Uitgelicht en gespot op internet (week 15, 2022)
Hierbij 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.
Vergeet niet om ook de ‘Events‘-pagina en de ‘Consultations‘-pagina te raadplegen.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Centrale Commissie Dierproeven (CCD)
Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Uploaden, naamgeving en wijzigen documenten in CTIS (11-04-2022).
- Uploading documents into CTIS: filename, CTIS title, version number and date
- Uploading documents into CTIS in response to an RFI: change application
Clinical Trials Information System (CTIS)
- EMA Guidance Defines Commercially Confidential Information for Redaction (18-04-2022). WCG CenterWatch.
- Euro Roundup: EMA shares draft guidance on protecting confidential data in CTIS (14-04-2022). Regulatory Focus.
Clinical Trials Regulation (CTR), EudraLex, Beslisboom klinische proeven
Clinical trial results reporting
- European parliamentarians urge action on missing clinical trial results (10-04-2022). TranspariMED.
- Key clinical trial data often inconsistent across registries, study finds (06-04-2022). TranspariMED.
- Where are the Clinical Study Reports we were promised? (31-03-2022). TranspariMED.
eClinical Forum
- eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021 (04-04-2022).
- eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire (31-03-2022).
- Implementing eSRA: Sponsor Perspective (31-03-2022).
- Difference between eSRA V2022 and eSRA V2021 (30-03-2022).
- Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA) – Release 2022 (29-03-2022).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
- ICH Statement on the situation in Ukraine (11-04-2022).
- Pediatric Extrapolation OK to Evaluate Safety, ICH Draft Guideline Says (11-04-2022). WCG CenterWatch.
- ICH drafts guideline on pediatric extrapolation in drug development (06-04-2022). Regulatory Focus.
International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)
Medicines and Healthcare products Regulatory Agency (MHRA)
Oorlog in Oekraine en klinisch onderzoek, European Medicines Agency (EMA)
- Impact of the war in Ukraine on methodological aspects of ongoing clinical trials
- Medicijnteksten vertaald naar Oekraïens op Apotheek.nl (14-04-2022). KNMP.
Proefpersonen, Inclusie, Consent, Inclusiviteit, Representativiteit
- Diversity in clinical research: public health and social justice imperatives. Journal of Medical Ethics Published Online First: 15 April 2022. doi: 10.1136/medethics-2021-108068.
- Cardiovascular Trials Still Predominantly Led by Men, Study Finds (11-04-2022). WCG CenterWatch.
Proefschriften
US Food and Drug Administration (FDA)
- FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials (13-04-2022).
- Newly added guidance documents
- Draft – Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet (15-04-2022).
- Final – Bioavailability Studies Submitted in NDAs or INDs – General Considerations (15-04-2022).
- Draft – Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability (13-04-2022).
- Final – ICH E8(R1) General Considerations for Clinical Studies (08-04-2022).
- Ask the Experts: The FDA’s New Remote Interactive Evaluation (18-04-2022). WCG CenterWatch.
- FDA Recommends Sponsors Submit Plans for Achieving Trial Diversity (18-04-2022). WCG CenterWatch.
- FDA issues new draft guidance to boost clinical trial diversity (14-04-2022). Clinical Trials Arena.
- FDA recommends sponsors plan to include race, ethnicity in clinical trial design (13-04-2022). Regulatory Focus.
- FDA bioavailability guidance takes industry feedback into consideration (15-04-2022). Regulatory Focus.
- FDA Adopts Revised ICH Guideline on Quality in Clinical Trial Design (11-04-2022). WCG CenterWatch.
- Alzheimer’s disease: FDA guidance had ‘strong influence’ on endpoint selection (04-04-2022). Regulatory Focus.
Vereniging Innovatieve Geneesmiddelen
Overige berichten
- Weekend reads: White academic’s book about Black feminism pulled; retraction notices as a genre; forget the scientific paper? (16-04-2022). Retraction Watch.
- Rater Success Begins with Open Communication, Targeted Training (18-04-2022). WCG CenterWatch.
- Legislation Proposed to Curb Research Drug Costs, Improve Trial Transparency (18-04-2022). WCG CenterWatch.
- Bill Gates: How to Develop Life-Saving Drugs Much Faster (15-04-2022). The New York Times.
- Former graduate student voices concerns for misconduct in bioengineering research lab (15-04-2022). The Daily Illini.
- Unethical studies of ivermectin for covid-19 BMJ 2022; 377 :o917.
- Expect the Unexpected: How Sites Can Prepare for Final Protocol Curveballs (11-04-2022). WCG CenterWatch.
- Site Spotlight: Patient Engagement Drives Rochester Clinical Research’s Retention Strategy (11-04-2022). WCG CenterWatch.
- Misconduct, failure to supervise earn researchers years-long funding bans (10-04-2022). Retraction Watch.
- Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis (08-04-2022). Clinical and Translational Report.
- Black Americans’ Views of and Engagement With Science (07-04-2022). Pew Research Center.
- Marks calls for new gene therapy development paradigm (05-04-2022). Regulatory Focus.
- Standards of Conducts for Biostatisticians and Stem Cell Researchers: A Call for Self-formulated Aspirational Ethics Over Built-in Prohibitive Ethics (17-03-2022). Science and Engineering Ethics.
- Off-label prescription of medicines: what do we know about the legislation in EU member states?. Rare Dis Orphan Drugs J 2022;1:5.
- The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions. Drug Saf 45, 83–95 (2022).