Knowledge and understanding among cancer patients consenting to participate in clinical trials

Standard 1: Consent and Recruitment

“…13,14 This suggests the need to continue to inform children and families about the research process even after formal consent has been given. This must be balanced with the knowledge that excessive information undermines understanding and is negatively perceived by families.…”

Patients’ regrets after participating in a randomized controlled trial depended on their involvement in the decision making

“…Perhaps these patients did not fully understand that they were going to be randomized. Previous studies have suggested that participants often fail to understand RCTs properly [6,7]. A longitudinal qualitative survey on breast cancer patients who declined to participate in an RCT showed that some patients regretted their hasty decision and lack of support and that their decision might have been different if the clinical staff had spent more time with them [31].…”

“…Although patients need time to absorb and discuss information [1], this decision has to be taken quickly when it focuses on adjuvant treatment. Although patients sign the mandatory consent form and despite the efforts made to improve consent procedures [2e5], many participants still do not completely understand what participating in clinical trials involves [6,7], which detracts from…”

Beyond the ‘therapeutic misconception’: Research, care and moral friction

“…An influential strain in the bioethics literature on clinical trials is devoted to revealing research participants' failure to appreciate that research and health care serve fundamentally different goals (Featherstone and Donovan, 2002;Brown et al, 2004;Bergenmar et al, 2008;Sand et al, 2008;Hereu et al, 2010;McCann et al, 2010;Behrendt et al, 2011;Sanchini et al, 2013). To explain this phenomenon, Appelbaum et al's concept of "therapeutic misconception" (Appelbaum et al, 1987;Lidz et al, 2004) is often evoked (Miller, 2000;Featherstone and Donovan, 2002;Miller and Rosenstein, 2003;Canvin and Jacoby, 2006).…”