Keys to Successful Clinical Trial Site Relationships
When aiming to improve site relationships, there is no better place to start seeking feedback than the sites themselves. In a recent survey by WCG CenterWatch,4 the top 10 CRO attributes most valued by sites were:
Quality of communication with study team/site staff
Responsiveness to site staff inquiries
Organization and preparedness
Professionalism, knowledge, and training of monitors/CRAs
Access to staff for escalation and resolution of issues
Professionalism of staff in clinical operations functions
Ongoing help/support provided in running the study
Ability to effectively work with sponsors
Professionalism and efficiency of administrative staff
Efficiency in contract and budget negotiation
While the list of attributes has mostly remained consistent over the past few years, attributes seven through 10 were new for 2023, reflecting a shift in site priorities when working with CROs toward “overall project support, study monitoring, and contracts and budget handling.”4
When considering the building blocks of successful site relationships, look to the qualities considered most important to sites, yet which received low actual rankings in delivery. Flexibility and openness when dealing with protocol and budget modifications, practicing open communication, and reducing staff turnover are among the top concerns for sites.5
Prioritizing technology and process integration can ease the technology burden of site staff, keeping training and retraining to a minimum.
A key reason for enrollment slow-down at the site level (as well as overall timeline delays and additional costs for sponsors) is excessive protocol amendments. To help guard against this risk, sponsors should seek to optimize protocols as much as possible during the trial design phase.5
Scientific Advisory Boards, are often valuable for assessing patient burden and suggesting improvements to study design and inclusion criteria during early review. Through PSI’s SAB protocol review and recommendations, future protocol amendments are minimized. When protocol and budget amendments occur, there should be thorough guidelines and clear communication of all necessary changes and processes to the site.
The patient journey is another element to consider during trial design and implementation.
Evaluating study procedures from the patient's perspective can help minimize patient burden and impact on sites. Providing site training and materials to smooth patient transitions and processes can improve the likelihood of meeting enrollment and retention goals. These materials offer guidance and reassurance to patients after they leave the site. This makes it easier for sites to develop meaningful and valuable relationships with patients because less time is spent on repetitive tasks such as reviewing basic study information and processes.6
PSI charts out the patient's journey for each study, allowing site teams to understand the needs of the patient and study requirements more clearly. For example, suppose the patient needs to have a lab specimen taken eight hours after the investigational product administration. In that case, the site team can plan for the patient’s needs, such as space for the patient or food vouchers. In turn, this reduces the potential protocol deviations, ensuring the quality of the study endpoints.
In addition to boosting engagement, making sites feel heard, and reducing turnover, there are many other benefits to building strong site relationships. As PSI has learned, when we can understand and even predict the needs of each site, we can provide sites with self-awareness about which trial programs are right for them. In turn, this allows us to provide our future sponsors with insight into how to identify the optimal sites for their particular trials, further reducing operational waste.
When it comes down to it, sites want to work with CROs and sponsors with whom they have positive experiences with. Making them feel heard, reducing project team turnover, optimizing change management, and providing support are all part of improving site relationships.
Take a look at what a patient journey may look like when you run your trial with PSI.
Our sites work hard to ensure that they make the patient experience as easy and comfortable as possible, whether that be by providing travel assistance, offering comfort and support while on site receiving treatment or cutting down on wait times so that the patients can return home as quickly as possible.
