PSI CRO explores solid site relationships and how they are the backbone of successful clinical trials. Without happy, supported sites, enrolment simply cannot happen predictably or within budgetary constraints.
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This task has only grown more complex in recent years. While historic challenges like staffing shortages, trial complexity, and issues related to site startup have intensified, they are now joined by the need to often learn and implement new technologies with little support and training.
This article will discuss the common challenges that impact sites’ efficiency and how strategic investment in building long-lasting site relationships benefits sponsors and sites alike.
Site relationship challenges across the industry
Understanding each site’s pain points is often a monumental task since it requires a highly tailored approach, yet doing so is essential to overcoming these obstacles.
In addition to hands-on experience, there is a growing body of existing data from sites to help sponsors and CROs make more effective decisions about site support from the beginning. Sites report similar challenges throughout the clinical trial process, including:
1. Lack of resources
In a recent survey, sites identified staffing, study budgets, and protocol complexity as the top areas that have become increasingly difficult over the last five years. Specific challenges sites may encounter in the current clinical trial landscape include navigating vendor arrangements, and addressing regional conflicts that affect normal operations and the patient population.
2. Lack of communication
Sponsors often wonder what they can do to help sites struggling to meet patient enrolment goals. Establishing clear lines of communication and providing the space for open conversation and feedback, including regular calls and face-to-face meetings to address questions and concerns, helps sites mitigate waste and handle change management more effectively. In addition, sites consistently mentioned a lack of communication before, during, and after the close of a trial as directly impacting their optimism and willingness to work with a sponsor or CRO again.
3. Lack of training and support
CROs and sponsors should aim to create as seamless an experience as possible for sites. Many sites have shared that they often feel they are participating in a “pilot” mode where sponsors or CROs are testing new combinations of technology tools or processes without consistency across the organisation or even the therapeutic team, often leading to additional workflow disruption due to retraining and unfamiliarity. A lack of support during trial operationalisation, including training on study design (and redesign), budgets, and data management and handling, can add further complexities.
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, 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 ten 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.”
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.
Prioritising technology and process integration can ease the technology burden of site staff, keeping training and retraining to a minimum.
A key reason for enrolment slowdown 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 optimise protocols as much as possible during the trial design phase.
Scientific Advisory Boards are often valuable for assessing patient burden and suggesting improvements to study design and inclusion criteria during early review. When protocol and budget amendments occur, there should be thorough guidelines and clear communication of all necessary changes and processes to the site.
Considering the patient journey
The patient journey is another element to consider during trial design and implementation.
Evaluating study procedures from the patient's perspective can help minimise patient burden. Providing site training and materials to smooth patient transitions and processes can improve the likelihood of meeting enrolment and retention goals. These materials offer guidance and reassurance to patients after they leave the site.
In addition to boosting engagement, making sites feel heard, and reducing turnover, there are many other benefits to building strong site relationships. 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.
Final thoughts
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, optimising change management, and providing support are all part of improving site relationships.
Sponsors and CROs that take the time to get to know each site’s individualised needs can help sites work more effectively for their trials. Maintaining authentic and meaningful site relationships while managing clinical trial sites boosts patient enrolment through team enthusiasm and optimism.