Faced with the threat of a swing in the centre of gravity for global biopharma R&D towards China, the US has launched a concerted effort to "restore American leadership in clinical trials."
The HHS department has said it will introduce a series of measures – under the Operation Trailblazer (PDF) banner – to speed up drug research by reducing unnecessary delays to studies, increase participation in clinical research, and strengthen domestic research capacity.
The drive recognises that, while the US still retains a scientific edge in R&D – at least, according to the Cure Innovation Index survey just released at the BIO convention in San Diego – China is ahead in terms of the speed, scale, and cost of converting science into medicines, with its share of global clinical trial starts rising from 1% in 2009 to 32% last year.
HHS acknowledged in a statement on Operation Trailblazer that "a growing share of early-stage clinical research has moved overseas," adding that it is taking "decisive action to reverse that trend and make the US the preferred destination for clinical research and medical discovery."
Several of the agencies that come under HHS' remit are being given the task of implementing the initiative, including the FDA, NIH, and the Office of the National Coordinator for Health Information Technology (ONC).
The FDA is proposing to develop a pilot programme to make it quicker to run first-in-human clinical trials, along with measures to reduce early trial timelines by six to 12 months, and previously announced plans to allow medicines to be approved with one, rather than two, pivotal trials.
The NIH will strengthen its support for clinical trials in areas like AI, human cell-based models, and real-world data, developing practical tools for drug developers, while the ONC is tasked with exploring ways to better connect patients with clinical trials through electronic health records.
HHS also wants to build a network of qualified research institutions – with partnerships between academic institutions, healthcare systems, regulators, and industry – to speed up clinical research of promising therapeutic candidates.
"For this to be a success, the entire US research enterprise will need to do its part to streamline their processes," said the department. "HHS will continue working with industry, academic medical centres, contract research organisations, patient groups, healthcare providers, and other partners to identify barriers to clinical research and remove unnecessary obstacles that slow innovation."
Similar strategies to restore clinical research sectors have also been announced by the EU, the UK, and Japan, setting up what looks likely to become a fiercely competitive environment for study starts in the coming years.
https://pharmaphorum.com/news/hhs-details-plan-regain-uss-edge-clinical-trials
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