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Conduct of cancer clinical trials: a qualitative study reporting views of patients, caregivers, public and clinical researchers

Datta, Soumitra S; Samanta, Bidisha; Chatterjee, Sanjoy; Mallick, Indranil; Sharma, Atul; Gangopadhyay, Gargi; Chattopadhyay, Shreshta; ... Menon, Usha; + view all (2025) Conduct of cancer clinical trials: a qualitative study reporting views of patients, caregivers, public and clinical researchers. ecancermedicalscience , 19 , Article 1950. 10.3332/ecancer.2025.1950. Green open access

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Abstract

Background: 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. Methods: We undertook a cross-sectional qualitative study using in-depth interviewing to explore the views of Indian cancer patients (n = 11), caregivers(n = 10) and public (n = 10), regarding clinical trials. Clinical researchers (n = 10) were also interviewed. Data were analysed using the framework of qualitative content analysis. Results: Five themes were identified regarding clinical trials: a) Perception: Only a minority had a prior understanding; when explained, most were willing to be randomised and attend additional monitoring visits. b) Recruitment: 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) Patient information: Need for both written and audio-visual information material using simple local language. d) Benefits/adverse effects: 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) Consent: Honesty and transparency, imbalance of power/trust between trialists and participants and financial vulnerability of patients were voiced by participants. Conclusion: 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.

Type: Article
Title: Conduct of cancer clinical trials: a qualitative study reporting views of patients, caregivers, public and clinical researchers
Open access status: An open access version is available from UCL Discovery
DOI: 10.3332/ecancer.2025.1950
Publisher version: https://doi.org/10.3332/ecancer.2025.1950
Language: English
Additional information: This work is licensed under a Creative Commons License. The images or other third-party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
Keywords: Science & Technology, Life Sciences & Biomedicine, Oncology, patient and public involvement (PPI), clinical trials, cancer, oncology, consent, LMICs
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10212028
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