Part 1/3: Top Site Challenges

Solid site relationships are the backbone of successful clinical trials. Without happy, supported sites, enrollment simply cannot happen predictably or within budgetary constraints. Yet fostering deep site relationships is often overlooked because many CROs are simply unable or unwilling to put in the effort, resources, and time necessary to do so.

While historic site 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 unfamiliar new technologies with little support and training. Our new white paper, Putting the Focus Back on Site Relationships in Clinical Trials, digs deeper into the evolving challenges sites face as well as PSI’s real-world strategies for supporting our site partners – and our sponsors in turn.

3 Top Challenges for Sites

Site relationship management is challenging no matter what, whether managing dozens of sites for a global trial with tight enrollment timelines, providing support and training for complex molecules, or building site-specific patient pathways. Understanding each site’s pain points is often a monumental task requiring a highly tailored approach, yet doing so is essential to overcoming these obstacles. It’s likely that many CROs neglect this critical step due to what is often perceived as a time-consuming and costly process.

In addition to hands-on experience, there is a growing collection of existing data and real-time feedback from sites to help sponsors and CROs make more effective decisions about site support from the beginning. Sites report similar challenges across therapeutic areas, 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.¹ Specific challenges sites may encounter in the current clinical trial landscape include navigating vendor arrangements, the impact of the COVID-19 pandemic, 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 enrollment goals. While the answer may seem simple, executing it is anything but: communication. 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.²

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 organization or even the therapeutic team, often leading to additional workflow disruption due to retraining and unfamiliarity. ¹ A lack of support during trial operationalization, including training on study design (and redesign), budgets, and data management and handling, can add further complexities.

Learn more from PSI’s site relationship experts

The success of clinical trials hinges on the quality of the relationship between CROs, sponsors, and sites. At PSI, we know a thing or two about providing site support and meeting enrollment goals. With more than 4,000 sites worldwide that love working with us, we specialize in providing sites with the tailored resources, training, and support they need to deliver our sponsors’ pivotal Phase 2 and 3 studies. Stay tuned for tips on how to mitigate site burdens in part 2 of our series. Discover more about how to navigate these challenges and the value of site relationships by reading the complete white paper here. To learn how PSI can support your next study, contact us today.

References

¹ Clinical Leader. (2023, April 18). Strengthening the Sponsor-Site Relationship in Clinical Trials . Clinical Leader. https://www.clinicalleader.com/doc/strengthening-the-sponsor-site-relationship-in-clinical-trials-0001

² Hosely, M. (2021, March 23). Improving site-sponsor relationships leads to transparent clinical trials. Advarra. https://www.clinicalleader.com/doc/strengthening-the-sponsor-site-relationship-in-clinical-trials-0001

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Putting the Focus Back on Site Relationships Part 1: Top Site Challenges