Collaboration Planning

As outsourcing to CROs and specialty providers continues to grow, and more sponsors move to strategic partner models with select providers engaged at program and enterprise levels, expectations for collaboration among study partners are rising. Sponsors are recognizing that there are opportunities for CROs and recruitment providers to be stronger allies for on-time, cost-efficient study completion through more intentional collaboration.

Some aspects to achieving a high-performing CRO-recruitment provider collaboration are particular to this combination of stakeholders. On-time study completion is central to both groups' performance measures. However, perceived and real overlap of their respective recruitment responsibilities can create counterproductive tensions and barriers to success. Sponsors can steer their study partners away from these roadblocks by driving the development of clear collaboration planning, based on an understanding of the dynamics between these provider types and how to best position them for shared success. The considerations offered here are from the recruitment provider's perspective with the intent of shining gentle light on some sensitive areas that are not often openly discussed.

The collaboration, or co-performance, plan starts with the sponsor's sourcing management. Primary factors in the dynamics between a CRO and recruitment provider are the sequencing of selection and whether the recruitment provider is engaged independently by the sponsor, along with the CRO, or solely by the CRO. When both the CRO and recruitment provider are selected by the sponsor, the recruitment provider is often engaged after the CRO partner is onboard. This allows the sponsor to consider the need for engaging a recruitment provider in the context of the CRO's recruitment expertise and capabilities. It also gives the CRO an opportunity to contribute their insights to the recruitment provider selection. This is especially appealing to sponsors when they are approaching a new therapeutic area or indication, or have limited experience working with recruitment providers.

Depending on the sponsor's familiarity working with independent patient recruitment providers, they may not consider that patient recruitment providers are often in competitive bidding with CRO patient recruitment teams. CRO recruitment teams range from small teams of strategists who manage preferred partners, to large groups that execute programs using a combination of in-house and external services. Many CROs have struggled to determine whether recruitment specialty services should be part of their capabilities, or are better strategically partnered. Not all trials need recruitment support, yet significant resources are needed to maintain strong talent, full capabilities, and keep up with emerging tactics. Sustaining an investment in capabilities that are needed for a subset of trials presents a business challenge. There is a contingency of CROs that have approached and abandoned, some several times, the development of internal recruitment service teams. Others have opted to form strategic partnerships with recruitment providers, which benefit from established working practices and team familiarity.

Postponing selection of the recruitment provider until the CRO is identified can have unintended consequences. CROs sometimes interpret a sponsor's request to engage a recruitment provider as a criticism or an indication that the sponsor lacks confidence in the CRO's capabilities. This can create a conflict of interest in their recommendations for recruitment provider selection. For example, one of the core strengths of a recruitment provider is crafting study value proposition messaging to patients, influencers, and referral sources. Even if the CRO does not have recruitment services and would need to outsource a patient outreach program, they may have materials development capabilities, and view the involvement of a recruitment provider as a lost revenue opportunity. Their recommendation may be based on which group they believe will defer to their boundaries and not challenge their primary position with the sponsor. The result can be that the recruitment provider that has the strongest capabilities is not selected; timing the recruitment provider selection after the CRO puts recruitment program start-up activities initiating closer to FPI. Ideally, recruitment providers have three months to launch a program to maximize efficiencies and avoid rush charges in pass through expenses. If the CRO is involved in recruitment provider selection, sponsors should recognize that the recruitment provider may be sensitive to the CRO having access to their budget and other competitive intelligence.

During program execution, CROs and recruitment providers intersect most heavily in the areas of IRB/EC approvals, materials fulfillment, and site support. Obviously the goal is to leverage the strengths of both groups and operate cohesively to achieve greater combined performance. The dynamic nature of patient recruitment management makes it more similar to how CROs operate than other specialty services. Central and core lab services, EDC, PRO and IWR systems, and drug supply support are designed to operate along a well-defined path. Adjustments are made to accommodate program specification changes, such as protocol amendments and shifts in study countries. In contrast, patient recruitment programs morph in flight with multiple variables being continually adjusted in response to changing conditions. Strong performance requires ongoing strategic planning, quick response, and nimble management, which are best achieved when recruitment providers have direct communication with sponsors and first-degree access to program data and information. A classic example of a communication cascade delay that derails recruitment performance is notification that an ethics approval has been secured to deploy outreach tactics for an individual site. If the CRO holds responsibility for all IRB/EC submissions, responding to reviewer questions takes longer and the process is delayed. While securing ethics approvals for outreach has a high urgency for the recruitment provider, it understandably ranks lower in priority for CROs who place higher priority on key study initiation performance indicators such as completing site identification and contracting tasks on schedule. With a myriad of moving parts and intersection points with multiple study partners for sometimes hundreds of sites, notification of an IRB approval for outreach can easily be delayed a week or more. The impact of seemingly small losses in outreach time on recruitment program effectiveness and cost efficiency is widely underestimated, and needs to be carefully considered when performance-based risk share agreements are involved.

Sponsors can empower their CRO and recruitment provider partners to achieve superior co-performance by crafting up-front collaboration plans that establish primary responsibility and relative roles for: recruitment strategy decisions; country and site allocation of recruitment tactics; IRB/EC submissions and tracking; materials and messaging development; provision of materials to sites; and recruitment-focused site communications and support. Ideally the plans should also address operational aspects, specifically information sharing practices, communication flow, and escalation pathways.

Thoughtfully designed, comprehensive CRO-recruitment provider collaboration plans empower study partners to fully leverage their combined capabilities and deliver superior outcomes for sponsors.

Helen West is VP, Strategic Development at MMG, 700 King Farm Boulevard, 5th Floor, Rockville, MD, e-mail: hwest@mmgct.com.