Clinical research environments are understaffed and overburdened, meaning clinical trials must compete fiercely for limited site bandwidth and patient populations. Sponsors who strategically design and position their studies will have a competitive edge in engaging saturated sites.
It begins with carefully strategizing study protocols. Aligning your study with the appropriate site and patient population enhances relevance, making your protocol far more appealing. Given that most sites place a cap on the number of new/ongoing studies that they participate in, ensuring appropriate scientific appeal and specificity in your study design can effectively attract the sites and Principal Investigators (PI) of interest. Summarizing compelling preclinical data and emphasizing your study’s unique design benefits can also be beneficial, a smaller study, for example, may not include a placebo arm, which can be an attractive prospect for both sites and potential participants.
Effective communication is key for relationship-building
With the heightened level of competition for both sites and patients within the broader umbrella of clinical research, direct communication is not only essential, but it can also become a deal-breaker if not navigated correctly.
- Direct emails from sponsors highlighting key study differentiators and presenting compelling data can go a long way in securing site and PI engagement.
- Adding a personal touch with physician-to-physician interaction helps build rapport, bridging the gap between a statistical data point and the real-world patient experience.
- Maintaining consistent, transparent communication about relevant interim study results further fosters a sense of partnership.
It is important to continually review and evolve site level communication strategies based on a site’s preferred ‘currency’, be it their unique patient population or enrollment goals, both of which foster a mutually beneficial relationship.
The Feasibility and Qualification Process: To Skip or Not to Skip
When startup and first patient in (FPI) timelines are on the critical path, sidestepping the site feasibility and/or qualification process may seem like an attractive shortcut. However, implementing this strategy may come with some unforeseen complications.
In balancing a fast-track selection to jump-start the regulatory review process, it is important to also consider future site level challenges that may arise due to missed upfront discussions and qualifications. Weighing such factors against your study’s unique needs can better inform the necessary decisions related to this critical step.
Elevating Site Support: The Power of Numbers
Overburdened sites may welcome assistance from third-party vendors to streamline tasks such as patient screening and data entry. In offering this additional level of support as a sponsor, you not only assist in alleviating some of the workload burden at the site, but also highlight your commitment to a successful partnership. These offers of assistance can be managed on a site by site basis to ensure integration with their own processes and ease of use.
- Tip: By leveraging your personal experience and/or knowledge of site processes you can be more proactive in risk management, ultimately leading to an increasingly efficient study operation.
Site Level Partnerships: Leveraging Relationships
A solid partnership with recently engaged sites sets the stage for a successful clinical trial. Our Precision Site Network (PSN), for instance, is built on the foundation of recent and direct site experience for oncology and rare disease indications.
- Tip: To minimize startup timelines and ensure site interest within a specific therapeutic area, it is critical to capitalize on pre-existing PI associations and historical site performance.
Thinking Outside the Box: Community Oncology Practices
One additional strategy for identifying a suitable site that could be perfect for your study is to expand our horizons beyond traditional academic institutions and engage community oncology practices. This broader approach to proper site and patient identification encourages the development of new relationships and taps into potentially undersaturated patient geographies.
- Tip: By leveraging a combination of academic and community sites in your clinical trial, we can both expand access to the study and include communities with the appropriate targeted patient populations.
Rewarding High Performing Sites: Sing Their Praises Often
Recognizing and rewarding high-performing sites encourages continued excellence and fosters a sense of community within the study. Prominently acknowledging efforts across study communications keeps sites feeling valued and motivated.
- Tip: Ensure to include accolades and shoutouts in the monthly newsletters or weekly investigator calls as these go a long way in maintaining motivation for patient enrollment.
Key takeaways
Engaging in-demand sites requires strategic planning, proactive communication, and solid partnerships. From understanding the particular needs of a site to streamlining their workload with tailored support, a targeted approach can elevate your study, making it a contender in this competitive arena.
Implementing unique strategies, such as exploring non-traditional clinical environments and emphasizing your study’s unique design benefits, can also provide a unique advantage over competing trials. Further, fostering strong partnerships with sites by engaging them with timely updates and recognitions can enhance the potential for successful study outcomes. Personal interaction, customized support, and effective communication form the bedrock of successful site engagement and relationship building.
