Monitoring the progress of the research represents a fundamental aspect of successful outcomes by ensuring that constraints to success are identified and resolved (Hurst & Dennis, 2013). This is particularly the case for the even more complex environment of oncology clinical research.
The centrality of monitoring to the success of research studies, combined with the increasing complexity within the field of oncology clinical research, force leading sponsors to increase their focus on this function and the role of clinical research associates.
Each study is uniquely designed, but CRAs are generally the ones tasked with ensuring that all contributors to the clinical trial production chain work effectively on time, within expected scope, on budget, within regulations, and safely for all patients involved. This reality makes the function of CRA the most important contact that a Site has with the Sponsor. How CRAs are assigned to an oncology program represents an important success factor for smooth study conduct.
CRAs are often assigned to trials based on their overall workload, with no real consideration for therapeutic experience, or which Sites will be involved in the given projects. In fact, it is not uncommon to see different monitor teams leading the feasibility, start-up and site activation, and enrollment phases of a project. And monitoring is often conducted by CRAs who tend to be treated as a pooled resource, graded on their percentage of full-time equivalent (FTE) availability or their ability to take on more projects.
While this approach to allocating CRAs on a per trial basis is a common practice in the industry, it does have certain disadvantages – the most important one being the inability to develop trusted relationships with the Sites.
Whether or not CRAs are assigned by Site (meaning they work on different trials but only at specific Sites) or by clinical trial, should be taken into consideration for each new trial requiring a team. For example, as a specialty oncology CRO dedicated to attracting novel oncology compounds and clinical trials to Canada, site assignments are finalized only once we have a good idea which provinces and Sites are likely to be involved in a given program. This strategy further nurtures our relationships with Sites as CRAs become very familiar with Sites’ internal procedures and continually build trust with Site personnel. In addition, team members are assigned to a project from the start-up phase which ensures continuity of operations as well as optimal application of lessons learned.
Improved reciprocity, quicker feedback and better results are derived when CRAs are assigned by Site, meaning they work on different trials but only at specific Sites, because it supports strong partnerships between the Sites, the CRO and the trial Sponsors.
It really comes down to trust. When you enter someone else’s territory, and expect them to do things for you the way you want them and when you want them done; knowing how and what to ask is ever so much more effective when you have an existing relationship with them.
Contributed by: Julie Martin, Director, Clinical Operations