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. Author manuscript; available in PMC: 2016 Dec 1.
Published in final edited form as: Clin Trials. 2015 Aug 28;12(6):567–574. doi: 10.1177/1740774515601679

Table 1.

Necessary Content Identified in the Literature

Code Jenkins Tomamichel Rodenhuis
Is research Used in animals and a few humans* Experimental – first in humans
Prognosis Prognosis
Treatment options Other treatment or care options Lack of proven treatments
Aims Major aims Objective is to further therapy progress
Benefit unknown Probable lack of therapeutic benefits Anti-tumor effect unknown/unlikely* Effect on tumor uncertain. Cure improbable
Extra Procedures Extra blood draws, frequent visits Extra Research Procedures
Unknown AEs Unknown adverse effects Limited knowledge of side effects* Side effects expected, may be serious
Voluntary Voluntary Voluntary*
Withdraw Can withdraw Can withdraw* Can withdraw
Questions Consent given and questions answered
*

Mentioned by Willems