Driving Drug Innovation and Market Access: Part 1-Clinical Trial Cost Breakdown

This is a three-part blog  that will highlight the challenges and opportunities of driving drug development through the lens of the clinical operations team and senior management.  We’ll discuss what the current breakdown of costs is, how you can immediately compile robust and meaningful data, and how to communicate (aka publish) this data to your audience.

The end first – There’s light at the end of the tunnel and it’s not a train!  Clinical trial costs are up but there are areas and ways to manage and even decrease them.  This means considering all the options that are available today and collaborating with experienced and progressive partners.  There is a realization that the process is evolving and technology is changing the landscape forever.

Where are we?  Drug development costs are increasing and the time it takes to bring a drug to market is becoming longer.  Also of consideration is the success rate for receiving regulatory approval to market your drug or device.  When we look at different therapeutic areas in Table 1, we see that the average cost of a Phase 2 clinical trial ranges from $7.0 million to $19.6 million, while the average costs of phase 3 clinical trials range from $11.5 million to $52.9 million.

Table 1- Average Cost per Therapeutic Area	Phase 2 Clinical Trials	Phase 3 Clinical Trials
Anti-infective	$14,200,000	$22,800,000
Cardiovascular	$7,000,000	$25,200,000
Central Nervous System	$13,900,000	$19,200,000
Dermatology	$8,900,000	$11,500,000
Endocrine	$12,100,000	$17,000,000
Gastrointestinal	$15,800,000	$14,500,000
Genitourinary	$14,600,000	$17,500,000
Hematology	$19,600,000	$15,000,000
Immunomodulation	$16,000,000	$11,900,000
Oncology	$11,200,000	$22,100,000
Ophthalmology	$13,800,000	$30,700,000
Pain and Anesthesia	$17,000,000	$52,900,000
Respiratory	$12,200,000	$23,100,000

 
What do the cost breakdowns look like?  More than $7 of every $10 dollars (phase 2 – 79.4% and phase 3 – 74.9%) is spent on administrative staff, clinical procedures, site monitoring and site retention.  Table 2 shows the breakdown by average cost center in both phase 2 and phase 3 trials of only two therapeutic areas, Nervous System and Endocrine.  I submit to you for consideration the costs wholly, and also by the broad summary area.  There are also the costs from the sponsor company, the clinical investigator sites, and those of the contract research organization (CRO).  Find and determine where the dollar is flowing to, what is the intrinsic value provided, and what options may be available to better execute that function.

	Phase 2			Phase 3
Table 2- Breakdown of Average Cost Center	Nervous System	Endocrine	Percent	Nervous System	Endocrine	Percent
Administrative staff	$2,960,027	$2,576,715	21.3%	$4,450,073	$3,940,169	23.2%
Clinical procedure	$3,243,374	$2,823,369	23.3%	$4,317,010	$3,822,352	22.5%
Data management	$131,667	$114,616	0.9%	$74,845	$66,269	0.4%
Patient recruitment	$354,002	$308,160	2.5%	$591,659	$523,865	3.1%
Patient retention	$33,917	$29,525	0.2%	$47,396	$41,966	0.2%
Physician	$839,130	$730,466	6.0%	$1,543,990	$1,367,074	8.0%
RN/CRA	$968,932	$843,459	7.0%	$1,800,901	$1,594,548	9.4%
Site monitoring	$2,379,608	$2,071,457	17.1%	$3,114,542	$2,757,668	16.2%
Site recruitment	$513,470	$446,977	3.7%	$757,481	$670,686	3.9%
Site retention	$2,475,872	$2,155,256	17.8%	$2,502,103	$2,215,404	13.0%
Total	$13,900,000	$12,100,000	100.0%	$19,200,000	$17,000,000	100.0%

 

What areas are ripe for disruption?  Now ask yourself, which areas are truly integral to the clinical trial process, and which areas exist because of the legacy model that is currently in place?  We can have spirited discussions about the benefits, risks, rewards and value of each.  In Table 2, we see that site monitoring, recruitment and retention account for approximately one-third (33.1% to 38.6%) of the average clinical trial cost.  This number approaches 50% when the physician and RN/CRA are added to it.  That means that $1 of every $2 is spent on maintaining the clinical sites and creating the audit trail and is not spent on the patient or patient behaviors.

So where do we go from here?  Now is the time to carefully look at which clinical process model you are utilizing and what other options are available today.  Certainly, there are therapeutic situations that demand 50 clinical sites or more for optimal study results.  There are also many therapeutic situations where very few clinical sites are necessary when the appropriate technology solution is utilized.

There are many options for the intelligent use of technology in clinical trial implementation and design.  The benefits include the breakdown of geographical barriers that hinder patient enrollment, collaborating with partner companies that can provide solutions to proactively identify patient behavioral issues that may impact protocol compliance and outcomes, and the need to compile and generate robust clinical and medial data to support market access and reimbursement decisions.

Coming up next Blog Tuesday,  October 4th, Part 2: Robust Data
And Tuesday, October 11th, Part 3: Strategic Data Mining

References:

1. http://ctj.sagepub.com/content/13/2/117.short?rss=1&ssource=mfr
2. https://www.nap.edu/download/12900
3. https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barriers-drug-development