The Pulse on Study Start-Up
A Successful Clinical Trial Begins with the Study Start-Up Phase
The study start-up phase sets the tone for a clinical research trial and is crucial to the overall success of a program. The critical nature of this phase places significant pressure on all stakeholders. The strength of the relationship between the site and CRO during study start-up is an important factor in creating a successful study outcome. Rather than a customer and vendor relationship, sites and CROs should strive to develop strategic alliances, partnering seamlessly through an entire clinical study and beyond. The study start-up stage offers ample opportunities for sites and CROs to establish the foundation of a trust-based relationship.
The feasibility and study start-up stage is a fundamental predictor of success and a key indicator of a site’s performance. CROs utilize this essential period as an opportunity to evaluate a site’s responsiveness and follow-up, and analyze the quality and accuracy of the information provided. All stakeholders are clearly invested in ensuring a highly productive, efficient clinical trial — therefore selecting high performing sites is critical to this success. When a few, high performing sites take on the majority of the work involved, CROs strive to implement processes to distribute the workload more evenly among all sites. Many CROs implement internal processes during feasibility aimed at distributing the workload more evenly among all sites. (See Figure 1.)
Sites should take advantage of the study start-up stage to conduct reciprocal feasibility on the CRO. How quickly does the CRO respond to requests for information? Will there be adequate training and patient recruitment support throughout a trial? If there are needs at the site level that may benefit from the additional resources a CRO can provide, they should be addressed as early as possible.
Clearly defining the roles and responsibilities as early as possible is extremely valuable to the overall relationship between a site and CRO. The beginning of a clinical study is a key time to establish the parameters of the study and outline expectations and responsibilities. Both parties can work together to set realistic goals and timelines that are mutually agreeable.
As clinical trials grow in complexity, it is increasingly common for sponsors to plan for earlier CRO involvement, often shifting CTA negotiations between sites and CROs. In addition to setting up the site budget for a specific trial, the two parties can work together to set up a master agreement for future studies. Ultimately, this will shorten the start-up timeline for additional projects, effectively making the CRO/site pair more attractive to a Sponsor.
CROs should consider providing a single point of contact to a site during a trial as roles and responsibilities are established. This is not always feasible; however, it is important for CROs to remain cognizant of the amount of pressure that sites are facing from working with multiple sponsors and CROs on other trials. CROs can help mitigate some of this pressure by ensuring that any contact is intentional and productive. Assigning a Site Relationship Manager or Site Liaison specifically to interact with sites is becoming more common.
A contract signature is merely the beginning of an open dialogue between a site and CRO. There are numerous opportunities throughout the feasibility and study start-up phase when both sides can work toward establishing a unified front. Ultimately, all entities involved in a clinical trial will benefit from a strong site and CRO partnership.
Brittany Parker is the Director of Marketing and Communications at Total Clinical Trial Management. She works closely with research sites and study staff to execute current programs and develop ongoing, long-term relationships. Please visit www.totalcro.com for more information.