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 of a clinical trial places significant pressure on all stakeholders. The strength of the relationship between the site and CRO during study start-up is a powerful tool 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 opportunity for sites and CROs to establish the foundation of a trust-based relationship.
One of the first opportunities for this relationship to develop is during the feasibility process. The feasibility and study start up stage is a fundamental predictor of success and 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 accurateness of information that is provided. All stakeholders are clearly invested in ensuring a highly productive, efficient clinical trial – therefore selecting high performing sites is critical to this success. CROs strive to perform better than the typical 80/20 rule, when a few, high performing sites take on the majority of the work involved. To accomplish this, many CROs implement internal processes during feasibility aimed at distributing the workload more evenly among all sites.
Sites should also take advantage of this time to conduct reciprocal feasibility on the CRO. For example, how quickly does the CRO respond to requests for information and 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 often provide, they should be addressed as early as possible. The initial stage of a relationship, particularly during the beginning of a new clinical program, provides considerable opportunity for all participants to work together to lay the groundwork for a long-lasting, mutually beneficial relationship.
Opportunities for sites and CROs extend past feasibility and into the contract negotiation process. As clinical trials grow in complexity, it is increasingly common for Sponsors to plan for earlier CRO involvement, often shifting the CTA negotiations to transpire between sites and CROs. The first CTA agreement between a site and CRO can set the groundwork for a long-lasting partnership. 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.
Relationships thrive when expectations are clearly set, and the importance of clearly defining 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 key expectations and responsibilities. Both entities can work together to set realistic goals and timelines that are mutually agreeable.
As roles and responsibilities are established, CROs should consider providing a single point of contact to a site during a trial. This is not always feasible, however it is important for CROs to remain cognizant of the amount of pressure sites are facing from working with multiple Sponsors and CROs on other trials. CROs can help mitigate some of this pressure by ensuring any contact is intentional and productive. Assigning someone to the project specifically to interact with sites is becoming more common, for instance a Site Relationship Manager, Or Site Liaison.
A contract signature is merely the beginning of creating 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.
This article was originally published March 12, 2018 in CenterWatch Weekly