Advanced techniques in DCTs provide a paradigm shift in patient-centricity – ET HealthWorld | Pharma

By Prathiba Raju & Prarthana Sharma

Mumbai: Decentralised clinical trials (DCT) are making healthcare patient-centric, and advancements in technology are making it easier, informed speakers at the inaugural edition of ETPharma’s Clinical Research Excellence Conference (CREC) 2024. A panel of experts shared their deep insights on the topic: Decentralised Clinical Trials or AI in Clinical Trials? The experts deliberated on how DCT methods can improve vaccine trials significantly by increasing the convenience and accessibility of clinical trial participants.

The panel consisted of Dr Arani Chatterjee, Joint President, Cadila Pharmaceuticals Ltd, Dr Subhash Thuluva, Senior VP and Head, Clinical Development and Pharmacovigilance, Biological E Ltd, Dr Vaibhav Salvi, Director and Head, Clinical Study Unit, India and South East Asia R&D, Clinical Sciences and Operations, Sanofi. The panel was moderated by Dr Shubhadeep Debabrata Sinha, Senior Vice President & Head (Global) – Clinical Development & Medical Affairs, Hetero Labs Limited.

Initiating the discussion, Dr Sinha, said, “DCTs have been the focus of much attention lately, especially when the FDA released a draft guidance in May 2023 that clarified their implementation and structure. DCTs, in contrast to conventional clinical trials, are patient-centred, employing nearby healthcare providers or the patient’s home for standard procedures and data gathering. With a focus on the needs of the patient, this strategy seeks to improve convenience and accessibility while also enhancing participant diversity and retention.”

Mentioning that DCTs are sometimes mistaken for fully digital trials, Dr Sinha pointed out that although digital health technologies make it easier for DCTs to collect data remotely, decentralisation is really about minimising the number of traditional clinical venues that participants must attend. This hybrid strategy provides a more adaptable and inclusive platform for doing clinical research by fusing local and digital approaches.”

Explaining the DCTs model, Dr Chatterjee said, “Decentralised methods can improve vaccine trials significantly by increasing convenience and accessibility of participants. These techniques lessen the need for frequent site visits, which is advantageous for trials including kids and those with limited mobility. These clinical trials reach a wider geographic audience by enabling participants to participate virtually, which guarantees a more varied and representative participant pool. In practice, we have used decentralised approaches in a few of our vaccine studies, and we have seen increases in trial efficiency overall, participant retention, and data collection efficiency. The eventual result of this strategy is more thorough and trustworthy trial results.”Elucidating that utilisation of cutting-edge techniques in DCTs provides a paradigm shift in speeding up the clinical development process, Dr Thuluva informed that prioritising the patient or subject experience, making participation simple, and creating a sense of purpose are all important components of DCTs. This is particularly important for vaccine trials, as recruiting healthy participants might be difficult.

Further, he added that adopting a patient-centric design and highlighting the wider social impact can increase participant motivation to participate in studies. Recruiting and retention are further improved by emphasising the contribution to humanity’s well-being in order to instil a sense of purpose.

“The use of digital tools in DCTs improves patient experience by enabling smooth communication, remote monitoring, and easier data collection, which in turn makes participation more approachable and interesting,” Dr Thuluva added.

Stating that the use of a patient-centric strategy is crucial, Dr Salvi cited that the revolutionary potential of decentralisation is highlighted by addressing diversity and inclusion concerns, such as making it easy for patients from rural areas to participate through direct-to-patient medicine transfers.

He highlighted that the use of AI technologies such as deep neural networks, computer-assisted drug design (CADD), and neurolinguistic programming models has revolutionised drug research and clinical operations at several levels. Even if the promise of AI-generated medications has encountered obstacles, ongoing clinical trials with AI-designed molecules suggest that the field is still being explored.

“Clinical research has achieved operational efficiency by eliminating the need for considerable on-site control using data-driven monitoring, predictive analytics for patient identification, and remote centralised monitoring. AI helps post-trial stages by cutting down on time for activities like pharmacovigilance, real-world evidence analysis, and submission preparation,” Dr Salvi stated.

Concluding the discussion, Dr Sinha spoke about the importance of following FDA guidelines, regarding the use of satellite or cluster sites in clinical trials. He emphasised the significance of specific components, including regular X-rays and local site involvement, in the documentation process, emphasising the necessity of appropriate training and confidentiality preservation. Stressing the critical role that patients play in clinical research and the importance of taking into account their circumstances and reasons for participating, he urged that patient-centricity and their well-being should be the core focus.

  • Published On May 17, 2024 at 05:27 PM IST

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