The DOI matches its Crossref record; 11 of the 11 references it cites were found in a registry or an index.
Drug safety assessment in clinical trials: methodological challenges and opportunities
Open accessAbstract
Randomized controlled trials are the principal means of establishing the efficacy of drugs. However pre-marketing trials are limited in size and duration and exclude high-risk populations. They have limited statistical power to detect rare but potentially serious adverse events in real-world patients. We summarize the principal methodological challenges in the reporting, analysis and interpretation of safety data in clinical trials using recent examples from systematic reviews. These challenges include the lack of an evidentiary gold standard, the limited statistical power of randomized controlled trials and resulting type 2 error, the lack of adequate ascertainment of adverse events and limited generalizability of trials that exclude high risk patients. We discuss potential solutions to these challenges. Evaluation of drug safety requires careful examination of data from heterogeneous sources. Meta-analyses of drug safety should include appropriate statistical methods and assess the optimal information size to avoid type 2 errors. They should evaluate outcome reporting biases and missing data to ensure reliable and accurate interpretation of findings. Regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety.
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Cites
Effects of Intensive Glucose Lowering in Type 2 Diabetes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0802743 · Cited by 7,888
Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0802987 · Cited by 7,397
Glucose control and vascular complications in veterans with type 2 diabetes
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Much ado about nothing: a comparison of the performance of meta-analytical methods with rare events
Bradburn, M. J., Deeks, J. J., Berlin, J. A., & Russell Localio, A. (2007) · Statistics in Medicine · doi:10.1002/sim.2528 · Cited by 938
The ClinicalTrials.gov Results Database — Update and Key Issues
Zarin, D. A., Tse, T., Williams, R. J., Califf, R. M., & Ide, N. C. (2011) · New England Journal of Medicine · doi:10.1056/nejmsa1012065 · Cited by 838
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Self-citationSuicidal Behavior and Depression in Smoking Cessation Treatments
Moore, T. J., Furberg, C. D., Glenmullen, J., Maltsberger, J. T., & Singh, S. (2011) · PLoS ONE · doi:10.1371/journal.pone.0027016 · Cited by 150
Self-citationNew FDA Regulation to Improve Safety Reporting in Clinical Trials
Behrman Sherman, R., Woodcock, J., Norden, J., Grandinetti, C., & Temple, R. J. (2011) · New England Journal of Medicine · doi:10.1056/nejmp1103464 · Cited by 50 · cited 1×
“Recent regulatory guidance from the FDA has limited the reporting of adverse events in clinical trials from sponsors to those that are unexpected and considered related to the drug [47].”
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PRISMA harms checklist: improving harms reporting in systematic reviews
Zorzela, L., Loke, Y. K., Ioannidis, J. P., Golder, S., Santaguida, P., Altman, D. G., Moher, D., Vohra, S., & PRISMA harms group (2016) · BMJ · doi:10.1136/bmj.i157 · Cited by 557
Self-citationSingh, S., Chang, H.-Y., Richards, T. M., Weiner, J. P., Clark, J. M., & Segal, J. B. (2013) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2013.2720 · Cited by 467
Self-citationChallenges and opportunities in NASH drug development
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Metadata
- Authors
- Singh, S., & Loke, Y. K.
- Venue
- Trials
- Published
- 2012-08-20
- Volume
- 13
- Issue
- 1
- Pages
- 138-138
- ISSN
- 1745-6215 (ISSN-L)
- OpenAlex
- W2137053633
- Cited by
- 227
- References
- 11
- FWCI
- 7.49
- Type
- journal article
- Language
- en
- Open access
- gold
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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