• 제목/요약/키워드: Multicenter

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중앙 임상시험심사위원회 역할과 한계 그리고 극복 방안 (Central Institutional Review Board: Past, Present, and Future)

  • 이대호
    • 대한기관윤리심의기구협의회지
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    • 제5권2호
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    • pp.33-42
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    • 2023
  • In the conduct of multicenter clinical trials, multiple reviews by multiple Institutional Review Board (IRB) result in unnecessary duplication of efforts, delays and increased expenses of the trials, placing unavoidable burdens on not only investigators and sponsors but also IRBs. During the coronavirus disease 2019 pandemic periods, as the need of multicenter clinical trials for its therapeutics and vaccines increased, a centralized IRB became more important than before in order to efficiently conduct the multicenter trials without unnecessary multiple reviews. Accordingly, government-supported central IBR as a new centralized IRB has launched to foster multicenter clinical trials while to avoid unnecessary reviews and delays and to reduce burdens of all stakeholders. However, there are still barriers to be overcome and problems to be solved in the central IRB. In this review, we introduce background and history of the central IRB and try to propose some strategies or solutions against the barriers and problems.

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RETROSPECTIVE MULTICENTER STUDY OF CSM ENDOSSEOUS DENTAL IMPLANT

  • Park, Eun-Young
    • 대한치과보철학회지
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    • 제45권3호
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    • pp.321-328
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    • 2007
  • Statement of problem. To work the economic limitation of dental implant usage, some types of domestic implant have been developing. But, there have been seldom reported about the clinical success rate of them as yet. Purpose. The aim of this retrospective multicenter study was to evaluate the performance of CSM implants(CSM company, Daegu, Korea). Material and methods. Thirty-five patients were rehabilitated with 150 CSM implants in this multicenter study. Results. The success rate was 96.2%. CSM Titanium fixtures can obtain slightly higher success rate when a cover screw was not used for implant installation than when used. However it doesn't show significant difference(p=.7615, Fisher's Exact test). Conclusion. This multicenter retrospective study demonstrated the efficacy of the CSM implant in the treatment of variety of clinical manifestation of tooth loss. And it can be assumed that whether a cover screw is used or not should no influence on the osseointegration.

국외논문정보 - 직업적인 PAHs 노출과 폐암 위험 : 유럽의 multicenter 연구를중심으로 (Occupational exposure to polycyclic aromatic hydrocarbons and lung cancer risk : a multicenter study in Europe)

  • Olsson, Ann C.; Fevotte, Joelle;Fletcher, Tony;Cassidy, Adrian;Mannetje, Andrea't;Zaridze, David;Szeszenia-Dabrowska, Neonila;Rudnai, Peter;Lissowska, Jolanta;Fabianova, Eleonora;Mates, Dana;Bencko, Vladimir;Foretova, Lenka;Janout, Vladimir;Brennan, Paul;Boffetta, Paolo
    • 월간산업보건
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    • 통권265호
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    • pp.44-51
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    • 2010
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MANAGEMENT OF MULTICENTER CONTROLLED CLINICAL TRIALS

  • Raub William F.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.336-341
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    • 1994
  • Multicenter controlled clinical trials require It synthesis of the scientific method and the precepts of modern management. The management tasks associated with these studies are akin to those found in other kinds of complex corporate endeavors. It is recommended that clinical investigators become more knowledgeable about management concepts and methods and management specialists be given a major role in the planning and conduct of large-scale clinical trials.

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Evaluation of Multicenter Multielectron Integrals Using One-range Addition Theorems in Terms of STOs for STOs and Coulomb-Yukawa Like Correlated Interaction Potentials with Integer and Noninteger Indices

  • Guseinov, I. I.
    • Bulletin of the Korean Chemical Society
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    • 제30권7호
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    • pp.1539-1542
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    • 2009
  • Using one-range addition theorems for Slater type orbitals (STOs) and Coulomb-Yukawa like correlated interaction potentials (CIPs) introduced by the author, the series expansion formulae are derived for the multicenter multielectron integrals. The expansion coefficients occurring in these relations are presented through the overlap integrals of two STOs. The convergence of series expansion relations is tested by calculating concrete cases. The accuracy of the results is quite high for quantum number, screening constants and location of orbitals. The final results are especially useful in the calculation of multielectron properties for atoms and molecules when Hartree-Fock-Roothaan (HFR) and explicitly correlated methods are employed.

