Uitgelicht en gespot op internet (week 27, 28, 29 & 30)
Hierbij een overvolle vakantie-editie van ‘Uitgelicht en gespot op internet‘.
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‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Uitgelicht & Gespot op Internet
ALL European Academies
AVG, Persoonsgegevens, Privacy
- € 500 per data subject – a quantification of why GDPR matters (25 juli 2019). Medicaldeviceslegal.
- Estimating the success of re-identifications in incomplete datasets using generative models (23 juli 2019). Nature Communications, volume 10, Article number: 3069 (2019).
- GDPR Brief: Are pseudonymised data within the GPDR’s scope? (1 juli 2019). Global Alliance for Genomics & Health.
- Playing by the rules: Impact of the new General Data Protection Regulation on retrospective studies: A researcher’s experience (21 juni 2019). European Heart Journal.
Biobanken, Organoids
- Public Attitudes toward Biobanking of Human Biological Material for Research Purposes: A Literature Review (21 juni 2019). Int. J. Environ. Res. Public Health 2019, 16(12), 2209.
- Secondary Use of Patient Tissue in Cancer Biobanks (10 juni 2019). The Oncologist.
- Reflections on Organoid Ethics: Jeremy Sugarman and Annelien Bredenoord (6 juni 2019). Cell Stem Cell.
Biomarkers
- A plea for taking all available clinical information into account when assessing the predictive value of omics data (24 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 162 (2019).
- Clinical biomarker innovation: when is it worthwhile? (9 juli 2019). Clinical Chemistry and Laboratory Medicine.
Celtherapie, CRISPR, Gentherapie, Germline editing, In vitro gametogenesis
- First CRISPR study inside the body to start in U.S. (25 juli 2019). STAT.
- Human germline editing is not prohibited by the Oviedo Convention: An argument (18 juli 2019). Medical Law Journal.
- Minister Van Nieuwenhuizen maakt werk van cel- en gentherapie (17 juli 2019). ACRON.
- In Vitro Gametogenesis and the Creation of ‘Designer Babies’ (12 juli 2019). Cambridge Quarterly of Healthcare Ethics.
- Canada case highlights possible long-term risks of experimental stem cell therapy (11 juli 2019). STAT.
- Are cell-based therapies for kidney disease safe? A systematic review of preclinical evidence. Pharmacology & Therapeutics, Volume 197, 2019, Pages 191-211.
- Risks and benefits of human germline genome editing: An ethical analysis (16 juli 2018). Asian Bioethics Review.
- ‘Pause button’ for CAR-T cells may overcome a dangerous side effect of cancer therapy (8 juli 2019). STAT.
- Ethical development of stem-cell-based interventions (3 juli 2019). Nature Medicine.
- Erfelijk DNA veranderen: dialoog over de grenzen (24 juli 2019). Rathenau Instituut.
- Germline gene editing and the precautionary principle (27 juni 2019). Bioethics.
- Minister draait bij gentherapie om hete brij heen (25 juni 2019). HollandBIO.
Centrale Commissie Mensgebonden Onderzoek
- Beoordeling substantiële amendementen door bevoegde instantie vertraagd (22 juli 2019).
- Beleid voor out of specification (OOS) ATMP’s (11 juli 2019).
- Publiceer resultaten onderzoek in ToetsingOnline en EudraCT-database (updated 11 juli 2019).
Cybriden en chimaeren
- Onderzoek mens-diercombinaties vraagt ethische toetsing (17 juli 2019). Medisch Contact.
- De regulering van cybriden en chimaeren. Gezondheidsraad.
- Factsheet over mens-diercombinaties verschenen (17 juli 2019). KNAW.
Delen van clinical trial data
- Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. BMJ 2019; 366 :l4217.
- Pharma continues to get poor grades when it comes to sharing clinical trial data (10 juli 2019). STAT.
Dierexperimenteel onderzoek
- Number of UK animal testing procedures falls to lowest level since 2007 (19 juli 2019). Pharmafile.
- Norecopa newsletter, 11 juli 2019.
- A randomised controlled trial of an Intervention to Improve Compliance with the ARRIVE guidelines (IICARus) (12 juni 2019). Research Integrity and Peer Reviewvolume 4, Article number: 12 (2019).
European Clinical Research Infrastructure Network
Good clinical practice
Information Commissioner’s Office
Informed consent
- Ask the Experts: Consent and Reconsent (15 juli 2019). CenterWatch.
- Ethical challenges of obtaining informed consent from surgical patients (11 juli 2019). Nursing Ethics.
- Bioethical reflexivity and requirements of valid consent: conceptual tools (4 juli 2019). BMC Medical Ethics, volume 20, Article number: 44 (2019).
