A C TA Obstetricia et Gynecologica
AOGS LE TT E R TO THE EDIT O R
An important consideration in research and clinical practice
Sir, We read the Editors Message by Prof. Ganesh Acharya (1) with great interest as it addressed an issue of current concern to researchers worldwide. Evidence-based medicine is now being actively applied to clinical practice and related healthcare fields, such as drug development and medical technology. Evidencebased findings from clinical studies guide medical decision-making, healthcare practice and policies, and the direction of research. Many systematic reviews of existing clinical studies have been published and their results have been applied to evidencebased medicine (2). However, the presumably scientific and objective data published during the data collection phase of clinical studies may reflect publication bias (3). Therefore, since the early 1980s, efforts have been made to develop a clinical trial registration system and reporting guidelines. These efforts have been strengthened by international participation (4). In the USA, clinical trial registration and reporting have been legally required since 2000. However, the number of clinical trials that meet international standards has decreased, such that few are available to test the validity of the registration system. This has prevented comparisons between foreign clinical registration sites and ClinicalTrials.gov, and therefore evaluation of the practice of registering clinical trials. In May 2010, South Korea’s Centers for Disease Control and the Prevention National Institutes of Health Clinical Research Information Service (CRIS) fulfilled the requirements for international academic publications and was accepted by the World Health Organization International Clinical Trial Registry Platform as the primary registry of clinical trials. CRIS is a web-based registration system that meets international standards for study registration and research. It is completely accessible to domestic and foreign researchers and to the general public. Its goal is to share data obtained from domestic clinical trials with the international community and to ensure transparent, ethical, and scientifically objective clinical research. The recruitment of participants before initiation of the clinical study, clinical studies in progress, and completed studies are examples of the types of studies/information that can be registered in CRIS. The enrollment of individuals in a clinical study must meet the requirements of the International Committee of Medical Journal Editors and the Helsinki Declaration. To date, CRIS includes 1414 clinical studies and clinical trials (5). Registration is possible for any study initiated in or after May 2010, regardless of the type of clinical research. The number of studies registered each year has been steadily increasing. Local researchers have recognized the significant improvements
that have been made with the ethical and transparent reporting of clinical trial results. The South Korean government has also promoted clinical trial registration requirements through mandatory registration of clinical studies in CRIS. This kind of research support has had positive effects on the participating institutions. CRIS helps to improve the quality of clinical studies by protecting clinical study subjects, ensuring the objectivity and transparency of the results, establishing the basis for ethical clinical research, and providing standardized guidelines for research reporting that enable access to all research required for clinical decision-making.
Tae-Hee Kim1, Eun-Ae Jung2,*, Hae-Hyeog Lee1 and Sun-Yong Hwang3 1 Department of Obstetrics and Gynecology, Soonchunhyang University College of Medicine, Bucheon, 2Medical Library, Soonchunhyang University Bucheon Hospital, Bucheon, and 3 Department of Interdisciplinary Program in Biomedical Science, Soonchunhyang University, Asan, Korea *Corresponding Author: Eun-Ae Jung E-mails: [email protected]
, [email protected]
References 1. Acharya G. Pragmatism, dynamism and flexibility in research and clinical practice. Acta Obstet Gynecol Scand. 2015;94:345–6. 2. Park HY. Primary registry of the WHO International Clinical Trial Registry Platform: Clinical Research Information Service (CRIS). J Korean Med Assoc. 2011;54:92–7. 3. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol. 1986;4:1529–41. 4. Kim SE. Registration and reporting guidelines for clinical trials. Korean J Med. 2012;83:309–18. 5. Korea National Institute of Heath. Clinical Research information Service (CRIS) statistic. 2015. Available online at: https://cris.nih.go.kr/cris/stats/cris_stats.jsp (accessed March 30, 2015).
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 909–909