CRO Use to Double
Pharmas will collaborate increasingly with third-party solution providers
Ben Adams, writing in Fierce Biotech, in 2016, reported that Cutting Edge Information, a Research Triangle Park, North Carolina-based firm that serves the drug industry, has done a survey of major pharmaceutical and therapeutic device makers. It has found that while 17 percent of them currently outsource their clinical trials to contract research organizations (CROs), this number is expected to climb to 52 percent within a few years as a cost-cutting measure.
"Projected changes to sponsor-CRO working relationships owe largely to shifts within large and mid-sized pharma companies," said Sarah Ray, senior analyst at Cutting Edge Information.
The report, “Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines,” highlights included: metrics detailing clinical trial activities from pharmaceutical, device, CRO and site perspectives; data on surveyed teams' vendor selection process and preferred collaboration type (master services agreement versus functional service provider); best practice recommendations and projected costs associated with selected patient recruitment activities; and profiles of 17 pharmaceutical, biotech, device and CRO-managed clinical trials, including overall trial costs, number of enrolled patients and sites and clinical team size.
Additionally, the report determined that most surveyed pharmaceutical and device teams prefer to work with third-party providers on a study-by-study basis. Still, a small percentage may collaborate with CROs on a more strategic basis. According to the report’s findings, the company type plays a critical role in the nature of the relationship that sponsors undertake with CROs. Cutting Edge Information determined that teams at large and mid-sized companies favor long-term alliances. On the other hand, small pharma is more likely to favor a fee-for-service structural agreement.
“Leveraging a functional service provider (FSP) agreement with CROs enables sponsors to initiate a flexible and short-term relationship,” the report said. According to the report, this type of strategy is especially appealing for teams at small pharma companies with limited budgets. However, when operational and resource risks are shifted from pharma to CROs, industry teams could witness an increase in strategic sponsor-CRO partnerships.
The report concluded, “Sponsor teams leverage CRO expertise for a multitude of clinical trial tasks, from strategic planning to trial trends within the clinical space, including the increased use of risk-based monitoring and adaptive trial design, have further expanded the need for CROs and their associated technologies. Increasing reliance on CROs underscores the importance of establishing strong partnerships between pharma and device companies and third-party providers. Certainly, very few sponsor-CRO partnerships are without their associated challenges. However, being realistic about inhouse capabilities and activity deadlines — from both sponsor and CRO perspectives — can help teams align their clinical objectives and strengthen their relationships going forward.”