Display options
Share it on

Clin Trials. 2014 Aug;11(4):445-456. doi: 10.1177/1740774514525691. Epub 2014 Apr 14.

SMART designs in cancer research: Past, present, and future.

Clinical trials (London, England)

Kelley M Kidwell

Affiliations

  1. Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA [email protected].

PMID: 24733671 PMCID: PMC4431956 DOI: 10.1177/1740774514525691

Abstract

BACKGROUND: Cancer affects millions of people worldwide each year. Patients require sequences of treatment based on their response to previous treatments to combat cancer and fight metastases. Physicians provide treatment based on clinical characteristics, changing over time. Guidelines for these individualized sequences of treatments are known as dynamic treatment regimens (DTRs) where the initial treatment and subsequent modifications depend on the response to previous treatments, disease progression, and other patient characteristics or behaviors. To provide evidence-based DTRs, the Sequential Multiple Assignment Randomized Trial (SMART) has emerged over the past few decades.

PURPOSE: To examine and learn from past SMARTs investigating cancer treatment options, to discuss potential limitations preventing the widespread use of SMARTs in cancer research, and to describe courses of action to increase the implementation of SMARTs and collaboration between statisticians and clinicians.

CONCLUSION: There have been SMARTs investigating treatment questions in areas of cancer, but the novelty and perceived complexity has limited its use. By building bridges between statisticians and clinicians, clarifying research objectives, and furthering methods work, there should be an increase in SMARTs addressing relevant cancer treatment questions. Within any area of cancer, SMARTs develop DTRs that can guide treatment decisions over the disease history and improve patient outcomes.

© The Author(s), 2014.

References

  1. Blood. 2006 Dec 15;108(13):4003-8 - PubMed
  2. Pharm Stat. 2013 Jan-Feb;12(1):35-42 - PubMed
  3. BMC Med Res Methodol. 2010 Jan 06;10:1 - PubMed
  4. Cancer. 1997 Dec 15;80(12):2222-9 - PubMed
  5. Am J Med. 1987 Feb;82(2):283-90 - PubMed
  6. J R Stat Soc Ser C Appl Stat. 2013 Jan;62(1):67-83 - PubMed
  7. Ann Oncol. 1994 Dec;5(10):921-8 - PubMed
  8. Am J Geriatr Psychiatry. 2001 Fall;9(4):346-60 - PubMed
  9. Stat Med. 2008 Sep 20;27(21):4161-74 - PubMed
  10. Stat Med. 2005 May 30;24(10):1455-81 - PubMed
  11. Biometrics. 2007 Jun;63(2):422-8 - PubMed
  12. Am J Public Health. 2011 Jan;101(1):40-5 - PubMed
  13. J Natl Cancer Inst. 2007 Nov 7;99(21):1577-82 - PubMed
  14. Lancet Oncol. 2010 Oct;11(10):934-41 - PubMed
  15. Stat Med. 2012 Jul 30;31(17):1887-902 - PubMed
  16. Stat Med. 2007 Nov 20;26(26):4687-702 - PubMed
  17. Blood. 2006 Nov 15;108(10):3295-301 - PubMed
  18. Biometrics. 2004 Mar;60(1):124-33 - PubMed
  19. Stat Med. 2004 Nov 15;23(21):3249-62 - PubMed
  20. Ann Stat. 2012 Feb 1;40(1):529-560 - PubMed
  21. Control Clin Trials. 2004 Feb;25(1):119-42 - PubMed
  22. Stat Med. 2009 Jul 10;28(15):2028-41 - PubMed
  23. Neuropsychopharmacology. 2007 Feb;32(2):257-62 - PubMed
  24. Lifetime Data Anal. 2008 Mar;14(1):37-53 - PubMed
  25. J Natl Cancer Inst. 2007 Nov 7;99(21):1613-22 - PubMed
  26. J Am Stat Assoc. 2012 Jun;107(498):493-508 - PubMed
  27. Stat Med. 2012 Apr 30;31(9):812-30 - PubMed
  28. Biometrika. 2011 Sep;98(3):503-518 - PubMed
  29. J Clin Oncol. 2006 Jul 1;24(19):3121-7 - PubMed
  30. Int J Biostat. 2010;6(2):Article 8 - PubMed
  31. Drug Alcohol Depend. 2007 May;88 Suppl 2:S24-30 - PubMed
  32. Clin Trials. 2010 Dec;7(6):643-52 - PubMed
  33. Basic Clin Pharmacol Toxicol. 2006 Mar;98(3):237-42 - PubMed
  34. Stat Med. 2010 Nov 10;29(25):2581-91 - PubMed
  35. N Engl J Med. 1995 Jun 22;332(25):1671-7 - PubMed
  36. CA Cancer J Clin. 2012 Jul-Aug;62(4):220-41 - PubMed
  37. Leukemia. 2007 Mar;21(3):453-61 - PubMed
  38. Biostatistics. 2013 Apr;14(2):299-312 - PubMed
  39. Biol Psychiatry. 2000 Sep 15;48(6):605-14 - PubMed
  40. Stat Med. 2000 Apr 30;19(8):1011-28 - PubMed
  41. J Clin Oncol. 2009 Mar 1;27(7):1007-13 - PubMed
  42. Biometrics. 2011 Dec;67(4):1422-33 - PubMed
  43. Psychol Methods. 2012 Dec;17(4):457-477 - PubMed
  44. Annu Rev Clin Psychol. 2012;8:21-48 - PubMed
  45. Stat Med. 2014 Feb 28;33(5):760-71 - PubMed
  46. Stat Med. 2008 Aug 30;27(19):3689-716 - PubMed
  47. N Engl J Med. 1999 Oct 14;341(16):1165-73 - PubMed
  48. Clin Trials. 2009 Oct;6(5):480-90 - PubMed
  49. Annu Rev Med. 2008;59:443-53 - PubMed
  50. Biometrics. 2006 Sep;62(3):901-9 - PubMed
  51. Stat Med. 2010 May 10;29(10):1114-26 - PubMed
  52. Clin Trials. 2004 Feb;1(1):9-20 - PubMed
  53. Blood. 2001 Aug 1;98(3):548-53 - PubMed
  54. J Am Stat Assoc. 2012 Sep 1;107(449):1106-1118 - PubMed
  55. Biometrics. 2002 Mar;58(1):48-57 - PubMed

Publication Types

Grant support