• Title/Summary/Keyword: multicenter

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

  • Dae Ho Lee
    • The Journal of KAIRB
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    • v.5 no.2
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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
    • The Journal of Korean Academy of Prosthodontics
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    • v.45 no.3
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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.

Comparison of the Initial Review Efficiency of Joint Institutional Review Board and Local Institutional Review Board for Multicenter Clinical Research (다기관 임상연구에 대한 공동 Institutional Review Board (IRB)와 개별 기관 IRB 초기 심사 효율성 비교)

  • Sun Choi;Sunhye Shin;Hee Young Ham;Jua Kwon;Joohee Park;Dong Won Yang;Hyeon Woo Yim
    • The Journal of KAIRB
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    • v.6 no.2
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    • pp.38-47
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    • 2024
  • Purpose: The purpose of this study is to compare the efficiency of 2 types of Institutional Review Boards (IRBs) for multicenter research. Methods: The 2 types are joint IRB and local IRB. For this study, we selected multicenter research reviewed and approved by joint or local IRBs between October 2019 and December 2022. We assessed the time it took for each IRB to approve the research based on the number of working days per IRB review case. We then stratified the data according to the number of participating institutions, the type of research, and the type of IRB review. Results: The results of our study show that joint IRB is more efficient than local IRB. The median IRB approval time for joint IRB was 27 days, 73.5% shorter than local IRB (27 days vs. 102 days, respectively, p<0.001). As the number of participating institutions in multicenter research increased, joint IRB reviews became more efficient regarding the required approval time than local IRB reviews. We also found that joint IRB was faster in every administrative step until new research was approved (p<0.005) when compared to local IRB. Conclusion: Our study highlights that a single review through a joint IRB can significantly reduce the time required for IRB approval of multicenter research. This approach can ensure that all participating institutions follow the same review results. Therefore, a single IRB review effectively reduces the burden of IRB for multicenter research.

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

  • 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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    • s.265
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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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    • 1994.02b
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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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    • v.30 no.7
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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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    • v.33 no.6
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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).