Uitgelicht en gespot op internet (week 39, 2022)

Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.

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Clinical trial results reporting

• US government spent $18 billion on drugs with overdue clinical trial results (01-10-2022). TranspariMED.
• New report flags gaps in clinical trial regulations across Europe (26-09-2022). TranspariMED.
• Euro Roundup: EU regulators start actively prompting trial sponsors to make results public (29-09-2022). Regulatory Focus.

Clinical trials, Decentralized Clinical Trials, Informed consent

• Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review (oktober 2022). Drug Discovery Today.
• Wearable smart devices in cancer diagnosis and remote clinical trial monitoring: Transforming the healthcare applications (oktober 2022). Drug Discovery Today.
• External control arms: when can historical data substitute for placebos? (29-09-2022). Clinical Trials Arena.
• How Sponsors and CROs can Fully Benefit from the Permanent Shift Toward Decentralized Clinical Trials Brought About by the COVID-19 Pandemic (26-09-2022). Applied Clinical Trials.
• DCT Planning Checklist: Your Guide to Ensuring a Successful Decentralized or Hybrid Trial (26-09-2022). Applied Clinical Trials.
• Transparency and reporting characteristics of COVID-19 randomized controlled trials (26-09-2022). BMC Medicine.
• Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases (15-09-2022). Trials.
• The improving benefit–risk balance of phase I cancer trials (31-08-2022). Nature Reviews Drug Discovery.
• Emergency use of unproven clinical interventions outside clinical trials: ethical considerations. Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO.
• The ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes. Front Med. 2022;9:950409. Published 2022 Aug 9. doi:10.3389/fmed.2022.950409
• When is it impractical to ask informed consent? A systematic review. Clin Trials. 2022;17407745221103567. doi:10.1177/17407745221103567
• Boosting ethics review capacity in public health emergency situations: Co-creation of a training model for French-speaking research ethics committees. Trop Med Int Health. 2022;10.1111/tmi.13815
• The ethics of exclusion: why pregnant and lactating women must be front and centre of HIV research. J Int AIDS Soc. 2022;25 Suppl 2(Suppl 2):e25926. doi:10.1002/jia2.25926

DCRF survey CTR

Combination products, Medical Devices, Medicinal Products

• Medicinal products meet medical devices: Classification and nomenclature issues arising from their combined use (oktober 2022). Drug Discovery Today.

Council for International Organizations of Medical Sciences (CIOMS) 

• Glossary of ICH terms and definitions (2022).
• CIOMS Cumulative Glossary, with a focus on Pharmacovigilance (Version 2.0) (2022).

Dutch Oncology Research Platform (DORP)

• Overzicht trials van Onderzoekbijkanker.nl nu ook op NVMO-website (30-09-2022).
• Eén protocol voor meerdere studies: DORP organiseert webinar over Master Protocols (29-09-2022).

EUDAT Collaborative Data Infrastructure

• Slides beschikbaar van EUDAT Conference 2022

EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)

Kindly note that the EMA Service Desk has changed to ServiceNow and can be accessed via https://support.ema.europa.eu/esc. If you cannot access through this portal, please report your issue or ask your question through using the email address EudraCT_notification@ema.europa.eu. We thank you very much for your collaboration.

bron: EudraCT public home page d.d. 26-09-2022

European Clinical Research Infrastructure Network (ECRIN) 

• Identifying obstacles hindering the development of academic-sponsored trials for drug repurposing on rare-diseases (29-09-2022).

European Federation of Pharmaceutical Industries and Associations (EFPIA), International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

• ATTENTION SOCIAL MEDIA USERS: New IFPMA and EFPIA Guidance on use of social media by industry (29-09-2022). BioSlice Blog.
• Joint Note for Guidance on social media and digital channels (28-09-2022). IFPMA.
• Joint Note for Guidance on social media and digital channels (28-09-2022).

European Medicines Agency (EMA)

• Presentaties online van: Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making (29-09-2022).
• EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products (29-09-2022).
• EMA qualifies Unlearn’s AI-driven approach for smaller trials (29-09-2022). Clinical Trials Arena.
• Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (28-09-2022).

Farmacovigilantie

• Safety surveillance and challenges in accelerated COVID-19 vaccine development. Ther Adv Drug Saf. 2022;13:20420986221116452. Published 2022 Sep 5.
• COVID-19 vaccine safety monitoring in low and middle income countries – Time for a bold new
  approach. Vaccine. 2022;40(32):4301-4302. doi:10.1016/j.vaccine.2022.06.053
• Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis. Drug Saf.

