A Study of the Implication of Clinical Trial Registration Information and its Application to Industry: Focused on「COVID-19」Registered in ICTRP

doi:10.15683/kosdi.2021.12.31.778

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2021 Vol.17, Issue 4 Preview Page Next Page

Original Article

A Study of the Implication of Clinical Trial Registration Information and its Application to Industry: Focused on「COVID-19」Registered in ICTRP 임상 시험등록정보의 산업적 활용과 시사점: ICTRP에 등록된 COVID-19 사례 중심으로: 이화정¹ㆍ김경미²*
Hwajung Lee², Kyungmi Kim²*; ¹Ph.D. Student, The College of SAIHST, Sungkyunkwan University, Seoul, Republic of Korea
²Professor, College of Business Administration, Incheon National University, Incheon, Republic of Korea

31 December 2021. pp. 778-785

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Abstract

Purpose: The study is to analyze the current status of international clinical trial information services related to COVID-19 and to find out the impact of disclosing activities of clinical trial registration on the medical and pharmaceutical industry. Method: To achieve the purpose of the study, this study analyzed the current status of 780 registered clinical trials for COVID-19 during March of 2020 by using regression analysis. Result: The analysis of clinical trial research registration information showed and proved its usefulness for the development of related new drugs, treatments, vaccines, predictive and prognostic diagnostic kits and treatments related to the COVID-19 (Corona 19) in the world. Conclusion: The study concludes and urges all medical and pharmaceutical companies to register their trials on CRIS and recommends utilizing this registered data to develop advanced drug to benefits all patients related to COVID-19.

Keywords

Pandemic

COVID-19

ICTRP

Regression Analysis

Correlation Analysis

연구목적: 본 연구의 목적은 팬데믹 상황에서 의료정보관리방식이 가져다 줄 국가적 통제 가능성과 그 한계를 제시하고자 하는 것으로 의료정보 관리와 정보의 이용허가가 의료산업에 미치는 영향을 분석하고자한다. 연구방법: 연구목적을 위해 본조사는 국가별 대응 움직임의 유일한 표준화 근거인 임상시험등록플랫폼(International Clinical Trial Registry Platform, ICTRP)의 primary registry, 2019년 12월 첫 발생 시점부터 2020년 3월 30일, 해당 기간 기준, 780명의 등록자료를 확보해 임상시험계획 승인을 위한 ‘임상 시험등록정보’공개 정도를 검토하고 그 영향을 분석하였다. 연구결과: 연구 결과는 임상시험 등록의 정보 이용은 COVID-19와 관련된 새 치료제 개발, 백신 개발 등에 효과가 있음을 입증하였다. 결론: 연구의 결론은 각 국가는 이번 COVID-19의 신약 개발을 위해 다양한 임상 시험방법을 시도하고 있는 것으로 나타났으며 제약회사들은 CRIS에 임상시험 결과를 등록하여 많은 나라가 데이터를 공유하도록 하여 치료제나 백신 개발에 전념해야 한다.

키워드

팬데믹

COVID19

ICTRP

상관관계분석

회귀분석

References

Choi, E., Park, H. (2015). A Study on the Domestic and Foreign Registration of Clinical Tests.
Choi, H. (2020). Industrial Use and Implications of Clinical Trial Registration Information. Master Thesis, Incheon National University.
Choi, J. (2019). Clinical Research Information Service(CRIS) Registration Status and Comparative Analysis with Clinical Trial.gov Registration Status in Elderly Clinical Research.
De, A.C., Drazen, J.M., Frizelle, F.A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A.J., Schroeder, T.V., Sox, H.C., Van, M.B. (2010). Clinical trial registration: a statement from the International Committee of Medical Journal Editors[Internet]. International Committee of Medical Journal Editors, http://www. icmje.org/clin_trial.pdf.
Dickersin, K., Rennie, D. (2003). "Registering clinical trials." JAMA 2003, Vol. 290, No. 4, pp. 516-523. 10.1001/jama.290.4.516
Jeong, H. (2017). An Analysis of the Performance of Clinical Trials in and out of Korea: Focusing on the U.S and Korea. Master Thesis, Sungkyunkwan University.
Kim, M., Choi, E., Park , H. (2016). Review of clinical studies registered with the Clinical Research Information Service. Division of Cardiovascular Disease, Center for Biomedical Science, KNIH, KCDC. 10.3346/jkms.2016.31.1.1 26770030 PMC4712566
Kim, W. (2009). Improvement of Management System for the Introduction of Clinical Test Reporting System. Master Thesis, Sookmyung Women's University.
Lee, J., Kim, M., Ko, J. (2021). "A study on the development plan for promotion of advanced disaster-safety awareness." Journal of the Society of Disaster Information, Vol. 17, No. 3, pp. 415-426.
Lee, S. (2017). A Study on the Establishment and Operation of the National Clinical Trial Network. Seoul National University Hospital, Clinical Trial Global Business Group.
Park, H. (2018). Introduction of the Centers for Disease Control, Clinical Research Support and Research Trends. Clinical Research Support Center.
Park, J., Beck, M. (2021). "A study on survey of improvement of non face to face education focused on professor of disaster management field in COVID-19." Journal of the Society of Disaster Information, Vol. 17, No. 3, pp. 640-654.
Silver Spring: Food and Drug Administration (2005). FDAMA Section 113: Status Report on Implementation[Internet]. http://www.fda.gov/downloads/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ UCM148894.pdf.
Thoma, A., Farrokhyar, M., McKnight, L., Bhandari, M. (2010). "How to optimize patient recruitment." Canadian Journal of Surgery, Vol. 53, No. 3, pp. 205-210.
WHO(World Health Organization). (2020). https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Information

