By Prathiba Raju and Abhijeet Singh
Mumbai: In order to ensure the efficacy and safety of a drug or any other medical device the findings of the clinical trials should be optimal. Given the diversity of Indian populace the drug which is meant to be used by a much larger group of patients on which trials be done needs to be truly representative and consciously selected. So what comes out as the best available solution is to go for Decentralised Clinical Trials (DCTs), informed Dr Sudipto Roy, Scientist ‘E’, Clinical Studies and Trials Unit (CSTU), Development Research, Indian Council of Medical Research (ICMR).
Dr Roy, shared his insights during his valedictory address on ‘Patient Recruitment and Retention Strategy in the age of Decentralised trials at the inaugural edition of ETPharma Clinical Research and Excellence Conference (CREC).
He elucidated the advantages of adopting DCTs in India, including wider reach, increased participation base, cost-effective solutions, real-time monitoring, and, most importantly, faster trial timelines.
Highlighting key challenges Dr Roy said, “Challenges of conducting DCT in India extends from lack of in-person contact, privacy concerns, to uncertainty of validity and accuracy of data provided by technologies like smart wearables which is a major tool used for data collection under DCTs.”
Extending further, Dr Roy evocated the level of digital and technological literacy in India as the biggest deciding factor in conducting decentralised trials.
In his address the expert emphasised over incorporating modern day technologies like AI and ML (Machine Learning) for making the process more simplified, accessible and expeditious. He also called for inducting ICT’s (Information and communication technology) for guiding and assisting participants at various stages and also providing them with complete information for building trust while in the beginning in-person assistance should also be available and the choice will rest on participants.
Citing a few examples from the west, Dr Roy cited that the success of DCT’s is in increasing participation and changing behavior of participants from traditional trials to remote ones as a more convenient alternative.
Elaborating on the second part of his address, ‘the retention of participants’ Dr Roy suggested that collaborating with family doctors will be a crucial step as they are more close to a particular participant and have a better knowledge of patients health history but first they need to be equipped with proper training.
Responding to the ongoing debate of whether AI and other modern day technology will replace clinical trials Dr Roy unequivocally rejected the claim stating “AI will not replace but it will only help.”
Concluding his address Dr Roy suggested a way forward for pursuing DCTs where he stressed that for the next decade focus should be on hybrid trials and then can move to full fledged decentralised trials.
