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data monitoring committee interim reports: We must get there soon!

CLINICAL TRIALS 2022年第1期19卷 107-111页

作者： DeMets, David L. Wittes, Janet Univ Wisconsin 6333 Landfall Dr Madison WI 53705 USA WCG Acquires Stat Collaborat Washington DC USA

Currently, too many data monitoring committee Reports for interim review of trial progress are quite inadequate for data monitoring committees to make informed decisions about risks and benefits. Immediate serious improvement is necessary for data monitoring committees to meet their ethical, clinical, and scientific responsibility to trial participants, investigators, sponsors, and participating institutions. To achieve this critical goal, all parties involved in the data monitoring committee process including sponsors, investigators, data monitoring committee members, and the independent statistical reporting group need to have a better understanding of the structure, function, and needs of a data monitoring committee and the content of a data monitoring committee Report. Training modules through the Society for Clinical Trials are now available on their website to facilitate this.

关键词： data monitoring committee interim statistical reports

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The data monitoring committee: A Collective or a Collection?

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THERAPEUTIC INNOVATION & REGULATORY SCIENCE 2023年第4期57卷 653-655页

作者： Wittes, Janet Fleming, Thomas DeMets, David Ellenberg, Susan Gerstein, Hertzel Pfeffer, Marc Rockhold, Frank Yusuf, Salim Hennekens, Charles Wittes LLC Washington DC 20008 USA Univ Washington Seattle WA USA Univ Wisconsin Madison WI USA Univ Penn Philadelphia PA USA McMaster Univ Populat Hlth Res Inst Hamilton ON Canada McMaster Univ Dept Med Hamilton ON Canada Hamilton Hlth Sci Hamilton ON Canada Harvard Med Sch Boston MA USA Brigham & Womens Hosp Boston MA USA Duke Univ Med Ctr Duke Clin Res Inst Durham NC USA Duke Clin Res Inst Durham NC USA McMaster Univ Populat Hlth Res Inst Hamilton ON Canada Florida Atlantic Univ Boca Raton FL USA

In this commentary, we urge that a data monitoring committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations;it should not attribute opinions to individual members. Importantly, the proceedings of the DMC meetings should not be electronically recorded.

关键词： data monitoring committee Randomized controlled trials Interim analysis Minutes Electronic recording Safety

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A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting

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PHARMACOEPIDEMIOLOGY AND DRUG SAFETY 2021年第1期30卷 9-16页

作者： Major-Pedersen, Atheline McCullen, Mary Kate Sabol, Mary Elizabeth Adetunji, Omolara Massaro, Joseph Neugut, Alfred I. Sosa, Julie Ann Hollenberg, Anthony N. Novo Nordisk AS Global Safety Copenhagen Denmark AstraZeneca US Patient Safety Surveillance Wilmington DC USA GlaxoSmithKline Safety Evaluat & Risk Management Philadelphia PA USA Eli Lilly & Co Global Patient Safety Windlesham Surrey England Boston Univ Sch Publ Hlth Dept Biostat Boston MA USA Columbia Univ Dept Med Med Ctr New York NY USA Columbia Univ Med Ctr Dept Epidemiol New York NY USA Univ Calif San Francisco UCSF Dept Surg San Francisco CA USA New York Presbyterian Hosp Weill Cornell Med Ctr Weill Cornell Med Joan & Sanford I Weill Dept Med New York NY USA

