Budgeting a Complex Trial
Applied Clinical Trials
Allison Burmeister discussed the average cost increase based on the per patient cost in a clinical trial during her presentation at the ExL Pharma C.R.O.W.N. Event.
"Clinical trials are labor intensive," emphasized Allison Burmeister, Senior Analyst, Clinical Business Operations for Janssen Alzheimer Immunotherapy R&D, during her presentation last month at the ExL Pharma C.R.O.W.N. Event, when presenting her case study on "Mitigating Risks and Variance When Budgeting and Contracting for a Complex Global Clinical Trial."
Burmeister's presentation began with an outline of the average cost increase based on the per patient cost in a clinical trial, from which she gleaned from a July 2011 article on Pharmalot that was based on a Cutting Edge Information survey. Those costs per patient are as follows in 2011: Phase I: $21,883; Phase II: $35,070; Phase IIIa: $47,523; Phase IIIb: $47,095; and Phase IV: $17,042.
That snapshot set the stage for Burmeister's case study, of which she referred to a 210 site, 1,670 subject, four-year long, 14 country, Phase III study. The average study start-up costs were budgeted at $4.4M—and this is even before a trial starts to enroll.
Burmeister urged the audience to consider that no scope or budget detail is too small because the chance for it not to be included could significantly shift the variance of a budget.
For example, screen fail rates. For this particular trial, Burmeister went to the project managers and the sites to ask how many patients they thought wouldn't pass the screen and came up with a 64%. So if a total of 7,200 potential subjects fail the screen, the cost would be $15 million. Said Burmeister, "If that is not factored into the budget, that could be a considerable variance to cost."
Other key factors beyond the screen fail rate that impact the trial include the number of subjects, the enrollment rate over the length of the trial (has to be factored over the number of years), drop-out rate, number of sites, the site activation rate, and the schedule of assessments. The schedule of assessments, again should be extremely detailed so that the number of procedures per patient are truly counted into the budget.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
