Close collaboration between a contract research organisation (CRO) and sponsor makes both firms aware of the others’ needs and limitations. This helps the sponsor select the CRO which can best meet its recruitment needs for specific phases, therapeutic areas or geographies.
Business intelligence firm Cutting Edge Information (CEI) reached this conclusion after surveying 84 companies and interviewing seven of these firms. In the resulting report it details best practices for increasing patient recruitment rates, including how and why to work with CROs.
Outsourcing allows firms to benefit from the dedicated patient recruitment groups and databases with site-specific demographic information possessed by many CROs. Using these tools CROs can determine the likelihood of seeing strong recruitment at each site for any trial type.
To maximise the advantages of working with CROs CEI recommends entering into strategic partnerships. CEI notes that the prospect of repeat business means CROs will strive to provide the best service to strategic partners, even making short-term sacrifices for the sponsor’s benefit.
When selecting a vendor CEI recommends firms follow certain principles. Master agreements should be used to reduce contract negotiation time and give the flexibility to speed up the process for a certain trial.
Collaborating gives a sponsor insight into the capabilities at different CROs. By understanding CROs expertise in specific trial phases, therapeutic areas, geographies and age ranges a sponsor can quickly select the most appropriate partner for a trial.
This process also gives the CRO an understanding of the sponsor’s needs. Using this experience the CRO can make informed decisions when selecting trials, which is particularly important if the sponsor fails to provide key information, such as per patient reimbursement or final trial protocol.
CROs may also have long-term relationships with sites and physicians. If the CRO knows the sponsor’s clinical pipeline for the coming year, and the capabilities of its partner sites, it can quickly determine which location is suitable for which developmental product.
A collaboration case study
The report cites the example of Company A, a large CRO at which a patient recruitment executive operates under the RACI (responsible, accountable, consult, inform) system.
At Company A one group is focused on recruitment and has ultimate responsibility for this task. However, this group collaborates closely with the sponsor’s project managers, clinical operations team, physicians on the study, medics, marketing department, and other units at the CRO.
“This cross-functional input ensures that the patient recruitment efforts incorporated into the trial protocol have been informed by knowledge companywide and that everyone is aware of the recruitment strategy”, wrote CEI.
Adopting an approach that considers patients’ perspectives avoids three major pitfalls by ensuring: protocol wording makes it easy for patients to participate; sites with access to targeted patients are selected; and the sponsor has a communication strategy in place.