Nailing the First Impression: How to Wow Sponsors at Site Evaluation Visits
Sponsors want to get more out of a site evaluation visit than a checklist of the site’s capabilities; they want a sense of the site’s enthusiasm for the trial and an understanding of its goals, according to one experienced CRA.
Even though demand for trial starts is outpacing the number of sites available to conduct the trials, sponsors still are looking for the sites most likely to perform well. So, sites need to bring their A game, selecting their best communicators and making sure they have all the information needed to show a sponsor that the trial is safe in the site’s hands.
Sponsors are especially impressed by a site that has a strong grasp of the protocol in question, Elizabeth Weeks-Rowe, a CRA, clinical research trainer and veteran site evaluator, told attendees at the Association of Clinical Research Professionals annual conference last week.
Sites won’t be expected to be intimately familiar with the entire protocol or even the full synopsis before a visit, Weeks-Rowe said, but a thorough review of the synopsis and endpoints will help them understand the trial’s logistical, personnel and equipment needs, and have productive discussions with sponsors.
“Having an understanding of endpoints and inclusion/exclusion highlights is something we would need to see so each side can have a transparent, productive information exchange,” she told CenterWatch Weekly. “A sponsor would be very impressed if a site knew a protocol well. It demonstrates consideration, enthusiasm and preparedness — all positive attributes of a successful site.”
Assigning the appropriate person to lead evaluation visits is key to impressing sponsors, Weeks-Rowe stressed. Effectively communicating a site’s capabilities and interest in a trial ultimately comes down to the behavior of the site rep(s), the industry veteran said.
The person (or persons in the case of a large medical center or academic health institute) the site selects to lead the visit should consider the “presentation is everything” mantra.
Reviewing the protocol will help the site rep understand not only the trial’s goals but the resources the site will need to bring to the table. The rep should confirm that the site’s equipment is fit for purpose and make sure he or she has input from all departments to ensure the site can give the sponsor a clear picture of its capabilities and adequate information for effective discussions.
Sponsors also appreciate sites that think outside the box and push for solutions when they don’t meet certain trial criteria, Weeks-Rowe said. Not having a specific capability required for the trial doesn’t need to be the end of the site’s chances, she said.
In one case, a site was actually selected by a sponsor based on its response to an equipment question. Although the site rep informed the sponsor it did not have the refrigerated centrifuge required, the rep expressed great interest in the trial and asked if the sponsor could provide one or if the site could budget to rent one. This forward thinking got them the centrifuge and the trial.
While it may be fairly obvious that site reps should have a good understanding of their sites’ clinical and logistical capabilities, this isn’t always the case, she cautioned. On occasion, Weeks-Rowe has run into site visit hosts who were strong, charismatic communicators but didn’t have a solid understanding of critical logistical points, leaving her with an unclear picture of the site itself. This could be a deciding factor in whether a site is selected. Reps don’t need to be the principal investigator (PI) or a decades-long employee, but they do need to have a strong understanding of the site model and its unique infrastructure, policies and research staff, or the support of someone who does.
“I’ve seen staff who were wonderful during prestudy visits, but they didn’t have particularly good engagement and interpersonal skills, so it was not clear to me there was a desire to even participate in the study,” she said. “I’ve also worked with and had business development people host a visit. They can sell sand to camels, however, sometimes they’re not equipped with the clinical information required to answer questions.”
A good site rep should make sure his or her knowledge gaps are filled or backed up by another staff member and prepare all site evaluation visit participants by providing them with an agenda, the trial protocol and slides, and coaching site staff on their interaction with the sponsor. Though this may seem like common sense, Weeks-Rowe said, previsit prep is an area that often is overlooked.
Repeat visits can be requested by sponsors and sites can cut down on that possibility by developing an information sheet ahead of time that gives the basic details about the site’s processes — regulatory approval, contract and budget timelines and requirements, clinical personnel and PI experience — that can be used for all sponsor visits.
Enough information is usually obtained during the site feasibility assessment process, which precedes site evaluation visits, to give sponsors a good working framework of the site’s capabilities. That means the actual site visit, especially in cases where the sponsor has worked with the site on other trials, can be somewhat of a formality. And WCG data show that perhaps 10 percent of sites are rejected after a site evaluation visit.
But it is considered an essential part of the site selection process for new sites to make sure that everything checks out. And with so many more sponsors seeking to work with new sites and investigators as part of their efforts to access untapped patient populations, it’s critical for sites to ace these visits, ensuring a site selection deal is sealed.
Overall, all involved staff should consider the site evaluation visit “an opportunity to build a relationship with the sponsor,” she said. How the site makes the sponsor feel can determine whether they will work together.