Clinical research is the raw pursuit of knowledge: there is experimentation following the scientific method. There are protocols, guidelines and regulations ensuring that all aspects of research are adequately controlled and accounted for and stakeholders are monitored to ensure the rigors of investigation are adequately respected. Yet, in the pursuit of knowledge, an aspect paramount to the success of clinical trials is often obviated: the relationship established between investigational sites and research organizations. In previous posts we spoke about the different approaches to functional service provision between large and small CROs, and one of the conclusions was that, while certainly each had certain pros and cons by design, there was a market for everyone. In the case of relationships with investigational sites one could come to similar conclusion.
Investigational sites are at the core of clinical research since they are the ones in direct contact with patients, conducting screening, administering treatments and compiling information about the therapy being studied. In this sense, CROs and Sponsors need to establish from the very beginning a positive working relationship that ensures the adequate execution of trials. Perhaps this is most evident during start-up activities, where communication with sites is constant and a wide array of persons from the study team are involved. Large CROs usually maintain several communication channels with the site to address different issues: finances, recruitment, equipment, drug supply, etc. This approach certainly has advantages and helps to streamline logistics from the CRO perspective.
However, some actors in the industry have realized the shortcomings of this model and have implemented alternative structures that aim at fostering trust and a positive working environment between sites and CROs. Such designs call for a single point of contact from the CRO. The contact person, the Clinical Research Associate (CRA), becomes the “face” of the organization for the site and conducts all site-related activities, creating a lasting relationship along the way. This structure presents its own set of pros and cons. On the positive side, long-term relationships are formed that facilitate work, improve overall quality and even contribute to the possibility of engaging sites again in the future. The downsides are evident: a change in personnel in either the site or, especially, the CRO, risks losing all energy and effort invested in developing the relationship. Such risk is especially acute once we consider the current turnover of CRAs in the industry, a problem that could become even worse according to some experts in the matter.
“With 5 or 6 persons speaking to site at the same time it is very difficult to create trust,” says Lea Ehrhardt, a CRA at KCR with 3 years of experience in the industry. “It is a fact that sites prefer to concentrate communication in a single point of contact, they feel listened and taken care of, in a trial with strict timelines trust is of foremost importance,” Ehrhardt continues.
As mentioned earlier, each communication model has pros and cons and each project has unique needs and characteristics and thus there are no “one-size-fits-all” recipes for creating a positive working relationship with sites and investigators based on trust. Also, it is evident the construction of such relationships is much more complex and nuanced than the number of people involved.
In a future piece we will continue the relationship theme and talk about investigator meetings and the potential they hold for building a sense of belonging and improve team work in projects.
Associate Director, PR & Marketing
mobile: (+48) 605 053 164