Tags

Type your tag names separated by a space and hit enter

Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks.

Abstract

The US Sentinel System and the Canadian Network for Observational Drug Effect Studies (CNODES) are two medical product safety surveillance networks. Using Sentinel's preprogrammed, parameterizable analytic tools, we reproduced two protocol-based studies conducted by CNODES to assess the risks of acute pancreatitis and heart failure (HF) associated with the use of incretin-based drugs, compared with use of ≥ 2 oral hypoglycemic agents. Results from the replication new-user cohort analyses aligned with those from the CNODES nested case-control studies. The adjusted hazard ratios were 0.95 (0.81-1.12; vs. 1.03 (0.87-1.22) in CNODES) for acute pancreatitis and 0.91 (0.84-1.00; vs. 0.82 (0.67-1.00) in CNODES) for HF among patients without HF history. The CNODES's common protocol approach allows studies tailored to specific safety questions, whereas the Sentinel's common data model plus pretested program approach enables more rapid analysis. Despite these differences, it is possible to obtain comparable results using both approaches.

Authors+Show Affiliations

Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada. Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Department of Medicine, McGill University, Montreal, Quebec, Canada.Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada. Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada. Gerald Bronfman Department of Oncology, Montreal, Quebec, Canada.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31630391

Citation

Huang, Ting-Ying, et al. "Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used By Two Medical Product Surveillance Networks." Clinical Pharmacology and Therapeutics, 2019.
Huang TY, Welch EC, Shinde MU, et al. Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks. Clin Pharmacol Ther. 2019.
Huang, T. Y., Welch, E. C., Shinde, M. U., Platt, R. W., Filion, K. B., Azoulay, L., ... Toh, S. (2019). Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks. Clinical Pharmacology and Therapeutics, doi:10.1002/cpt.1698.
Huang TY, et al. Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used By Two Medical Product Surveillance Networks. Clin Pharmacol Ther. 2019 Oct 20; PubMed PMID: 31630391.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reproducing Protocol-Based Studies Using Parameterizable Tools-Comparison of Analytic Approaches Used by Two Medical Product Surveillance Networks. AU - Huang,Ting-Ying, AU - Welch,Emily C, AU - Shinde,Mayura U, AU - Platt,Robert W, AU - Filion,Kristian B, AU - Azoulay,Laurent, AU - Maro,Judith C, AU - Platt,Richard, AU - Toh,Sengwee, Y1 - 2019/10/20/ PY - 2019/06/10/received PY - 2019/09/12/accepted PY - 2019/10/21/pubmed PY - 2019/10/21/medline PY - 2019/10/21/entrez JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. N2 - The US Sentinel System and the Canadian Network for Observational Drug Effect Studies (CNODES) are two medical product safety surveillance networks. Using Sentinel's preprogrammed, parameterizable analytic tools, we reproduced two protocol-based studies conducted by CNODES to assess the risks of acute pancreatitis and heart failure (HF) associated with the use of incretin-based drugs, compared with use of ≥ 2 oral hypoglycemic agents. Results from the replication new-user cohort analyses aligned with those from the CNODES nested case-control studies. The adjusted hazard ratios were 0.95 (0.81-1.12; vs. 1.03 (0.87-1.22) in CNODES) for acute pancreatitis and 0.91 (0.84-1.00; vs. 0.82 (0.67-1.00) in CNODES) for HF among patients without HF history. The CNODES's common protocol approach allows studies tailored to specific safety questions, whereas the Sentinel's common data model plus pretested program approach enables more rapid analysis. Despite these differences, it is possible to obtain comparable results using both approaches. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/31630391/Reproducing_Protocol-based_Studies_Using_Parameterizable_Tools_-_Comparison_of_Analytic_Approaches_Used_by_Two_Medical_Product_Surveillance_Networks L2 - https://doi.org/10.1002/cpt.1698 DB - PRIME DP - Unbound Medicine ER -