By Melynda Geurts and Carl T. Wibbenmeyer
Although the manufacturing, healthcare and technology industries have employed risk-share agreements for decades, they first appeared in centralized patient recruitment contracts in the 1990s then soon disappeared due to declining demand. But risk-share agreements have made a comeback in the pharmaceutical industry over the past three years, most notably during the economic downturn of 2008. Once a model offered by vendors as a partnership overture, risk-share agreements have emerged from obscurity to become an increasingly common requirement in patient recruitment and retention contracts.
By classic definition, a risk-share agreement is a business management method whereby the financial consequences of a risk are distributed among a vendor and client. The goal is to ensure all parties have a vested interest in the success of the venture—and shared accountability.
Clinical trial sponsors and patient recruitment organizations are working together to develop a more standardized approach to risk-share models, including: (1) establishing dual accountability related to milestone completion targets to ensure the vitality of the program investment by the sponsor, (2) sponsors requiring sites (contractually) to utilize the recruitment program offered and/or (3) sponsors requiring sites (again contractually) to actively report initiative outcomes.
Constructing a risk-share model can have varying degrees of complexity. Given their intricacy, not all clinical trials warrant a risk-share agreement. For those trials that do, the most successful models are simple in nature and flexible to accommodate study changes that impact the study endpoint. Examples include protocol amendments, study start delays or even study termination.
A sound risk-share agreement requires complete buy-in and support from all the stakeholders in the clinical trial process—sponsor, CRO, sites and patient recruitment vendor.
Payment Markers in Patient Recruitment Risk-Share Agreements
The metric incorporated into a risk-share agreement is referred to as the “payment marker.” To be effective, the payment marker must: 1) represent a measurable level of performance by the patient recruitment organization and 2) be considered by both client and vendor to be a fair assessment of performance. However, the nature of patient recruitment and the complexities of clinical research can raise barriers to achieving these two requirements. There are three key patient recruitment metrics which may be considered payment markers in risk-share agreements. These include the randomized subject, the screened referral and the pre-screened referral.
The challenge of choosing an acceptable payment marker is finding a marker that does not reflect the performance or decisions of third parties, including the sponsor. This is most apparent when randomized subjects are used as payment markers.
For the sponsor, paying the patient recruitment organization for each randomized subject is attractive because it mitigates their risk, is an easy marker to apply, and aligns with the ultimate purpose for hiring the patient recruitment organization. However, the evolution of a potential study participant from first contact to randomized subject involves many variables over which the patient recruitment organization has little or no control.
From the standpoint of the patient recruitment organization, screened referrals are better markers compared to randomized subjects because post-screening events and clinical setting have no bearing. Nonetheless, these payment markers are materially influenced by the decisions and actions of third parties.
A risk-share model is only as sound as the tactics to evaluate return on investment (ROI). There are several external tracking mechanisms that ensure accuracy in program reporting. A few of these include utilizing an IVRS system or call center. While these systems can accurately capture the status of a referral and/or screened individual, the final and most important level of accountability lies with the study coordinator who must report patient.
While there can be a number of management challenges associated with the implementation of a risk share, there are benefits in using this accountability system. If structured appropriately and developed jointly by the sponsor and provider, such a model can solidify a stronger partnership between parties. Most importantly, this measurement system allows for ROI analysis to be conducted proactively and on an ongoing basis. This level of analysis permits timely program modifications as necessary to ensure the highest level of return per initiative.
Melynda Geurts is chief operating officer for D. Anderson & Company (DAC), a global patient recruitment and retention provider serving the clinical trials sector.
Carl T. Wibbenmeyer is chief operating officer for The Patient Recruiting Agency™ an Austin-based company specializing in direct-to-patient advertising and technological solutions.