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Role of Decentralized Trials for Newer Drug Approvals

Decentralized clinical trials (DCTs) are an innovative approach to conducting clinical research where aspects of the trial are carried out remotely, allowing patients to participate from their homes or local healthcare facilities. DCTs offer several advantages over traditional trials, including increased patient participation and diversity, improved convenience and flexibility for patients, and faster, more efficient trial execution. They have been particularly valuable during the COVID-19 pandemic by enabling the continuation of clinical research while minimizing the risk of exposure to the virus. Health authorities, such as the FDA and EMA, generally support the use of DCTs but emphasize the importance of addressing regulatory compliance and potential challenges associated with remote trial conduct.

In the Indian context, the Central Drugs Standard Control Organization (CDSCO) has recognized the potential benefits of DCTs and has been supportive of their use. CDSCO issued guidance during the pandemic, acknowledging the effectiveness of DCTs in continuing clinical research while mitigating risks. The organization has also taken steps to facilitate the use of technology in clinical trials, such as allowing electronic submissions and establishing an online platform for trial applications. DCTs conducted in India have demonstrated their feasibility and benefits, particularly in response to the pandemic, where alternative approaches to trial conduct were needed. However, challenges related to regulatory oversight, technological barriers, and the lack of face-to-face interaction must be carefully addressed in the design and implementation of DCTs for new drug approvals.

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Ram Prasanna, Director, HEOR & RWE
Ram Prasanna
Director, HEOR & RWE

Ram has over 15 years’ experience in health care domain with hands on experience in executing market research projects, evidence synthesis, observational studies, data analytics, real world evidence and assisting health economic project execution…