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Nieuwsbrief voor Goede Onderzoekspraktijken
Nummer. 38 - 17 Augustus 2017
Beste lezer,
Hierbij ontvangt u de Nieuwsbrief voor Goede Onderzoekspraktijken van 17 augustus 2017, met de laatste ontwikkelingen rond medisch-wetenschappelijk onderzoek met mensen, nieuwe wet- en regelgeving en gereviseerde richtlijnen.
Met vriendelijke groet,
Inhoudsopgave
- EudraLex volume 10 'clinical trials guidelines' is vernieuwd: twee nieuwe en één gewijzigd guidance document
- Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
- Nederlands Normalisatie-instituut kondigt herziening aan van ISO 14155 'Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)'
- Publieke consultaties
- Uitgelicht
Onderzoek met Geneesmiddelen
EudraLex volume 10 'clinical trials guidelines' is vernieuwd: twee nieuwe en één gewijzigd guidance document
Ergens begin augustus 2017 is EudraLex volume 10 vernieuwd en zijn er twee nieuwe guidance documenten toegevoegd en is er één guidance document gewijzigd.
De drie guidance documenten betreffen "Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use". Deze 'recommendations' zullen zodra Verordening (EU) nr. 536/2014 in werking treedt van toepassing zijn (bron: CCMO nieuwsbericht d.d. 14 augustus 2017).
Download de "Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use":
- Summaries of Clinical Trial Results for Laypersons (26 January 2017)
- Risk proportionate approaches in clinical trials (25 April 2017)
- Auxiliary medicinal products in clinical trials (rev. 2, June 2017)*
*Het guidance document 'Auxiliary medicinal products in clinical trials' vervangt de 'Guidance on Investigational Medicinal Products (IMPs) and "non investigational medicinal products" (NIMPs)' (bron: EudraLex, volume 10).
Reacties publieke consultatie
Op 7 augustus 2017 zijn de reacties gepubliceerd die zijn ontvangen tijdens de publieke consultaties van de guidance documenten:
- Responses to the public consultation on "Summary of Clinical Trial Results for Laypersons"
- Responses to the public consultation on "Risk proportionate approaches in clinical trials"
- Responses to the public consultation on the revision of the "Definition of Investigational Medicinal Products (IMPs) and use of Auxiliary Medicinal Products (AMPs)" (previously called "Guidance on Investigational Medicinal Products (IMPS) and Non-Investigational Medicinal Products (NIMPs)")
Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors
Op 7 augustus 2017 heeft de Europese Commissie de reacties gepubliceerd van de publieke consultatie van de "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors".
Onderzoek met Medische Hulpmiddelen
Nederlands Normalisatie-instituut kondigt herziening aan van ISO 14155 'Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)'
Op 27 juni 2017 maakte het Nederlands Normalisatie-instituut (NEN) bekend dat de ISO 14155 norm 'Klinisch onderzoek van medische hulpmiddelen voor gebruik bij mensen - Goede klinische praktijkrichtlijnen (GCP)' (laatste versie uit 2011) momenteel wordt gereviseerd.
Belanghebbenden die een bijdrage willen leveren kunnen zich aanmelden bij het NEN.
NC3Rs: Assessing the impact of the ARRIVE guidelines
EMA: Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population
Consultatie open tot 13 oktober 2017
EMA: Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version
Consultatie open tot 31 oktober 2017
EMA: Reflection paper on the pharmaceutical development of medicines for use in the older population - First version
Consultatie open tot 31 januari 2018
Meer bijeenkomsten en consultaties?
Voor meer bijeenkomsten en lopende publieke consultaties zie:
Ontvangt u nog geen 'maandelijkse overzicht met bijeenkomsten en publieke consultaties'? Klik hier naar uw voorkeuren te gaan, en vink de maandelijkse overzichten aan.
