Clinical Trials Initial Budgets for Patient Recruitment: Phases of Study

Health & FitnessMedicine

  • Author Lydia Daisy
  • Published November 27, 2012
  • Word count 506

Patient optimization, recruitment and retention, a key determinant of the success of a clinical trial, has always been a challenge. It is becoming more challenging with the increased complexity of clinical trial design, stringent eligibility criteria and the trend toward more targeted patient population. Considering importance of patient recruitment & retention in clinical trials to achieve the business objective but surprisingly, many companies do not dedicate any funds to this activity in the initial budgeting process. In fact, many companies do not plan for patient recruitment at all, believing that patient recruitment will happen some companies invest a lump sum to CROs, SMOs or sites and rely on them to recruit patients.

Pharmaceutical companies know that quick enrollment is essential. To aid in the process, some companies employ patient recruitment companies. Others design creative campaigns specifically aimed at the patient set needed for their trials. Whatever their efforts, the companies that support their site's efforts with good recruitment campaigns, fueled by appropriate budgets, and more success in trial recruitment. This level of support is important because, after all, trial delays lead to product-launch delays which cost money in the long run.

This article en lights on average estimated costs spent by the pharmaceutical companies for patient recruitment for clinical trials from phase I to Phase IV.

Patient Recruitment Budgets

The recruitment pattern for Phase 1 trials is different as well. One Phase 1 patient enrolled is equal to 10 to 20 Phase 3 patients enrolled. This is partly because of the complications that come along with recruiting patients for Phase 1 trials. After all, the primary goals of Phase 1 trials do not include therapeutic benefit and most often require healthy patients. For Phase 3 studies, doctors will bring in patients one at a time, but for a Phase 1 study, they'll bring in 30 at a time because it's not cost-feasible to do one at a time. In phase 1 overall initial budget dedicated for patient recruitment is 0% and 15%, site budget is $10,000 and $800,000 and patient budget is $2,108.

As companies enter Phase 2 trials, the number of patients required increases, raising the stakes in terms of patient recruitment that overall trial budgets increase for sponsor companies/CROs as well. Along with increases in budgets from Phase 1, the percentage of budgets dedicated to patient recruitment also increases. In phase 2 overall initial budget dedicated for patient recruitment is 50%, site budget is $5,000 to $90,000 and patient budget is $52.

Phase 3 trials generally require a much larger number of patients than either Phase 1 or 2 trials. As such, it is not surprising that overall trial budgets increase significantly over the previous two phases. In phase 3a overall initial budget dedicated for patient recruitment is 50%, site budget is $5,000 to $90,000 and patient budget is $60 and $250. For phase 3b overall initial budget dedicated for patient recruitment is 6% to 20%, site budget is Higher percentage of their budgets to patient recruitment than 3a and patient budget is in line with that of Phase 3a.

Phase 4 trials can vary fairly widely in size and scope. For Phase 4 trial overall initial budget dedicated for patient recruitment is 53%, site budget $1,200 and patient budget is $736.

This article is written by an employee of MakroCare, explaining the budgets spent for patent recruitment from Phase I to Phase IV. MakroCare, established in 1996, is an international Drug Development and Commercialization services firm that is dedicated to support Life Sciences industry.

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