Uitgelicht en gespot op internet (week 29 & 30, 2021)
Hierbij een overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet. Omdat er vorige week geen supplement ‘Uitgelicht & gespot op internet’ is verschenen is het een goed gevuld overzicht van berichten geworden.
Ook de ‘Events‘ pagina en de ‘Consultations‘-pagina zijn weer bijgewerkt en voorzien van nieuwe evenementen en publieke consultaties.
Heeft u zelf iets gespot meldt het via het contact formulier.
Association of Clinical Research Organizations (ACRO)
Biobanking
Clinical trials, Informed consent, Inclusive, Participation
- Errors in the implementation, analysis, and reporting of randomization within obesity and nutrition research: a guide to their avoidance (29 juli 2021). International Journal of Obesity.
- Decentralization Leads Trials to Increasing Use of New Digital Tools, Report Shows (26 juli 2021). WCG CenterWatch.
- With High Investigator Dropout Rates in Trials, Sites and Sponsors Must Offer More Support (26 juli 2021). WCG CenterWatch.
- Updating the ethical guidance for gene and cell therapy research participation (22 juli 2021). Molecular Therapy.
- Global regulators promote platform trials to assess new COVID vaccines (19 juli 2021). Regulatory Focus.
- Gecontroleerde humane infectiestudies. Efficiënt onderzoek naar tropische infectieziekten (19 juli 2021). NTvG.
- Oncology Research Has Shifted Toward New Endpoints, but Further Analysis is Needed (19 juli 2021). WCG CenterWatch.
- Ask the Experts: FDA IND and nonIND Acceptance (19 juli 2021). WCG CenterWatch.
- Despite Surge in Virtual Adaptations for Trials, Patient Perspective Should Be Kept at Forefront (19 juli 2021). WCG CenterWatch.
- Terugkijken: New regulatory requirements have sparked more interest in stand-alone long-term follow up studies for monitoring patient outcomes and safety (19 juli 2021). ICON.
- Klinisch onderzoek? Als klein land mogen we echt groter denken (12 juli 2021). Skipr.
Clinical trial results reporting
- FDA threatens second company with fines over missing clinical trial results (29 juli 2021). TranspariMED.
- Clinical trial results for FDA-approved drugs often remain hidden, new study finds (28 juli 2021). TranspariMED.
- Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis (19 juli 2021). BMJ Open.
Centre for Journalology – Ottawa Hospital Research Institute
Commissie Genetische Modificatie (COGEM)
Commissie Regelgeving Onderzoek (COREON)
- Publieksconsultatie concept Gedragscode gezondheidsonderzoek (27 juli 2021).
- Concept Gedragscode Gezondheidsonderzoek – Consultatieversie 26-07-2021
Committee on Publication Ethics (COPE)
Dierexperimenteel onderzoek
Dutch Clinical Research Foundation (DCRF)
- Achter de schermen bij de totstandkoming van de verklaring geschiktheid onderzoeksinstelling (VGO) (19 juli 2021).
- Belangrijk: Verduidelijking met betrekking tot de Verklaring Geschiktheid Onderzoeksinstelling (VGO) (13 juli 2021).
Ethics review
- Ethical review of COVID-19 research in the Netherlands; a mixed-method evaluation among medical research ethics committees and investigators (23 juli 2021). PLoS One.
- The review of the global first SARS COV 2 Human Infection Challenge studies (13 juli 2021). Blog, Journal of Medical Ethics.
European Clinical Research Infrastructure Network (ECRIN)
EU Clinical Trial Regulation (ECTR), Clinical Trials Information System (CTIS), Voluntary Harmonization Procedure (VHP)
- Commission Decision (EU) 2021/1240 of 13 July 2021 on the compliance of the EU portal and the EU database for clinical trials of medicinal products for human use with the requirements referred to in Article 82(2) of Regulation (EU) No 536/2014 of the European Parliament and of the Council (C/2021/5063) d.d. 31 juli 2021.
- Presentaties beschikbaar: EMA Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS (updated 30 juli 2021).
- Clinical Trial Information System (CTIS) – Sponsor
Handbook (28 juli 2021). EMA.
A compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS. - EMA Clinical Trials Information System (CTIS) webinar (14 juli 2021). ACRON.
- Conclusion of the Voluntary Harmonization Procedure project. Deadline for submissions to VHP in the context of the Christmas Break 2021/2022 and
transition to CTIS/CTR starting with the CTR application (July 2021). Heads of Medicines Agencies.