Incidental findings
Ministerie Volksgezondheid, Welzijn en Sport
- Brief regering ‘Derde schriftelijk verslag over de voortgang constructie Europees Geneesmiddelen Agentschap (EMA)’ d.d. 5 juli 2019.
- Brief regering ‘Reactie op de motie van het lid Bruins Slot c.s. over een ethisch en juridisch kader voor human enhancement’ d.d. 4 juli 2019.
Medicines and Healthcare products Regulatory Agency
NHS Health Research Authority
Niet-informatieve klinische proeven
Patient participatie, Recruitment, Enrollment
- Enthousiaste IPF-patiënten doen graag mee aan onderzoek naar thuismonitoring. ZonMw.
- Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled ‘study within a trial’ (SWAT) of a multimedia information resource (24 juli 2019). Trials, volume 20, Article number: 453 (2019).
- Patient recruitment strategies for adaptive enrichment designs with time-to-event endpoints (22 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 159 (2019).
- Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context (11 juli 2019). Trials, volume 20, Article number: 422 (2019).
- Can targeted cover letters improve participation in health surveys? Results from a randomized controlled trial (17 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 151 (2019).
- Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework (5 juli 2019). Trials, volume 20, Article number: 401 (2019).
- Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States (1 juli 2019). Clinical Trials.
- Ethical Challenges Related to Patient Involvement in Health Technology Assessment (28 juni 2019). International Journal of Technology Assessment in Health Care.
- Incorporating Patient Preferences in Noninferiority Trials. JAMA. Published online June 24, 2019322(4):305–306. doi:10.1001/jama.2019.7059.
- BBK Worldwide Survey Reveals Physician Support for Referring Patients to Clinical Studies (24 juni 2019). BBK Worldwide.
- Paying Clinical Trial Participants: Legal Risks and Mitigation Strategies (14 juni 2019). Journal of Clinical Oncology.
Patient registries
- Patient Registries: An Underused Resource for Medicines Evaluation (13 juli 2019). Drug Saf (2019).
- ‘Prospectieve dataregistratie en toestemming vragen zouden de norm moeten zijn’ (2 juli 2019). Medische oncologie.
Personalised Medicine
Protocol ontwikkeling, Bias
- Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions (22 juli 2019). Trials, volume 20, Article number: 449 (2019).
- Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial (18 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 156 (2019).
- “Spatial heterogeneity of environmental risk in randomized prevention trials: consequences and modeling” (15 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 149 (2019).
- Adaptive propensity score procedure improves matching in prospective observational trials (16 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 150 (2019).
- Potential Causes of Irreproducibility Revealed (11 juli 2019). The Scientist.
- The Future of Phase I Oncology Studies (10 juli 2019). Advarra.
- Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality (10 juli 2019). Trials, volume 20, Article number: 416 (2019).
- How to design and set up a clinical trial part 1: the research question (10 juli 2019). Orthodontic Update.
- Methodology and reporting characteristics of studies using interrupted time series design in healthcare (4 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 137 (2019).
- Quantifying Sex Bias in Clinical Studies at Scale With Automated Data Extraction. JAMA Netw Open. Published online July 03, 20192(7):e196700. doi:10.1001/jamanetworkopen.2019.6700.
- Ideal vs. real: a systematic review on handling covariates in randomized controlled trials (3 july 2019). BMC Medical Research Methodology, volume 19, Article number: 136 (2019).
- Evaluating selection bias in a population-based cohort study with low baseline participation: the LIFE-Adult-Study (1 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 135 (2019).
- The ethical justification for inclusion of neonates in pragmatic randomized clinical trials for emergency newborn care (2 juli 2019). BMC Pediatricsvolume 19, Article number: 218 (2019).
- Getting Ready for Godot: Rehearsals for Europe’s New Clinical Trials Rules (1 juli 2019). Applied Clinical Trials.
- Novelty in science should not come at the cost of reproducibility (27 juni 2019). The FEBS Journal.
- Medicinal products and medical devices in clinical trials conduct and disclosure, Volume 28, Issue 2 – Generics and biosimilars.
Publications
- Q&A Wendy Belcher: How to write a journal article in 12 weeks (11 juli 2019). Nature Index.
- “Widely cited study of fake news retracted by researchers” (10 juli 2019). Statistical Modeling, Causal Inference, and Social Science.
- Farewell authors, hello contributors (5 juli 2019). Nature.
Questionable research practices
- How a data detective exposed suspicious medical trials (23 juli 2019). Nature.
- Scandal-weary Swedish government takes over research-fraud investigations (9 juli 2019). Nature.
- Science Means Never Having to Say You’re Sorry? Apologies for Scientific Misconduct (5 juli 2019). Science Communication.