Gegevensuitwisseling

• NFU ontvouwt plannen voor dataplatform CumuluZ (29-09-2022). Skipr.
• Secundair gebruik maakt data-dans tot feestnummer  (27-09-2022). HollandBIO.

Inspectie Gezondheidszorg en Jeugd (IGJ)

• Interventiebeleid medisch-wetenschappelijk onderzoek met mensen (28-09-2022).

International Rare Diseases Research Consortium (IRDiRC) 

• IRDiRC Announces Creation of Regulatory Scientific Committee to Tackle Regulatory Challenges in Rare Diseases Research – Press Release (22 september 2022).

Isala

• Isala verlengt maatregelen bij wetenschappelijk onderzoek cardiologie (23-09-2022).
• Patiënten Isala Zwolle deden zonder overleg arts mee aan studie (23-09-2022). Skipr.

Medicines and Healthcare products Regulatory Agency (MHRA)

• Good clinical practice for clinical trials (27-09-2022), (Updated CAPA guidance PDF).

Medische hulpmiddelen

• Devices that are used together, components, accessories, systems, procedure packs, and the rest… (25-09-2022). Boumans Regulatory Consulting.

National Academies of Sciences, Engineering, and Medicine

• Measuring Sex, Gender Identity, and Sexual Orientation (2022). Washington, DC: The National Academies Press.

NHS Health Research Authority

• Our response to concerns raised about research proposed by the Cass Review (19-08-2022).

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken, nr. 154 van 26 september 2022.

Regulatory Science Network Netherlands (RSNN)

• RSNN Newsletter September 2022 (26-09-2022).
• FAST and RSNN collaborate to advance and innovate the regulatory system (23-09-2022).
• RSNN Special Interest Group Advanced Therapies

Towards the European Health Data Space (TEHDAS)

• TEHDAS convenes European initiatives to discuss impact of EHDS proposal (30-09-2022).
• EU Legislation in Progress: European health data space (September 2022).

U.S. Food and Drug Administration (FDA), Verenigde Staten

• Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs (draft 26-09-2022).
• Has the FDA fallen short with its new draft guidance for paediatric clinical trials? (30-09-2022). Clinical Trials Arena.
• Keys to Unblocking the Innovation Bottleneck in Research (29-09-2022). Advarra.
• New FDA guidance offers ethical roadmap for including children in clinical trials (26-09-2022). Regulatory Focus.
• OIG raises concerns about accelerated approval pathway (30-09-2022). Regulatory Focus.
• A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases (30-09-2022). FDA Law Blog, Hyman, Phelps & McNamara, P.C.
• FDA Expands Patient Input on Drug Development (29-09-2022). Applied Clinical Trials.
• Informed Consent Writing Tip Sheet (28-09-2022). Advarra.
• FDA seek to harmonize human subject protections with revised Common Rule (27-09-2022). Regulatory Focus.

ZonMw

• Palliatieve zorg. Diversiteit in onderzoek: zó lukt het. In gesprek met het Netwerk van Organisaties van Oudere Migranten (NOOM) en Stichting Gezondheid Allochtonen Nederland (SGAN) (september 2022).
• ZonMw stopt financiering OPERA studie vanwege te weinig deelnemers (22-09-2022).
• Negentig procent publicaties NWO- en ZonMw-onderzoek Open Access (21-09-2022).

Overig

• Weekend reads: Troubles in Romania; an erroneous erratum about fraud; Nature and discriminatory science (01-10-2022). Retraction Watch.
• Drug Discovery Today, Volume 27, Issue 10, October 2022.
• Nature Reviews Drug Discovery, Volume 21 Issue 10, October 2022.
• Are Your Patient Narratives Too Broad? (30-09-2022). Applied Clinical Trials.
• Collaboration, expertise, and infrastructure: key ingredients for gene therapy to thrive in Europe (30-09-2022). EuropaBio.
• ‘Honorary authors’ of scientific papers abound—but they probably shouldn’t (28-09-2022). Science.
• Start-Up Pharma Weathering the Inflation (28-09-2022). Applied Clinical Trials.
• Quality Output Checklist and Content Assessment (QuOCCA): a new tool for assessing research quality and reproducibility (26-09-2022). BMJ Open.
• What is the sensitivity and specificity of the peer review process? (27-09-2022). Accountability in Research.
• CRISPR/Cas9 in the era of nanomedicine and synthetic biology (27-09-2022). Drug Discovery Today.
• Intranasal delivery of biotechnology-based therapeutics (26-09-2022). Drug Discovery Today.
• Tackling bias in AI health datasets through the STANDING Together initiative (26-09-2022). Nature Medicine.
• mRNA pioneers refocus on therapeutics (15-09-2022). Nature Reviews Drug Discovery.

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