ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS
Abstract
During the analysis of international requirements for designing of clinical trials we found that principal documents are provided by ICH. The main standard in Russian Federation is the National State Standard “Good Clinical Practice”, that is similar to ICH GCP. Thorough industrial standards are issued by global regulators: FDA and EMA. Currently there is absence of local regulatory documents on designing clinical trials in Russia, thus there might be a distinct need in development of national regulatory documents and its harmonization with international standards for pharmaceutical industry.
About the Authors
O. S. Kobyakova
Siberian State Medical University
Russian Federation
Russian Federation
E. S. Kulikov
Siberian State Medical University
Russian Federation
Russian Federation
I. A. Deev
Siberian State Medical University
Russian Federation
Russian Federation
A. A. Dmitriev
Siberian State Medical University
Russian Federation
Russian Federation
N. A. Tabakaev
Siberian State Medical University
Russian Federation
Russian Federation
I. D. Pimenov
Siberian State Medical University
Russian Federation
Russian Federation
D. S. Tyufilin
Siberian State Medical University
Russian Federation
Russian Federation
References
1. ClinicalTrials .gov database / U.S. National Institute of Health, National Library of Medicine, 2016. URL: https://clinicaltrials.gov/ct2/results/details?rcv_s=01%2F01%2F1995&rcv_e=01%2F01%2F2005 (дата обращения 30.03.2016).
2. ClinicalTrials .gov database / U.S. National Institute of Health, National Library of Medicine, 2016. URL: https://clinicaltrials.gov/ct2/results/details?rcv_s=01%2F01%2F2005&rcv_e=01%2F01%2F2015 (дата обращения 30.03.2016).
3. D. Dogramatzis. Healthcare Biotechnology: A Practical Guide. - Boca Raton: CRC Press, 2011. 689 p.
4. ГОСТ Р 52379-2005. Надлежащая клиническая практика. Утвержден приказом Федерального агентства по техническому регулированию и метрологии от 27 сентября 2005 г. № 232-ст.
5. Guideline for Good Clinical Practice. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf (дата обращения 01.03.2016).
6. Pharmacovigilance. Clinical safety data management: Definitions and standards for expedited reporting E2A. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf (дата обращения 01.03.2016).
7. Clinical Study Reports. Structure and content of clinical study reports E3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf (дата обращения 10.03.2016).
8. Dose-Response Studies. Dose-response information to support drug registration E4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E4/Step4/E4_Guideline.pdf (дата обращения 10.03.2016).
9. Clinical Trials in Geriatric Population. Studies in support of special populations: geriatrics E7. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E7/Step4/E7_Guideline.pdf (дата обращения 10.03.2016).
10. General Considerations for Clinical Trials E8. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf (дата обращения 10.03.2016).
11. Statistical Principles for Clinical Trials E9. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf (дата обращения 10.03.2016).
12. Choice of Control Group in Clinical Trials E10. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E10_Guideline.pdf (дата обращения 10.03.2016).
13. Clinical Trials in Pediatric Population. Clinical investigation of medicinal products in the pediatric population E11. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf (дата обращения 10.03.2016).
14. Clinical Evaluation by Therapeutic Category Principles for clinical evaluation of new antihypertensive drugs E12A. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E12/Step4/E12_Guideline.pdf (дата обращения 10.03.2016).
15. Definitions in Pharmacogenetics / Pharmacogenomics. Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories E15. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E15/Step4/E15_Guideline.pdf (дата обращения 10.03.2016).
16. General principle on planning/designing Multi- Regional Clinical Trials E17. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E17/E17_Final_Concept_Paper_July_2014.pdf (дата обращения 10.03.2016).
17. MedDRA® Term Selection:Points to Consider. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.meddra.org/sites/default/files/guidance/file/9491-1900_termselptc_r4_11_mar2016.pdf (дата обращения 10.03.2016).
18. Guidance on nonclinical safety studies for the Conduct of human clinical trials and marketing authorization For pharmaceuticals M3(R2). International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). URL: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf (дата обращения 10.03.2016).
19. Guideline for Industry: Structure and Content of Clinical Study Reports. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 1996.
20. Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application Guidance for Industry Electronic Source Data in Clinical Investigations. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2003.
21. Guidance for Industry: Computerized Systems Used in Clinical Investigations. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2007.
22. Guidance for Industry: Development and Use of Risk Minimization Action Plans. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2005.
23. Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2004.
24. Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2012.
25. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2005.
26. Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2005.
27. Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2012.
28. Guidance for Industry: Pharmacogenomic Data Submissions. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2005.
29. Guidance for Industry: Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2013.
30. Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2013.
31. Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2008.
32. Guidance for Sponsors, Investigators, and Institutional Review Boards. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2006.
33. Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2009.
34. Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2006.
35. Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2006.
36. Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2006.
37. Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2002.
38. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2009.
39. Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2009.
40. Guidance for Industry: Premarketing Risk Assessment. U.S. Department of Health and Human Services, Food and Drug Administration. - Washington, DC: U.S. Government Printing Office, 2005.
41. EMA: Clinical efficacy and safety guidelines. European Medicines Agency. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000085.jsp (дата обращения 05.04.2016).
42. EMA: Good pharmacovigilance practices. European Medicines Agency. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp#section4 (дата обращения 05.04.2016).
43. EMA: Clinical Trial Regulation. European Medicines Agency. URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df (дата обращения 05.04.2016).
44. Руководство по проведению доклинических исследований лекарственных средств. Ч. 1 / Под ред. А.Н. Миронова. - М.: Гриф и К, 2012. 944 с.
45. Руководство по проведению доклинических исследований лекарственных средств (иммунобиологические лекарственные препараты). Ч. 2 / Под ред. А.Н. Миронова. - М.: Гриф и К, 2012. 536 с.
46. Руководство по проведению клинических исследований лекарственных средств. Ч. 1 / Под ред. А.Н. Миронова. - М.: Гриф и К, 2012. 244 с.
47. Руководство по проведению клинических исследований лекарственных средств (иммунобиологические лекарственные препараты). Ч. 2 / Под ред. А.Н. Миронова. - М.: Гриф и К, 2012. 212 с.
48. Руководство по экспертизе лекарственных средств. Том I. - М.: Гриф и К, 2013. 328 с.
49. Руководство по экспертизе лекарственных средств. Том II. - М.: Гриф и К, 2013. 280 с.
Review
For citations:
Kobyakova O.S., Kulikov E.S., Deev I.A., Dmitriev A.A., Tabakaev N.A., Pimenov I.D., Tyufilin D.S. ANALYSIS OF INTERNATIONAL REQUIREMENTS FOR DESIGNING OF CLINICAL TRIALS. Drug development & registration. 2016;(2):172-178. (In Russ.)
Views:
1038
Email this article 