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Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges

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Abstract

Decentralised clinical trials (DCTs) encompass various terms such as virtual, home-based, remote and siteless trials. The objectives of DCTs are to enhance the ease of participation for patients in clinical trials by minimising or removing the necessity for trial subjects to travel to the trial sites. This approach has been shown to reduce drop-out rates, increase study effectiveness and ultimately get life-altering drugs to market faster—saving sponsors billions. At the outset, DCTs deploy a wide range of digital technologies to collect safety and efficacy data from study participants, providing study treatments and performing investigations from the comfort of the patient’s own home. The aim of decentralised trials includes patient centricity, enhanced efficacy in clinical trial conduct and generating real-world data. This is done by not only making it convenient for the patient to participate in the trial execution, but also involving them from the planning stage and taking their inputs during designing of trials and consenting documentation, understanding their treatment requirements and designing the studies accordingly. Various regulatory authorities have published guidelines governing DCT principles, especially after the coronavirus disease 2019 (COVID-19) experience of undertaking multicentric clinical trials. Both United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) have newer, recently updated guidelines to capture this growing reality to undertake clinical trials using patient technology or patient-centric technologies. Other regulatory agencies are accepting data generated using decentralised and patient-centric technologies and making an effort to include elements of decentralised trials in their regulatory guidelines. Decentralised trials follow a hybrid approach to have a balanced mix of remote and in-person data collection and trial procedures. Decentralised and patient-centric approaches are the future of any organisation for the conduct of clinical trials. Globally, all sponsor pharmaceutical companies must start undertaking drug development and clinical trials using a decentralised approach while keeping patient centricity in mind.

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Authors and Affiliations

  1. Department of Clinical Development and Medical Affairs, Hetero Labs Limited, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, 500018, India

    Shubhadeep D. Sinha, Sreenivasa Chary Sriramadasu, Ruby Raphael & Sudeshna Roy

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S.D.S. contributed with manuscript design, writing and data collection. R.R. and S.C.S. contributed with revision, editing and re-writing of the manuscript. S.R. contributed with review, copyediting and data verification of the manuscript.

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Sinha, S.D., Chary Sriramadasu, S., Raphael, R. et al. Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges. Pharm Med 38, 109–120 (2024). https://doi.org/10.1007/s40290-024-00518-x

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