Uitgelicht en gespot op internet (week 18 & 19, 2021)
Vorige week niet aan toegekomen vanwege andere activiteiten maar hierbij weer een nieuw overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet. Ook de ‘Events‘ pagina en de ‘Consultations‘ pagina zijn weer bijgewerkt en van nieuwe bijeenkomsten en consultaties voorzien.
Association of Clinical Research Organizations (ACRO)
Artificial Intelligence
Bescherming persoonsgegevens, AVG
Besluit Centrale Beoordeling (BCB), MDR, ECTR
Biobanken, Wet zeggenschap lichaamsmateriaal (WZL)
- Wetsvoorstel zeggenschap lichaamsmateriaal naar Tweede Kamer (12 mei 2021). Ministerie van Volksgezondheid, Welzijn en Sport.
- Researchers seek contact with Dutch biobanks to explore and compare policies (5 mei 2021). BBMRI.nl.
Centrale Commissie Dierproeven (CCD)
Clinical trial results reporting, Transparancy
- Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO (7 mei 2021). WHO.
- Global regulators issue call for clinical trial data transparency (7 mei 2021). Regulatory Focus.
- European regulators urged to crack down on missing clinical trial results (6 mei 2021). BMJ.
- FDA Cracks Down on ClinicalTrials.gov Reporting Failures (4 mei 2021). FDA Law Blog, Hyman, Phelps & McNamara.
- FDA Issues First-Ever Rebuke to Sponsor for Failing to Submit ClinicalTrials.gov Info (3 mei 2021). WCG CenterWatch.
- Reporting Clinical Trial Results – The Why and the How (3 mei 2021). Wiley.
College ter Beoordeling van Geneesmiddelen (CBG)
Commissie Regelgeving Onderzoek (COREON)
Dutch Association of Research Quality Assurance (DARQA)
European Commission
European CRO Federation (EUCROF)
European Medicines Agency
European Organisation for Research and Treatment of Cancer (EORTC)
Goede Onderzoekspraktijken, Fieldlab
International Council for Harmonisation (ICH)
- The ICH S1B(R1) draft Guideline reaches Step 2 of the ICH process (10 mei 2021).
- To speed drug development, ICH proposes reducing rat carcinogenicity testing (14 mei 2021). Regulatory Focus.
Medicines and Healthcare products Regulatory Agency (MHRA)
- Is your eSystem actually an eCRF (electronic case report form)? (11 mei 2021).
- Virtual conference: The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) Revision (7 mei 2021).
Medische hulpmiddelen, MDR
- Euro Convergence: Mind the gap in MDR’s treatment of combo products (11 mei 2021). Regulatory Focus.
- Hooray: EU medical device clinical trial guidance one minute to midnight! (9 mei 2021). Medical Devices Clinical.
- HPRA Medical Devices Newsletter, April 2021. Health Products Regulatory Authority (HPRA) [Ierland]
Nationaal Comité advies dierproevenbeleid (NCad)
National Institute for Health Research (NIHR)
Reproducibility
- Good research begins long before papers get written (29 april 2021). Nature.
- The MDAR Framework – a new tool for life sciences reporting (26 april 2021). PLOS Blogs.
US Food and Drug Administration (FDA)
- Newly added guidance documents
- ICH-M9 Biopharmaceutics Classification System-Based Biowaivers – Final (11 mei 2021).
- ICH -E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials – Final (11 mei 2021).
- ICH Q3D(R2) – Guideline for Elemental Impurities-Investigators – Final (11 mei 2021).
- ICH S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals – Final (11 mei 2021).
- ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry – Final (11 mei 2021).
- ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex – Final (11 mei 2021).
- ICH S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals – Final (11 mei 2021).
- Qualified Infectious Disease Product Designation Questions and Answers – Draft (11 mei 2021).
- FDA issues ICH Q12 guidance and others on clinical trials, safety testing and biowaivers (11 mei 2021). Regulatory Focus.
- Changing FDA Approval Standards: Ethical Implications for Patient Consent (8 april 2021). J Gen Intern Med.
Overige
- Study Coordinator Charged in Scheme to Falsify Clinical Trial Data (12 mei 2021). Department of Justice.
- Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization (12 mei 2021). Regulatory Focus.
- Clinical trial paper that made anemia drug look safer than it is will be retracted (11 mei 2021). Retraction Watch.
- Oncology Trials Outpacing Rest of the Field in Complexity and Duration, Study Shows (10 mei 2021). WCG CenterWatch.
- As the Pandemic Eases, Sites Focus On Improving Study Startup Times (10 mei 2021). WCG CenterWatch.
- The weird science of the placebo effect keeps getting more interesting (5 mei 2021). Vox.
- A doctor trained nurse practitioners to do colonoscopies. Critics say his research exploited Black patients (4 mei 2021). STAT.
- ASCO-ACCC Piloting Test Tools to Diversify Cancer Clinical Trials (3 mei 2021). Association of Community Cancer Centers.
- CDISC, NORD to Develop Data Standards for Rare Disease Trials (3 mei 2021). WCG CenterWatch.
- ‘Betrek patiënten met lage digitale vaardigheden meer bij onderzoek’ (3 mei 2021). Skipr.
- Ethics review of big data research: What should stay and what should be reformed? (30 april 2021). BMC Medical Ethics.
- Pre-market development times for innovative vaccines – to what extent are the COVID-19 vaccines outliers? (29 april 2021). Clin Infect Dis.
- A Review of the Dose Justification of Phase 3 Trials to Regulatory Authorities for Drugs Intended for the Treatment of Type 2 Diabetes in Europe (28 april 2021). Front. Pharmacol.
- When Can Nonrandomized Studies Support Valid Inference Regarding Effectiveness or Safety of New Medical Treatments? (7 april 2021). Clin Pharmacol Ther.
- Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics (1 april 2021). JAMA Netw Open.
- Placebo—The Unknown Variable in a Controlled Trial (22 februari 2021). JAMA Internal Medicine.
- Collider bias undermines our understanding of COVID-19 disease risk and severity (12 november 2020). Nature Communications.
- A new Tuskegee? Unethical human experimentation and Western neocolonialism in the mass circumcision of African men (9 september 2020). Developing World Bioethics.
Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.
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