58
Views
2
CrossRef citations to date
0
Altmetric
Open Peer Commentaries

Perverse Effects: How Insufficient Guidance to IPFs Can Undermine Both Research and Health Outcomes of Clinical Trials

REFERENCES

  • Chow, S.-C., and J.-P. Liu. 2014. Sample size determination. In Design and analysis of clinical trials: Concepts and methodologies, 3rd ed., 441–518. Hoboken, NJ: John Wiley & Sons.
  • Davila, M. L., I. Riviere, X. Wang, et al. 2014. Efficacy and toxicity management of 19–28z CAR T cell therapy in B cell acute lymphoblastic leukemia. Science Translational Medicine 6 (224):1–10. doi:10.1126/scitranslmed.3008226.
  • Jecker, N. S., A. G. Wightman, A. R. Rosenberg, and D. S. Diekema. 2017. From protection to entitlement: Selecting research subjects for early phase clinical trials involving breakthrough therapies. Journal of Medical Ethics 43 (6):391–400. doi:10.1136/medethics-2016-103868.
  • Jecker, N. S., A. G. Wightman, A. R. Rosenberg, and D. S. Diekema. 2018. Ethical guidance for selecting clinical trials to receive limited space in an immunotherapy production facility. American Journal of Bioethics 18 (4):58–67.
  • Lee, D. W., J. N. Kochenderfer, M. Stetler-Stevenson, et al. 2015. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: A phase 1 dose-escalation trial. Lancet 385 (9967):517–28. doi:10.1016/S0140-6736(14)61403-3.
  • Piantadosi, S. 2017. Clinical trials: A methodologic perspective. Wiley Series in Probability and Statistics. Hoboken, NJ: Wiley.
  • Sanders, D., and J. Dukeminier. 1968. Medical advance and legal lag: Hemodialysis and kidney transplantation. UCLA Law Review 15:357–413.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.