Early phase clinical trials: communicating the uncertainties of `magnitude of benefit' and `likelihood of benefit'

Siminoff LA , Fetting JH Effects of outcome framing on treatment decisions in the real world: impact of framing on adjuvant breast cancer decisions. Med Decis Making 1989; 9: 262-71.

Featherstone K. , Donovan JL `Why don't they just tell me straight, why allocate it?` The struggle to make sense of participating in a randomised controlled trial. Soc Sci Med 2002; 55: 709-19.

Flory J. , Emanuel E. Interventions to improve research participants' understanding in informed consent for research. JAMA 2004; 292(13): 1593-601.

Wadey V. , Frank C. The effectiveness of patient verbalization on informed consent. Can J Surg 1997; 40(2): 124-28.

Kass N. , Sugarman J. , Taylor H. , Fogarty L. , Goodman SN , Goodwin-Landher A. , et al. Purpose and benefits of early phase cancer trials: What do oncologists say? What do patients hear? JERHRE 2008 September 2008:57-68.

von Hoff DD , Turner J. Response rates, duration of response, and dose response effect in Phase I studies in antineoplastics. Invest New Drugs 1997; 9: 115-22.

Arkenau H. , Olmos D. , Ang JE et al. Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience . Br J Cancer 2008; 98: 1029-33.

Horstmann E. , McCabe M. , Grochow L. et al. Risks and benefits of phase I oncology trials, 1991 through 2002. NEJM 2005; 352(9): 895-904.