“The ubiquity digital technologies is evidently growing, as these (including but not limited to ingestible devices, sensors, and wearable health monitors) hold the potential to disrupt the aspects of clinical trials. Digital technologies are revolutionizing the antiquated process of new drug development, even as optimizing the way health data is collected, measured, and assessed”.

According to the study, the clinical trials landscape is witnessing a paradigm shift toward patient centricity, in a bid to incorporate perspective of patients during the clinical trial design. Clinical trial sponsors have aligned their methods with the voice of patients, by launching communication channels during the study’s execution. Key enterprises are adopting unconventional approaches by implementing site-centric method, using operational support systems and technology for bringing studies to the trial-naïve physicians.

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Industry Sponsors Account for Majority Clinical Trial Spending

The most remarkable advances in medicine are realized from sponsorships of companies for clinical trials, in the anticipation of turning a profit. A notable percentage of clinical trials being conducted to support approval of vaccines, devices, or drugs, and track their safety, have been industry-sponsored in recent years.

The study estimates industry-sponsored clinical trials to account for ~60% of overall spending in 2019, and in the foreseeable future. Recent studies state that industry-sponsored trials yield positive results compared to academic-run trials, which also account for a significant share of clinical trial spending.

According to FMI, sponsors, such as academic institutes, research institutes and medical centers, are estimated to account for ~30% clinical trial spending in 2019. As the imperativeness of evidence-based therapies continue to be progressively emphasized, most of the randomized clinical trials are driven by the ability of developing profitable new therapies. Guidelines recommended by regulatory bodies for clinical trial enrichment, and risk-based monitoring are likely to lay the groundwork for more targeted approach toward cost-intensive clinical trials.

The study opines that North America and Europe will continue to lead the clinical trials landscape, collectively accounting for ~80% of global spending. These regions present a standardized and favorable environment for the clinical trials landscape, in light of their economic vigor that enables them to benefit from most of the technology disruptions prior to other nations. Pharmaceutical and medical device giants in these two regions are adopting AI for disrupting every stage of the clinical trial, which range from linking studies to eligible patients, to data collection and adherence.

According to the study, opportunities abound for conducting clinical trials in developing economies, such as in East Asia and South Asia, owing to the access to huge patient pool. Sponsors are likely to realize greater success in these regions as low government healthcare budgets represent cost-effective methods of providing patients with access to innovative therapies. Additionally, conducting clinical trials in these regions comes with other broader advantages, including pragmatic & efficient regulatory pathway, and tax incentives for conducting the trials.