Abstract:

Decentralized clinical trials (DCTs) use technology and knowledge advancements to conduct clinical trials or trials of specific activities when compared to the traditional trial location. During the pandemic and currently, the use of DCTs has been widely implemented globally. Despite the global momentum, their adoption in India remains restricted. The purpose of this study is to evaluate the awareness and understanding of the DCTS and to assess perceived benefits and barriers among clinical research professionals in India with respect to their adoption and implementation. A questionnaire with a cross-sectional approach has been developed using Google forms and was distributed to clinical research professionals across India; 112 clinical researcher’s responses were received. We evaluated the responses using descriptive statistics and thematic analysis. The result indicates a high level of awareness (70.5%), while 28.6% are ‘somewhat familiar’ with DCTs among clinical researchers in India. Most respondents, around 72%, have previously participated in the conduct of DCTs and possess hands-on experience in managing such trials. Hybrid trial design was more prevalent in most therapeutic areas compared to traditional and fully decentralized trials. Most respondents perceived that the key benefits of decentralized clinical trials (DCTs) included improved access to a diverse patient pool and faster data collection and analysis, which were noted by 77.7% of respondents, as well as enhanced compliance and satisfaction among patients, reported by 76.8%. Major barriers identified included lack of technological infrastructure (84.8%), data privacy concerns (84.8%), and regulatory uncertainty (76.8%). While DCTs have advantages, regulatory uncertainties and infrastructure challenges remain barriers for their widespread adoption and implementation in India. We need targeted strategies in digital infrastructure, regulatory reforms, capacity building, and stakeholder engagement to address these challenges and facilitate broader adoption.

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