Uitgelicht en gespot op internet (week 49, 2021)
Hierbij een overzicht van actualiteiten en nieuwsberichten die de afgelopen week zijn gespot op het internet.
Ook de ‘Events‘ pagina en de ‘Consultations‘-pagina zijn weer voorzien van nieuwe bijeenkomsten en consultaties.
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trial results reporting
Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)
Dutch Association of Research Quality Assurance (DARQA)
Dutch Oncology Research Platform (DORP)
European Clinical Research Infrastructure Network (ECRIN)
European Medicines Agency (EMA)
- ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic (3-12-2021).
- Subject: Integrity of clinical data, additional clinical trials and studies, pharmacovigilance and mRNA COVID-19 vaccine safety (3-12-2021).
Europese Commissie
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)
Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Remote inspections
- Global reflections on international inspection transformation: ICMRA remote inspections (10-12-2021). MHRA.
- FDA Sheds Light on International GCP Inspection Collaborations (6-12-2021). WCG CenterWatch.
- Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development (10-12-2021). FDA.
Informed consent
Medical Device Regulation (MDR), Medical Devices Coordination Group (MDCG)
US Food and Drug Administration (FDA)
- FDA issues draft guidance on study designs using real-world data (9-12-2021). Regulatory Focus.
- FDA Offers Advice on Using Real-World Evidence from Registries (6-12-2021). WCG CenterWatch.
- FDA rolls out more guidance on ‘N of 1’ gene therapies (7-12-2021). Regulatory Focus.
- PhRMA, AdvaMed weigh in on safety reporting draft guidance (8-12-2021). Regulatory Focus.
- Clarifying US regulations on xenotransplantation (2-12-2021). Nature Biotechnology.
- New guidances
- Draft guidance: Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products (10-12-2021).
- Final guidance: Development of Anti-Infective Drug Products for the Pediatric Population (9-12-2021).
- Draft guidance: Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment (9-12-2021).
- Draft guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products (8-12-2021).
- Draft guidance: Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations (7-12-2021).
- Draft guidance: Investigational New Drug Application Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations, Guidance for Sponsor-Investigators (7-12-2021).
- Draft guidance: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products (29-11-2021).
Overige
- Weekend reads: Hundreds of researchers in China sanctioned; phony finance research; results of the cancer research reproducibility project (11-12-2021). Retraction Watch.
- Regulatory oversight on the use of experimental therapies during a pandemic: the case of early access to convalescent plasma therapy in three LMICs (11-12-2021). Drug Discovery Today.
- Innoveren zonder proefdieren? ZonMw.
- The overlooked vital sign: the importance of measuring sleep in drug development studies (9-12-2021). Drug Discovery Today.
- Should we trust what Pfizer tells us about its vaccine and omicron? (9-12-2021). Quartz.
- Integriteit is ieders verantwoordelijkheid (8-12-2021). Vereniging Innovatieve Geneesmiddelen.
- INTERVIEW: Wat is de impact van VGO en ECTR op klinisch onderzoek? (7-12-2021). Vereniging Innovatieve Geneesmiddelen.
- Scholarly communication in times of crisis: The response of the scholarly communication system to the COVID-19 pandemic. Research on Research Institute. Report.
- Vat, L. E. (2021). Transforming the health research system: Embedding patient engagement in decision-making.
- Researchers sound alarm on ‘predatory’ rankings (7-12-2021). Retraction Watch.
- Hybrid Trials May Overtake Traditional Studies in 2022, New Data Show (6-12-2021). WCG CenterWatch.
- Who bears the responsibility for ethical misconduct in scientific research collaborations? (6-12-2021). Scroll.in.
- Violation of research integrity principles occur more often than we think (3-12-2021). Reproductive Biomedicine Online.
- ‘It’s misinformation at worst.’ Weak health studies can do more harm than good, scientists say (2-12-2021). Science.
- Patiënten: Amsterdam UMC vertelt niet dat ruggenprik of scan mogelijk overbodig is (18-11-2021). NOS.
- Assessing Sponsor and CRO Awareness (15-11-2021). Applied Clinical Trials.
- Forum on Drug Discovery, Development, and Translation: 10 Year Review: 2011-2020 (2021). Washington, DC: The National Academies Press.
- Questionable Research Practices and Open Science in Quantitative Criminology (19-8-2021). Journal of Quantitative Criminology.
- Some Cancer Studies Fail to Replicate. That Might Be OK (2021). WIRED.
Meer actueel nieuws, bijeenkomsten en publieke consultaties