Enabling Oncology Site Success: Tackling the Barriers That Slow Cancer Research

Oncology clinical trials are becoming increasingly complex, placing new operational and administrative demands on both sponsors and research sites. Protocols are growing longer and more intricate, administrative work continues to pile up, technology systems often fail to communicate with one another, and many research sites are stretched thin, with staff balancing competing priorities across multiple studies. These pressures slow activation, make coordination harder, and, ultimately, delay the delivery of new therapies to patients.

In a recent Fierce Pharma webinar sponsored by Advarra and moderated by Christine Senn, Senior Vice President, Site-Sponsor Innovation, Advarra, leaders from Yale Cancer Center, the University of Chicago, AbbVie, and Takeda came together to discuss what it will take to overcome these challenges. Their discussion spanned key stages of the clinical trial process—from protocol design and feasibility through site activation and day-to-day operations—and explored the cultural and structural changes needed to make research more efficient. What emerged was a shared understanding: the future of oncology research will increasingly rely on study designs grounded in clinical reality, partnerships built on trust, open communication, and meaningful measures of progress.

Much of the burden sites experience downstream can be traced back to protocol design. Takeda’s Sean Cunningham, Regional Director, Americas, Study Site Engagement, stressed that the process must start with practicality. “We universally recognize that simply we have to make our clinical process easier to manage,” he said, emphasizing that sponsors need to be more deliberate about distinguishing the “must-haves” from the “nice-to-haves” when developing protocols.

The panelists agreed that designing a trial with feasibility in mind helps prevent many of the issues that can emerge later, including avoidable amendments, redundant data entry, or unrealistic visit requirements. If flexibility and efficiency are embedded in the design from the start, studies can adapt more easily when challenges inevitably arise.

While sound design lays the foundation, sustained improvement depends on how sponsors and sites work together in practice. Meredith Hightower, Director, Strategic Site Partnerships, Clinical Field Excellence, CSM, AbbVie, described how her organization has adopted a collaboration model built on continuous dialogue and feedback. “We’re listening to our sites, making sure we have a clear understanding of what’s working well, what’s not, and asking a question on every clinical trial: what do you need to be successful?”

AbbVie’s model includes detailed mapping of each partner site’s end-to-end processes to identify both inefficiencies and opportunities for improvement. Hightower explained: “We’re looking for areas of what I call ‘white space,’ meaning the site has process steps where they’ve done them consecutively in the past, but we can explore the opportunity to do them in parallel moving forward. We’re also looking for what I would call ‘red spaces,’, where have we experienced past challenges—and those, as an example, may be contract negotiation timelines or IRB delays. —We’re really focusing a lot of time and effort and support to find any and all operational optimization opportunities.”

The impact shows up in cycle times. As Hightower noted, “We’ve noticed that when we communicate and meet more frequently, we’re able to accelerate timelines pretty significantly.”

For Cunningham, strong partnerships begin with mindset. “For me, the cornerstones of any successful partnership are transparency and humility—transparency to say this is what we believe, this is what I believe I can bring to this partnership, and this is what I’m hoping to get. And then the humility to say we don’t have all the answers, this is what we need to be better together. We’re all in this together. It’s never sponsors versus sites versus CROs—it’s all of us against the diseases that we’re fighting.”

He shared a concrete example of aligning early with a partner site: “Through the course of our discussion, we discovered that one of our challenges is startup, but more specifically ICF review… We had them send us their required ICF language, we gave it to our ICF group, we worked on it, and we came up with sort of a master ICF for that particular partner. Now we’re ahead of the game.”

Taken together, these perspectives demonstrate that partnership grounded in trust, open communication, and shared accountability can drive faster activation, smoother execution, and more effective collaboration.

Sara Moellering, Director of Clinical Research Operations, University of Chicago, offered the site perspective on how structured collaboration with sponsors can transform trial operations. “When you regularly meet with a strategic partner, you can definitely identify which trials went through the study startup process well and which ones did not, and then really do a root-cause analysis for the trials that got hung up,” she said.

