Uitgelicht en gespot op internet (week 32)
Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘. Heeft u een nieuwstip voor het volgende overzicht? Stuur uw tip in via het contactformulier.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Uitgelicht & Gespot op Internet
Agence Nationale de Sécurité du Médicament et des Produits de Santé
Biobanken
- What Egyptians think. Knowledge, attitude, and opinions of Egyptian patients towards biobanking issues (9 augustus 2019). BMC Medical Ethics, volume 20, Article number: 57 (2019).
- BBMRI-ERIC to establish an Industry Stakeholder Forum to increase access to samples and boost biomedical research (8 augustus 2019). BBMRI-ERIC via LinkedIn.
Brexit
- Medicines and Healthcare Products Regulatory Agency
- Further guidance note on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit (updated 8 augustus 2019).
- Regulating medical devices in the event of a no-deal Brexit (updated 8 augustus 2019).
- Completed Paediatric Studies – submission, processing and assessment in a no-deal Brexit (updated 8 augustus 2019).
- Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal (updated 7 augustus 2019).
Big data, Data sharing
- Big Data, Big Tech, and Protecting Patient Privacy. JAMA. Published online August 09, 2019.
- It is not enough that we require data to be shared; we have to make sharing easy, feasible and accessible too! (22 juli 2019). BMJ Global Health.
- Paving the way in social license research: an interview with Ghislaine van Thiel and Shona Kalkman (10 juli 2019). BigData@Heart.
- Dealing with sensitive data (21 juni 2019). Springer Nature.
Clinical trial registry
CRISPR
- China approves ethics advisory group after CRISPR-babies scandal (8 augustus 2019). Nature.
- Disgraced CRISPR scientist had plans to start a designer-baby business (1 augustus 2019). MIT Technology Review.
Data manipulation, Misconduct
- Senators blast Novartis over data manipulation before approval of Zolgensma (9 augustus 2019). STAT.
- ICER Issues Statement Regarding Manufacturer’s Manipulation of Data from Animal Testing of Zolgensma (7 augustus 2019). Institute for Clinical and Economic Review.
- Farmaceut Novartis hield gesjoemel onder de pet (7 augustus 2019). Skipr.
- Novartis was aware of manipulation of data supporting gene therapy approval, FDA says (6 augustus 2019). STAT.
- Misconduct investigators, show your work (31 juli 2019). Chemistry World.
Dierexperimenteel onderzoek
European Medicines Agency
- New template: Clinical Trial assignment request PDF form
- From lab to patient: the journey of a centrally authorised medicine.
Human-monkey chimera
- Human-animal hybrids are coming and could be used to grow organs for transplant – a philosopher weighs in (2 augustus 2019). The Conversation.
- Scientists are making human-monkey hybrids in China (1 augustus 2019). MIT Technology Review.
- First human-monkey chimera raises concern among scientists (3 augustus 2019). The Guardian.
International Council for Harmonisation
League of European Research Universities
Medische hulpmiddelen
Privacy by design
Recruitment, Informed consent
- Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial (9 augustus 2019). Trials, volume 20, Article number: 492 (2019).
- Indigenous traumatic brain injury research: responding to recruitment challenges in the hospital environment (7 augustus 2019). BMC Medical Research Methodology, volume 19, Article number: 172 (2019).
- Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK (5 augustus 2019). Trials, volume 20, Article number: 474 (2019).
- Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys. JAMA Netw Open. Published online July 24, 20192(7):e197591.
- Accelerating Oncology Trial Recruitment by Identifying Patients at Diagnosis (11 juni 2019). ACRP.
The Global Health Network
Trial Master File
U.S. Food and Drug Administration
Overig nieuws
- Human Factor Looms as Significant Hurdle to Expanding Virtual Trials (9 augustus 2019). ACRP.
- Progression criteria in trials with an internal pilot: an audit of publicly funded randomised controlled trials (9 augustus 2019). Trials, volume 20, Article number: 493 (2019).
- High-performing physicians are more likely to participate in a research study: findings from a quality improvement study (7 augustus 2019). BMC Medical Research Methodology, volume 19, Article number: 171 (2019) .
- Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny (6 augustus 2019). STAT.
- Unethical work must be filtered out or flagged (5 augustus 2019). Nature.
- FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval (5 augustus 2019). Hogan Lovells, Focus on Regulation.
- Risk of bias judgments for random sequence generation in Cochrane systematic reviews were frequently not in line with Cochrane Handbook (5 augustus 2019).
- Fort Detrick lab shut down after failed safety inspection; all research halted indefinitely (2 augustus 2019). The Frederick News-Post.
- A watchdog group sets aside emotions to assess drugs’ value. Patients say their lives are more than a number (2 augustus 2019). STAT.
- ACRES Launches Global Accreditation of Clinical Research Sites (23 juli 2019). Alliance for Clinical Research Excellence and Safety.
Recent verschenen
- Overzicht bijeenkomsten & consultaties (3 August 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 96 (1 augustus 2019)
- Nieuwsbrief voor Goede Onderzoekspraktijken nr. 95 (4 juli 2019)
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