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Accountability in Research
Ethics, Integrity and Policy
Volume 22, 2015 - Issue 3
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Original Articles

Defining the Research Category in Pediatric Phase I Oncology Trials

Pramod M. LadHuman Subjects Protection Program, Children’s Hospital Los Angeles, Los Angeles, California, USACorrespondence[email protected]
, Ph.D., C.I.P. &
Rebecca DahlHuman Subjects Protection Program, Children’s Hospital Los Angeles, Los Angeles, California, USA
, Ph.D., C.I.P.
Pages 139-147 | Published online: 30 Jan 2015

REFERENCES

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  • Applebaum, P. S. (1982). The therapeutic misconception: Informed consent in psychiatric research. J. Law Psychiatry, 5(3-4):319–329.
  • Daugherty, C., Ratain, M., and Grochowski, E. (1995). Perceptions of cancer patients and their physicians involved in phase I trials. J. Clin. Oncology 13(5):1062–1072.
  • Daugherty, C. K., Ratain, M., and Minami, H. (1998). Study of cohort specific consent and patient control in Phase I cancer trials. J. Clin. Oncology, 16(7):2305–2312.
  • Decoster, G. and Cavalli, F. (1987). Design of Phase I and II clinical trials in cancer: A stistician’s view. Cancer Invest., 5(6):649–650.
  • Decoster, G., Stein, G., and Holdener, E. E. (1990). Response and toxic deaths in Phase I clinical trials. Ann. Oncology, 1(3):175–181.
  • Freedman, B. (1990). Cohort specific consent: An honest approach to Phase I clinical cancer studies. IRB: A Review of Human Subjects Research, 12(1):5–7.
  • Kodish, E., Stockin, C., and Ratain, M. (1992). Ethical issues in Phase I oncology research: A comparison of investigators and Institutional Review Board chairpersons. J. Clin. Oncol., 10(11):1810–1816.
  • Lad, P. M. and Dahl, R. (2013). An IRB-based clinical research quality assurance program. Accountability in Research, 20:13–26.
  • Lad, P. M. and Dahl, R. (2014a). Audit of the informed consent process as a part of clinical research quality assurance program. Science and Engineering Ethics, 20(1):469–479.
  • Lad, P. M. and Dahl, R. (2014b). Overcoming language barriers in the informed consent process: Regulatory and compliance issues with the use of the “short form.” Accountability in Research, 21:315–320.
  • Ratain, M. J. (1993). Statistical and ethical issues in the design and conduct of Phase I and II clinical trials of new anti-cancer agents. J. Nat. Cancer Inst., 85(20):1637–1643.
  • Storer, B. (1987). Current phase I/II designs: Are they adequate? J. Clin. Res. Drug Dev., 1:121–130.
  • Van Hoff, D. D. (1996). Is response in phase I trials a useful predictor for the future clinical activity of a new agent. Ann Oncology, 7(Suppl1):14–17.

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