“The CTFG informs the Sponsors that the full implementation of the CTR 536/2014 is planned for the 31 January 2022. In order to organise a smooth transition of the VHP-Processes into CTIS and the CTR, especially in the light of the VHP-Christmas break the following deadlines were defined.
The VHP Christmas break 2021/2022 will take place between 22 December 2021 and 7 January 2022 (including). All VHPs procedures should be finalised in January 2022. In order to achieve this goal and to offer clear guidance the last day for any VHP submission (initial, substantial amendment, 2nd round) will be 15 October 2021.“
bron: HMA nieuwsbericht d.d. 19 juli 2021
European Medicines Agency (EMA)
EU Medical Device Regulation (MDR), Medische hulpmiddelen, MDCG
Informed consent, Inclusion, Patients, Participation
- Gurus and Griots: Revisiting the research informed consent process in rural African contexts (23 juli 2021). BMC Medical Ethics.
- Updating the ethical guidance for gene and cell therapy research participation (22 juli 2021). Molecular Therapy.
- FDA seeks global shift to include pregnant women in medical research (21 juli 2021). Regulatory Focus.
- Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines (19 juli 2021). FDA.
- Consent Process Best Practices for Special Populations to Reduce Perceived Pressure to Participate in Clinical Trials (19 juli 2021). Clinical Researcher, ACRP.
- Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences (13 juli 2021). AJOB Neuroscience.
- Lack of consideration of sex and gender in COVID-19 clinical studies (6 juli 2021). Nature Communications.
- Assessing population diversity in phase III trials of cancer drugs supporting Food and Drug Administration approval in solid tumors (14 juni 2021). Int J Cancer.
Inspectie Gezondheidszorg en Jeugd (IGJ)
Integraal Kankercentrum Nederland (IKNL)
Kwaliteitsregistraties
National Academy of Medicine
- Biomedical Research COVID-19 Impact Assessment: Lessons Learned and Compelling Needs (26 juli 2021). NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC.
- Quality, Safety, and Standards Organizations COVID-19 Impact Assessment: Lessons Learned and Compelling Needs (26 juli 2021). NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC.
Open data, FAIR data, Publications
- Self-reporting data assets and their representation in the pharmaceutical industry (28 juli 2021). Drug Discovery Today.
- Should a researcher who was no longer at an institution when a study began be a co-author? (28 juli 2021). Retraction Watch.
- Biogen pulled Aduhelm paper after JAMA demanded edits (27 juli 2021). Axios.
- Registered Reports free for authors and readers (26 juli 2021). School of Psychology blog, University of Sussex.
- Nee, die data zijn niet van jou (22 juli 2021). Statistiek Spinsels.
Persoonsgegevens, Schrems II
Research integrity
- Why Bad Science Is Sometimes More Appealing Than Good Science (august 2021). Scientific American.
- When a retraction notice leaves out important details: COVID-19, prisoners, and an IRB (23 juli 2021). Retraction Watch.
- Two Texas studies on COVID-19 retracted because ‘previously approved study protocols appear to violate IRB guidelines around prisoner research’ (22 juli 2021). Retraction Watch.
- 8% of researchers in Dutch survey have falsified or fabricated data (22 juli 2021). Nature.
World Health Organization (WHO)
- New WHO Draft on GMP for IMPs (29 juli 2021). ECA Academy.
- New WHO Draft on GxP for Development (29 juli 2021). ECA Academy.
Overige
- Weekend reads: The unintended consequences of “trust in science”; Biogen, Aduhelm, and JAMA; how to determine author order, part 592 (31 juli 2021). Retraction Watch.
- France issues moratorium on prion research after fatal brain disease strikes two lab workers (28 juli 2021). Science.
- Merendeel onderzoek totaal irrelevant voor maatschappelijke uitdagingen (27 juli 2021). ScienceGuide.
xkcd: Flawed Data
- Pro-tip: When claiming to use a dataset, make sure it collects what you say it does (26 juli 2021). Retraction Watch.
- UK to Streamline Trial Review Process, Accelerate Startup (26 juli 2021). WCG CenterWatch.
- On the Child’s Right to Bodily Integrity: When Is the Right Infringed? (5 juli 2021). The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine.
- Hoe vaak is vaak? VVSOR Blog.
- Methodology over metrics: Current scientific standards are a disservice to patients and society (30 mei 2021). Journal of Clinical Epidemiology.
- Emery University maakt die tegendraadse keuzes al (16 november 2013). NRC.
Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.
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