A well-planned site selection process is essential for the smooth execution of your clinical study. How do you choose the best sites considering all the choices available? Do you need a key opinion leader (KOL) as your national principal investigator? Some sites are large and have prestigious reputations, and others are smaller yet more efficient and cost-effective. Some have better access to patients, some are more committed to robust follow-up, and all of them deal with staffing challenges. Like most things in life, balance is key. Read on as we discuss five tips to help you select a well-balanced set of clinical sites.
Study Leadership: KOLs vs. Up-And-Comers
You’ve no doubt heard an impassioned presentation from a study investigator about the latest study results and thought, “That’s exactly who we need to lead our study!” It’s certainly beneficial to obtain experienced investigator input on your study endpoints, eligibility criteria, and study strategy; however, remember that you may not be the only sponsor jockeying for position with these influencers. In fact, KOLs and their support staff are often juggling multiple institutional commitments and other, sometimes competing, research.
Instead of trying to finagle your way onto a KOL’s already full dance card, consider engaging with up-and-coming investigators who are dedicated, hardworking, and interested in your study. This match-up can lead to great results for all parties involved and, who knows, that up-and-coming investigator may become the next big KOL, in part thanks to your study.
Contract Negotiations: Bureaucracy vs. Efficiency
While there may be some benefit to include large, prestigious sites in your study, in our experience, it is usually easier and faster to negotiate study contracts and budgets with smaller sites that have a less bureaucratic infrastructure and no (or at least fewer) lengthy contract requirements. This allows for faster essential document collection, site activation, subject screening, and enrollment. Therefore, we advise including an optimal balance of these smaller, more efficient sites to get your study rolling while the wheels churn more slowly to get the larger sites activated.
How will you know which sites are more efficient? Nothing personal against them, but it’s simply a fact that academic sites involve more bureaucracy. For any type of site, pay attention to how responsive they are during your initial interactions, such as signing and returning nondisclosure agreements. Ask about their policies on reviewing draft documents and whether they are willing to work in parallel with other entities that need to approve the study (e.g., finance, legal, institutional review board (IRB)).
Speaking of IRB review, the timeline for sites to obtain review and approval from their local IRB is dependent on how full their docket is and how often their IRB meets. Pay attention to this information, as it could add a month or more to your schedule. Consider sites that can use a central IRB to expedite the review timeline; this can streamline overall study start-up because central IRB approvals are applicable to multiple sites.
Budgets: The Price of Prestige vs. Cost Efficiencies
As you conduct your site selection surveys, obtain information about the institution’s overhead and start-up fees. The prestige associated with larger commercial and academic sites comes with a price; in our experience, it will likely cost up to 20% more for overhead and start-up fees. How many of those sites can your budget support? We encourage you to seek a balanced mix of the pricier prestigious sites with smaller, more efficient sites that have straight-forward budget negotiations with lower overhead and start-up fees.
As mentioned above, the use of central IRBs saves time, and it can also save money. While sponsors pay a per-site fee using a central IRB, that fee is typically lower than those charged by local IRBs. Another important element of the budget is monitoring fees. Ask your potential sites if they will allow for remote monitoring via secure access to their electronic medical records.
Patient Logistics: Referral Networks & Commitment to Follow-Up
If your selected sites don’t have access to eligible patients and capability to follow subjects through the appropriate timepoints, even a perfectly designed study means nuthin’. While it may seem intuitive that larger sites located in densely populated areas would have an advantage over smaller regional centers when it comes to patient access, that’s not always the case. Major metropolitan sites often have several other large sites competing for the same patients. We’ve found great success working with regional centers that have broad referral networks drawing from large patient populations in surrounding areas.
In addition to patient recruitment capability, ensure your sites are committed to keeping subjects engaged and involved throughout the study duration; this commitment to thorough follow-up is especially essential for long-term studies. Ask them about their experience in this area and what tactics they use to ensure diligent patient engagement and follow-up. For example, is the site willing to provide:
- Metrics on recent similar studies (e.g., rates of subject completion, withdrawal, lost-to-follow-up)?
- A recruitment and retention plan that identifies methods the site will use to recruit subjects, maintain engagement during the study, and mitigate the most common reasons for study discontinuation or low subject compliance?
- A dedicated staff member responsible for subject recruitment and retention?
- Active PI leadership and established practices to routinely communicate study status with site staff members (e.g., meetings, email updates)?
Adequate Staffing: A Balancing Act for All Sites
Consider the staffing resources available at each of your potential sites. Adequate staffing is a balancing act that large and small sites deal with. Larger sites may employ well-respected researchers, but they may also need to support several high-profile studies. They might struggle with turnover when principal investigators, sub-investigators, and research coordinators leave to pursue academic endeavors, or when research fellows move on to permanent assignments.
Smaller sites are less likely to have multiple studies competing for your study team’s attention; however, personnel changes may be more difficult to address in more remote geographies that have fewer job pool candidates. Regardless of site or staff size, robust communication skills are key to build excitement, heighten engagement, and drive execution of your study. For more tips on this topic, be sure to read our blog post about Developing Strong Relationships in Clinical Research.
While some may think that using large, prestigious clinical sites is the only way to get their study accomplished, we disagree. In fact, we believe a strategic balance of large and small clinical sites has been one of the keys to our success at BRIGHT. We hope these five tips will help you establish a well-balanced set of sites for your clinical study.