- Terence Stephenson: Reducing questionable research practices and biases (4 juli 2019). The BMJ Opinion.
Real world evidence, Real world data
- Role of Real-World Evidence in Clinical Trials Needs Definition, Industry and FDA Agree (15 juli 2019). CenterWatch.
- Attempt to replicate clinical trials with real-world data generates real-world criticism, too (3 july 2019). STAT.
- EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-making (14 juni 2019). BMJ Open 2018;8:e021864.
Regulatory Science Network Netherlands
Risk based monitoring
TransCelerate
U.S. Food and Drug Administration
- Draft Guidance for Industry. Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues (17 juli 2019).
- Draft Guidance for Industry. Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy (11 juli 2019).
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff (final, July 2019).
- Draft Guidance for Industry. Population Pharmacokinetics (11 juli 2019).
- The FDA’s Janet Woodcock talks about some big changes she’s pushing for in drug development, and agency reviews (10 juli 2019). Endpoints News.
Vereniging Innovatieve Geneesmiddelen
- Infographic: Nederland aantrekkelijk voor medicijnontwikkeling (23 juli 2019).
- Schouw: ‘Exodus bedrijven door regelgeving gentherapie’ (15 juli 2019).
- Meer ruimte voor gentherapie (9 juli 2019).
Wearables, Mobile clinical trials
- Patient preferences for using mobile technologies in clinical trials, Contemporary Clinical Trials Communications.
- Fitbits and other wearables may not accurately track heart rates in people of color (24 juli 2019). STAT.
- Privacy and Consent with Innovative Neurotech and Neuroinformation (9 juli 2019). The Neuroethics Blog.
- A Prepared Approach To Technology In Clinical Trials (27 juni 2019). Clinical Leader.
- Patient Technology Adoption In Clinical Trials: 4 Barriers Holding Us Back (20 juni 2019). Clinical Leader.
- Neuroethics of Augmenting Human Memory Using Wearable Pervasive and Ubiquitous Technologies (19 mei 2019). In: ICT Unbounded, Social Impact of Bright ICT Adoption. TDIT 2019. IFIP Advances in Information and Communication Technology, vol 558. Springer, Cham.
Overig nieuws
- Nature Reviews Drug Discovery, July 2019, Volume 18, Number 7.
- Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs, Health Policy, Volume 123, Issue 8, 2019, Pages 721-727.
- Methodological steps used by authors of systematic reviews and meta-analyses of clinical trials: a cross-sectional study (26 juli 2019). BMC Medical Research Methodology, volume 19, Article number: 164 (2019).
- mCODE Improves EHR Data Standardization for Cancer Research. EHR Intelligence.
- Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial (26 juli 2019). Trials, volume 20, Article number: 458 (2019).
- Tackling rare diseases a ‘European success story’ (23 juli 2019). The Parliament Magazine.
- The failure of neuroscience education (23 juli 2019). NeuroDojo.
- Sites: Make Financial Audits Work for You (22 juli 2019). CenterWatch.
- A bird’s-eye view of clinical trials provides new perspectives on drug research and development (18 juli 2019). STAT.
- “Attitudes Regarding Enrollment in a Genetic Research Project: An Informed Consent Simulation Study Comparing Views of People With Depression, Diabetes, and Neither Condition”, Journal of Empirical Research on Human Research Ethics.
- Everything you wanted to know about the international implications of reanimating pig brains but were afraid to ask (8 juli 2019). The Washington Post.
- Agile isn’t Always Cheaper, But it Should Mitigate Risk (8 juli 2019). The Scholary Kitchen.
- Sponsors Need Vendors’ Metrics to Select the Best (1 juli 2019). CenterWatch.
- Preparing for the Unexpected is a Team Effort (1 juli 2019). CenterWatch.
- Pharma to FDA: Limit or Spell Out Use of Covariates in Randomized Trials (1 juli 2019). CenterWatch.
- Harnessing reliability for neuroscience research (28 juni 2019). Nature Human Behavior.
- Non-Inferiority Designed Cardiovascular Trials in Highest-Impact Journals: Main Findings, Methodological Quality and Time Trends (10 juni 2019). Circulation.
- Timing of first-in-child trials of FDA-approved oncology drugs. European Journal of Cancer.
- European mental health research resources: Picture and recommendations of the ROAMER project. European Neuropsychopharmacology, Volume 29, Issue 2, 2019, Pages 179-194.
- “Minimally invasive research?” Use of the electronic health record to facilitate research in pediatric urology. Pediatric Urology, October 2018, Volume 14, Issue 5, Pages 374–381.
Recent verschenen
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 95 (4 juli 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 94 (18 juni 2019)
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