When Great Research Ideas Stall, Clinical Research Hub Helps Move Them Forward

Faster Starts

Contract negotiations are often one of the longest delays in launching a clinical study.

According to Marco Perez, MD, medical director of Stanford’s Clinical Coordinating Center, contract negotiations alone often take six to nine months before a study can begin. That timeline is common across academic medicine and can delay research long before the first participant enrolls.

A recent collaboration with Apple showed what can happen when those barriers are reduced.

The project built on Stanford’s relationship with Apple, which began with the Apple Heart Study. That landmark study enrolled more than 400,000 participants and helped validate the Apple Watch’s ability to detect atrial fibrillation. Years later, when Stanford and Apple began planning a new study, both organizations agreed to prioritize the effort. 

Perez says dedicated startup, legal, and operational teams worked directly with one another to resolve questions and move negotiations forward. Rather than waiting weeks for responses to move back and forth between organizations, both sides maintained direct lines of communication and focused resources on the project.

The result was a fully executed contract in roughly six weeks. “This timeline is practically unheard of for a study of that scale,” Menendez reflects. The experience is now helping inform a new startup process that CRH hopes to apply to future research partnerships, he adds.

Expanding Access

Not every request that reaches CRH involves a clinical trial.

The team has helped clinicians pursue something called “compassionate-use requests” for patients who have exhausted available treatment options. These requests seek FDA permission to use experimental drugs or devices that have not yet been approved for a particular condition.

“These are often situations where there are no good alternatives left,” Perez says.

Menendez says CRH has supported several compassionate-use requests during the past year. The process requires extensive paperwork, regulatory expertise, and direct communication with federal regulators. CRH staff help prepare submissions, coordinate documentation, and work directly with the FDA to move requests forward.

The work falls outside traditional clinical research. Menendez describes it as a way to use the team’s expertise to help clinicians navigate a complex process while providing patients access to potential treatments that otherwise might not be available.

The Clinical Research Hub team works behind the scenes to help investigators move promising studies forward.

Making Research Possible

Clinical trials can be daunting, even for experienced investigators.

Perez says researchers often have the scientific expertise needed to pursue important questions but lack the infrastructure required to launch and manage a complex study. Rather than taking over a project, Perez says, CRH serves as a partner in the process, helping investigators map what is needed and connect them with the expertise required to move forward.

“A lot of academics don’t realize they can run clinical trials,” Perez says. “That’s exactly what we do. We help them get started.”

He points to a researcher with a successful career in epidemiology who was approached by a sponsor about leading a major clinical trial. Although the investigator had never conducted a clinical trial, CRH was able to provide startup expertise, regulatory support, and operational leadership needed to launch the study.

Perez says the same support can benefit seasoned investigators managing increasingly complex projects. The goal, he says, is to allow researchers to focus on the science and patient care while CRH helps navigate the operational demands of running a study.

Menendez says he regularly encounters investigators who describe studies they never pursued because the process seemed too complicated or burdensome. Those conversations, he says, are exactly why CRH exists: to give investigators a place to start, a team to call, and a path forward.

“You could have just asked me,” he says.