Uitgelicht en gespot op internet (week 20, 2022)
Hierbij ontvangt u een nieuwe uitgave van het supplement ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.
Ook zijn er weer nieuwe bijeenkomsten en consultaties toegevoegd aan de ‘Events‘ en de ‘Consultations‘-pagina.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Algemene verordening gegevensbescherming (AVG), Uitvoeringswet Algemene verordening gegevensbescherming (UAVG)
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trials
- Outcomes and endpoints in clinical trials supporting the marketing authorisation of treatments in paediatric acute lymphoblastic leukaemia (18-05-2022). Drug Discovery Today.
- Study: Novel drug approvals in 2020 continue trend of fewer preapproval pivotal trials, surrogate endpoints (17-05-2022). Regulatory Focus.
- Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes (16-05-2022). Trials.
- AI in clinical trial adherence and retention: is it a Pandora’s box? (13-05-2022). Clinical Trials Arena.
- Association of Quality-of-Life Outcomes in Cancer Drug Trials With Survival Outcomes and Drug Class. JAMA Oncol. 2022 Apr 28:e220864. doi: 10.1001/jamaoncol.2022.0864. Epub ahead of print.
- RADIAL Country selection process (2022). Trials@Home.
Clinical trial registries, Clinical trial results reporting
- Why did clinical trial registries fail to prevent Covid research chaos? (17-05-2022). TranspariMED.
- Clinical Trial Registration Patterns and Changes in Primary Outcomes of Randomized Clinical Trials From 2002 to 2017. JAMA Intern Med. Published online May 16, 2022.
- New report documents rampant research waste in Covid trials (14-05-2022). TranspariMED.
Clinical Trials Transformation Initiative (CTTI)
Commissie Regelgeving Onderzoek
Diversiteit, Representativiteit
- Why “Participant Voice and Experience” Matters in Clinical Research (mei 2022). DIA Global Forum.
- New Requirements for Lay Language Summaries of Clinical Trials Are Here—Are You Prepared? (mei 2022). DIA Global Forum.
- Nature journals raise the bar on sex and gender reporting in research (18-05-2022). Nature.
- New report urges more clinical trial diversity, recommends incentives (18-05-2022). Regulatory Focus.
- National Academies report cites ‘urgent’ need to recruit more diverse participants for clinical trials (17-05-2022). STAT.
- Nothing about Us without Us: Inclusion and IRB Review of Mental Health Research Protocols (11-05-2022). Ethics & Human Research.
Dutch Clinical Research Foundation (DCRF)
EU Digital Health Policy
- EU Digital Health Policy: European Commission launches European Health Data Space (19-05-2022). BioSlice Blog, Arnold & Porter.
- Your health data can help scientific research. But how will it be protected? (19-05-2022). Euronews.
- Impact EU-voorstel op wet elektronische gegevensuitwisseling in de zorg (19-05-2022). Ministerie van VWS.
European Medicines Agency (EMA), Good Clinical Practice
- Clinical Trials Regulation: progress on implementation (20-05-2022).
- Key performance indicators (KPIs) to monitor the European clinical trials environment (20-05-2022).
- Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020 (20-05-2022).
- Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes – Revision 2 (20-05-2022).
- Synchron Research Service: suspension of medicines over flawed studies (20-05-2022).
Findable, Accessible, Interoperable and Reusable (FAIR) data
- Selection of data sets for FAIRification in drug discovery and development: Which, why, and how? (17-05-2022). Drug Discovery Today.
- European Commission report on FAIR data highlights ELIXIR (13-05-2022). Elixir.
History of Clinical Trials
- The evolution of clinical trials: Can we address the challenges of the future? (16-02-2018). Clinical Trials.
- Evolution of Clinical Trials throughout History (2017). Marshall Journal of Medicine: Vol. 3: Iss. 1, Article 9
- Evolution of clinical research: A history before and beyond james lind. Perspect Clin Res [serial online] 2010 [cited 2022 May 22];1:6-10.