At the University of Chicago, that collaborative approach has led to several operational improvements, particularly in reducing repeated revisions to informed consent forms. Moellering noted: “We were doing multiple rounds with the informed consent form—it was a lot of word smithing missing issues. We were able to identify that as a roadblock to opening trials faster, so we worked with our partners to have agreed-upon language for some of the sections of the informed consent that are not trial specific but are more general.”

Protocol amendments have been another source of friction. “I will say protocol amendments, especially during startup, are particularly brutal and can really set back activation of the trial. So, either having better communication— ‘Hey, we expect to have a protocol amendment in 30 or 60 days’—would allow sites to better plan, or allowing sites to open under the original protocol version that they received would be helpful,” Moellering explained. “Something that our site has done is create a policy that says we will try to work to activate off the original protocol received, and then we’ll go back and do the amendment.”

Technology-enabled visibility, like task lists form Oncore, have also proven to be a powerful tool, Moellering added. “It’s been really helpful to visually see when you are on track and when you are off track, it allows you to reach out to your partners and say, ‘Hey, we still haven’t received the informed consent back in two weeks—where are we?’”

Her experience highlights a consistent theme across the conversation: strong alignment between sponsors and sites does not just make teams feel more connected—it helps to accelerate activation, minimize rework, and keep studies on schedule.

Throughout the discussion, communication emerged as the most consistent predictor of progress. Sara Raboin, Director of Operations, Yale Cancer Center, captured the sentiment succinctly: “The single most important thing to achieve alignment is communication.”

At Yale Cancer Center, Raboin and her team focus on identifying potential friction points early. “Bringing those conversations up at the beginning is critical, otherwise it’s going to hold up the informed consent and the budget,” she said. Even seemingly small operational decisions, such as how patient reimbursements are handled, can have a significant impact on workload.

Technology, several panelists noted, can be both a solution and a source of strain. “Each company may have three systems that they’re using, which are different from the next company, which are different from the next company, which are different from this academic partner, which are different from that academic partner,” Raboin explained. “While the purpose of technology is to make things more efficient, the reality is that it can become clunky and burdensome. Even larger initiatives across companies to share platforms failed because having the same system isn’t enough. You also need to implement it consistently with both sponsor and site workflows in mind.”



From the sponsor perspective, Cunningham added that Takeda is working to streamline those interactions: “We understand how challenging it can be for sites that have a lot of touch points at sponsors… So, on our end, it’s important to make sure we’re keeping all of those communications transparent across all of our teams. We now utilize a connected CRM [customer relationship management solution] so that, for example, if an MSL [medical science liaison] connects with the site, someone on the study operations team can see what that communication was. That way, we’re using technology to keep all of our ducks in a row on our side, before burdening the sites with multiple communications.”

Even with new tools to streamline communication, direct conversation is often the most effective way to resolve issues. As Raboin noted, “The best communication that we still have with our sponsors is picking up the phone and having a conversation when there’s an issue.”

Measuring progress, the panelists agreed, is essential, but it requires looking beyond speed alone. At AbbVie, Hightower said, to better understand where operational improvements are taking hold, teams track indicators across the trial lifecycle, including site selection time, activation and contract negotiation timelines, site satisfaction, and study adoption.

Cunningham added: “One of the things we look at is time to issue resolution and opportunities for early intervention. If we have a good relationship, are issues getting resolved more quickly.”

Meaningful measurement should capture not only efficiency but also the strength of collaboration and the quality of decision-making, indicators that show whether process improvements are actually reducing burden, not just moving work faster.

Progress, the panelists agreed, is not just about speeding up activation, but about making research sustainable for the people who conduct it and accessible for the patients who depend on it. When studies are designed with real-world clinical practice in mind, when sites and sponsors communicate transparently, and when performance is measured thoughtfully, research can advance more efficiently.

Watch the webinar, now available on demand, to hear the full discussion and learn more about Advarra’s Oncology Research Pulse, an initiative bringing research leaders together to advance collaboration and innovation in cancer research.