Purpose To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint-industry sponsorship. Methods A DMC model was created to monitor data from an observational, retrospective, post-authorization safety study investigating risk of medullary thyroid cancer in patients treated with long-acting glucagon-like peptide-1 receptor agonists (LA GLP-1RAs) (NCT01511393). Sponsors reviewed regulatory guidelines, best practice and sponsors' standard operation procedures on DMCs. Discussions were held within the four-member consortium, assessing applicability to observational, retrospective, real-world studies. A DMC charter was drafted based on a sponsor-proposed, adapted DMC model. Thereafter, a kick-off meeting between sponsors and DMC members was held to receive DMC input and finalize the charter. Results Due to this study's observational, retrospective nature, assuring participant safety - central for traditional explanatory clinical trial models - was not applicable to our DMC model. The overall strategy and key indication for our real-world model included preserving study integrity and credibility. Therefore, DMC member independence and their contribution of expert knowledge were essential. To ensure between-sponsor data confidentiality, all study committees/corporations and sponsors, besides the DMC, received blinded data only (adapted to refer to data blinding that revealed the specific marketed LA GLP-1RA/sponsor). Communication and blinding/unblinding of these data were facilitated by the contract research organization, which also provided crucial operational oversight. Conclusions To our knowledge, we have established the first DMC model for joint industry-sponsored, observational, retrospective safety studies. This model could serve as a precedent for others performing similar post-marketing, joint industry-sponsored pharmacovigilance activities.

关键词： data monitoring committee joint sponsorship observational real‐ world data retrospective

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Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program

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CLINICAL TRIALS 2019年第3期16卷 253-262页

作者： Shavadia, Jay S. Sharma, Abhinav Gu, Xiangqiong Neaton, James DeLeve, Laurie Holmes, David Home, Phillip Eckel, Robert H. Watkins, Paul B. Granger, Christopher B. Duke Clin Res Inst 2400 Pratt StRm 7035 Durham NC 27705 USA Univ Saskatchewan Div Cardiol Dept Med Saskatoon SK Canada Univ Minnesota Sch Publ Hlth Minneapolis MN USA Univ Southern Calif Keck Sch Med Los Angeles CA USA Mayo Clin Rochester MN USA Newcastle Univ Inst Cellular Med Newcastle Upon Tyne Tyne & Wear England Univ Colorado Div Endocrinol Metab & Diabet Boulder CO 80309 USA Univ N Carolina Inst Drug Safety Sci Chapel Hill NC 27515 USA

Background Different approaches to safety event collection influence the determination of liver toxicity within drug development programs. Herein, a description of how fasiglifam-induced liver injury was detected is provided. Methods This eight-trial drug development program was intended to evaluate fasiglifam (25 mg, 50 mg) against placebo or active comparators (glimepiride, sitagliptin) in approximately 11,000 suboptimally controlled patients with type 2 diabetes (terminated Dec 2013 due to liver toxicity). Liver safety had been pre-identified as a concern, and within the phase 3 trials, was measured through (1) adverse event reporting, (2) central predefined liver monitoring schedule with various thresholds for potential drug-induced liver injury, and (3) blinded adjudication of serious liver toxicity by a panel of experts in drug-induced liver injury. A single data monitoring committee provided safety oversight across all trials within the program. Findings Prior to program termination, 7595 of 7602 (99.9%) randomized participants across the eight trials received at least one dose of the study drug (fasiglifam, placebo, or active control). No concerning trends were noted in adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events as reported by local site investigators. However, the predefined central liver safety measurements revealed a greater frequency of possible Hy's Law cases (5 vs 2) and a 3- to 7-fold greater relative risk in alanine or aspartate transaminase elevation (with respect to upper limit of normal) within fasiglifam recipients compared with placebo/active control: alanine or aspartate transaminase > 3x: relative risk 3.34 (95% confidence interval 2.29-4.90), alanine or aspartate transaminase > 5x: relative risk 6.60 (95% confidence interval 3.03-14.38), alanine or aspartate transaminase > 8x: relative risk 6.14 (95

关键词： data monitoring committee fasiglifam hepatotoxicity

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How to construct an optimal interim report: What the data monitoring committee does and doesn't need to know

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CLINICAL TRIALS 2018年第4期15卷 359-365页

作者： Neaton, James D. Grund, Birgit Wentworth, Deborah Univ Minnesota Sch Publ Hlth Div Biostat Suite 2002221 Univ Ave SE Minneapolis MN 55414 USA Univ Minnesota Sch Stat Minneapolis MN 55414 USA

