Cost and ROI

What one day of enrollment delay costs a clinical trial

Three clinical research professionals reviewing printed reports at a conference table with a laptop and a wall calendar
Short answerTufts CSDD's 2024 analysis puts the average direct cost of running a Phase II or Phase III clinical trial at about $40,000 per day: $55,716 per day for Phase III and $23,737 for Phase II. Each day a drug reaches market later also costs an estimated $500,000 to $800,000 in lost sales, depending on which Tufts publication you cite. The often repeated $4 million to $5 million per day figure dates to 1993.

What is the direct daily cost of a clinical trial?

Tufts CSDD analyzed 409 clinical trial budgets and found a direct cost of approximately $40,000 per day for Phase II and III trials (PubMed). By phase, Phase III trials had the highest direct cost at $55,716 per day, and Phase II ran roughly half that at $23,737 (Tufts CSDD white paper).

$55,716
direct cost per day, Phase III
$23,737
direct cost per day, Phase II
~$40,000
average per day, Phase II and III

Respiratory, rheumatology, and dermatology trials had the highest relative daily direct costs (PubMed).

How much revenue does a day of delay cost?

Tufts' peer reviewed paper estimates a single day equals approximately $500,000 in lost prescription drug or biologic sales, based on 645 drugs launched since 2000 (PubMed). Tufts' published summary of the research reports approximately $800,000 per day (Contract Pharma). We show both because the two Tufts outputs differ.

Where did the $4 million per day figure come from?

The widely quoted $4 million to $5 million per delay day came from 1993 estimates by the Office of Technology Assessment and Boston Consulting Group, based on 1990s blockbuster drug revenue (Contract Pharma). Tufts' updated research replaces it. If a vendor still quotes it, the rest of their numbers deserve a second look.

What does a 30 day enrollment slip cost?

At Tufts' Phase III rate of $55,716 per day, a 30 day slip adds roughly $1.67 million in direct trial cost before any lost sales are counted. At the site level, Phesi estimates a site that enrolls one patient over a 30 month study costs a sponsor $130,000 (Applied Clinical Trials).

What does this mean for a research site?

Sponsors carry these costs, and they pass the pressure on through enrollment tracking, rescue sites, and future site selection. A site that adds reliable patient sources protects its standing for the next study. Physician referrals are one of the most underused: see why sites miss enrollment targets and how to get physicians to refer.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

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Sources

  1. Tufts CSDD, "Quantifying the Value of a Day of Delay in Drug Development" white paper (2024)
  2. Smith Z. et al., "New Estimates on the Cost of a Delay Day in Drug Development," PubMed
  3. Contract Pharma, "Updates on the Value of a Day of Delay in Drug Development" (Tufts CSDD)
  4. Applied Clinical Trials, "Phesi Report: Assessing Single Patient Investigator Sites in Cancer Clinical Trials"