regulation (CTR)
Credibility crisis
Dierexperimenteel onderzoek
Diversity, equity, and inclusion (DE&I)
- Tips and Tools to Overcome DE&I Challenges in Clinical Trials (02-12-2022). Applied Clinical Trials.
- Steps to building a more patient-centric industry (01-12-2022). Pharmaphorum.
- Population diversity in immuno-oncology trials (08-11-2022). Nature Reviews Drug Discovery.
Ethics, Integrity, CRISPR
- Empowering the Research Community to Investigate Misconduct and Promote Research Integrity and Ethics: New Regulation in Scandinavia. Sci Eng Ethics 28, 59 (2022).
- Image manipulation in science is suddenly in the news. But these cases are hardly rare (02-12-2022).
- The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa (29-11-2022). Health Policy Analysis.
- Is kiembaanmodificatie ethisch verantwoord? (28-11-2022). NTvG.
- The Invisible Patient: Concerns about Donor Exploitation in Stem Cell Research. Health Care Anal (2022).
- Why the World Needs Bioethics Communication. Perspectives in Biology and Medicine 65(4), 629-636.
European Commission, Clinical Trials, COVID-19 vaccines
Federatie Medisch Specialisten
Good Clinical Trials Collaborative
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
In vitro diagnostica, IVDR
Medical Device Regulation (MDR), Annex XVI
- Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (Text with EEA relevance).
- Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (Text with EEA relevance)
Medicines and Healthcare products Regulatory Agency (MHRA) – Verenigd Koninkrijk
Methodology, Endpoints, Estimans, Trial within Cohorts (TwiCs)
- The Trial within Cohorts (TwiCs) study design in oncology: Experience and methodological reflections (18-11-2022). arXiv.
- Are regulators “on board” with estimands? (02-12-2022). Kaspar Rufibach, via LinkedIn.
- Clinical and Statistical Perspectives on the ICH E9(R1) Estimand Framework Implementation (06-07-2022). Statistics in Biopharmaceutical Research.
- Digital endpoints for patient-focused health management (30-11-2022). EFPIA.
- Oncology estimands working group ‘I have never heard of estimands – where should I start?’
MRC Biostatistics Unit University of Cambridge
- What are adaptive clinical trials? Via YouTube.
- Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Med 16, 29 (2018).
- Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs. BMC Med 18, 352 (2020).
- What is an adaptive design? PANDA (A Practical Adaptive & Novel Designs and Analysis toolkit).
- A New Approach to Treatment Selection to Benefit Patient Outcomes in Clinical Trials (04-10-2022). YoungStatS, The blog of Young Statisticians Europe (YSE).
NCATS Assay Guidance Manual programme
NHS Health Research Authority (HRA)
- Blog: The only way is ethics (Down Under edition) (30-11-2022).
- Health Data Research UK joins public involvement pledge (15-11-2022).
Nieuwsbrief voor Goede Onderzoekspraktijken
Patient Focused Medicines Development
- Rules of Engagement: new PE Guidelines offer clarity on national codes of conduct (28-11-2022). Patient Engagement Synapse.
- Patient Engagement (PE) Country Guidelines
Registered Reports
- Pleased to announce we’ve just launched Registered Reports Community Feedback – a site to better understand authors’ and reviewers’ experience of the Registered Reports peer review process (30-11-2022). Ben Meghreblian, via LinkedIn.
- Registered Reports Community Feedback
Retraction
Simultaneous National Scientific Advice Pilot (SNSA)
- Simultaneous National Scientific Advice Pilot (23-11-2022). Health Products Regulatory Authority (HPRA) (Ierland).
- Zie ook Nieuwsbrief voor Goede Onderzoekspraktijken nr. 158 van 2 december 2022.
TRANSVAC2, Vaccine Development Training
UMC Utrecht
- Impuls voor fase 1 onderzoek van nieuwe geneesmiddelen in UMC Utrecht (23-11-2022). UMC Utrecht.
- The Netherlands and South-Africa take hands in UMC Utrecht and TASK collaboration agreement (28-11-2022). TASK Research International BV.
US Food and Drug Administration (FDA), Verenigde Staten
- Draft guidance: Statistical Approaches to Establishing Bioequivalence (02-12-2022).
- FDA updates statistical approaches for assessing bioequivalence (02-12-2022). Regulatory Focus.
- Key Guidance Updates in 2022 (02-12-2022). Applied Clinical Trials.
- Why Keep HIPAA Separate from the Informed Consent Form (01-12-2022). Advarra.
- Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies (29-11-2022).
- Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials (17-11-2022). Advarra.
- FDA’s September 2022 NPRMs: What They Mean for Academia and Industry (10-11-2022). Advarra.
- FDA releases tissue-agnostic cancer drug draft guidance (04-11-2022). Nature Reviews Drug Discovery.
World Health Organization (WHO)
Zorgevaluatie en Gepast Gebruik (ZE&GG)
Vanaf 1 maart 2023 is de Veldnorm van kracht en kan iedereen die een zorgevaluatie opstart, deze gebruiken.
Overig
- Weekend reads: Allegations about Stanford’s president; time to pay peer reviewers?; questions about a publisher mount (03-12-2022). Retraction Watch.
- Euro Roundup: EMA starts first real-world evidence studies under DARWIN EU (01-12-2022). Regulatory Focus.
- Greater genetic diversity is needed in human pluripotent stem cell models. Nat Commun 13, 7301 (2022).
- Guest Post — Exploring the Strengths and Limitations of Replication in the Humanities: Two Case Studies (30-11-2022). Center for Open Science.
- Neurofeedback as placebo: a case of unintentional deception? Journal of Medical Ethics 2022;48:1037-1042.
- Mitigating bias in pharmaceutical R&D decision-making (27-09-2022). Nature Reviews Drug Discovery.
- Another Twitter blow to science as Musk ends COVID misinformation policy (30-11-2022). Pharmaphorum.
- Twitter ends its ban on covid misinformation (29-11-2022). The Washington Post.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties