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Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.

Publication ,  Journal Article
Reed, SD; Anstrom, KJ; Seils, DM; Califf, RM; Schulman, KA
Published in: Health Aff (Millwood)
2008

Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations.

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Published In

Health Aff (Millwood)

DOI

EISSN

1544-5208

Publication Date

2008

Volume

27

Issue

5

Start / End Page

w360 / w370

Location

United States

Related Subject Headings

  • United States
  • Sample Size
  • Models, Theoretical
  • Humans
  • Health Policy & Services
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Industry
  • Drug Approval
  • Databases, Factual
  • Cost-Benefit Analysis
 

Citation

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Reed, S. D., Anstrom, K. J., Seils, D. M., Califf, R. M., & Schulman, K. A. (2008). Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs. Health Aff (Millwood), 27(5), w360–w370. https://doi.org/10.1377/hlthaff.27.5.w360
Reed, Shelby D., Kevin J. Anstrom, Damon M. Seils, Robert M. Califf, and Kevin A. Schulman. “Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.Health Aff (Millwood) 27, no. 5 (2008): w360–70. https://doi.org/10.1377/hlthaff.27.5.w360.
Reed SD, Anstrom KJ, Seils DM, Califf RM, Schulman KA. Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs. Health Aff (Millwood). 2008;27(5):w360–70.
Reed, Shelby D., et al. “Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs.Health Aff (Millwood), vol. 27, no. 5, 2008, pp. w360–70. Pubmed, doi:10.1377/hlthaff.27.5.w360.
Reed SD, Anstrom KJ, Seils DM, Califf RM, Schulman KA. Use of larger versus smaller drug-safety databases before regulatory approval: the trade-offs. Health Aff (Millwood). 2008;27(5):w360–w370.

Published In

Health Aff (Millwood)

DOI

EISSN

1544-5208

Publication Date

2008

Volume

27

Issue

5

Start / End Page

w360 / w370

Location

United States

Related Subject Headings

  • United States
  • Sample Size
  • Models, Theoretical
  • Humans
  • Health Policy & Services
  • Drug-Related Side Effects and Adverse Reactions
  • Drug Industry
  • Drug Approval
  • Databases, Factual
  • Cost-Benefit Analysis