Pawlowski Jamie, Malik Laeeq, Mahalingam Devalingam
a Department of Medicine, Division of Hematology/Oncology , University of Texas Health Science Center , San Antonio , TX , USA.
b Institute for Drug Development , University of Texas Health Science Center , San Antonio , TX , USA.
Cancer Invest. 2015;33(10):490-5. doi: 10.3109/07357907.2015.1069833. Epub 2015 Oct 13.
This questionnaire-based study assessed the understanding and perceptions of cancer patients who were participating in a Phase I clinical trial at baseline and determined any changes after enrollment. Thirty-six patients participated. Less than one-third of respondents (28.5%) thought the purpose of Phase I trials was dose escalation for safety and efficacy. Patients anticipated varying degree of therapeutic benefit ranging from stable disease (47.1%) to complete shrinkage of the tumor (32.4%). No change in measured themes was observed. Patients participating in Phase I trials need further education to improve their understanding of the true intent of early Phase trials.
这项基于问卷的研究评估了参与一期临床试验的癌症患者在基线时的理解和认知，并确定了入组后的任何变化。36名患者参与了研究。不到三分之一的受访者（28.5%）认为一期试验的目的是为了安全性和有效性而进行剂量递增。患者预期的治疗益处程度各不相同，从疾病稳定（47.1%）到肿瘤完全缩小（32.4%）。未观察到所测量主题的变化。参与一期试验的患者需要进一步教育，以提高他们对早期试验真正意图的理解。
