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Considerations for Working with Research-Naive vs. Experienced Sites

November 15th, 2018 | Article

When recruiting patients with hard-to-enroll indications, such as rare diseases, it is sometimes necessary to dip into creative resources for finding sites. Sometimes this means looking across the ocean, or sometimes there may be opportunities in your backyard. Some sites have a lot of experience, and those are generally sought after, but they can be busy running other trials and may not prioritize yours. It may be beneficial to include less experienced sites in order to have better chances of enrolling. But of course, there are some necessary considerations when turning to these sites.

Pros of using research-naïve sites

  • Depending on the method and amount of startup funding the investigator has, new sites may have newer equipment, which could be very beneficial if the trial relies on certain instruments for study assessments.
  • New sites may be running few to no other trials concurrently; other trials can compete for the same patient population, especially if the site physician or principal investigator (PI) is a specialist.
  • Some of the sites that are newer to research may be more gung-ho about getting involved in research, and motivating the study team to enroll may not be much of an issue at all.
  • New sites don’t have a track record of audit violations, and as such, they may be more inclined to carefully follow the rules and keep their record clean, especially if they believe they are under tighter scrutiny.

Cons of using research-naïve sites

  • Depending on the background of the PI, new sites may need lots of training. The vast amounts of training required for starting up sites may be overwhelming to the site staff, especially if they are still finding their rhythm. Sponsors need to select CRO partners who have a long history of training investigators, who are knowledgeable in both the therapeutic area and in training methodology, and who are proactive and urgent in other matters such as project planning or protocol amendment coordination.
  • New sites may not know for certain how many potential patients they can recruit, and they may be overzealous in estimating their enrollment rates during the feasibility process. One solution is to assume that their rate will be a little lower than expected, and anything higher than that will be a pleasant surprise.
  • Along the same lines as audit violations, new sites don’t yet have a track record of successes, either. It can feel risky to choose a site that has a shorter history to evaluate.

Other considerations

  • Just because a site is research-naïve doesn’t mean the PI is. When choosing a site, it’s important to look into the individual PI’s experience and audit records.
  • “New” sites may not actually be new; they may just be operating under a new name. Whether the name change was benign or not is not always clear, so some deeper digging may be required to find out if a name change was enacted to dispel a bad reputation.
  • At Biorasi, our project managers do not outright reject sites that have the patient population but lack adequate human resources to support the trial. If the patient population is proven available, we instead support such sites personally to build up their capacity so that they can successfully recruit the targeted patient population.

All sites were new at some point. Someone took a chance with them, and that chance has paid off in many instances. Having a mixture of experienced and not-so-experienced sites can also be beneficial in the same sense as diversifying financial assets is desirable, just in case there are certain characteristics that predict success that have not yet been identified. Careful monitoring is, of course, paramount to make sure that sites, old or new, are carefully recording trial data and handling adverse events.