How Much Does a Day of Delay in a Clinical Trial Really Cost?

Commentary
Article
Applied Clinical TrialsApplied Clinical Trials-06-01-2024
Volume 33
Issue 6

New research updates estimated value of lost time.

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Raise your hand if you have recently heard at a conference, meeting, or in a sales pitch—or read in an article or in sales material—the statistic that a clinical trial delay costs sponsor companies $4 million a day in lost prescription drug sales. I suspect that nearly all of us would raise our hand.

That figure is widely cited and has been kicking around for decades. The figure is also inaccurate. It is many magnitudes too high, it varies by therapeutic area, and it is declining every year.

There is no question that time is extremely valuable in drug development. It is also extremely important that drug development stakeholders use more accurate measures of the value of time for decision-making and planning purposes, and for quantifying the financial return on time saved through innovative approaches and new investments.

The value of unrealized daily sales

The $4 million-per-delay-day figure associated with unrealized drug sales is, to our knowledge, based on estimates calculated in 1993 from two separate sources: the Office of Technology Assessment and the Boston Consulting Group. These estimates were based on the expected annual revenue from prescription sales of a typical 1990s-era blockbuster drug divided by 365 days in a year.

In October 2023, the team at Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a robust study to provide more accurate measures of the out-of-pocket cost of a missed day of prescription drug or biologic sales and of the cost of a day conducting a clinical trial. Tufts CSDD also conducted this analysis to test the hypothesis that average prescription drug sales per day have been decreasing over time. Recently launched drugs and biologics are targeting much smaller markets containing more narrowly defined patient populations, including those living with rare and ultra-rare diseases.

Tufts CSDD created a dataset drawn from commercially available data, supplemented by primary research. Specifically, we gathered pharmaceutical sales data in US dollars ($) for drugs and biologics launched anywhere around the world since Jan. 1, 2000. Drugs approved as treatments for COVID-19 were removed from the dataset. All sales data was converted to 2023 $US dollars using the Gross Domestic Product (GDP) Implicit Price Deflator published by the Federal Reserve Bank.

The average value of a sales day was calculated by dividing total aggregate sales of a given drug or biologic by the number of days the product generated sales beginning with the day the drug was first launched. We analyzed a number of subgroups, including therapeutic area and launch year. Correlations and analyses of variance (ANOVA) were conducted to test for significant differences.

Off by a factor of eight!

In all, 645 drugs were analyzed; the majority (61%) included the US among countries where the biologic or drug was first launched. The two largest therapeutic areas were oncology, which represented 28% of the total products analyzed, and CNS, which represented 27% of the total.

The results of our analyses indicate that the $4 million estimate is highly inaccurate. At the present time, a single day is worth approximately $500,000 in lost prescription drug or biologic sales. In addition, that $4 million figure has been a gross misestimation for more than 25 years (see Table 1).

Therapeutic areas with the highest relative average prescription drug sales—in 2023 $US dollars—included cardiovascular, hematology, immunology and infectious diseases, and oncology drugs and biologics, at a median of $1.4 million, $1.3 million, $880,000, and $840,000 respectively.

Our study also found—as we hypothesized—that average prescription drug and biologic sales per day have been steadily declining over time—decreasing by approximately $80,000 to $100,000 each year!

A negative correlation was observed between average sales per day and the year the product was first launched.

The value of direct daily clinical trial costs

To our knowledge, the average daily direct cost to conduct a clinical trial comes from DataEdge (acquired by FastTrack Systems, then Medidata Solutions (now part of Dassault Systems). Estimated to be $35,000, the figure is based on a robust analysis that was conducted more than three decades ago.

Tufts CSDD’s updated analysis is based on proprietary budget data gathered during our protocol design benchmark studies conducted between 2016 and 2021.Protocols for COVID-19 drugs were not included in this analysis. Actual clinical trial budgets were inflated to 2023 $US dollars using the GDP Implicit Price Deflator. Total clinical trial durations were calculated as the number of days from protocol approval to database lock (or primary completion date if database lock date was not available). Average cost per day was calculated by dividing the total budget for each protocol, expressed in 2023 $US dollars, by the total reported duration of the clinical trial.

Total budgets for 409 protocols were analyzed. The results indicate that, across all therapeutic areas, the mean direct cost to conduct a clinical trial per day is approximately $40,000—about half of the inflation-adjusted 30-year-old estimate.Phase III clinical trials had the highest direct cost per day at $55,716. Phase II clinical trials cost roughly half that amount at $23,737 per day. Phase IV and Phase I trials had the lowest daily cost at $14,091 and $7,829 per day, respectively. Clinical trials in respiratory, immunology, rheumatology, and dermatology had the highest direct costs per day. Although the daily direct cost to conduct a clinical trial fluctuated over time, there was no discernible trend.

Closing

At this time, the value of a single day of delay is worth approximately $500,000 in unrealized or lost prescription drug sales and $40,000 in direct daily clinical trial costs. The former estimate is a fraction of the 1993 published $4 million-per-day figure and it is declining by more than
$80,000 annually.

Putting this into context, we are witnessing a “perverse” and unsustainable economic relationship between risk and reward in drug development: As drug and biologic success rates—IND filing to FDA approval—have been declining during the past several decades (a measure of increasing risk), so too have the total sales and the average daily sales generated per drug or biologic that enters the market (a measure of return).

The estimated value of the direct cost of a clinical trial delay day is less than half the inflation-adjusted 1990s figure, suggesting that certain direct costs may be lower today (e.g., operating, procedural and technology costs). The estimate may also reflect intensifying demand that sponsors and contract research organizations place on investigative sites to drive operating efficiencies and work harder with lower relative study grants. It’s important to note that this cost estimate does not include sponsor company indirect personnel and infrastructure costs.

We hope that this analysis will inform those interested in using up-to-date figures derived by Tufts CSDD’s empirical methods. Our study results and analysis—published in detail in Therapeutic Innovation and Regulatory Science—include important subgroup distinctions to promote and inform more appropriate use of the updated figures, including the value of a delay day by therapeutic area.

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

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