Background: data monitoring committees for randomized clinical trials have the responsibility of safeguarding interests of trial participants. To do so, the data monitoring committee must receive reports on safety and efficacy to assess risk/benefit and on trial conduct to ensure that the study can achieve its goals. This article outlines the key components of reports to the data monitoring committee and the important role of the unblinded statistician in preparing those reports. Methods: Most data monitoring committee meetings include open and closed sessions. For each session, there is a report of interim results. The open session is attended by the sponsor and lead investigators, including the statistician(s) responsible for the trial design. These investigators are blinded to the interim treatment comparisons. The closed session is attended by the data monitoring committee members and by the statistician(s) who prepared the closed report. These individuals are unblinded to interim treatment comparisons and therefore are not involved in study design changes. The optimal content of data monitoring committee reports and qualifications of the unblinded statistician(s) are discussed. Reports: Open reports should include responses to data monitoring committee recommendations, a synopsis of the protocol, a review of the protocol history and amendments, and information on enrollment, baseline characteristics, completeness of follow-up, and data quality. The open report is also a vehicle through which the sponsor and investigators should inform the data monitoring committee of relevant external information. data in the open report are pooled over the treatment groups. The open report should not include data summaries by treatment group. The closed report should include a written summary with references to key tables and figures and methods used to prepare them. Tables and figures should summarize baseline characteristics, follow-up completeness, treatment adherence, and

关键词： data monitoring committee open report closed report unblinded statistician

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External data required timely response by the Trial Steering-data monitoring committee for the NALoxone InVEstigation (N-ALIVE) pilot trial

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CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS 2017年 5卷 100-106页

作者： Bird, Sheila M. Strang, John Ashby, Deborah Podmore, John Robertson, J. Roy Welch, Sarah Meade, Angela M. Parmar, Mahesh K. B. MRC Biostat Unit Cambridge CB2 0SR England Kings Coll London Natl Addict Ctr London SE5 8BB England Sch Publ Hlth Imperial Clin Trials Unit London W12 7RH England Univ Durham Sch Appl Social Sci Durham DH1 3LE England Univ Edinburgh Usher Inst Populat Hlth Sci & Informat Edinburgh EH16 4UX Midlothian Scotland Turning Point Gloucester GL1 2HT England UCL MRC Clin Trials Unit London WC2B 6NH England

The prison-based N-ALIVE pilot trial had undertaken to notify the Research Ethics committee and participants if we had reason to believe that the N-ALIVE pilot trial would not proceed to the main trial. In this paper, we describe how external data for the third year of before/after evaluation from Scotland's National Naloxone Programme, a related public health policy, were anticipated by eliciting prior opinion about the Scottish results in the month prior to their release as official statistics. We summarise how deliberations by the N-ALIVE Trial Steering-data monitoring committee ( TS-DMC) on N-ALIVE's own interim data, together with those on naloxone-on-release ( NOR) from Scotland, led to the decision to cease randomization in the N-ALIVE pilot trial and recommend to local Principal Investigators that NOR be offered to already-randomized prisoners who had not yet been released. (C) 2017 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license

关键词： data monitoring committee Randomized pilot trial External evidence Elicitation Causality Cessation

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data monitoring committees and clinical trials: From scientific justification to organisation

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THERAPIE 2024年第1期79卷 111-121页