Publisher :The Korean Society of Disaster Information
Publisher(Ko) :한국재난정보학회
Journal Title :Journal of the Society of Disaster Information
Journal Title(Ko) :한국재난정보학회논문집
Volume : 17
No :4
Pages :778-785
DOI :https://doi.org/10.15683/kosdi.2021.12.31.778

[1] Choi, E., Park, H. (2015). A Study on the Domestic and Foreign Registration of Clinical Tests.

[2] Choi, H. (2020). Industrial Use and Implications of Clinical Trial Registration Information. Master Thesis, Incheon National University.

[3] Choi, J. (2019). Clinical Research Information Service(CRIS) Registration Status and Comparative Analysis with Clinical Trial.gov Registration Status in Elderly Clinical Research.

[4] De, A.C., Drazen, J.M., Frizelle, F.A., Haug, C., Hoey, J., Horton, R., Kotzin, S., Laine, C., Marusic, A., Overbeke, A.J., Schroeder, T.V., Sox, H.C., Van, M.B. (2010). Clinical trial registration: a statement from the International Committee of Medical Journal Editors[Internet]. International Committee of Medical Journal Editors, http://www. icmje.org/clin_trial.pdf.

[5] Dickersin, K., Rennie, D. (2003). "Registering clinical trials." JAMA 2003, Vol. 290, No. 4, pp. 516-523. 10.1001/jama.290.4.516

[6] Jeong, H. (2017). An Analysis of the Performance of Clinical Trials in and out of Korea: Focusing on the U.S and Korea. Master Thesis, Sungkyunkwan University.

[7] Kim, M., Choi, E., Park , H. (2016). Review of clinical studies registered with the Clinical Research Information Service. Division of Cardiovascular Disease, Center for Biomedical Science, KNIH, KCDC. 10.3346/jkms.2016.31.1.1 26770030 PMC4712566

[8] Kim, W. (2009). Improvement of Management System for the Introduction of Clinical Test Reporting System. Master Thesis, Sookmyung Women's University.

[9] Lee, J., Kim, M., Ko, J. (2021). "A study on the development plan for promotion of advanced disaster-safety awareness." Journal of the Society of Disaster Information, Vol. 17, No. 3, pp. 415-426.

[10] Lee, S. (2017). A Study on the Establishment and Operation of the National Clinical Trial Network. Seoul National University Hospital, Clinical Trial Global Business Group.

[11] Park, H. (2018). Introduction of the Centers for Disease Control, Clinical Research Support and Research Trends. Clinical Research Support Center.

[12] Park, J., Beck, M. (2021). "A study on survey of improvement of non face to face education focused on professor of disaster management field in COVID-19." Journal of the Society of Disaster Information, Vol. 17, No. 3, pp. 640-654.

[13] Silver Spring: Food and Drug Administration (2005). FDAMA Section 113: Status Report on Implementation[Internet]. http://www.fda.gov/downloads/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ UCM148894.pdf.

[14] Thoma, A., Farrokhyar, M., McKnight, L., Bhandari, M. (2010). "How to optimize patient recruitment." Canadian Journal of Surgery, Vol. 53, No. 3, pp. 205-210.

[15] WHO(World Health Organization). (2020). https://www.who.int/emergencies/diseases/novel-coronavirus-2019

Journal of the Society of Disaster Information ISSN:1976-2208(Print) 2671-5287(Online) 한국재난정보학회논문집

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