International Committee of Medical Journal Editors (ICMJE)
Medicines and Healthcare products Regulatory Agency (MHRA)
- International Clinical Trials Day (20-05-2022). Blog MedRegs.
- Guidance – Notify the MHRA about a clinical investigation for a medical device (updated 19-05-2022: Added section for “Study deviations” and related XLS)
Open Science and Intellectual Property Rights
Pharos
Proefschriften
- Replication, bias, and meta-research in animal cognition research (11-05-2022). Farrar, Benjamin.
- Transforming the health research system: Embedding patient engagement in decision-making (17-12-2021). Lidewy Eva Vat.
Rathenau Instituut
- Society and synthetic cells. A position paper by the Future Panel on Synthetic Life (26-04-2022).
- Society and synthetic cells – A position paper by the Future Panel on Synthetic Life. The Hague: Rathenau Instituut.
Real World Evidence (RWE)
Technische Universiteit Delft
U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH)
- FDA updates guidance on evaluating out-of-specification results for drugs (18-05-2022). Regulatory Focus.
- FDA Offers Advice on Human Radiolabeled Mass Balance Studies (16-05-2022). WCG CenterWatch.
- FDA works to advance real-world data collection in pregnancy and lactation (16-05-2022). Regulatory Focus.
- NIH Should Create an Office of Autoimmune Disease Research, Says New Report (10-05-2022). National Academies of Sciences, Engineering, and Medicine.
- Automated Research Workflows Are Speeding Pace of Scientific Discovery; New Report Offers Recommendations to Advance Their Development (10-05-2022). National Academies of Sciences, Engineering, and Medicine.
Vereniging Innovatieve Geneesmiddelen
- Blog Erwin Vermeulen: World Clinical Trial Day (17-05-2021).
- Sofie Boutkan (NKI): ‘Passende behandeling voor elke patiënt’ (17-05-2021).
- Lidewij Vat: ‘Patiëntenparticipatie als het nieuwe normaal’ (16-05-2021).
Overige berichten
- Drug Discovery Today, Volume 27, Issue 6, Pages 1531-1784 , June 2022.
- DIA Global Forum – Driving Insights to Action (May 2022).
- Weekend reads: Dogs removed from controversial research facility; ‘an unacceptable idea’; ‘blind spots on western blots’ (21-05-2022). Retraction Watch.
- Failed to properly register your trial? Just use a different study’s number. Actually, don’t (20-05-2022). Retraction Watch.
- Universiteit openbaart alsnog zeven frauduleuze artikelen van Colzato (18-05-2022). Mare.
- Artificial intelligence in virtual screening: models versus experiments (18-05-2022). Drug Discovery Today.
- Overplaying N=1 in the stem cell therapy world (17-05-2022). The Niche.
- Pivot into COVID-19 research eases as publishing surge starts to level off (17-05-2022). Science.
- FDA, EMA officials discuss impediments to cell and gene therapies (17-05-2022). Regulatory Focus.
- Ethical microbiome research with Indigenous communities (16-05-2022). Nature Microbiology.
- Use Data and Details to Convince Site Leadership to Add Staff (16-05-2022). WCG CenterWatch.
- Europe PMC: Harnessing the power of text mining to accelerate life sciences research (12-05-2022). EMBL.
- Two kinds of embryo research: four case examples (09-05-2022). Journal of Medical Ethics.
- Blind spots on western blots: a meta-research study highlighting opportunities to improve figures and methods reporting (13-05-2022). bioRxiv.
- How to Reduce Errors and Improve Transparency by Using More Precise Citations (29-04-2022). Front. Cardiovasc. Med.
- European patent protection for medical uses of known products and drug repurposing. Nat Biotechnol. 2022 Apr;40(4):465-471.
- A new taxonomy was developed for overlap across ‘overviews of systematic reviews’: A meta-research study of research waste (19-12-2021). Research Synthesis Methods.