Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting

Cancer ◽  
2021 ◽  
Author(s):  
Eli R. Abernethy ◽  
Gavin P. Campbell ◽  
Rachel S. Hianik ◽  
Mary Catherine Thomson ◽  
Shannon M. Blee ◽  
...  
Cancer ◽  
2012 ◽  
Vol 118 (18) ◽  
pp. 4571-4578 ◽  
Author(s):  
Rebecca D. Pentz ◽  
Margaret White ◽  
R. Donald Harvey ◽  
Zachary Luke Farmer ◽  
Yuan Liu ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6573-6573
Author(s):  
A. Gibbs ◽  
J. F. Merz ◽  
L. Gore ◽  
C. L. O'Bryant

6573 Background: Research industry practice reimburses healthy phase 1 study subjects and yet cancer patients who participate in a phase 1 study are rarely reimbursed. The ethical problems of disproportionate risk/benefit ratio and coercive informed consent are cited as reasons for not paying cancer study subjects. The purpose of this study is to determine if payment to participate in a phase 1 clinical trial affects a cancer subject's willingness to participate (WTP) in a clinical trial and to determine if any payment would reduce the therapeutic misconception. Methods: Eligible adults had consented to participate in a phase 1 clinical trial of an investigational drug at UCCC but had not yet initiated treatment. Subjects were identified by UCCC staff, consented to participate in this study, and then administered a questionnaire by phone. Primary analyses were descriptive in nature. Results: Thirty subjects were enrolled. The median age was 57 years (range 30–76); 53% were female; 97% were Caucasian; 77% had at least some college education; 47% had an annual household income of < $50,000. When asked an open-ended question, 53% of subjects stated that the main purpose of the phase 1 trial in which they consented to participate was efficacy. The majority of subjects (80%) did not think they should be paid to participate in a phase 1 cancer trial. Most subjects (73%) expected to benefit from phase I study participation and greater than 80% of subjects stated that payment would not change their perception or hope of benefit. There was a minor trend towards increased WTP with increased reimbursement or payment. Thirty-seven percent of subjects acknowledged that payment might affect what side effects they report. Conclusions: While payment appeared to have little or no affect on a cancer subject's expectation of benefit from a phase 1 trial, WTP increased slightly with increasing payment. Given these results, it seems that payment would not reduce the therapeutic misconception related to participation in phase 1 cancer trials. This study should be expanded to confirm these findings. No significant financial relationships to disclose.


2001 ◽  
Vol 60 (4) ◽  
pp. 215-230 ◽  
Author(s):  
Jean-Léon Beauvois

After having been told they were free to accept or refuse, pupils aged 6–7 and 10–11 (tested individually) were led to agree to taste a soup that looked disgusting (phase 1: initial counter-motivational obligation). Before tasting the soup, they had to state what they thought about it. A week later, they were asked whether they wanted to try out some new needles that had supposedly been invented to make vaccinations less painful. Agreement or refusal to try was noted, along with the size of the needle chosen in case of agreement (phase 2: act generalization). The main findings included (1) a strong dissonance reduction effect in phase 1, especially for the younger children (rationalization), (2) a generalization effect in phase 2 (foot-in-the-door effect), and (3) a facilitatory effect on generalization of internal causal explanations about the initial agreement. The results are discussed in relation to the distinction between rationalization and internalization.


2004 ◽  
Author(s):  
Carl L. Henderson
Keyword(s):  
Phase 1 ◽  

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