Skip to main content

Clinical Trials

  • Chapter
  • First Online:
Book cover Cancer in Adolescents and Young Adults

Part of the book series: Pediatric Oncology ((PEDIATRICO))

  • 1957 Accesses

Abstract

The concept of the ‘adolescent and young adult (AYA) gap’ in relation to recruitment to cancer clinical trials was first described in 1997. The ‘AYA gap’ refers to the association between lesser survival gains and poorer recruitment to cancer clinical trials for this group. Since then, many countries have reported lesser involvement of AYAs in cancer trials compared to children and older adults. Lately a number of initiatives have served to improve recruitment for AYAs with cancer, and barriers and facilitators to recruitment have been identified. This chapter summarises the concept of clinical trials and some of the challenges faced by AYAs with cancer and the healthcare teams caring for them.

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

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 189.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 249.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 329.99
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. Altman DG (2002) Poor-quality medical research: what can journals do? JAMA 287(21):2765–2767

    Article  PubMed  Google Scholar 

  2. Hilsenbeck SB, Berg SL (2010) Cancer clinical trials: design, conduct, analysis, and reporting. In: Phillip A, Pizzo DGP (eds) Principles and practice of paediatric oncology. Lippincott, Philadelphia

    Google Scholar 

  3. Van Hoff DCJ, Kuhn CI (1984) Design and conduct of phase I trials. In: Buyse MSM, Sylvester R (eds) Cancer clinical trials: methods and practice. Oxford University Press, London

    Google Scholar 

  4. Carter S (1983) Clinical aspects in the design and conduct of phase II trials. In: Buyse MSM, Sylvester R (eds) Cancer clinical trials: methods and practice. Oxford University Press, London

    Google Scholar 

  5. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45(2):228–247

    Article  CAS  PubMed  Google Scholar 

  6. Marsoni S, Wittes R (1984) Clinical development of anticancer agents – a National Cancer Institute perspective. Cancer Treat Rep 68(1):77–85

    CAS  PubMed  Google Scholar 

  7. Mastrangelo R, Poplack D, Bleyer A, Riccardi R, Sather H, D’Angio G (1986) Report and recommendations of the Rome workshop concerning poor-prognosis acute lymphoblastic leukemia in children: biologic bases for staging, stratification, and treatment. Med Pediatr Oncol 14(3):191–194

    Article  CAS  PubMed  Google Scholar 

  8. Fifty years of systemic therapy for breast cancer: from one size fits all to tailored therapy American Society of Oncology (2014) Chicago, ASCO

    Google Scholar 

  9. SM (2010) The Emperor of all Maladies: A biography of cancer by Siddhartha Mukherjee. Scribner, New York

    Google Scholar 

  10. Bessell EM, Bouliotis G, Armstrong S, Baddeley J, Haynes AP, O’Connor S et al (2012) Long-term survival after treatment for Hodgkin’s disease (1973–2002): improved survival with successive 10-year cohorts. Br J Cancer 107(3):531–536

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Fifty years of progress in radiation therapy for breast cancer (2014) American Society of Clinical Oncology. American Society of Clinical Oncology Education Book, Alexandria, VA, USA

    Google Scholar 

  12. Fifty years of advances in sarcoma treatment: moving the needle from conventional chemotherapy to targeted therapy American Society of Clinical Oncology (2014) Chicago

    Google Scholar 

  13. Radiotherapy for soft tissue sarcoma: 50 years of change and improvement (2014) American Society of Clinical Oncology, Chicago

    Google Scholar 

  14. Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT et al (2014) Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol 32(31):3490–3496

    Article  CAS  PubMed  Google Scholar 

  15. Wong RK, Paul N, Ding K, Whitehead M, Brundage M, Fyles A et al (2006) 5-hydroxytryptamine-3 receptor antagonist with or without short-course dexamethasone in the prophylaxis of radiation induced emesis: a placebo-controlled randomized trial of the National Cancer Institute of Canada Clinical Trials Group (SC19). J Clin Oncol 24(21):3458–3464

    Article  CAS  PubMed  Google Scholar 

  16. Association WM (2013) Declaration of Helsinki- Ethical Principles for medical research involving human subjects

    Google Scholar 

  17. Group IEW (1996) Guideline for Good Clinical Practice E6 (R1). International Conference on Harmonization, Rockville, MD, USA

    Google Scholar 

  18. Council for International Organisations of Medical Sciences (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva

    Google Scholar 

  19. Bleyer A, Barr R, Hayes-Lattin B, Thomas D, Ellis C, Anderson B et al (2008) The distinctive biology of cancer in adolescents and young adults. Nat Rev Cancer 8(4):288–298

