Uitgelicht en gespot op internet (week 26, 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.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Clinical research, Clinical trials, Diversity, Informed consent
- This clinical trial wanted to end breast cancer disparities. But first it needed to enroll Black women (30-06-2022). STAT.
- Rule over your eTMF: how to optimise the electronic master file (30-06-2022). Clinical Trials Arena.
- Overcoming obstacles in trans and nonbinary participation in clinical trials (29-06-2022). Clinical Trials Arena.
- Empowering Sites to Optimize Clinical Trial Performance (28-06-2022). Applied Clinical Trials.
- Towards a Global Implementation of eConsent in Clinical Trials (28-06-2022). Applied Clinical Trials.
- An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior (28-06-2022). Developing Word Bioethics.
- Getting it wrong most of the time? Comparing trialists’ choice of primary outcome with what patients and health professionals want (27-06-2022). Trials.
- Regulators Seek More Drug Effects Research Related to Pregnancy, Lactation (27-06-2022). Applied Clinical Trials.
- Better Patient Engagement Begins With Electronic Informed Consent (24-06-2022). Applied Clinical Trials.
- Outcome Domain and Measurement Instrument Reporting in Randomized Controlled Trials of Interventions for Lumbar Spinal Stenosis: A Systematic Review (21-06-2022). Journal of Orthopaedic & Sports Physical Therapy.
- Myths about diversity in clinical trials reduce return on investment for industry (06-06-2022). Nature Medicine.
- Recruitment of Pregnant Women to Randomised Trials of COVID 19 Treatments, and Pharmaceutical Treatments Received Outside such Trials: A Research Article [published online ahead of print, 2022 March 13]. Eur J Obstet Gynecol Reprod Biol. 2022. 10.1016/j.ejogrb.2022.05.009.
- Ethical considerations in international clinical trial site selection. BMJ Global Health 2022;7:e008012. doi:10.1136/bmjgh-2021-008012.
- Should Children Be Enrolled in Clinical Research in Conflict Zones? AMA J Ethics. 2022;24(6):E463-E471. doi:10.1001/amajethics.2022.463.
- The ethical anatomy of payment for research participants. [published online ahead of print, 2022 May24]. Med Health Care Philos. 2022. 10.1007/s11019-022-10092-1.
- Setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned. Vaccine. 2022;40(25):3470-3480. doi:10.1016/j.vaccine.2022.04.094.
Clinical Trial Center (CTC) Erasmus MC
Website voor klinische studies Erasmus MC
“Met één druk op de knop een overzicht van alle lopende klinische studies in het Erasmus MC. Met de nieuwe website trials-zwn.nl is dat vanaf 1 juli mogelijk. Verwijzers van alle ziekenhuizen uit de regio krijgen toegang tot de site. Doel: behandelopties toegankelijker maken.”
bron: Clinical Trial Center – Website voor klinische studies Erasmus MC
Clinical Trials Regulation (CTR)
EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)
Following the issuing of the Joint Letter by the European Commission, EMA and HMA, National Competent Authorities and European Medicines Agency have sent reminders to sponsors who were not compliant with the European Commission guideline on results posting. Thanks to these reminders, the percentage of posted results substantially increased. However, for some trials the reminders were not successful: detailed lists of these trials can be found here.
European Health Data Space, Joint Action Towards the European Health Data Space (TEHDAS)
European Clinical Research Infrastructure Network (ECRIN)
- ICTD 2022: a Successful hybrid event on Patient Recruitment (29-06-2022).
- ECRIN Annual Report 2021 (27-06-2022).
European Medicines Agency
European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
- ENCePP nieuwsbericht ’10th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published” d.d. 1 juli 2022
- 10th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology
“The 10th Revision includes two new chapters on the use of artificial intelligence in pharmacoepidemiology (Chapter 15.5) and on real-world evidence and pharmacoepidemiology (15.6), and a new comprehensive Annex 2 on Methods for the evaluation of medicines in pregnancy and breastfeeding. Besides the updating of nearly all existing chapters, including considerations on methodological standards for COVID-19 studies, two chapters have been extensively revised: Comparative effectiveness research (15.1) and Vaccine research (15.2). Recommendations on the use of statistical significance for the interpretation of evidence have been added in the Overview of study designs (4.1). ….. This 10th Revision of the Guide provides a useful resource for researchers, regulators, marketing authorisation holders and applicants.”
