Operationalizing Collaboration: How Sponsor-CRO Disconnects Hold Back Clinical Trial Quality

By  Lakshmi Sundar, VP strategy and development, The Avoca Group

In recent years, the pharmaceutical industry has been pulled in opposite directions by the historic approaches that have served it well in the past and the new thinking many claim it must adopt to thrive going forward. Advocates of the new approach argue pharma must “bust silos” and forge ever-closer ties with CROs and even rivals. Research conducted by The Avoca Group reveals clear boundaryless communication is a crucial aspect of driving quality in clinical trials. With some silos essential to pharma and an industry built on protecting intellectual property, can we perform precision silo-busting?

The argument in favor of eliminating the barriers both within and between organizations is now well into its third decade. Since 1990 when GE first envisioned building “a boundaryless company … where we knock down the walls that separate us from each other on the inside and from our key constituencies on the outside,” many an article has espoused the monetary and nonmonetary value of breaking down silos for better collaboration. Yet businesses in multiple industries are still trying, with varying degrees of success, to achieve this goal.

Part of the difficulty stems from the fact that rigid, demarcated structures can be advantageous. When such structures are in place, roles and reporting lines, which are valuable at large organizations, are clear and easily understood. The sprawling global operations of the leading pharma companies and CROs make them prime candidates to benefit from internal silos. As well as contending with these pan-industry issues, large pharma companies face a set of challenges specific to drug development. Collaboration is difficult, yet survey data suggests it is something the industry must embrace if it is to eliminate current inefficiencies.

DEMONSTRATING THE SPONSOR-CRO DISCONNECT
The results of a 2015 Avoca survey of 226 people from sponsors and 202 from CROs illustrate the shortcomings of the current situation. While many sponsors have tried to form closer ties to a small pool of outsourcing partners in recent years, the survey suggests the relationships are yet to mature into the seamless collaborative alliances GE envisioned in 1990.

“[Sponsors don’t give us] ownership of decisions that we should have. This delays our deliverables which sponsors will hold us accountable for in the end.” [CRO]

“CROs don’t like to problem solve and offer suggestions. They’d rather just do as they are told.” [Sponsor]

“One sponsor that I work with is new to fully outsourced trials, so at the beginning of our working relationship, they micromanaged us.“ [CRO]

Such struggles are evident in sponsor and CRO perceptions of their own and each other’s attempts to create integrated quality management systems (QMS). There is widespread acceptance that an integrated QMS, in which all of the processes and tools work together to ensure clinical trial quality, is of value. Yet when Avoca asked sponsors and CROs about the extent to which they and their partners have integrated QMS, neither group came close to strongly agreeing that such systems are in place.

The shortcomings of existing attempts at integrated QMS were one of the few areas of agreement between CROs and sponsors. CROs consistently rated all other aspects of their own QMS highly. Yet when sponsors were asked to rate their CROs’ QMS, they gave middling scores across the board. The disconnect in perceptions suggests there is a breakdown in communication. If the QMS are as good as CROs think they are, the benefits are not being made clear to sponsors. If the QMS are as flawed as sponsors think they are, the shortcomings are not being conveyed clearly to CROs.

There is clear evidence that high levels of sponsor satisfaction are highly correlated to clear articulation of roles and responsibilities in forging strategic relationships between sponsor and CRO.

LEARNING FROM OTHER INDUSTRIES
In trying to successfully operationalize collaboration, sponsors and CROs can learn from experiments run by their peers and companies grappling with similar problems in other industries. Younger companies, uninhibited by the institutionalized thinking that can take hold over decades, are trying some of the bolder ideas. Facebook, for example, puts each new hire through a six-week boot camp before they join their specialized teams so as to form bonds between people in different parts of the company.

If sponsor and CRO staff went through intercompany bootcamps, would they retain the divergent perceptions that are evident in the survey data? Or would their shared backgrounds lead to a more coherent vision of the state of clinical trials and how they can be improved? Given the specialized skills and intercompany collaboration that characterize clinical research, it may be impossible to copy the Facebook approach directly, but our industry can try — and, in some cases, is trying — to implement methods that share its intentions.

At Avoca, we have seen some of the companies we work with apply innovative approaches to breaking down barriers and facilitating better collaboration. Clear discussions centered on partnering for risk mitigation appear to open up new lines of dialogue and innovative approaches.

The endeavor to facilitate collaboration by altering the mindsets of workers has parallels in other parts of the healthcare system. In a hospital, doctors are typically segregated as they were in medical school, putting physicians and surgeons on opposite sides. Yet when a patient goes to a hospital, they just want the most appropriate, skilled group of people to work collectively to treat their condition. Recognizing this, the Cleveland Clinic reorganized its teams around how patients interact with the hospital, and their organization rose to the top of patient satisfaction tables.

In clinical research, the need for intercompany collaboration adds an extra layer of complexity, but sponsors and CROs, like the Cleveland Clinic, are still trying to instill mindsets that facilitate the operationalization of collaboration. The aforementioned joint team is one way to try to achieve this goal. Another is being pursued by a large CRO. The firm has set up a team dedicated to running big trials for small biotechs, a group that can get overlooked by CROs. While Big Pharma companies account for most of the CRO’s sales, the biotech-focused team’s success is tied to different metrics.

The team’s overarching task is to understand and meet the needs of biotechs. By learning to think like a biotech, the team may be able to resolve some of the disconnected perceptions evident in the survey data. Ironically, the CRO is driving toward this goal by siloing off the team from the rest of the company, which only serves to reiterate the complexity of operationalizing collaboration.

RUNNING EXPERIMENTS TO OPERATIONALIZE COLLABORATION
The experience of the large CRO illustrates the naïveté of the gung-ho calls for silo-busting. In a field as complex, multifaceted, and reliant on intellectual property as clinical research, some barriers are needed. The challenge for sponsors and CROs is to know which business structures are essential and which are burdens.

Lessons learnt from experiments now under way at sponsors and CROs will shape the path forward, as will analyses of what is working in other industries. Yet the slow progress seen in survey data from the past few years shows we must continue to propose and test hypotheses. If we are to create highly functional and integrated clinical operations that are based on sharing of information between functions and partners, we will need to try and test new ideas. Applying technological Band-Aids to a system that needs surgery will deprive us of true collaboration and insight.