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Adv 3:47–50. doi: 10.1182/bloodadvances.2018025858 43. Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N, Bi Y, Ma X, Zhan F, Wang L, Hu T, Zhou H, Hu Z, Zhou W, Zhao L, Chen J, Meng Y, Wang J, Lin Y, Yuan J, Xie Z, Ma J, Liu WJ, Wang D, Xu W, Holmes EC, Gao GF, Wu G, Chen W, Shi W, Tan W (2020) Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet 395:565–574. doi: 10.1016/S0140-6736(20)30251-8 44. Lythgoe MP, Middleton P (2020) Ongoing Clinical Trials for the

/ICH/2711/99). Available at: http://www.emea.europa.eu/pdfs/human/ich/271199EN.pdf ALRAVILLA, A. - MANFREDI, C. - BAIARDI, P. et al.: Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr, 2012, 101, No. 1, p. e27-32. (Epub 2011 Jul 23). ICH E11, p. 5 - 6. ICH E11, p. 5 - 6. ICH E11, p. 6 - 7. ICH E11, p. 11 - 13. Ethical Considerations for Clinical Trials on Medicinal Products Conducted with Paediatric Population. Recommendations of the ad hoc group for the development of implementing guidelines for

electroporation, in COST action TD 1104 EP4Bio 2 Med, and is included in the series of publications addressing the same topic in preclinical research in electroporation as well as in the pulsed electric fields for industrial purposes. 31 Several guidelines exist with the aim of assuring sound research practices, and improving the quality of clinical trials and, ultimately, allow for generalizable results. At a basic level, Good Clinical Practice (GCP) represents an international ethical and scientific quality standard for designing, conducting, recording and reporting trials

;63:411-36. 36. Brodniewicz T. Badania kliniczne. Wyd 1. Warszawa. CeDeWu. 2015. 37. Jachowicz R. Farmacja praktyczna. Warszawa: Państwowy Zakład Wydawnictw Lekarskich; 2007. 38. Mahan V. Clinical trial phases. Int J Clin Med. 2014;5:1374-83. 39. National Centre for the Replacement, Refinement and Reduction of Animals in Research. https://www.nc3rs.org.uk/the-3rs (stan z 01.03.2018). 40. Portal Farmaceutyczno-Medyczny. Patent na lek. https://www.pfm.pl/artykuly/patent-na-lek/275 (stan z 01.03.2018).

Abstract

Background and aims: The objective of this study was to conclude if there are enough scientific evidences to consider metformin as a potential treatment for pancreatic cancer. Material and Method: We performed a systematic search using PubMed and MedlinePlus up to September 2012. Reference list of relevant peer reviewed literature were hand searched. Ultimately 15 articles were included. Results: Epidemiological studies had revealed that therapy with metformin was associated with 21% reduced risk for all types of malignancies, 31% reduction in overall summary relative risk, the median survival was longer: 16.6 vs. 11.5 months and the risk of death has decreased with 33%. In vitro it was proven that low doses of metformin block the stimulation of DNA synthesis and the growth of human pancreatic cancer cells. Prospective randomized clinical trials to confirm these data were already launched. Conclusions: These results raise the possibility that metformin could improve the poor prognostic of patients suffering from pancreatic cancer. Other clinical trials should confirm this hypothesis.

References Alam M.I. (2016): A comparison between the continual reassessment method and D-optimum design for dose finding in phase I clinical trials. Biometrical Letters 53(2): 69-82. Atkinson A.C., Fedorov V.V., Herzberg A.M., Zhang R. (2014): Elemental information matrices and optimal experimental design for generalized regression models. Journal of Statistical Planning and Inference 144(1): 81-91. Brunier H.C., Whitehead J. (1994): Sample sizes for phase II clinical trials derived from Bayesian decision theory. Statistics in Medicine 13(23-24): 2493

, (no serious adverse events associated with these trials) but none resulted in long-term expression of clotting factor at therapeutic levels [ 9 ]. Looking back over two decades of intensive gene therapy research, it can be seen that the early studies have paved the way for the increasingly sophisticated therapies currently under investigation ( Table 1 ). Table 1 Clinical trials for gene therapy of haemophilia (from Cancio et al, 2013 [ 1 ]) Reference Gene and vector Administration and subjects Outcome • Roth et al, 2001 [ 11 ] hFVIII via plasmid DNA Laparoscopic

R eferences Atkinson A.C., Fedorov V.V., Herzberg A.M., Zhang R. (2014): Elemental information matrices and optimal experimental design for generalized regression models. Journal of Statistical Planning and Inference 144(1): 81–91. Babb J., Rogatko A., Zacks S. (1998): Cancer phase I clinical trials: Efficient dose escalation with overdose control. Statistics in Medicine 17(10): 1103–1120. Chernoff H. (1953): Locally optimal designs for estimating parameters. The Annals of Mathematical Statistics 24(4): 586–602. Collins J.M., Grieshaber C.K., Chabner B.A. (1990

. Ghafarzadeh M, Moeininasab S, Namdari M. Effect of early amniotomy on dystocia risk and cesarean delivery in nulliparous women: a randomized clinical trial. Arch Gynecol Obstet . 2015;292(2):321-5. 11. WHO Reproductive Health Library. WHO recommendation on the use of active phase partograph with a four-hour action line for monitoring the progress of labour. (May 2014). The WHO Reproductive Health Library; Geneva: World Health Organization. 12. Fraser WD, Turcot L, Krauss I, Brisson-Carrol G, Smyth R. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev

References 1. Tulvatana W, Thinkhamrop B, Kulvichit K, Tatsanavivat P. Thai Clinical Trials Registry. J Evid Based Med. 2011; 4:182-4. 2. De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med. 2004; 351: 1250-1. 3. World Health Organizaion. International Clinical Trials Registry Platform (ICTRP): What is a clinical trial? Available at: http://www.who.int/ictrp/en/. Accessed May 3, 2011. 4. World Health Organizaion. International