publication . Other literature type . Article . 2016


Henshall, C.; Latimer, N.R.; Sansom, L.; Ward, R.L.;
Open Access
  • Published: 14 Sep 2016
  • Publisher: Cambridge University Press (CUP)
<jats:p><jats:bold>Objectives:</jats:bold> Treatment switching occurs when patients in a randomized clinical trial switch from the treatment initially assigned to them to another treatment, typically from the control to experimental treatment. This study discusses the issues this raises and possible approaches to addressing them in trials of cancer drugs.</jats:p><jats:p><jats:bold>Methods:</jats:bold> Stakeholders from around the world were invited to a 1.5-day Workshop in Adelaide, Australia. This study attempts to capture the key points from the discussion and the perspectives of the various stakeholder groups, but is not a formal consensus statement.</jats:p...
free text keywords: clinical trials, cancer, treatment switching, decision making, ethics, Health Policy
23 references, page 1 of 2

1. Jones B, Kenward MG. Design and analysis of cross-over trials. Monographs on Statistics and Applied Probability 98. London: Chapman and Hall/CRC; 2003.

2. Prasad V, Grady C. The misguided ethics of crossover trials. Contemp Clin Trials. 2014;37:167-169. doi: 10.1016/j.cct.2013.12.003.

3. Chan A-W, Altman DG. Epidemiology and reporting of randomised trials published in PubMed journals. Lancet. 2005;365:1159-1162.

4. Latimer NR, Abrams KR, Lambert PC, et al. Adjusting survival time estimates to account for treatment switching in randomized controlled trials-An economic evaluation context: Methods, limitations and recommendations. Med Decis Making. 2014;34:387-402. doi:10.1177/ 0272989X13520192.

5. Latimer NR, Bell H. The challenge of crossover in oncology trials. University of Sheffield School of Health and Related Research, Health Economics and Decision Science Discussion Paper Series, 2015, No 15.06. 526965.

6. Drummond M, Evans B, LeLorier J, et al. Evidence and values: Requirements for public reimbursement of drugs for rare diseases - A case study in oncology. Can J Clin Pharmacol. 2009;16:e273-e281. [OpenAIRE]

7. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry: Expedited programs for serious conditions - drugs and biologics. Silver Spring, MD: Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), editors. May 2014.

8. U.S. Department of Health and Human Services Food and Drug Administration. Guidance for Industry: Clinical trial end points for the approval of cancer drugs and biologics. Silver Spring, MD: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research, editors. 2007.

9. Committee for Medicinal Products for Human Use (CHMP). Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man (CHMP/EWP/205/95 REV.3). Methodological considerations for using progression-free survival (PFS) as primary end point in confirmatory trials for registration. 201. London: European Medicines Agency.

10. Fleming TR, Rothman MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol. 2009;27:2874- 2880.

11. Chua W, Clarke SJ. Clinical trial information as a measure of quality cancer care. J Oncol Pract. 2010;6:170-171.

12. Therapeutic Goods Administration. Special access scheme (updated 17 April 2015). (accessed April 29, 2015).

13. Fojo T, Mailankody S, Lo A. Unintended consequences of expensive cancer therapeutics - The pursuit of marginal indications and a metoo mentality that stifles innovation and creativity. JAMA Otolaryngol Head Neck Surg. 2014;140:1225-1236. doi:10.1001/jamaoto.2014. 1570. [OpenAIRE]

14. European Medicines Agency. Guideline on the evaluation of anticancer medicinal products in man. EMA/CHMP/205/95/Rev.4 Oncology Working Party, December 2012. jsp?curl=pages/news_and_events/news/2012/12/news_detail_001679. jsp&mid=WC0b01ac058004d5c1# (accessed September 25, 2015).

15. National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal. London: NICE, 2013. https://www. -of-technology-appraisal-2013-pdf (accessed September 25, 2015).

23 references, page 1 of 2
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