The clinical research plays a critical role in developing novel treatments and improving healthcare access especially in a nation like India where the population is distributed across urban and rural regions. The traditional clinical trials have been the foundation for evaluating the safety and efficacy of new therapies. However, due to evolving patient expectations, and rapid advancements in digital technologies there is a shift toward Decentralized Clinical Trials (DCTs). The DCTs utilize components such as remote patient monitoring, telemedicine platforms, electronic informed consent and mobile health applications to enhance patient engagement and also streamline data collection. Therefore, these advancements have the potential to make research more patient-centric and also improve trial efficiency. Several pharmaceutical companies like StriderDCT and Karkinos Healthcare, along with bodies like ICMR, are recognizing and adopting early DCTs in India due to its promising results. Despite this, there are challenges such as digital divide, lack of trained personnel to manage DCT workflows creating operational hurdles. Moreover, regulatory framework such as New Drugs and Clinical Trial Rules, 2019 currently lack provisions for e-consent and DCT processes which limits large scale implementation. This presentation addresses these challenges by proposing actionable strategies such as investment in digital infrastructure, development of training programs for research personnel, and amendments to existing regulatory framework to facilitate the widespread adoption of DCTs in India. Also, the 2024 draft guidance from the United States Food and Drug Administration provides a useful framework for DCT that can be adapted to India's healthcare system. Thus, by addressing both operational and regulatory hurdles, the widespread implementation of DCTs can be achievable resulting in expanded patient access to clinical research and improved health outcomes across diverse population.
Keywords: Decentralized Clinical Trials, Clinical Research, e-consent, Telemedicine, Remote Monitoring