    Article  CAS  PubMed  Google Scholar 

  20. Bleyer A, Budd T, Montello M (2005) Lack of participation of older adolescents and young adults with cancer in clinical trials: impact in the USA. Cancer Adolesc, 2nd ed 32–45. ISBN 9780470994733

    Google Scholar 

  21. Bleyer A, Budd T, Montello M (2006) Adolescents and young adults with cancer: the scope of the problem and criticality of clinical trials. Cancer 107(7 Suppl):1645–1655

    Article  PubMed  Google Scholar 

  22. Bleyer A, Montello M, Budd T, Saxman S (2005) National survival trends of young adults with sarcoma – lack of progress is associated with lack of clinical trial participation. Cancer 103(9):1891–1897

    Article  PubMed  Google Scholar 

  23. Lethaby CD, Picton S, Kinsey SE, Phillips R, van Laar M, Feltbower RG (2013) A systematic review of time to diagnosis in children and young adults with cancer. Arch Dis Child 98(5):349–355

    Article  PubMed  Google Scholar 

  24. Bleyer A (2002) Older adolescents with cancer in North America: deficits in outcome and research. Pediatr Clin North Am 49(5):1027–1042

    Article  PubMed  Google Scholar 

  25. Ferrari A, Montello M, Budd T, Bleyer A (2008) The challenges of clinical trials for adolescents and young adults with cancer. Pediatr Blood Cancer 50(S5):1101–1104

    Article  PubMed  Google Scholar 

  26. Ferrari A, Arico M, Dini G, Rondelli R, Porta F (2012) Upper age limits for accessing pediatric oncology centers in Italy: a barrier preventing adolescents with cancer from entering national cooperative AIEOP trials. Pediatr Hematol Oncol 29(1):55–61

    Article  PubMed  Google Scholar 

  27. Ferrari A, Dama E, Pession A, Rondelli R, Pascucci C, Locatelli F et al (2009) Adolescents with cancer in Italy: entry into the national cooperative paediatric oncology group AIEOP trials. Eur J Cancer 45(3):328–334

    Article  PubMed  Google Scholar 

  28. Mitchell AE, Scarcella DL, Rigutto GL, Thursfield VJ, Giles GG, Sexton M et al (2004) Cancer in adolescents and young adults: treatment and outcome in Victoria. Med J Aust 180(2):59–62

    PubMed  Google Scholar 

  29. O Brien T SA, Thomas D, Treadgold C, Young A (2006) The need for change, why we need a new model of care for adolescents and young adults with cancer. A document for discussion. Improving the management of cancer services conference. Melbourne

    Google Scholar 

  30. Shaw PH, Ritchey AK (2007) Different rates of clinical trial enrollment between adolescents and young adults aged 15 to 22 years old and children under 15 years old with cancer at a children’s hospital. J Pediatr Hematol Oncol 29(12):811–814

    Article  PubMed  Google Scholar 

  31. Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC et al (2007) Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 112(2):228–242

    Google Scholar 

  32. Fern L, Davies S, Eden T, Feltbower R, Grant R, Hawkins M et al (2008) Rates of inclusion of teenagers and young adults in England into National Cancer Research Network clinical trials: report from the National Cancer Research Institute (NCRI) Teenage and Young Adult Clinical Studies Development Group. Br J Cancer 99(12):1967–1974

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  33. Bleyer A, Bud T, Montello M (2007) Older adolescents and young adults with cancer, and clinical trials: lack of participation and progress in North America. In: Bleyer A, Barr R (eds) Cancer in adolescents and young adults. Springer, Berlin

    Chapter  Google Scholar 

  34. Bleyer A, Hag-Alshiekh M, Montello M, Budd T, Bendel A, Beaty O et al (2004) Older adolescents and young adults with brain tumors in the United States: lack of clinical trial participation and of survival prolongation and mortality reduction. Neuro Oncol 6(4):417–17

    Google Scholar 

  35. Bleyer A, Montello M, Budd T (2004) Young adults with leukemia in the United States: lack of clinical trial participation and mortality reduction during the last decade. J Clin Oncol 22(14):6623

    Article  Google Scholar 

  36. Krailo MD, Bernstein L, Sullivan-Halley J, Hammond GD (1993) Patterns of enrollment on cooperative group studies. An analysis of trends from the Los Angeles County Cancer Surveillance Program. Cancer 71(10 Suppl):3325–3330

