Redefining Clinical Oncology Trials: How Agile Site Networks Accelerate Novel Cancer Therapies

1. Selective site relationships. A network that cultivates genuine rapport and partnership with its sites — instead of a more transactional business relationship — can often accelerate processes due to its in-depth site knowledge. For example, a deep understanding of a site’s capabilities will expedite the feasibility study or pre-study site visit (PSSV). Rather than taking a week to compile the required information, the necessary details might already be on file and available through a single email. By extension, such relationships also make it easier for sponsors and CROs to operate.      

Repeated use of the network typically leads to more open and transparent communication between all parties, which is crucial. To evaluate how a network nurtures its site relationships, ask about ongoing communication methods and feedback loops. Do hundreds of sites meet for a monthly or quarterly team call? Or do smaller teams meet consistently to discuss current and upcoming studies at a deeper level of detail? How are sites publicly recognized and appreciated for their efforts? Ongoing communication before, during, and after studies helps to ensure site participation and more enthusiastic engagement in both current and future research.   

In addition, review the network’s attempts to alleviate site and patient burdens. Embedding dedicated, oncology-fluent, and trusted clinical research associates (CRAs) at sites is one way to generate efficiencies across multiple studies, for instance. Regular site visits will also be used to understand and proactively address sites’ study stresses — such as the bottlenecks that often occur in oncology studies around pharmacy, medical imaging, and lab services. With supportive and transparent relationships in place, sites are more likely to actively engage in the trials they accept. 

2. Strategically blended site array. The “right” site networks are highly dependent on each study’s goals and will therefore vary from study to study. Although large academic institutions with leading researchers may be desirable sites — especially for some rare oncology indications — they often come with slower setup processes and already overburdened clinicians and staff. Conversely, smaller sites that are less experienced with oncology trials may be highly motivated and capable of enrolling an untapped patient population quickly. Geography plays a role, too, in access to medications, costs, and patient diversity. The best networks usually comprise a strategic blend of sites that aligns with the study protocol. 

Once again, site intelligence is an essential part of confirming that a network’s site array aligns with a sponsor’s study priorities. Sites must be able to accommodate the phase of research (i.e., early- vs. late-phase studies) and tumor type being examined. Is the site already conducting other trials — and if so, are they complementary? For example, are the patients who are ruled out of another study at the site perfect candidates for your trial? It can be said that clinically high-performing sites are those that build a balanced study portfolio, providing treatment options for as many of their patients as possible.  

Using scenario modeling and site-specific knowledge and data, sponsors and CROs should work with the protocol to pressure-test various blends of public, private, large, and small sites across different geographies to optimize speed, cost, and outcomes.

3. Deep team expertise. It’s often advantageous for an oncology study to involve one or two leading clinical experts. However, top-name researchers may be involved in multiple trials simultaneously. In studies that involve community-based sites that are more experienced in chronic disease research, an outside expert may act as Lead Investigator while a generalist looks after daily patient needs.   

The goal, of course, is to find experienced research teams that are fully committed to the study at hand. With strong network relationships, experienced PIs and other team members may be willing to offer insights to strengthen protocol development. 

Sponsors should also ask about the experience of the whole research team (not just the PI), including research nurses and junior clinicians. Have they performed similar studies before? Do junior clinicians know the signs/symptoms of cytokine release syndrome or other potentially critical adverse events? Transparency is a “must.” Sites should be “anytime accessible” by email, phone, etc., and PIs should be directly accessible; any gatekeepers should be considered a red flag. 

4. Site-sensitive operational efficiencies. When evaluating a site network’s operational efficiencies, data should be paramount. Look for a track record of sites willing to share metrics captured from past studies, such as speed to enrollment, percentage of data entered within 48 hours, and speed to data lock. 

In addition, be sure to consider how operational efficiencies could ease site and patient burdens. For example, master contracts and CDAs can reduce paperwork for sites — especially during multiple or subsequent trials — as well as speed up timelines for sponsors.  Minimizing administrative work (including ongoing management processes like streamlining invoicing and payment procedures) and offering a single point of contact to facilitate communication help to ensure that sites can remain focused on their priority — their patients.