• The effort is designed to nix barriers, reduce costs and help effective treatments reach patients sooner.
• An Oct. 15 webinar will allow stakeholders to offer ideas to help achieve program goals.

HHS launched a multi-component effort intended to improve the speed and efficiency with which clinical trials are conducted.

The series of initiatives is designed to eliminate duplication, ensure more efficient enrollment and provide patients with earlier access to promising therapies.

“The goal is straightforward — generate rigorous evidence faster, reduce unnecessary costs and burdens, and make the United States the best place in the world to engage in clinical trial research,” HHS Secretary Robert F. Kennedy Jr. said during a launch event held at UT Dell Medical Center in Texas.

Clinical development for drugs and biologics in the U.S. can take a decade and cost up to $2 billion, but 90% of drugs that start the process ultimately fail, Kennedy said.

The system “takes far too long, costs too much and asks too much of patients,” he said, adding that a more efficient approach is necessary to ensure the U.S. research enterprise can compete with other countries.

“We want to move from a system built around disconnected trials, repetitive processes and fragmented data to one built around reusable infrastructure, secure information, adaptive research, wider patient access and easier patient recruitment.”

The reforms fall under an umbrella program called SURPASS, the core objectives of which are to build continuous adaptive-platform trials that incorporate predictive computational models, shared trial infrastructure, common control groups and real-time analysis.

The program will aim to:

• integrate digital twins and other predictive models into trial design to simulate outcomes prior to launch and develop evidence necessary to support regulatory confidence in this effort;
• enable real-time or on-demand analysis that can support rapid trial adaptation and minimize the need for large conventional control groups; and
• create what HHS calls an “agentic operations layer” to reduce costs and time through several strategies, such as automating important trial start-up and accelerating data collection.

“Instead of treating every trial like an isolated project, SURPASS will ... help researchers identify ineffective or unsafe therapies much earlier, concentrate resources on treatments that show promise, and reduce the time and number of participants that is required to reach a reliable, dependable conclusion,” Kennedy said.

The Advanced Research Projects Agency for Health (ARPA-H) — an agency the Biden administration created within HHS to drive high-impact biomedical and health breakthroughs — will seek ideas from leaders in clinical trial design, operations and regulation, as well as those with expertise in AI and statistics, to help achieve program goals.

An informational webinar will be held Oct. 15.

Federal officials also outlined three other separate but complementary initiatives intended to address infrastructure challenges — branded as STACK, COMMONS and CINCH — that extend beyond clinical trial design.

STACK aims to incorporate AI to accelerate trial site activation and help research-naive sites become capable of conducting studies, with the goal of helping more patients access research closer to home.

COMMONS will focus on improving infrastructure for connecting and sharing health data nationwide, relying on a privacy-by-design framework to establish research-ready databases.

CINCH aims to help patients contribute their own real-world data — often spread across multiple institutions — to support care continuity and coordination and make it easier to identify trials that may be appropriate for them.

Together, these efforts could shorten the clinical trial timeline from a decade to 4 years or less, according to SURPASS program manager Daria Fedyukina, PhD.

“Why do we have to build clinical trial infrastructure every time we do a trial and then dismantle it completely without reusing it for another trial?” Fedyukina said during the launch event. “Why do we have to enroll patients in placebo or control arms even in situations when we already have enough data accumulated to learn from it? Why do we need to wait to complete a trial when, in the middle of a trial, we have already discovered if a treatment is working? We really can do much better.”

During a panel discussion that followed the unveiling of SURPASS and the complementary initiatives, Nilay Shah, PhD, chief strategy officer at UT Dell Medical School, outlined multiple hurdles in clinical trial design and conduct that SURPASS and the complementary efforts could help address.

“One of the challenges [these initiatives] are trying to solve is how do we get to activation quicker,” Shah said. “That is a really important piece because each trial, over and over, requires the same infrastructure — especially from the health care system side. They’re spending a lot of resources to activate each trial.

“The second piece is, how do you enable better enrollment?” Shah added. “How do you take trials to the community, leverage community health workers and other approaches to bring trials to people instead of waiting for them to come to a large health system or academic medical center where the trial might be running?”

Over the past decade, more drug developers have been moving early-stage trials overseas “to escape the regulatory and administrative friction of an outdated system here at home,” acting FDA Commissioner Kyle Diamantas said during the event.

SURPASS and the other complementary initiatives are an important step toward establishing a clinical trials ecosystem that is “fast, adaptive and proudly anchored to the United States,” Diamantas said.

“When trials move across the globe, it is more challenging for FDA to verify that the data from those trials are reliable,” Diamantas said. “Modernizing regulatory science is not about cutting corners on safety. ... What it does mean is using gold-standard science and the tools available to work smarter, cutting out any steps that add delay without adding protection, and give innovators a clear path to bring safe and effective treatments to the Americans waiting for them.”