作者： Locher, Clara Laporte, Silvy Derambure, Peggy Chassany, Olivier Girault, Cecile Avakiantz, Alix Bahans, Claire Deplanque, Dominique Fustier, Pierre Germe, Anne-Francoise Kassai, Behrouz Lacoste, Louis Petitpain, Nadin Roustit, Matthieu Simon, Tabassome Train, Cecile Cucherat, Miche CHU Rennes Ctr Invest Clin Rennes CIC1414 Serv Pharmacol Clin Inst Rech Sante Environm & Travail IrsetInsermU F-35000 Rennes France Univ Jean Monnet St Etienne CHU St Etienne INSERM UMR 1059URC Pharmacol Clin F-42055 St Etienne France AbbVie F-94528 Rungis France Hop Hotel Dieu AP HP Unite Rech Clin Econ Sante URC ECO F-75004 Paris France FFCD F-21000 Dijon France Novartis Pharma SAS F-92500 Rueil Malmaison France CHU Limoges Dept Pediat F-87000 Limoges France Univ Lille CHU Lille Ctr Invest Clin CIC 1403Inserm F-59000 Lille France Switzerland GmbH BeiGene Dept Rech & Dev Clin Hematol CH-4051 Basel Switzerland CHU Lille Inst Pharm F-59000 Lille France Univ Lyon Hosp Civils Lyon Ctr Invest Clin 1407 CNRSUMR 5558Serv PharmacotoxicolInserm F-69000 Lyon France CHU Poitiers Anesthesie Reanimat Pole USSAR F-86021 Poitiers France DRCI CHRU Nancy Unite Vigilance Essais Clin F-54500 Vanoeuvre Les Nancy France Univ Grenoble Alpes CHU Grenoble INSERM CIC1406 F-38000 Grenoble France Sorbonne Univ Hop St Antoine AP HP Serv Pharmacol ClinPlateforme Rech Est Parisien F-75000 Paris France Clinsearch F-92240 Malakoff France Hosp Civils Lyon MetaEvidence Org Serv Pharmacotoxicol F-69000 Lyon France

Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity of the results, which is counterproductive. To minimise this risk and ensure that the treatments are assessed reliably, safety and/or efficacy criteria are monitored during the study by a data monitoring committee. After receiving the results confidentially, the data monitoring committee assesses the benefit/risk ratio of the study treatment and recommends that the trial be continued, modified or terminated. data monitoring committee members issuing these recommendations have an important responsibility: a hasty decision to end the trial may lead to inconclusive results unable to answer the initial question and, inversely, delaying the decision to end the trial may expose the subjects to potentially ineffective or even harmful interventions. The data monitoring committee's task is therefore particularly complex. With this in mind, the round table discussion at the Giens workshops was a chance to review the scientific justification for creating data monitoring committees and to recall the need for their members to receive comprehensive training on the complexities of multiple analyses, confidentiality requirements applying to the results and the need for them to be aware that recommendations to end a trial must be based on data that is robust enough to assess the benefit/risk ratio of the treatment studied. (c) 2023 Published by Elsevier Masson SAS on behalf of Societe francaise de pharmacologie et de therapeutique.

关键词： data monitoring committee Benefit/risk ratio Interim analyses Integrity

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A Sponsor's Best Practice and Operating Principles to Manage data monitoring committees

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THERAPEUTIC INNOVATION & REGULATORY SCIENCE 2025年第2期59卷 215-221页

作者： Birck, Malene Muusfeldt Rasmussen, Josephine Skovgaard Helmark, Ida Caroe Lollike, Karsten Novo Nord AS Safety Surveillance Copenhagen Denmark Novo Nord AS Med & Sci Copenhagen Denmark Novo Nord AS Global Patient Safety DK-2860 Soborg Denmark

The use of data monitoring committees (DMC) to safeguard patients' safety in clinical trials has evolved over the last decades and has become increasingly common. To ensure well-operating and high-performing DMCs, pharmaceutical companies need to establish clearly defined operational processes while continuously seeking to optimize these and adapt to the needs of drug development. Although there are health authority guidelines on establishing and managing a DMC, the perspectives and experiences of sponsors are often underrepresented. This publication shares insights on a sponsor, Novo Nordisk (NN), regarding principles and practices for DMC establishment and management across varying trial types and therapeutic areas, including challenges and solutions. Highlighting NN's structured and successful approach to DMCs, it details clearly defined roles and responsibilities that ensure productive DMC meetings and high-quality data for the DMC. Additionally, NN's practices for clear, transparent, and trustful communication between the sponsor, the DMC, and the independent external statistical vendor are described. Processes for quality control, internal audits, and learnings from inspections and how these are incorporated for continuous improvement of the DMC process are discussed. While the processes and practices described are primarily designed for medium and large pharmaceutical companies, certain aspects may also be relevant and beneficial for smaller companies.

