A New Approach to Psychiatric Drug Approval in Europe
article has not abstract
Vyšlo v časopise:
A New Approach to Psychiatric Drug Approval in Europe. PLoS Med 10(10): e32767. doi:10.1371/journal.pmed.1001530
Kategorie:
Policy Forum
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.1001530
Souhrn
article has not abstract
Zdroje
1. BighelliI, BarbuiC (2012) What is the European Medicines Agency? Epidemiol Psychiatr Sci 21: 245–247.
2. DuijnhovenRG, StrausSM, RaineJM, deBA, HoesAW, De BruinML (2013) Number of patients studied prior to approval of new medicines: a database analysis. PLoS Med 10: e1001407 doi:10.1371/journal.pmed.1001407
3. BarbuiC, BaschirottoC, CiprianiA (2011) EMA must improve the quality of its clinical trial reports. BMJ 342: d2291.
4. BarbuiC, BighelliI (2013) Regulatory science in Europe: the case of schizophrenia trials. Lancet 381 In press.
5. European Medicines Agency (2010) Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available. European Medicines Agency EMA/759784/2010.
6. Bertele'V, BanziR, GluudC, GarattiniS (2012) EMA's reflection on placebo does not reflect patients' interests. Eur J Clin Pharmacol 68: 877–879.
7. DeshauerD, MoherD, FergussonD, MoherE, SampsonM, GrimshawJ (2008) Selective serotonin reuptake inhibitors for unipolar depression: a systematic review of classic long-term randomized controlled trials. CMAJ 178: 1293–1301.
8. CiprianiA, PurgatoM, BarbuiC (2009) Why internal and external validity of experimental studies are relevant for clinical practice? Epidemiol Psichiatr Soc 18: 101–103.
9. BarbuiC, CiprianiA, LintasC, BerteleV, GarattiniS (2007) CNS drugs approved by the centralised European procedure: true innovation or dangerous stagnation? Psychopharmacology (Berl) 190: 265–268.
10. Food and Drug Administration (2010) Guidance for industry non-inferiority clinical trials. Rockville (Maryland): FDA.
11. GotzschePC (2006) Lessons from and cautions about noninferiority and equivalence randomized trials. JAMA 295: 1172–1174.
12. GarattiniS, BerteléV (2007) Non-inferiority trials are unethical because they disregard patients' interests. Lancet 370: 1875–1877.
13. HuitfeldtB, HummelJ (2011) The draft FDA guideline on non-inferiority clinical trials: a critical review from European pharmaceutical industry statisticians. Pharm Stat 10: 414–419.
14. MullaSM, ScottIA, JackeviciusCA, YouJJ, GuyattGH (2012) How to use a noninferiority trial. JAMA 308: 2605–2611.
15. HrobjartssonA, ThomsenAS, EmanuelssonF, TendalB, HildenJ, BoutronI, et al. (2012) Observer bias in randomised clinical trials with binary outcomes: systematic review of trials with both blinded and non-blinded outcome assessors. BMJ 344: e1119.
16. BarbuiC, FurukawaTA, CiprianiA (2008) Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials. CMAJ 178: 296–305.
17. O'ConnorAB (2010) Building comparative efficacy and tolerability into the FDA approval process. JAMA 303: 979–980.
18. PsatyBM, MeslinEM, BreckenridgeA (2012) A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report. JAMA 307: 2491–2492.
19. PurgatoM, BarbuiC (2012) What is the WHO essential medicines list? Epidemiol Psychiatr Sci 21: 343–345.
20. van OmmerenM, BarbuiC, deJK, DuaT, JonesL, Perez-SalesP, et al. (2011) If you could only choose five psychotropic medicines: updating the interagency emergency health kit. PLoS Med 8: e1001030 doi:10.1371/journal.pmed.1001030
21. GarattiniS, ChalmersI (2009) Patients and the public deserve big changes in evaluation of drugs. BMJ 338: b1025.
22. GarattiniS, BerteleV (2002) Efficacy, safety, and cost of new anticancer drugs. BMJ 325: 269–271.
23. GarattiniS, Bertele'V (2003) Efficacy, safety and cost of new cardiovascular drugs: a survey. Eur J Clin Pharmacol 59: 701–706.
24. GarattiniS, Bertele'V (2003) Efficacy, safety and cost of new drugs acting on the central nervous system. Eur J Clin Pharmacol 59: 79–84.
25. BarbuiC, CiprianiA (2012) Agomelatine and the brave old world of narrative-based medicine. Evid Based Ment Health 15: 2–3.
26. European Medicines Agency. Guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/10/WC500133437.pdf. Accessed 18 February 2013.
27. European Medicines Agency. Guideline on clinical investigation of medicinal products in the treatment of depression. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/10/WC500116160.pdf. Accessed 18 February 2013.
28. European Medicines Agency. Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003528.pdf. Accessed 18 February 2013.
29. European Medicines Agency. Guideline on the development of medicinal products for the treatment of post-traumatic stress disorder. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003489.pdf. Accessed 18 February 2013.
30. European Medicines Agency. Guideline on medicinal products for the treatment of insomnia. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/02/WC500102351.pdf. Accessed 18 February 2013.
31. European Medicines Agency. Guideline on the clinical investigation of medicinal products indicated for generalized anxiety disorder. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003510.pdf. Accessed 18 February 2013.
32. European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of panic disorder. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003511.pdf. Accessed 18 February 2013.
33. European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of social anxiety disorder. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003490.pdf. Accessed 18 February 2013.
34. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of obsessive-compulsive disorder. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003512.pdf. Accessed 18 February 2013.
Štítky
Interné lekárstvoČlánok vyšiel v časopise
PLOS Medicine
2013 Číslo 10
- Statiny indukovaná myopatie: Jak na diferenciální diagnostiku?
- MUDr. Dana Vondráčková: Hepatopatie sú pri liečbe metamizolom väčším strašiakom ako agranulocytóza
- Vztah mezi statiny a rizikem vzniku nádorových onemocnění − metaanalýza
- Nech brouka žít… Ať žije astma!
- Parazitičtí červi v terapii Crohnovy choroby a dalších zánětlivých autoimunitních onemocnění
Najčítanejšie v tomto čísle
- Utility of the Xpert MTB/RIF Assay for Diagnosis of Tuberculous Meningitis
- Modelling the Strategic Use of Antiretroviral Therapy for the Treatment and Prevention of HIV
- Diagnostic Accuracy of Quantitative PCR (Xpert MTB/RIF) for Tuberculous Meningitis in a High Burden Setting: A Prospective Study
- Assessing Optimal Target Populations for Influenza Vaccination Programmes: An Evidence Synthesis and Modelling Study