Medical Device Link.

Originally Published MX November/December 2001

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Budgeting and Contracting for Patient Recruitment

Once all decisions regarding the recruitment tactics to be implemented have been made, the clinical trial sponsor has in hand the most important information necessary as a basis for determining an appropriate recruitment budget. The investment in tactics—in marketing the trial to patients—may very well be the most significant expense in that budget. This is especially true for campaigns that rely heavily on paid television advertising, a notoriously expensive tactic.

In the highly competitive and rapidly growing field of clinical trials, creating a patient recruitment budget and considering contracting options is becoming increasingly important. Clinicians, administrators, sponsors, and others involved in clinical trials must think strategically in deciding when, where, how, and why to budget and contract for patient recruitment.² The following areas of growth and change in the budgeting and contracting process need to be considered when planning a new study.

Decentralized versus Centralized Budgets. In the past, when clinical trial sponsors contracted solely with physicians, patient-recruitment components of the budget were decentralized, incorporated into each investigator’s budget. But today’s more-competitive product development climate places corresponding pressure on the organization of the clinical trial process. Centralizing the budget for patient recruitment in the hands of the trial sponsor has proven to be an effective model for achieving economies of scale.

Determining a Recruitment Funnel. A promotional campaign used to recruit patients must be supported by a model developed to project the number of individuals who must respond to the campaign, pass various medical screens, and ultimately be randomized into the study.

Recruiting Competitively or Not. Site support in recruiting patients is often critical. Sponsors have options for distributing budgetary funds to encourage the help of institutions where investigators are conducting the trial. When competitive recruitment is the tactic, sites are rewarded financially for the number of patients they enroll. Alternatively, when sponsors think they know capabilities of various sites to recruit patients, it may be more effective to budget fixed amounts pegged to the anticipated performance of each.

Budget Follow-Through. Designing a budget is just a first step. It must be followed by consideration of contingency plans, patient-retention techniques, and, perhaps most important, means of gaining the approval and support of the product manufacturer’s upper management. Performance projections and return-on-investment charts can help sell a budget to that group.

Contracting. Contracting is becoming an increasingly popular and essential budget management tool in the competitive arena of patient recruitment. Risk-reward contracts enable the financial risk of recruitment to be shared among sponsors, investigators, sites, and any outside communications agencies that may have helped plan the clinical trial.

Copyright ©2001 MX