Skip to main content
Journal cover image

The economic returns of pediatric clinical trials of antihypertensive drugs.

Publication ,  Journal Article
Baker-Smith, CM; Benjamin, DK; Grabowski, HG; Reid, ED; Mangum, B; Goldsmith, JV; Murphy, MD; Edwards, R; Eisenstein, EL; Sun, J; Califf, RM; Li, JS
Published in: Am Heart J
October 2008

BACKGROUND: Congress has authorized the United States Food and Drug Administration (FDA) to provide industry sponsors with a 6-month extension of drug marketing rights under the Pediatric Exclusivity Provision if FDA-requested pediatric drug trials are conducted. The cost and economic return of pediatric exclusivity to industry sponsors has been shown to be highly variable. We sought to determine the cost of performing pediatric exclusivity trials within a single therapeutic area and the subsequent economic return to industry sponsors. METHODS: We evaluated 9 orally administered antihypertensive drugs submitted to the FDA under the Pediatric Exclusivity Provision from 1997 to 2004 and obtained key elements of the clinical trial designs and operations. Estimates of the costs of performing the studies were generated and converted into after-tax cash outflow. Market sales were obtained and converted into after-tax inflows based on 6 months of additional patent protection. Net economic return and net return-to-cost ratios were determined for each drug. RESULTS: Of the 9 antihypertensive agents studied, an average of 2 studies per drug was performed, including at least 1 pharmacokinetic study and a safety and efficacy study. The median cost of completing a pharmacokinetic trial was $862,000 (range $556,000 to 1.8 million). The median cost of performing safety and efficacy trials for these agents was $4.3 million (range $2.1-12.9 million). The ratio of net economic return to cost was 17 (range 4-64.7). CONCLUSION: We found that, within a cohort of antihypertensive drugs, the Pediatric Exclusivity Provision has generated highly variable, yet lucrative returns to industry sponsors.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2008

Volume

156

Issue

4

Start / End Page

682 / 688

Location

United States

Related Subject Headings

  • United States
  • Research Support as Topic
  • Research Design
  • Humans
  • Drug Industry
  • Clinical Trials as Topic
  • Child
  • Cardiovascular System & Hematology
  • Antihypertensive Agents
  • 3201 Cardiovascular medicine and haematology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Baker-Smith, C. M., Benjamin, D. K., Grabowski, H. G., Reid, E. D., Mangum, B., Goldsmith, J. V., … Li, J. S. (2008). The economic returns of pediatric clinical trials of antihypertensive drugs. Am Heart J, 156(4), 682–688. https://doi.org/10.1016/j.ahj.2008.05.001
Baker-Smith, Carissa M., Daniel K. Benjamin, Henry G. Grabowski, Elizabeth D. Reid, Barry Mangum, John V. Goldsmith, M Dianne Murphy, et al. “The economic returns of pediatric clinical trials of antihypertensive drugs.Am Heart J 156, no. 4 (October 2008): 682–88. https://doi.org/10.1016/j.ahj.2008.05.001.
Baker-Smith CM, Benjamin DK, Grabowski HG, Reid ED, Mangum B, Goldsmith JV, et al. The economic returns of pediatric clinical trials of antihypertensive drugs. Am Heart J. 2008 Oct;156(4):682–8.
Baker-Smith, Carissa M., et al. “The economic returns of pediatric clinical trials of antihypertensive drugs.Am Heart J, vol. 156, no. 4, Oct. 2008, pp. 682–88. Pubmed, doi:10.1016/j.ahj.2008.05.001.
Baker-Smith CM, Benjamin DK, Grabowski HG, Reid ED, Mangum B, Goldsmith JV, Murphy MD, Edwards R, Eisenstein EL, Sun J, Califf RM, Li JS. The economic returns of pediatric clinical trials of antihypertensive drugs. Am Heart J. 2008 Oct;156(4):682–688.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2008

Volume

156

Issue

4

Start / End Page

682 / 688

Location

United States

Related Subject Headings

  • United States
  • Research Support as Topic
  • Research Design
  • Humans
  • Drug Industry
  • Clinical Trials as Topic
  • Child
  • Cardiovascular System & Hematology
  • Antihypertensive Agents
  • 3201 Cardiovascular medicine and haematology