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Oriol Canela-Xandri, Konrad Rawlik, Albert Tenesa (16 August 2017). An atlas of genetic associations in UK Biobank. bioRxiv 176834. This article is a preprint and has not been peer-reviewed. |
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Crotty, D. (16 August 2017). Revisiting: Is Access to the Research Paper the Same Thing as Access to the Research “Results”?. The Scholary Kitchen. |
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Zheng SY, Dhruva SS, Redberg RF. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements. JAMA. 2017;318(7):619–625. doi:10.1001/jama.2017.9414 |
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Naci H, Smalley KR, Kesselheim AS. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration. JAMA. 2017;318(7):626–636. doi:10.1001/jama.2017.9415 |
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Califf RM. Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk. JAMA. 2017;318(7):614–616. doi:10.1001/jama.2017.9412 |
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Califf RM, McCall J, Mark DB. Cosmetics, Regulations, and the Public Health Understanding the Safety of Medical and Other Products. JAMA Intern Med. 2017;177(8):1080–1082. doi:10.1001/jamainternmed.2017.2773 |
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Tyrell, S. & Michels, L.L. (14 August 2017). Regulatory Strategies for AI and Emerging Technologies. GxP Lifeline. |
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Christison, N. (14 August 2017). Why are Soft Skills So Hard? Part III. ACRP [blog]. |
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Anand B. Jain, Annette Mollet & Thomas D. Szucs (13 August 2017). Regulatory watch: Structural and procedural characteristics of international regulatory authorities. Nature Reviews Drug Discovery (2017) doi:10.1038/nrd.2017.135 |
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Komaroff AL. Gene Editing Using CRISPR Why the Excitement?. JAMA. Published online August 10, 2017. doi:10.1001/jama.2017.10159 |
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Rhys D.O. Jones, Marie Cooke, James Hinchliffe, Justin Morley, Simon T. Barry, Developing PreDICT − a fully integrated data platform for preclinical in vivo data: learning from experience, Drug Discovery Today, Available online 9 August 2017, ISSN 1359-6446 |
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Wendler D. A pragmatic analysis of vulnerability in clinical research. Bioethics. 2017;31:515–525. |
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EMA News (10 August 2017). Science and innovation for better medicines |
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Smit, G. (10 August 2017). Why it doesn’t seem fair to prefer male mice in behavioral studies. Behavioral Research Blog. |
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Newsletter 'SCOPE Stem Cell Roundup' (10 August 2017) |
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EMA (gepubliceerd op 8 augustus 2017). Annual report of the Pharmacovigilance Inspectors Working Group for 2016 Adopted by the PhV IWG on 15 June 2017 |
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EMA News (8 August 2017). EMA supports regulatory harmonisation in East Africa |
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Editorial (7 August 2017). Drug approval needs a helping hand. Nature. |
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EMA News (7 August 2017). Platform for post-authorisation studies registered as EU trade mark |
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National Academies of Sciences, Engineering, and Medicine. 2017. Developing a Methodological Research Program for Longitudinal Studies: Proceedings of a Workshop—in Brief. Washington, DC: The National Academies Press. |
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Papageorgiou SN, Antonoglou GN, Sándor GK, Eliades T (2017) Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all. PLOS ONE 12(8): e0182785. |
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Ross A, Rankin J, Beaman J, Murray K, Sinnett P, et al. (2017) Methodological quality of systematic reviews referenced in clinical practice guidelines for the treatment of opioid use disorder. PLOS ONE 12(8): e0181927. |
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Drazen, J., et al. (3 August 2017). Evidence for Health Decision Making — Beyond Randomized, Controlled Trials. N Engl J Med 2017; 377:465-475 |
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Adrian J Smith, R Eddie Clutton, Elliot Lilley, Kristine E Aa Hansen, Trond Brattelid (3 August 2017). PREPARE: guidelines for planning animal research and testing. Laboratory Animals, First published date: August-03-2017 |
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Djurisic, S., et al., (1 August 2017). Barriers to the conduct of randomised clinical trials within all disease areas. Trials 2017 18:360 |
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EMA News (1 August 2017). EMA prepares for Brexit |
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Journal of Medical Ethics, issue August 2017, Volume 43, 8 |
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Vollebregt, E. (31 July 2017). An unsurprising case of software qualification. medicaldeviceslegal [blog]. |
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Richard Horton, R. (29 July 2017). Offline: Medicines leadership—Britain's loss, Europe's gain. The Lancet. DOI: http://dx.doi.org/10.1016/S0140-6736(17)31995-5 |
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EFPIA statement on BMJ study on company policies for clinical trials transparency (27 Juy 2017) |
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Blasingim, J. (27 July 2017). Evaluating eConsent: Some Considerations from an IRB Perspective. Schulman IRB [blog]. |
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Schroeder, J. (26 July 2017). Patient Centricity: making clinical trials more effective by keeping focus on the patient. The Pharma Letter. |
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FDA (July 2017). IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects. |
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FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research. Ropes & Gray [blog] (25 July 2017). |
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Mueller, J. (21 July 2017). What do funders want, and why?. Insight, Medical Research Council [blog]. |
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Phillips, A.T., et al. (18 July 2017). Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials 2017 18:333 |
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Gray, R., et al., (16 July 2017). Registration of randomized controlled trials in nursing journals. Research Integrity and Peer Review 2017 2:8 |
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Lose G, Klarskov N. Why published research is untrustworthy. Int Urogynecol J. |
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Sayligil O, Ozden H. A written consent form dating back to 1524 in Bursa .er’iye (Sharia Court) records and a proposal of a new start date for consent forms. Ann Saudi Med 2014; 34(5): 433-436. |
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