The Importance of Relationships Between CROs and Clinical Trial Sites

ACT: How important is it for CROs to form strong relationships with sites, especially in the rare disease space?

Lwoff: If the CRO has a strong relationship with sites, the sites will be more proactive in addressing issues, providing timely feedback and ultimately ensuring trial success. In addition to this, fostering a good side relationship can lead to long term ownership, which can streamline processes and improve overall efficiency for future trials that we want to do.

First and most importantly, addressing issues and providing prompt feedback is the most important piece. I think those relationships will affect how far they go to get patients enroll and the care they give to them to retain them in the study afterwards. This is especially important in their rare disease space, considering the challenges that we have for enrolling patients due to the small population available. They’ll put in more effort when the CRO is working closely with them.

ACT: What are currently some key drivers influencing the decision-making process of sponsors?

Lwoff: Clinical trials are often expensive. Before engaging in a clinical trial, sponsors weigh the cost of the trial with its potential benefit and seek ways to optimize resources and reduce expenses without compromising quality. The main driver for selecting sites in rare disease is where the patients are, as well as timelines to have those sites activated once this is known. Regions and countries are selected and within those sites having the experience and capabilities to conduct the study with high quality are identified. An important consideration to be made by sponsors is trying to keep a balance between a sound and detailed protocol and ensuring that they are not excluding too much of the population by having eligibility criteria that is too restrictive, leading to a declining number of sites participating in clinical trials.