关键词： data monitoring committee data Safety monitoring Board Operating principles Regulatory requirements Independency data quality

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Stakeholders' Perspectives on Current Issues in data monitoring committees

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BIOMETRICAL JOURNAL 2024年第7期66卷 e202300384页

作者： Cartwright, Michael J. Friede, Tim Lawrence, David May, Emma Muetze, Tobias Roes, Kit Parexel Int Ltd Sheffield England Univ Med Ctr Gottingen Dept Med Stat Gottingen Germany DZHK German Ctr Cardiovasc Res Gottingen Germany Novartis Pharm AG Analytics Basel Switzerland ICON Plc Reading England BioNTech SE Mainz Germany Radboud Univ Nijmegen Med Ctr Nijmegen Netherlands

data monitoring committees (DMCs) are groups of experts that review accumulating data from one or more ongoing clinical studies and advise the Sponsor regarding the continuing safety of study subjects along with the continuing validity and scientific merit of the study. Although DMCs are widely used, considerable variability exists in their conduct. This paper offers recommendations, derived from sessions given at the 2023 Central European Network International Biometric and Statisticians in the Pharmaceutical Industry Conferences' and the authors' experiences. We focus on four topics that are part of the DMC process and where there is unclarity and inconsistency in current practices: (1) Communication with the DMC-We reflect on the importance of effective, proper communication channels between the DMC and relevant stakeholders to foster collaboration and exchange of critical information while retaining study integrity throughout. (2) Open sessions-We discuss the benefits of incorporating open sessions in DMC meetings to enhance transparency, inclusivity, and the consideration of diverse perspectives, as well as pitfalls of open sessions. (3) Access to efficacy data-We highlight the need for appropriate access to efficacy data by DMCs and discuss how to implement this in practice and how to address potential concerns regarding multiplicity. (4) Interactive data displays-We outline the utilization of interactive data displays to facilitate a more intuitive understanding of study results by the DMC. By addressing these topics, we aim to provide comprehensive practical recommendations that bridge the gap between current practices and optimal DMC functionality.

关键词： benefit-risk data monitoring committee patient safety study integrity

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Standard Operating Procedures for Chinese Medicine data monitoring committees of Clinical Studies

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Chinese Journal of Integrative Medicine 2021年第7期27卷 483-489页

作者： LIU Jun WANG Nian DANG Hai-xia CHEN Bing-wei ZHANG Li ZOU Chong ZHONG Cheng-liang HUANG Ju-kai LIU Qiong YU Ya-nan JIANG Meng LIANG Wei-xiong CHEN Qi-guang WANG Yong-yan SHEN Chun-ti WANG Zhong World Federation of Chinese Medicine Societies—data monitoring committee for Clinical Studies Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical SciencesBeijing100700China China Academy of Chinese Medical Sciences Beijing100700China School of Public Health Southeast UniversityNanjing210009China Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Beijing100078China Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated Hospital of Nanjing University of Traditional Chinese MedicineNanjing210029China First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin300381China Guangdong Hospital of Traditional Chinese Medicine Guangzhou510120China Changzhou Traditional Chinese Medicine Hospital ChangzhouJiangsu Province213004China 不详

Although there is guidance from different regulatory agencies,there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee(DMC)for clinical studies of Chinese *** names it as a Chinese Medicine data monitoring committee(CMDMC).A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of ***,a community standard on CMDMCs(T/CACM 1323-2019)was issued by the China Association of Chinese Medicine on September 12,*** paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs,which will further develop the scientific integrity and quality of clinical studies.

关键词： data monitoring committee Chinese Medicine data monitoring committee clinical trial community standard Chinese medicine

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