American Heart Journal
Volume 156, Issue 4 , Pages 682-688 , October 2008

The economic returns of pediatric clinical trials of antihypertensive drugs

  • Carissa M. Baker-Smith, MD, MS

      Affiliations

    • Department of Pediatrics, Duke University Medical Center, Durham, NC
    • ,
  • Daniel K. Benjamin Jr, MD, PhD

      Affiliations

    • Department of Pediatrics, Duke University Medical Center, Durham, NC
    • Duke Clinical Research Institute, Durham, NC
    • ,
  • Henry G. Grabowski, PhD

      Affiliations

    • Department of Economics, Duke University, Durham, NC
    • ,
  • Elizabeth D. Reid, BA

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • ,
  • Barry Mangum, PharmD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • ,
  • John V. Goldsmith, PhD

      Affiliations

    • US Food and Drug Administration, Rockville, MD
    • ,
  • M. Dianne Murphy, MD

      Affiliations

    • US Food and Drug Administration, Rockville, MD
    • ,
  • Rex Edwards, BS

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • ,
  • Eric L. Eisenstein, DBA

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • ,
  • Jessica Sun, MD

      Affiliations

    • Department of Pediatrics, Duke University Medical Center, Durham, NC
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • ,
  • Jennifer S. Li, MD, MHS

      Affiliations

    • Department of Pediatrics, Duke University Medical Center, Durham, NC
    • Duke Clinical Research Institute, Durham, NC
    • Corresponding Author InformationReprint requests: Jennifer S. Li, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27705.

Received 28 February 2008 ,Accepted 2 May 2008.

References 

  1. Department of Health and Human Services , U.S. Food and Drug Administration . The Pediatric Exclusivity Provision: January 2001 Status Report to Congress. Available at: http://www.fda.gov/cder/pediatric/reportcong01.pdf.Last accessed November 27, 2007
  2. Department of Health and Human Services , U.S. Food and Drug Administration . Approved active moieties to which FDA has issued a written request for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act. US Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/Pediatric/wrlist.htm.Last accessed November 27, 2007
  3. Department of Health and Human Services , U.S. Food and Drug Administration . Pediatric exclusivity labeling changes. US Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/pediatric/labelchange.htm.Last accessed November 27, 2007
  4. Breslow LH. The Best Pharmaceuticals for Children Act of 2002: the rise of the voluntary incentive structure and congressional refusal to require pediatric testing. Harvard J Legis. 2003;40:133–193
  5. Li JS, Eisenstein EL, Grabowski HG, et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA. 2007;297:480–488
  6. US General Accounting Office . Testimony before the Committee on Health, Education, Labor, and Pensions, US Senate. Pediatric drug research: substantial increase in studies of drugs for some children but challenges remains. GAO-01-705 T. Available at: http://www.gao.gov/new.items/d01705t.pdf.Last accessed November 27, 2007
  7. IMS Health Inc . IMS Health home page. Available at: http://www.imshealth.com.Last accessed January 5, 2007
  8. Grabowski HG, Vernon JM, Dimasi JA. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics. 1994;20(Suppl 3):11–29
  9. National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004;114(2 Suppl 4th report):555–576
  10. Hypertension in America: a national reading. Am J Manag Care. 2005;11(13 Suppl):S383–S385
  11. Hunt SA, American College of Cardiology , American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure) . ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. 2005;46:e1–e82
  12. Wilson JT. An update on the therapeutic orphan. Pediatrics. 1999;104:585–590
  13. Roberts R. Pediatric drug labeling: improving the safety and efficacy of pediatric therapies. JAMA. 2003;290:905–911
  14. Ogden CL, Flegal KM, Carroll MD, et al. Prevalence and trends in overweight among U.S. children and adolescents, 1999-2000. JAMA. 2002;288:1728–1732
  15. Meyer AA, Joharchi MS, Kundt G, et al. Predicting the risk of early atherosclerotic disease development in children after repair of aortic coarctation. Eur Heart J. 2005;26:617–622
  16. Belay B, Belamarich P, Racine AD. Pediatric precursors of adult atherosclerosis. Pediatr Rev. 2004;25:4–16
  17. Daniels SR. Hypertension-induced cardiac damage in children and adolescents. Blood Press Monit. 1999;4:165–170
  18. Strong JP. The natural history of atherosclerosis in childhood. Ann N Y Acad Sci. 1991;623:9–15
  19. Lauer RM, Clarke WR. Childhood risk factors for high adult blood pressure: the Muscatine Study. Pediatrics. 1989;84:633–641
  20. Department of Health and Human Services , U.S. Food and Drug Administration . Pediatric exclusivity labeling changes as of April 10, 2008. U.S. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/pediatric/labelchange.htmLast accessed April 10, 2008
  21. Benjamin DK, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296:1266–1273

 Dr Baker-Smith is funded by National Institutes of Health (Bethesda, MD) T32 grant (HL069749-04). Drs Li and Benjamin received support from the National Institute of Child Health and Human Development (NICHD) (Rockville, MD) 1U10-HD45962-04 and the US Food and Drug Administration (Rockville, MD). Drs Benjamin, Li, and Califf received support from 1UL1RR024128-01.

 The views expressed are those of the authors. No official endorsement by the US Food and Drug Administration is provided or should be inferred.

 The Duke Clinical Research Institute (Durham, NC) was the coordinating center for 2 of the trials of drugs mentioned in this study.

PII: S0002-8703(08)00351-7

doi: 10.1016/j.ahj.2008.05.001

American Heart Journal
Volume 156, Issue 4 , Pages 682-688 , October 2008

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