    Article  CAS  PubMed  Google Scholar 

  37. Bleyer WA, Tejeda H, Murphy SB, Robison LL, Ross JA, Pollock BH et al (1997) National cancer clinical trials: children have equal access; adolescents do not. J Adolesc Health 21(6):366–373

    Article  CAS  PubMed  Google Scholar 

  38. Ferrari A, Bleyer A (2007) Participation of adolescents with cancer in clinical trials. Cancer Treat Rev 33(7):603–608

    Article  PubMed  Google Scholar 

  39. Fern LA, Lewandowski JA, Coxon KM, Whelan J (2014) Available, accessible, aware, appropriate, and acceptable: a strategy to improve participation of teenagers and young adults in cancer trials. Lancet Oncol 15(8):e341–e350

    Article  PubMed  Google Scholar 

  40. Miller VA, Baker JN, Leek AC, Hizlan S, Rheingold SR, Yamokoski AD et al (2013) Adolescent perspectives on phase I cancer research. Pediatr Blood Cancer 60(5):873–878

    Article  PubMed  Google Scholar 

  41. Momper JD, Mulugeta Y, Green DJ, Karesh A, Krudys KM, Sachs HC et al (2013) Adolescent dosing and labeling since the Food and Drug Administration Amendments Act of 2007. JAMA Pediatr 167(10):926–932

    Article  PubMed  Google Scholar 

  42. Smith MA, Seibel NL, Altekruse SF, Ries LA, Melbert DL, O’Leary M et al (2010) Outcomes for children and adolescents with cancer: challenges for the twenty-first century. J Clin Oncol 28(15):2625–2634

    Article  PubMed  PubMed Central  Google Scholar 

  43. Shaw PH, Hayes-Lattin B, Johnson R, Bleyer A (2014) Improving enrollment in clinical trials for adolescents with cancer. Pediatrics 133(Suppl 3):S109–S113

    Article  PubMed  Google Scholar 

  44. Monfardini S, Sorio R, Boes GH, Kaye S, Serraino D (1995) Entry and evaluation of elderly patients in European Organization for Research and Treatment of Cancer (EORTC) new-drug-development studies. Cancer 76(2):333–338

    Article  CAS  PubMed  Google Scholar 

  45. Aapro MS, Kohne CH, Cohen HJ, Extermann M (2005) Never too old? Age should not be a barrier to enrollment in cancer clinical trials. Oncologist 10(3):198–204

    Article  PubMed  Google Scholar 

  46. Downs-Canner S, Shaw PH (2009) A comparison of clinical trial enrollment between adolescent and young adult (AYA) oncology patients treated at affiliated adult and pediatric oncology centers. J Pediatr Hematol Oncol 31(12):927–929

    Article  PubMed  Google Scholar 

  47. Birch JM, Alston RD, Kelsey AM, Quinn MJ, Babb P, McNally RJ (2002) Classification and incidence of cancers in adolescents and young adults in England 1979–1997. Br J Cancer 87(11):1267–1274

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  48. Neuman HB, Charlson ME, Temple LK (2007) Is there a role for decision aids in cancer-related decisions? Crit Rev Oncol Hematol 62(3):240–250

    Article  PubMed  Google Scholar 

  49. Freyer D, Seibel N (2015) The Clinical Trials Gap for Adolescents and Young Adults with Cancer: recent progress and conceptual framework for continued research. Curr Paediatr Rep 3:137–145. doi 10.1007/s40124-015-0075-y

  50. Department of Health (2007) Cancer Reform Strategy, Chapter 6 Reducing cancer inequalities. London, pp 89–90

    Google Scholar 

  51. International Conference on Harmonisation EWG (1993) ICH Harmonised Tripartite Guideline: studies in support of special populations: E7 Geriatrics pg 2

    Google Scholar 

  52. Administration FaD (2000) Clinical Investigation of medicinal products in the paediatric population. Guideline for Industry. Silver Spring, Rockville, MD, USA

    Google Scholar 

  53. Rethinking trial eligibility in the NCD era (2015) Lancet Oncol 16(3):233

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Annette E. Hay MB ChB, MRCP, FRCPath .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2017 Springer International Publishing

About this chapter

Cite this chapter

Hay, A.E., Fern, L., Meyer, R.M., Seibel, N., Barr, R. (2017). Clinical Trials. In: Bleyer, A., Barr, R., Ries, L., Whelan, J., Ferrari, A. (eds) Cancer in Adolescents and Young Adults. Pediatric Oncology. Springer, Cham. https://doi.org/10.1007/978-3-319-33679-4_21

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-33679-4_21

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-33677-0

  • Online ISBN: 978-3-319-33679-4

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics