Skip to main content
SpringerLink
Log in

History and Background

  • Chapter
  • First Online:
Clinical Dermatology Trials 101

  • 1027 Accesses

Abstract

Clinical trials have a history of independent development in a variety of civilizations. Early studies were limited to observation. Subsequently, trials became more interventional, and incorporated controls and patient protection for scientific rigor and human subject safety. The modern era of clinical trials has been marked by increasing complexity, regulation, and globalization. Upcoming promises and challenges for clinical dermatology trials include new technologies, privacy, and intellectual property rights.

We choose to go to the moon. We choose to go to the moon… (interrupted by applause) we choose to go to the moon in this decade and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win, and the others, too.

John F. Kennedy, Jr.

12 September 1962

Rice University

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 99.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Endo J, Nakamura T, Yamaki H, Miyamoto H. [Studies of the fifth section in the introduction of the Qian jin yao fang—Writings quoted from the Shen nong ben cao jing and the Yao dui]. Yakushigaku Zasshi. 1993;28(1):1–5.

    Google Scholar 

  2. Hamada T. [On the arrangement of the drugs contained in “shen nong ben cao jing” (2): botanical drugs] (Jpn). Yakushigaku Zasshi. 1980;15(1):26–38. Japanese. PubMed PMID: 11620818.

    Google Scholar 

  3. Roddis LH. From the case books of Hippocrates: case reports for diagnosis. Mil Med. 1964;129:143–4.

    CAS  PubMed  Google Scholar 

  4. Pasipoularides A. Galen, father of systematic medicine. An essay on the evolution of modern medicine and cardiology. Int J Cardiol. 2014;172(1):47–58. doi:10.1016/j.ijcard.2013.12.166. Epub 2014 Jan 8. Review.

    Article  PubMed  Google Scholar 

  5. Shoja MM, Rashidi MR, Tubbs RS, Etemadi J, Abbasnejad F, Agutter PS. Legacy of Avicenna and evidence-based medicine. Int J Cardiol. 2011;150(3):243–6. doi:10.1016/j.ijcard.2010.10.019.

    Article  PubMed  Google Scholar 

  6. Lind J. A treatise of the scurvy by James Lind. MDCCLIII.

    Google Scholar 

  7. Ford JM. Edward Jenner, MD FRS (1749–1823). J Med Biogr. 2003;11(4):241.

    PubMed  Google Scholar 

  8. Baxby D. Edward Jenner’s inquiry; a bicentenary analysis. Vaccine. 1999;17(4):301–7.

    Article  CAS  PubMed  Google Scholar 

  9. Centers for Disease Control (CDC). National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR Morb Mortal Wkly Rep. 1988;37(13):197–200.

    Google Scholar 

  10. Cook KM, Evans G. The National Vaccine Injury Compensation Program. Pediatrics. 2011;127 Suppl 1:S74–7. doi:10.1542/peds.2010-1722K. Epub 2011 Apr 18.

    Article  PubMed  Google Scholar 

  11. Bassetti M, Merelli M, Temperoni C, Astilean A. New antibiotics for bad bugs: where are we? Ann Clin Microbiol Antimicrob. 2013;12:22. doi:10.1186/1476-0711-12-22. Review.

    Article  PubMed Central  PubMed  Google Scholar 

  12. Pendleton JN, Gorman SP, Gilmore BF. Clinical relevance of the ESKAPE pathogens. Expert Rev Anti Infect Ther. 2013;11(3):297–308. doi:10.1586/eri.13.12. Review.

    Article  CAS  PubMed  Google Scholar 

  13. Boucher HW, Talbot GH, Bradley JS, Edwards JE, Gilbert D, Rice LB, Scheld M, Spellberg B, Bartlett J. Bad bugs, no drugs: no ESKAPE! An update from the Infectious Diseases Society of America. Clin Infect Dis. 2009;48(1):1–12. doi:10.1086/595011. Review.

    Article  PubMed  Google Scholar 

  14. Bigby M, Gadenne AS. Understanding and evaluating clinical trials. J Am Acad Dermatol. 1996;34(4):555–90. quiz 591–3.

    Article  CAS  PubMed  Google Scholar 

  15. Barlas S. Congress passes unambitious user fee reauthorization and expansion: act omits key provisions sought by pharmacy groups. Proc Natl Acad Sci U S A. 2012;37(8):433–4.

    Google Scholar 

  16. Kaitin KI. The prescription Drug User Fee Act of 1992 and the new drug development process. Am J Ther. 1997;4(5–6):167–72.

    Article  CAS  PubMed  Google Scholar 

  17. Attarwala H. TGN1412: from discovery to disaster. J Young Pharm. 2010;2(3):332–6.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  18. Eastwood D, Bird C, Dilger P, Hockley J, Findlay L, Poole S, Thorpe SJ, Meenu W, Robin T, Richard S. Severity of the TGN1412 trial disaster cytokine storm correlated with IL-2 release. Br J Clin Pharmacol. 2013;76(2):299–315.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  19. Stebbings R, Eastwood D, Poole S, Thorpe R. After TGN1412: recent developments in cytokine release assays. J Immunotoxicol. 2013;10(1):75–82. doi:10.3109/1547691X.2012.711783. Published online 2012 September 11.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  20. Goodyear M. Learning from the TGN1412 trial: this experience should foster an open culture in medical research. BMJ. 2006;332(7543):677–8. doi:10.1136/bmj.38797.635012.47.

    Article  PubMed Central  PubMed  Google Scholar 

  21. Carson KR, Focosi D, Major EO, Petrini M, Richey EA, West DP, Bennett CL. Monoclonal antibody-associated progressive multifocal leucoencephalopathy in patients treated with rituximab, natalizumab, and efalizumab: a review from the Research on Adverse Drug Events and Reports (RADAR) Project. Lancet Oncol. 2009;10(8):816–24. doi:10.1016/S1470-2045(09)70161-5.

    Article  CAS  PubMed  Google Scholar 

  22. Schwab N, Ulzheimer JC, Fox RJ, Schneider-Hohendorf T, Kieseier BC, Monoranu CM, Staugaitis SM, Welch W, Jilek S, Du Pasquier RA, Brück W, Toyka KV, Ransohof RM, Wiendl H. Fatal PML associated with efalizumab therapy: insights into integrin αLβ2 in JC virus control. Neurology. 2012;78(7):458–67. doi:10.1212/WNL.0b013e3182478d4b; discussion 465.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  23. Seminara NM, Gelfand JM. Assessing long-term drug safety: lessons (re) learned from raptiva. Semin Cutan Med Surg. 2010;29(1):16–9. doi:10.1016/j.sder.2010.01.001.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  24. Udhrain A, Skubitz KM, Northfelt DW. Pegylated liposomal doxorubicin in the treatment of AIDS-related Kaposi’s sarcoma. Int J Nanomedicine. 2007;2(3):345–52. Review.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  25. Tyner K, Sadrieh N. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review. Methods Mol Biol. 2011;697:17–31. doi:10.1007/978-1-60327-198-1_3.

    Article  CAS  PubMed  Google Scholar 

  26. Offit K, Bradbury A, Storm C, Merz JF, Noonan KE, Spence R. Gene patents and personalized cancer care: impact of the Myriad case on clinical oncology. J Clin Oncol. 2013;31(21):2743–8. doi:10.1200/JCO.2013.49.7388. Epub 2013 Jun 13.

    Article  PubMed  Google Scholar 

  27. Cancer Genome Project: cancergenome.nih.gov

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Dermatology, UNC School of Medicine, Thurston Bowles Building 3100, Chapel Hill, NC, 27554, USA

    Adnan Nasir M.D., Ph.D.

  2. Medical Director, Dermatology Research, Wake Research Associates, 3100 Duraleigh Rd Ste 304, Raleigh, NC, 27612, USA

    Adnan Nasir M.D., Ph.D.

Authors
  1. Adnan Nasir M.D., Ph.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Adnan Nasir M.D., Ph.D. .

Editor information

Editors and Affiliations

  1. Dermatology, UNC School of Medicine, Chapel Hill, North Carolina, USA

    Adnan Nasir

Rights and permissions

Reprints and permissions

Copyright information

© 2015 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Nasir, A. (2015). History and Background. In: Nasir, A. (eds) Clinical Dermatology Trials 101. Springer, Cham. https://doi.org/10.1007/978-3-319-09027-6_1

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-09027-6_1

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-09026-9

  • Online ISBN: 978-3-319-09027-6

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation