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Why Do Clinical Research?

  • Cara East
Chapter

Abstract

We need more good clinical research sites in the United States. If a drug, device, or treatment is to be approved in the United States, it needs to be tested in a sample representative of the entire population, including children and the elderly, both genders, all races and ethnicities, in patients with concomitant illnesses and medications, and those living in urban and rural environments. Reasons to participate in clinical research include enrolling a widely generalizable population in clinical research, involve enlightened clinical research personnel and protocols in the work being done, and meaningfully contribute to how medicine is practiced today.

Keywords

Clinical research Subjects Cutting edge Representative population Adverse events Viagra Thalidomide Placebo 

References

  1. 1.
    Liu KA, Dipietro Mager NA. Women’s involvement in clinical trials: historical perspective and future implications. Pharm Pract. 2016;14(1):708.  https://doi.org/10.18549/PharmPract.2016.01.708.CrossRefGoogle Scholar
  2. 2.
    Watts G. Why the exclusion of older people from clinical research must stop. Brit med Journal 2012; 344: e 3445.Google Scholar
  3. 3.
    http://grants.nih.gov/grants/guide/notice-files/not94-100.html. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. n.d.
  4. 4.
  5. 5.
    US Food and Drug Administration. The Pediatric Exclusivity Provision. Jan 2001. Status report to Congress. https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/.
  6. 6.
    Husten L. AstraZeneca: Ticagreor (Brilinta) gains FDA approval?. CardioBrief. 2011. Blog at WordPress.com.
  7. 7.
    Press Release. Mar 28, 2018. First vaccine approved by FDA to prevent serogroup B meningococcal disease. https://fda.gov/NewsEvents.
  8. 8.
    Mac Kenzie WF, Garner F. Comparison of neoplasms in six sources of rats. J Natl Cancer Inst. 1973;50(5):1243–57.CrossRefPubMedGoogle Scholar
  9. 9.
    Wilson J. Viagra: The little pill that could. CNN. 2013. https://cnn.com/2013/03/27/health/viagra-anniversary-timeline/Google Scholar
  10. 10.
    Fintel B, Samzras AT, Carias E. The thalidomide tragedy: lessons for drug safety and regulation. 2009. https://helix.northwestern.edu/article/thalidomide-tragedy-lessons.Google Scholar
  11. 11.
    Palumbo A, Bringhen S, Caravita T, Merla E, Capparella V, Callea V, Cangialosi C, Grasso M, Rossini F, Galli M, Catalano L. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomized controlled trial. Lancet. 2006;367:825–31.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Cara East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

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