Harmonization of laboratory results by data adjustment in multicenter clinical trials

  • Lee, Sang Gon;Chung, Hee-Jung;Park, Jeong Bae;Park, Hyosoon;Lee, Eun Hee
    • The Korean journal of internal medicine
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    • 제33권6호
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    • pp.1119-1128
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    • 2018
  • Background/Aims: In multicenter clinical trials, laboratory tests are performed in the laboratory of each center, mostly using different measuring methodologies. The purpose of this study was to evaluate coefficients of variation (CVs) of laboratory results produced by various measuring methods and to determine whether mathematical data adjustment could achieve harmonization between the methods. Methods: We chose 10 clinical laboratories, including Green Cross Laboratories (GC Labs), the central laboratory, for the measurement of total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), serum triglycerides, creatinine, and glucose. The serum panels made with patient samples referred to GC Labs were sent to the other laboratories. Twenty serum samples for each analyte were prepared, sent frozen, and analyzed by each participating laboratory. Results: All methods used by participating laboratories for the six analytes had traceability by reference materials and methods. When the results from the nine laboratories were compared with those from GC Labs, the mean CVs for total cholesterol, HDL-C, LDL-C, and glucose analyzed using the same method were 1.7%, 3.7%, 4.3%, and 1.7%, respectively; and those for triglycerides and creatinine analyzed using two different methods were 4.5% and 4.48%, respectively. After adjusting data using Deming regression, the mean CV were 0.7%, 1.4%, 1.8%, 1.4%, 1.6%, and 0.8% for total cholesterol, HDL-C, LDL-C, triglyceride, creatinine, and glucose, respectively. Conclusions: We found that more comparable results can be produced by laboratory data harmonization using commutable samples. Therefore, harmonization efforts should be undertaken in multicenter trials for accurate data analysis (CRIS number; KCT0001235).

Quality improvement in pediatric care

  • Park, Moon Sung
    • Clinical and Experimental Pediatrics
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    • 제61권1호
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    • pp.1-5
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    • 2018
  • We often overlook the importance of several safety issues such as identification of patients, timeout procedure, hand hygiene, handoff communication, and many others. This ignorance, along with many other issues, leads to medical error being ranked as a third leading cause of death in the U.S. Consequently, quality improvement (QI) has become one of the major subjects in healthcare despite a relatively short history. Improving quality is about making healthcare safe, effective, patient-centered, timely, efficient, and equitable. Understanding the need and methodology of QI as well as participation is now essential for physicians. Although basic QI methodology has not changed, one of the most fascinating changes in recent QI is conducting large-scale QI projects through multicenter networks. Prospective multicenter QI projects utilizing the Korean Neonatal Network are a substantial initiation of pediatric QI in Korea. The Korean Pediatric Society should set ambitious goals for QI activities for every primary care pediatrician and pediatric subspecialist.

Recent Advances in Sentinel Node Navigation Surgery for Early Gastric Cancer

  • Eisuke Booka;Hiroya Takeuchi
    • Journal of Gastric Cancer
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    • 제23권1호
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    • pp.159-170
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    • 2023
  • Maintaining the postoperative quality of life (QOL) while ensuring curability without overtreatment is important in the treatment of early gastric cancer. Postoperative QOL is anticipated to be maintained through minimally invasive function-preserving gastrectomy in early gastric cancer. The concept of the sentinel lymph node (SN) basin is essential to maintain the curability of early gastric cancer using minimally invasive function-preserving gastrectomy. However, additional resection after surgery is difficult to perform in gastric cancer. Thus, the SN basin theory is important. Recently, a multicenter randomized phase III trial in South Korea (SENORITA trial) proved that laparoscopic sentinel node navigation surgery (LSNNS) for stomach preservation results in better postoperative QOL compared with standard gastrectomy in patients with early gastric cancer. LSNNS contributes to patients' QOL based on the concept that curability is not impaired. A multicenter nonrandomized phase III trial is ongoing in Japan, and oncologic safety is expected to be demonstrated. LSNNS has been established as a treatment option for selected patients with early gastric cancer, and its application will become widespread in the future.