Uitgelicht en gespot op internet (week 50 & 51)
Beste abonnee,
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Nieuwstips ontvang ik graag via het contactformulier op de website.
Met vriendelijke groet,
Vincent Bontrop
www.bontrop.com
U kunt met mij linken via LinkedIn.
Uitgelicht & Gespot op Internet
Advanced therapy medicinal products
- EMA Guidance on Comparability Exercise for ATMPs (19 december 2019). BioSlice Blog, Arnold & Porter.
Associatie van Contract Research Organisaties in Nederland
- Clinical Trials Information System – oftewel CTIS Portal – wat is het? (12 december 2019).
- ‘Onze’ Ingeborg Boddeke test de functionaliteit van de CTIS portal! (12 december 2019).
Brexit,
- Brexit bulletin (20 december 2019). NHS European Office.
- UK government announces “competitive approach” to regulating medicines and medical devices post Brexit (19 december 2019). TranspariMED.
Centrale Commissie Mensgebonden Onderzoek
- Gevolgen EU-verordening medische hulpmiddelen voor klinisch onderzoek (20 december 2019).
- Algemene informatie voor proefpersonen online beschikbaar (19 december 2019).
- Vernieuwde e-learning over toetsing medisch-wetenschappelijk onderzoek (16 december 2019).
Clinical trials
- Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials (March 2020). Contemporary Clinical Trials Communication.
- Designing and evaluating dose-escalation studies made easy: The MoDEsT web app (19 december 2019). Clinical Trials.
- Strategic Need for Large Prospective Studies in Different Populations (9 december 2019). JAMA.
- Non-inferiority designs comparing placebo to a proven therapy for childhood pneumonia in low-resource settings (8 december 2019). Clinical Trials.
- Adequate reporting of the sample size calculation in surgical randomized controlled trials (28 november 2019). Surgery.
- Don’t abandon RCTs in IVF. We don’t even understand them (17 november 2019). Human Reproduction.
- Public sector financial support for late stage discovery of new drugs in the United States: cohort study (23 oktober 2019). BMJ.
- Availability of study protocols for randomized trials published in high-impact medical journals: A cross-sectional analysis (26 augustus 2019). Clinical Trials.
- Bayesian clinical trials at The University of Texas MD Anderson Cancer Center: An update (26 augustus 2019). Clinical Trials.
- Noninferiority trials with nonadherence to the assigned randomized treatment (14 augustus 2019). Clinical Trials.
- A win ratio approach to the re-analysis of Multiple Risk Factor Intervention Trial (7 augustus 2019). Clinical Trials.
- Public views regarding the responsibility of patients, clinicians, and institutions to participate in research in the United States (1 juli 2019). Clinical Trials.
Datamanagement, Data sharing, Transparancy
- Let go of your data (18 december 2019). Nature Materials.
- Guest Post: Interesting Versus True? Measuring Transparency and Reproducibility of Biomedical Articles (18 december 2019). The Scholary Kitchen.
- NWO herziet datamanagementprotocol per 1 januari 2020 (12 december 2019). NWO.
- UCL Statement on Transparency in Research (November 2019). University College London.
Dierexperimenteel onderzoek
Dutch Clinical Research Foundation
- Bijeenkomst deelnemers pilot Stap 2 (18 december 2019).
- Update werkgroep CTA (17 december 2019).
- Onderzoekersnetwerken vertegenwoordigd in DCRF (16 december 2019).
- Vernieuwde website Kind en Onderzoek (13 december 2019).
European Medicines Agency
- EMA Management Board: highlights of December 2019 meeting (20 december 2019).
- Video recording: Multi-stakeholder workshop on draft ‘Regulatory Science to 2025’ strategy (stakeholders for human medicines).
Genome editing
- Could CRISPR babies experiment have been made public earlier? (19 december 2019). New Scientist.
- A year after the first CRISPR babies, stricter regulations are now in place (11 december 2019).MedicalXpress.
- Human germline genome editing (2 december 2019). Nature Cell Biology.
- AMA Journal of Ethics. Governing Human Genome Editing (December 2019).
- Russia’s stance on human genome editing (26 november 2019). Nature.
Gentherapie
- Milieuregels belemmeren kankeronderzoek en -therapie (12 december 2019). NTvG.
- Loket Gentherapie (12 december 2019). NTvG.
Inclusie, Informed consent, Involvement
- The Case for Including Patients in Protocol Design (15 december 2019). CenterWatch.
- Increasing Diversity in Trials Requires Understanding Special Populations (15 december 2019). CenterWatch.
- Gesprekstraining verhoogt patiënteninclusie bij klinische studies (december 2019). ZonMw.
- From patients to policymakers: widening stakeholder participation in research (28 november 2019). NIHR School for Primary Care Research.
- Informed Consent Matrix for Clinical Trials (version 2 juli 2019). CORBEL.
International Council for Harmonisation
- Webcasts ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Studies.
- Quality by Design, ICH E8(R1) General Considerations for Clinical Studies (18 december 2019). Cyntegrity.
KCE Trials
Medische hulpmiddelen
National Institutes of Health
Privacy
- Berisping voor Akwa GGZ na overnemen ROM-data (16 december 2019). Autoriteit Persoonsgegevens.
- Protecting health privacy even when privacy is lost (5 december 2019). Journal of Medical Ethics.
Society for Clinical Data Management
TransCelerate
U.S. Food and Drug Administration
- When FDA Requires Pediatric Studies for New Cancer Drug Submissions: New Draft Guidance (12 december 2019). Regulatory Focus.
- FDA Finalizes Adaptive Clinical Trial Design Guidance (8 december 2019). CenterWatch.
- Recently Posted Guidance Documents
Overig nieuws
- Ontwikkelingen in de anesthesiologie 2010-2030 (19 december 2019). NTvG.
- Big Data is dood – lang leve AI? (16 december 2019). NTvG.
- ‘A long and lonely process:’ Whistleblowers in a misconduct case speak out (11 december 2019). Retraction Watch.
- Schrödinger’s pipeline and the outsourcing of pharmaceutical innovation (10 december 2019). Drug Discovery Today.
- Raising research quality will require collective action (10 december 2019). Nature.
- How Twitter is changing medical research (9 december 2019). Nature Medicine.
- Ethical considerations for health policy and systems research (december 2019). Alliance for Health Policy and Systems Research.
- Addressing Bias in Artificial Intelligence in Health Care (22 november 2019). JAMA.
- Academia – Industry Collaboration Best Practices Guide (maart 2019). CORBEL.
Recent verschenen
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 102 (16 december 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 101 (9 december 2019)
- Overzicht bijeenkomsten & consultaties (1 December 2019)
Meer nieuws van elders is te vinden op news.bontrop.com
Ook een notificatie ontvangen bij een nieuwe uitgave van ‘Uitgelicht & Gespot op internet‘?
Bent u reeds abonnee van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘ en ontvangt u nog geen notificatiebericht bij een nieuwe ‘Uitgelicht & Gespot op internet‘?
Wijzig vandaag nog uw abonnementsvoorkeuren en vink het wekelijkse supplement ‘Uitgelicht & Gespot op internet‘ aan.