OBJECTIVES

To examine accuracy of subjects’ knowledge of the terms “constipation” and “diarrhea” to determine the need for subject training in oncology clinical trials.

METHODS

Participants responded to questions on an online survey in which they were asked about their knowledge of the terms “constipation” and “diarrhea.” Demographic data were also collected.

RESULTS

Of the 127 participants who responded to a question defining “constipation,” only 75 participants (55%) chose the correct response. Out of the remaining 52 participants (45%) that chose one of the incorrect responses, 26 participants (50%), provided the correct response (p < .04) after viewing a training consisting of 1 sentence defining constipation.

Of the 125 participants who responded to a question defining “diarrhea,” only 84 participants (67%) chose the correct response. Out of the remaining 41 participants (33%) that chose one of the incorrect response options, 22 participants (54%) provided the correct response (p < .03) after a viewing a training only consisting of 1 sentence defining diarrhea.

CONCLUSIONS

The 2018 FDA Guidance in Oncology stresses the importance of direct evidence of clinical benefit, including PROs in determining efficacy in oncology drug trials. Thus, accurate assessment of symptoms using PROs is now crucial to determine treatment efficacy in oncology clinical trials. Subjects understanding of the questions are paramount to the integrity of the data.

The results of this study demonstrate, a large number of subjects do not understand the intended meaning of “constipation” or “diarrhea,” terms often used in oncology studies, which can be detrimental to endpoint data. As indicated in this study, subjects’ understanding of key concepts can significantly improve with only a one sentence training providing a key definition. If such a brief training can provide significant improvement, the expectation of a full training would be far more beneficial in improving clinical trial data.