ecancermedicalscience

Research

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

22 Jul 2025
Soumitra S Datta, Bidisha Samanta, Sanjoy Chatterjee, Indranil Mallick, Atul Sharma, Gargi Gangopadhyay, Shreshta Chattopadhyay, Chitralekha Bhowmick, Neha Chawla, Caroline Clarke, Duncan Gilbert, Usha Menon

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.

Related Articles

Mayank Chhabra, Somika Meet, Gandhar Tendulkar, Kunal Oswal, Milan Toraskar, Sai Murali, Bharat Kumar Sarvepalli, Sripriya Rao, Ramachandran Venkataramanan, Yogesh Jain
Vanlaltluangi, Lalengkimi Ralte, John Zothanzama, Lalrammawia Tochhawng, Ruby Zothankimi Ralte, Harvey Vanlalpeka, Nachimuthu Senthil Kumar
Atul Budkh, Sonali Bagal, Deepak Gupta, Sharyu Mhamane, Ravikant Singh, Burhanuddin Qayyumi, Abha Rani Sinha, Sanjay Kumar Singh, Satyajit Pradhan, Pankaj Chaturvedi, Rajendra Badwe, Sudeep Gupta