Datta Soumitra S, Samanta Bidisha, Chatterjee Sanjoy, Mallick Indranil, Sharma Atul, Gangopadhyay Gargi, Chattopadhyay Shreshta, Bhowmick Chitralekha, Chawla Neha, Clarke Caroline, Gilbert Duncan, Menon Usha
Department of Palliative Care and Psycho-Oncology, Tata Medical Centre, Kolkata 700160, India.
MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, 90 High Holborn, London WC1V 6LJ, UK.
Ecancermedicalscience. 2025 Jul 22;19:1950. doi: 10.3332/ecancer.2025.1950. eCollection 2025.
The rising cancer burden in low- and middle-income countries (LMICs) has been accompanied by an increase in clinical trials. However, there is a paucity of research from LMICs on patient preferences for trial participation.
We undertook a cross-sectional qualitative study using in-depth interviewing to explore the views of Indian cancer patients ( = 11), caregivers( = 10) and public ( = 10), regarding clinical trials. Clinical researchers ( = 10) were also interviewed. Data were analysed using the framework of qualitative content analysis.
Five themes were identified regarding clinical trials: a) Only a minority had a prior understanding; when explained, most were willing to be randomised and attend additional monitoring visits. b) Consensus that trial discussions should be with the patient, with caregivers and family included where appropriate, variability in when a patient should be first approached. c) Need for both written and audio-visual information material using simple local language. d) : Discussion of all pros and cons, including the possibility of dying was preferred. There were divided views regarding disclosure of all versus common risks. Challenges in understanding quantitative risks/benefits were voiced. e) Honesty and transparency, imbalance of power/trust between trialists and participants and financial vulnerability of patients were voiced by participants.
Cancer clinical trials in LMICs can be enriched by patient and public involvement during planning research and conduct of the clinical trial. The financial vulnerability of patients and the power imbalance between them and researchers need to be addressed, especially in international multiregional clinical trials.
低收入和中等收入国家（LMICs）癌症负担的不断增加伴随着临床试验数量的增多。然而，来自LMICs的关于患者参与试验偏好的研究却很少。
我们采用深入访谈进行了一项横断面定性研究，以探讨印度癌症患者（n = 11）、护理人员（n = 10）和公众（n = 10）对临床试验的看法。还对临床研究人员（n = 10）进行了访谈。使用定性内容分析框架对数据进行了分析。
确定了关于临床试验的五个主题：a）只有少数人有事先了解；经解释后，大多数人愿意被随机分组并接受额外的监测访视。b） 一致认为试验讨论应与患者进行，酌情包括护理人员和家属，对于何时应首先接触患者存在差异。c） 需要使用简单的当地语言编写书面和视听信息材料。d） ：倾向于讨论所有利弊，包括死亡可能性。对于披露所有风险与常见风险存在不同观点。有人提到在理解定量风险/益处方面存在挑战。e） 参与者提到了诚实和透明度、试验者与参与者之间的权力/信任失衡以及患者的经济脆弱性。
在规划研究和进行临床试验期间，患者和公众的参与可以丰富LMICs的癌症临床试验。需要解决患者的经济脆弱性以及他们与研究人员之间的权力不平衡问题，特别是在国际多区域临床试验中。
