Making Clinical Trial Start-Up More Efficient

What can delay the start of a clinical trial?

Once a clinical trial protocol (plan) is approved internally, numerous steps must take place before the first participant can enroll. The study must be reviewed by an ethics committee, agreements must be finalized with participating hospitals, and medicines and other materials must be made available for the trial.

Clinical trial start-up is a complex process involving multiple stakeholders and requirements. During this phase, additional information, protocol updates, contractual arrangements, or operational activities may need to be completed, which can affect timelines. According to Watkins, overall timelines are often influenced by a combination of factors across the process.

How does the BeOne Australia/New Zealand team reduce clinical trial start up timelines?

Watkins and her team focus on identifying and addressing common sources of delay before they arise. For instance, they anticipate questions that may come up as the protocol moves through the review process.

“We know the type of questions that each of the committees or investigators commonly ask,” she says. Her team prepares by getting answers in advance. Because BeOne manages much of its clinical development through internal teams, the people responsible for the science, study operations, and local execution can collaborate directly. “The scientists and the clinicians that we work with are used to responding quickly,” she says.

The team also has measures in place to reduce unnecessary back and forth during contract negotiations.

According to Watkins, small steps like these add up. “Getting a document to us a day earlier could help avoid downstream delays,” Watkins says.

How are participant safety and data quality maintained when starting clinical trials more quickly?

Watkins and her team keep the purpose of clinical trials firmly in mind: evaluating experimental medicines in people while protecting participant safety and generating reliable data. “We maintain that level of responsibility and rigor,” she says.

She emphasizes that her team aims to remove waiting times, not safeguards. Study protocols continue to undergo independent review, and the processes that support participant safety, data quality, and regulatory compliance remain in place. “There are no shortcuts,” she says.

What factors support the Australia/New Zealand team as they work to reduce clinical trial timelines?

In addition to BeOne’s streamlined clinical development model, the ANZ team benefits from its experience navigating local regulatory requirements and its collaborative relationships with hospitals and investigators.

Australia is recognized as a competitive location for clinical trials, supported by efficient regulatory pathways and ethics approvals, experienced investigators and strong research infrastructure.^1,2 Several of BeOne’s earliest experimental compounds entered clinical development in Australia between 2013 and 2015. Since then, the ANZ team has continued to play an important role in Phase 1 studies, generating data that can inform decisions about later stages of global clinical development. “Data from these early-phase studies can inform decisions about later stages of global clinical development,” Watkins says.

What still needs to be done?

While Watkins and her team continue looking for ways to move these studies forward more efficiently, she sees another important opportunity: expanding research participation and capability.

“What’s next, in my mind, is how we expand opportunities for more eligible patients to participate in clinical trials, in Australia, New Zealand and around the world,” she says.

More can be done to increase awareness of clinical trials, she says. “Imagine what can be done if people with limited alternatives for treatment discussed clinical trial opportunities with a treating doctor.”