Putting the Focus Back on Site Relationships Part 2: 3 Strategies for Mitigating Trial Site Burden

By Staff Writer

This is the second in a series of posts based on PSI’s new white paper, Putting the Focus Back on Site Relationships in Clinical Trials. In Part 1, we discussed three of the most common challenges sites encounter while running clinical trials with sponsors and CROs. A lack of communication, resources, training and support can impact sites’ ability to enroll patients, in addition to complicating the patient journey. In this post, we share three of PSI’s strategies to help ease the burden of sites, which ultimately supports sponsors in meeting trial timelines and milestones.

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,1 the top 10 CRO attributes most valued by sites are:

  • 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 remained largely consistent over the past few years, attributes seven through ten were added this year, reflecting a shift in site priorities when working with CROs toward “overall project support, study monitoring, and contracts and budget handling.”1

Strategies for successful site relationships

When considering how to build strong site relationships, look to the qualities considered most important to sites, yet which received low actual rankings in terms of 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.2

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.2

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. We’ll dive into this further in our third and final post in this series.

Site support solutions for pivotal Phase 2 and 3 trials

Understanding how to navigate the needs of individual trial sites is crucial for the success of your trial. With a global database of more than 4,000 sites and a unique approach to site support, including our dedicated Site Support Specialists, PSI excels in delivering studies on time and on budget.

Download the full white paper here, or contact us to learn more about running your pivotal Phase 2 and 3 trials with PSI.

1 WCG CenterWatch. (2023). 2023 WCG CenterWatch Global Site Relationship Benchmark Survey Report for Sponsors. Falls Church, VA. WCG CenterWatch. https://www.centerwatch.com/products/587-2023-wcg-centerwatch-global-site-relationship-benchmark-survey-report-for-sponsors#:~:text=The%202023%20Global%20Site%20Relationship,more%20than%203%2C600%20site%20representatives.

2 Malloy, M., & Cammarata, N. (2022, July 18). Tips For Clinical Trial Sponsors To Cultivate Meaningful Relationships With Sites. Clinical Leader. Retrieved November 21, 2023, from https://www.clinicalleader.com/doc/tips-for-clinical-trial-sponsors-to-cultivate-meaningful-relationships-with-sites-0001

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