Centralize data monitoring;
Risk based data monitoring;
DATA QUALITY;
D O I:
10.1016/j.cct.2021.106368
中图分类号:
R-3 [医学研究方法];
R3 [基础医学];
学科分类号:
1001 ;
摘要:
Objectives: COVID-19 pandemic caused several alarming challenges for clinical trials. On-site source data verification (SDV) in the multicenter clinical trial became difficult due to travel ban and social distancing. For multicenter clinical trials, centralized data monitoring is an efficient and cost-effective method of data monitoring. Centralized data monitoring reduces the risk of COVID-19 infections and provides additional capabilities compared to on-site monitoring. The key steps for on-site monitoring include identifying key risk factors and thresholds for the risk factors, developing a monitoring plan, following up the risk factors, and providing a management plan to mitigate the risk. Methods: For analysis purposes, we simulated data similar to our clinical trial data. We classified the data monitoring process into two groups, such as the Supervised analysis process, to follow each patient remotely by creating a dashboard and an Unsupervised analysis process to identify data discrepancy, data error, or data fraud. We conducted several risk-based statistical analysis techniques to avoid on-site source data verification to reduce time and cost, followed up with each patient remotely to maintain social distancing, and created a centralized data monitoring dashboard to ensure patient safety and maintain the data quality. Conclusion: Data monitoring in clinical trials is a mandatory process. A risk-based centralized data review process is cost-effective and helpful to ignore on-site data monitoring at the time of the pandemic. We summarized how different statistical methods could be implemented and explained in SAS to identify various data error or fabrication issues in multicenter clinical trials.
机构:
Hosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, BrazilHosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, Brazil
Lara Gongora, Aline Bobato
Fontes Jardim, Denis Leonardo
论文数: 0引用数: 0
h-index: 0
机构:
Hosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, Brazil
Latin Amer Cooperat Oncol Grp LACOG, Porto Alegre, RS, BrazilHosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, Brazil
Fontes Jardim, Denis Leonardo
Bastos, Diogo Assed
论文数: 0引用数: 0
h-index: 0
机构:
Hosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, Brazil
Inst Canc Estado Sao Paulo, Ave Doutor Arnaldo 251, BR-01246000 Sao Paulo, Brazil
Latin Amer Cooperat Oncol Grp LACOG, Porto Alegre, RS, BrazilHosp Sirio Libanes, Oncol Ctr, Rua Dona Adma Jafet 91, BR-01308050 Sao Paulo, Brazil
机构:
Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USAUniv Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA
Collier, Erin K.
Hsiao, Jennifer L.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Calif Los Angeles, David Geffen Sch Med, Dept Med, Div Dermatol, Los Angeles, CA 90095 USAUniv Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA
Hsiao, Jennifer L.
Shi, Vivian Y.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Arizona, Dept Med, Div Dermatol, Tucson, AZ USAUniv Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA
机构:
Harvard Med Sch, Brigham & Womens Hosp, Div Cardiovasc Med, Boston, MA 02115 USAHarvard Med Sch, Brigham & Womens Hosp, Div Cardiovasc Med, Boston, MA 02115 USA
Gaba, Prakriti
Bhatt, Deepak L.
论文数: 0引用数: 0
h-index: 0
机构:
Harvard Med Sch, Brigham & Womens Hosp, Div Cardiovasc Med, Boston, MA 02115 USAHarvard Med Sch, Brigham & Womens Hosp, Div Cardiovasc Med, Boston, MA 02115 USA
机构:
Mayo Clin, Dept Surg, Rochester, MN USAMayo Clin, Dept Surg, Rochester, MN USA
Boughey, Judy C.
Snyder, Rebecca A.
论文数: 0引用数: 0
h-index: 0
机构:
East Carolina Univ, Brody Sch Med, Div Surg Oncol, Greenville, NC 27858 USAMayo Clin, Dept Surg, Rochester, MN USA
Snyder, Rebecca A.
Kantor, Olga
论文数: 0引用数: 0
h-index: 0
机构:
Brigham & Womens Hosp, Dept Surg, Div Breast Surg, 75 Francis St, Boston, MA 02115 USAMayo Clin, Dept Surg, Rochester, MN USA
Kantor, Olga
Zheng, Linda
论文数: 0引用数: 0
h-index: 0
机构:
Amer Coll Surg, Canc Res Program, Chicago, IL USAMayo Clin, Dept Surg, Rochester, MN USA
Zheng, Linda
Chawla, Akhil
论文数: 0引用数: 0
h-index: 0
机构:
Northwestern Univ, Dept Surg, Div Surg Oncol, Northwestern Med Reg Med Grp,Feinberg Sch Med, Chicago, IL 60611 USAMayo Clin, Dept Surg, Rochester, MN USA
机构:
Icahn Sch Med Mt Sinai, Dept Populat Hlth Sci & Policy, New York, NY 10029 USAIcahn Sch Med Mt Sinai, Dept Populat Hlth Sci & Policy, New York, NY 10029 USA
Bagiella, Emilia
Bhatt, Deepak L.
论文数: 0引用数: 0
h-index: 0
机构:
Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA 02115 USAIcahn Sch Med Mt Sinai, Dept Populat Hlth Sci & Policy, New York, NY 10029 USA
Bhatt, Deepak L.
Gaudino, Mario
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, 525 East 68th St, New York, NY 10065 USAIcahn Sch Med Mt Sinai, Dept Populat Hlth Sci & Policy, New York, NY 10029 USA
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Audisio, Katia
论文数: 引用数:
h-index:
机构:
Lia, Hillary
Robinson, Newell Bryce
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Robinson, Newell Bryce
Rahouma, Mohamed
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Rahouma, Mohamed
Soletti Jr, Giovanni
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Soletti Jr, Giovanni
Cancelli, Gianmarco
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Cancelli, Gianmarco
Perezgrovas Olaria, Roberto
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Perezgrovas Olaria, Roberto
Chadow, David
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Chadow, David
Tam, Derrick Y.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Schulich Heart Ctr, Toronto, ON M4N 3M5, CanadaWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Tam, Derrick Y.
Vervoort, Dominique
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Schulich Heart Ctr, Toronto, ON M4N 3M5, CanadaWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Vervoort, Dominique
Farkouh, Michael E.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Peter Munk Cardiac Ctr, Toronto, ON M5G 2N2, CanadaWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Farkouh, Michael E.
Bhatt, Deepak L.
论文数: 0引用数: 0
h-index: 0
机构:
Harvard Med Sch, Brigham & Womens Hosp, Div Cardiovasc Med, Boston, MA 02115 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Bhatt, Deepak L.
Fremes, Stephen E.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Toronto, Sunnybrook Hlth Sci Ctr, Schulich Heart Ctr, Toronto, ON M4N 3M5, CanadaWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA
Fremes, Stephen E.
Gaudino, Mario
论文数: 0引用数: 0
h-index: 0
机构:
Weill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USAWeill Cornell Med, Dept Cardiothorac Surg, New York, NY 10065 USA