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Nederlands Trial Register
Nederlandse Vereniging van Medisch-Ethische Toetsingscommissies (NVMETC)
NHS Health Research Authority (Verenigd Koninkrijk)
- UK-wide plan to boost clinical research (01-07-2022).
- How looking back helped us plan for the future – a blog by interim Director of Policy and Partnerships, Becky Purvis (30-06-2022).
- Putting people first in research – a blog by Barbara Molonyoates and Kate Greenwood (30-06-2022).
- Doomed tomatoes and sticky notes: if you want things to be different you have to do things differently – a blog by Leni Sivey (28-06-2022).
- New guidance for easier payment of public research contributors (27-06-2022).
Nieuwsbrief voor Goede Onderzoekspraktijken
Orphan Drug Access Protocol (ODAP)
- Nieuwe route voor weesgeneesmiddelen geen verbetering (28-06-2022). Vereniging Innovatieve Geneesmiddelen.
- Naar een nieuwe, gecontroleerde toegangsroute voor veelbelovende weesgeneesmiddelen (23-05-2022). Zorgverzekeraars Nederland.
Pharma.be
- beTransparent.be en de recent gepubliceerde Open pharma files (30-06-2022).
- Beleid dat innovatie ondersteunt, werpt vruchten af (29-06-2022).
- “Successen uit het verleden bieden geen garantie voor de toekomst” – Een perspectief op de farmasector 2021 (29-06-2022).
U.S. Food and Drug Administration (FDA)
- Draft guidance: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (29-06-2022).
- Final guidance: Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry (28-06-2022).
- Final guidance: Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for Industry (27-06-2022).
- Draft guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics (27-06-2022).
- Innovative Trials Opens First US Office (01-07-2022). Applied Clinical Trials.
ZonMw
Overige berichten
- Weekend reads: Retracted COVID-19 papers keep being cited; “‘difficult’ name penalty”; economist accused of plagiarism (02-07-2022). Retraction Watch.
- Comparison of the 2021 International Society for Stem Cell Research (ISSCR) guidelines for “laboratory-based human stem cell research, embryo research, and related research activities” and the corresponding Japanese regulations (2022). Regenerative Therapy.
- Care Access acquires trial centre in Brazil to expand DCT capability (30-06-2022). Clinical Trials Arena.
- China dominates ongoing-planned trials researching cervical cancer (30-06-2022). Clinical Trials Arena.
- How the Dobbs decision changed my research on reproductive health technology (30-06-2022). STAT.
- Retracted randomised controlled trials were cited and not corrected in systematic reviews and clinical practice guidelines (29-06-2022). Journal of Clinical Epidemiology.
- Prof. dr. Cornelis Boersma en Farminform starten partnerschap voor gepast geneesmiddelengebruik (28-06-2022). HollandBIO.
- Miljarden extra voor onderwijs gaan o.m. naar verbetering valorisatie (28-06-2022). HollandBIO.
- Zonder patiënt geen rendement (28-06-2022). HollandBIO.
- Placebo response reveals unconscious bias among white patients toward female, Black physicians (28-06-2022). STAT.
- ‘Minstens vijf cardiologen van Isala verdacht van corruptie’ (30-06-2022). Skipr.
- How Do Accredited Organizations Evaluate the Quality and Effectiveness of Their Human Research Protection Programs? (22-06-2022). AJOB Empirical Bioethics.
- Ten simple rules for good research practice (23-06-2022).PLoS Comput Biol 18(6): e1010139.
- Re-orienting anti-malarial drug development to better serve pregnant women. Malar J. 2022;21(1):121. Published 2022 Apr 12. doi:10.1186/s12936-022-04137-2.
- A chronological discourse analysis of ancillary care provision in guidance documents for research conduct in the global south. BMC Med Ethics. 2022;23(1):51. doi:10.1186/s12910-022-00789-6
- A blank check or a global public good? A qualitative study of how ethics review committee members in Colombia weigh the risks and benefits of broad consent for data and sample sharing during a pandemic. PLOS Global Public Health. 2022; 2(6): e0000364. doi: 10.1371/journal.pgph.0000364.
- WHO. Sharing and reuse of health-related data for research purposes: WHO policy and implementation guidance. Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO. WHO website.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties