Izazovi u kliničkim ispitivanjima – uticaj nove uredbe na sprovođenje kliničkih ispitivanja
Reference
800x600
Normal
0
false
false
false
EN-US
X-NONE
X-NONE
MicrosoftInternetExplorer4
DefSemiHidden="false" DefQFormat="false" DefPriority="99"
LatentStyleCount="371">
UnhideWhenUsed="true" QFormat="true" Name="heading 2"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 3"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 4"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 5"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 6"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 7"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 8"/>
UnhideWhenUsed="true" QFormat="true" Name="heading 9"/>
Name="index 1"/>
Name="index 2"/>
Name="index 3"/>
Name="index 4"/>
Name="index 5"/>
Name="index 6"/>
Name="index 7"/>
Name="index 8"/>
Name="index 9"/>
UnhideWhenUsed="true" Name="toc 1"/>
UnhideWhenUsed="true" Name="toc 2"/>
UnhideWhenUsed="true" Name="toc 3"/>
UnhideWhenUsed="true" Name="toc 4"/>
UnhideWhenUsed="true" Name="toc 5"/>
UnhideWhenUsed="true" Name="toc 6"/>
UnhideWhenUsed="true" Name="toc 7"/>
UnhideWhenUsed="true" Name="toc 8"/>
UnhideWhenUsed="true" Name="toc 9"/>
Name="Normal Indent"/>
Name="footnote text"/>
Name="annotation text"/>
Name="header"/>
Name="footer"/>
Name="index heading"/>
UnhideWhenUsed="true" QFormat="true" Name="caption"/>
Name="table of figures"/>
Name="envelope address"/>
Name="envelope return"/>
Name="footnote reference"/>
Name="annotation reference"/>
Name="line number"/>
Name="page number"/>
Name="endnote reference"/>
Name="endnote text"/>
Name="table of authorities"/>
Name="macro"/>
Name="toa heading"/>
Name="List"/>
Name="List Bullet"/>
Name="List Number"/>
Name="List 2"/>
Name="List 3"/>
Name="List 4"/>
Name="List 5"/>
Name="List Bullet 2"/>
Name="List Bullet 3"/>
Name="List Bullet 4"/>
Name="List Bullet 5"/>
Name="List Number 2"/>
Name="List Number 3"/>
Name="List Number 4"/>
Name="List Number 5"/>
Name="Closing"/>
Name="Signature"/>
UnhideWhenUsed="true" Name="Default Paragraph Font"/>
Name="Body Text"/>
Name="Body Text Indent"/>
Name="List Continue"/>
Name="List Continue 2"/>
Name="List Continue 3"/>
Name="List Continue 4"/>
Name="List Continue 5"/>
Name="Message Header"/>
Name="Salutation"/>
Name="Date"/>
Name="Body Text First Indent"/>
Name="Body Text First Indent 2"/>
Name="Note Heading"/>
Name="Body Text 2"/>
Name="Body Text 3"/>
Name="Body Text Indent 2"/>
Name="Body Text Indent 3"/>
Name="Block Text"/>
Name="Hyperlink"/>
Name="FollowedHyperlink"/>
Name="Document Map"/>
Name="Plain Text"/>
Name="E-mail Signature"/>
Name="HTML Top of Form"/>
Name="HTML Bottom of Form"/>
Name="Normal (Web)"/>
Name="HTML Acronym"/>
Name="HTML Address"/>
Name="HTML Cite"/>
Name="HTML Code"/>
Name="HTML Definition"/>
Name="HTML Keyboard"/>
Name="HTML Preformatted"/>
Name="HTML Sample"/>
Name="HTML Typewriter"/>
Name="HTML Variable"/>
Name="Normal Table"/>
Name="annotation subject"/>
Name="No List"/>
Name="Outline List 1"/>
Name="Outline List 2"/>
Name="Outline List 3"/>
Name="Table Simple 1"/>
Name="Table Simple 2"/>
Name="Table Simple 3"/>
Name="Table Classic 1"/>
Name="Table Classic 2"/>
Name="Table Classic 3"/>
Name="Table Classic 4"/>
Name="Table Colorful 1"/>
Name="Table Colorful 2"/>
Name="Table Colorful 3"/>
Name="Table Columns 1"/>
Name="Table Columns 2"/>
Name="Table Columns 3"/>
Name="Table Columns 4"/>
Name="Table Columns 5"/>
Name="Table Grid 1"/>
Name="Table Grid 2"/>
Name="Table Grid 3"/>
Name="Table Grid 4"/>
Name="Table Grid 5"/>
Name="Table Grid 6"/>
Name="Table Grid 7"/>
Name="Table Grid 8"/>
Name="Table List 1"/>
Name="Table List 2"/>
Name="Table List 3"/>
Name="Table List 4"/>
Name="Table List 5"/>
Name="Table List 6"/>
Name="Table List 7"/>
Name="Table List 8"/>
Name="Table 3D effects 1"/>
Name="Table 3D effects 2"/>
Name="Table 3D effects 3"/>
Name="Table Contemporary"/>
Name="Table Elegant"/>
Name="Table Professional"/>
Name="Table Subtle 1"/>
Name="Table Subtle 2"/>
Name="Table Web 1"/>
Name="Table Web 2"/>
Name="Table Web 3"/>
Name="Balloon Text"/>
Name="Table Theme"/>
Name="List Paragraph"/>
Name="Intense Quote"/>
Name="Subtle Emphasis"/>
Name="Intense Emphasis"/>
Name="Subtle Reference"/>
Name="Intense Reference"/>
UnhideWhenUsed="true" Name="Bibliography"/>
UnhideWhenUsed="true" QFormat="true" Name="TOC Heading"/>
Name="Grid Table 1 Light Accent 1"/>
Name="Grid Table 6 Colorful Accent 1"/>
Name="Grid Table 7 Colorful Accent 1"/>
Name="Grid Table 1 Light Accent 2"/>
Name="Grid Table 6 Colorful Accent 2"/>
Name="Grid Table 7 Colorful Accent 2"/>
Name="Grid Table 1 Light Accent 3"/>
Name="Grid Table 6 Colorful Accent 3"/>
Name="Grid Table 7 Colorful Accent 3"/>
Name="Grid Table 1 Light Accent 4"/>
Name="Grid Table 6 Colorful Accent 4"/>
Name="Grid Table 7 Colorful Accent 4"/>
Name="Grid Table 1 Light Accent 5"/>
Name="Grid Table 6 Colorful Accent 5"/>
Name="Grid Table 7 Colorful Accent 5"/>
Name="Grid Table 1 Light Accent 6"/>
Name="Grid Table 6 Colorful Accent 6"/>
Name="Grid Table 7 Colorful Accent 6"/>
Name="List Table 1 Light Accent 1"/>
Name="List Table 6 Colorful Accent 1"/>
Name="List Table 7 Colorful Accent 1"/>
Name="List Table 1 Light Accent 2"/>
Name="List Table 6 Colorful Accent 2"/>
Name="List Table 7 Colorful Accent 2"/>
Name="List Table 1 Light Accent 3"/>
Name="List Table 6 Colorful Accent 3"/>
Name="List Table 7 Colorful Accent 3"/>
Name="List Table 1 Light Accent 4"/>
Name="List Table 6 Colorful Accent 4"/>
Name="List Table 7 Colorful Accent 4"/>
Name="List Table 1 Light Accent 5"/>
Name="List Table 6 Colorful Accent 5"/>
Name="List Table 7 Colorful Accent 5"/>
Name="List Table 1 Light Accent 6"/>
Name="List Table 6 Colorful Accent 6"/>
Name="List Table 7 Colorful Accent 6"/>
/* Style Definitions */
table.MsoNormalTable
{mso-style-name:"Table Normal";
mso-tstyle-rowband-size:0;
mso-tstyle-colband-size:0;
mso-style-noshow:yes;
mso-style-priority:99;
mso-style-parent:"";
mso-padding-alt:0cm 5.4pt 0cm 5.4pt;
mso-para-margin:0cm;
mso-para-margin-bottom:.0001pt;
mso-pagination:widow-orphan;
font-size:10.0pt;
font-family:"Times New Roman",serif;}
1. Dombernowsky T, Hædersdal M, Lassen U, Thomsen SF. Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities. BMJ Open 2017; 7(7): e015579.
2. Djurisic S, Rath A, Gaber S, Garattini S, Bertele V, Ngwabyt SN, et al. Barriers to the conduct of randomised clinical trials within all disease areas. Trials 2017; 18(1): 360.
3. European Parliament and Council of the European Union. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J 2001; L121: 34‒44.
4. European Parliament and Council of the European Union. Regulation (EU) 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Official J 2014; L158: 1‒76.
5. EMA. Highlights of Management Board: June 2020 meeting. 2020 Jun [cited 2021 Mar 8]; Available from: https://www.
/>ema.europa.eu/en/documents/press-release/highlights-manag
ement-board-june-2020-meeting_en.pdf
6. Lemaire F, Bion J, Blanco J, Damas P, Druml C, Falke K, et al. The European Union Directive on Clinical Research: present status of implementation in EU member states' legislations with regard to the incompetent patient. Intens Care Med 2005; 31(3): 476‒9.
7. Moulton B. Save European research campaign. BMJ 2004; 328(7434): 286.
8. Hartmann M, Hartmann-Vareilles F. The clinical trials directive: how is it affecting Europe's noncommercial research? PLoS Clin Trials 2006; 1(2): e13.
9. Vyve D, Meunier F. Facing the Challenges of the European Clinical Trials Directive – The European Organisation for Research and Treatment of Cancer Perspective. Eur Oncol Haematol 2008; 4(1): 14‒8.
10. SCORR Marketing and Applied Clinical Trials. Mobile Health in Clinical Trials Survey Report. 2015 Feb [cited 2021 Mar 8]. Available from: https://www.scorrmarketing.com/wp-content/uploads/SCORR_ACT_Mobile-Health-in-Clinical-Trials-Survey-Report.pdf
11. Mayor S. Squeezing academic research into a commercial strait jacket. BMJ 2004; 328(7447): 1036.
12. Liddell K, Chamberlain D, Menon DK, Bion J, Kompanje EJ, Lemaire F, et al. The European Clinical Trials Directive revisited: the VISEAR recommendations. Resuscitation 2006; 69(1): 9‒14.
13. Højgaard L. Proposal for a revision of the "Clinical Trials Directive" (2011/20/EC) and other recommendations to facilitate clinical trials. In ESF-EMRC Position paper. EMRC 2012.
14. European Commission. Proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.COM (2012) 369 final. 2012 July [cited 2021 Mar 8]. Available from: http://ec.europa.eu/health/files/clinic
/>altrials/2012_07/proposal/2012_07_proposal_en.pdf
15. Abou-El-Enein M, Schneider CK. Deciphering the EU clinical trials regulation. Nat Biotechnol 2016; 34(3): 231‒3.
16. Cave E. EU Clinical Trials Regulation 2014: Fetter or facilitator? Med Law Int 2018; 18(2‒3): 179‒94.
17. Kim D, Hasford J. Redundant trials can be prevented, if the EU clinical trial regulation is applied duly. BMC Med Ethics 2020; 21(1): 107.
18. Chan AW, Hróbjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations. Trials 2018; 19: 116.
19. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009; 374(9683): 86–9.
20. Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383(9912): 156–65.
21. Clarke M, Brice A, Chalmers I. Accumulating research: a systematic account of how cumulative meta-analyses would have provided knowledge, improved health, reduced harm and saved resources. PLoS One 2014; 9(7): e102670.
22. Warren E. Strengthening research through Data Sharing. N Engl J Med 2016; 375: 401‒3.
23. Thomas K. Transparency of clinical trial data – where does medical writing fit in? 2nd European Medical Writers Association Symposium 2014; 2014 [cited 2021 Mar 15]. Available from: http://www.emwa.org/Documents/Transp
/>arency%20Symposium%20Budapest%20Final.pdf
24. Minssen T, Rajam N, Bogers M. Clinical trial data transparency and GDPR compliance: Implications for data sharing and open innovation. Science Public Policy 2020; 47(5): 616‒26.
25. European Medicines Agency. Publication and access to clinical-trial data. EMA/240810/2013; 2013 June [cited 2021 Mar 15]. Available from: www.ema.europa.eu/docs/en_GB/document
_library/Other/2013/06/WC500144730.pdf
26. Petrini C. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview. Ann Ist Super Sanita 2014; 50(4): 317‒21.
27. Abou-El-Enein M, Bauer G, Reinke P, Renner M, Schneider CK. A roadmap toward clinical translation of genetically-modified stem cells for treatment of HIV. Trends Mol Med 2014; 20(11): 632‒42.
28. Chung KC, Song JW. WRIST Study Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg 2010; 126(2): 515‒23.
29. Rosemann A. Why regenerative stem cell medicine progresses slower than expected. J Cell Biochem 2014; 115(12): 2073‒6.
30. Meinert CL, Tonascia S. Single-center versus multicenter trials. In: Meinert CL, editor. Clinical trials: design, conduct and analysis. New York: Oxford University Press; 1986. p. 23–9.
31. Petrini C. What is the role of ethics committees after Regulation (EU) 536/2014? J Med Ethics 2016; 42(3): 186‒8.
32. Stahl E. Implementation status of Regulation EU 536/2014 in the member states. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2017; 60(8): 836‒40. (German)
33. Gefenas E, Cekanauskaite A, Lekstutiene J, Lukaseviciene V. Application challenges of the new EU Clinical Trials Regulation. Eur J Clin Pharmacol 2017; 73(7): 795‒8.
34. Tenti E, Simonetti G, Bochicchio MT, Martinelli G. Main changes in European Clinical Trials Regulation (No 536/2014). Contemp Clin Trials Commun 2018; 11: 99‒101.
35. Druml C, Wolzt M, Pleiner J, Singer EA. Research ethics committees in Europe: trials and tribulations. Intensive Care Med 2009; 35(9): 1636‒40.
36. van Doorn E, Hak E, Wilffert B. National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC. Vaccines (Basel) 2015; 3(2): 263‒92.
37. da Silva RE, Amato A, Guilhem D, Novaes MG. Globalization of clinical trials: ethical and regulatory implications. Int J Clin Trials 2016; 3(1): 1‒8.
38. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009; 360(8): 816‒23.
39. Law on Health Care 2019 (SRB) art 141, 142. (Serbian)
40. Law on Medicines 2020 (MNE) art 93. (Montenegrin)