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Driving Drive Drug Innovation and Market Access – Part 2: Utilizing Technology and Maximizing Resources

October 4, 2016
Posted by: Joe Martinez, RPh, PDE, PPC

This is Part 2 of a three-part blog series that will highlight the challenges and opportunities of driving drug development through the lens of the clinical operations team and senior management. We discussed the current breakdown of costs in Driving Innovation Blog Part 1. In Part 2 we discuss considerations for utilizing technology and maximizing resources, and then in Part 3 we’ll look at how best to implement and communicate (aka publish) this data to your audience.

The end first – If you do the same thing, you can expect the same result! No time is better than the present to consider all options to increase the effectiveness of your clinical trial, including patient enrollment, enhance compliance, retention, and to ensure that your data is free from any behavioral and situational biases. In addition, considering small scale observational studies and even real world retrospective database reviews can provide compelling documentation and support for your current and short-term brand needs.

Where are we? As a former Medicaid Pharmacy Director myself, one of the first thoughts in my mind is “how does your clinical trial population of patients compare to mine AND will your outcomes be replicated in the population of patients that my program serves?” As a former leader of Medical and Clinical Operations, my second thought is “how can our clinical trial provide credible, robust and unbiased medical data to support an informed decision by health care decision-makers for favorable access and utilization IN a cost-efficient and timely manner?” Let’s talk more with the thought to answer those points in mind…as we look at Table 1 and the 10 clinical trial cost centers.

Phase 2 Phase 3
Table 1- 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 do options look like? In our two examples there is an average total clinical trial cost of $16.5 million. In our discussions going forward, we’ll use the CNS example to be conservative. Table 1 reflects the 10 cost centers generally observed in most clinical trails to date. The model these costs reflect consists of multiple clinical sites, multiple investigators, a large CRO provider and a legacy model of enrolling patients. This model also was dependent on the regulatory environment, incumbent support service companies and available technology at the time. So, what if we were to expand our vision and thinking to encompass newer potential options and technology, what would that look like?

What does the new ‘sand box’ look like? It’s a brave new world! Already more than a few clinical trials have been successfully implemented using an updated business model and newer technologies. You may have heard of Direct-to-Patient (DtP) clinical supplies management, where clinical medicines are delivered directly to the patients door. Shortly, you will be hearing more about Site-less CRO™ services, where the communications of the patient and the health care team are facilitated by a clinical pharmacist. What this means is that the costs of a clinical trial can be reduced by half or more. Yes, that means you can save $1 of every $2 in a clinical trial and potentially get better and faster data and outcomes to support the market access and utilization of your drug, device or procedure.

As noted in Table 2, more than 40% of the average costs are derived from clinical site activities, multiple physician investigators add another 6%, and administrative staff costs contribute another 20% of the total average clinical costs. In summary, potentially $7 million of a typical $13.9 million clinical trial can be saved for use elsewhere to support the brand.

Table 2 – Potential Savings by Cost Center Phase 2 Percent Phase 3 Percent
Nervous System Nervous System
RN/CRA $968,932 7.0% $1,800,901 9.4%
Site monitoring $2,379,608 17.1% $3,114,542 16.2%
Site recruitment $513,470 3.7% $757,481 3.9%
Site retention $2,475,872 17.8% $2,502,103 13.0%
Sub-total $6,337,882 45.6% $8,175,027 42.5%
 
Physician $839,130 6.0% $1,543,990 8.0%
Sub-total $7,177,012 51.6% $9,719,017 50.5%
 
Administrative Staff $2,960,027 21.3% $4,450,073 23.2%
Sub-total $10,137,039 72.9% $14,169,090 73.7%
 
Less 30% Efficiency
Net Potential Savings $7,095,927 51.0% $9,918,363 51.6%

 

So where do we go from here? The answer is not to just close down clinical sites or operate from one major site because these options have major risks and challenges to address. The answer may be to look to thoughtfully and strategically consider how to combine off-the-shelf technology with an experienced partner to collaborate on a clinical trial design. This design would create a protocol that allows the sponsor company and site-less CRO partner to proactively identify patients at risk for non-compliance and retention. Which would in turn help to drive robust outcomes in a real world context, and in a totally compliant manner.

Closing Thoughts – There is a need to define and address patient-centricity in clinical trials and all forms of health care today. The thought comes to mind of how to get a patient enrolled in a clinical trial, comply with the trial protocol, stay in the study for the duration, so the trial accurately reflects the actions of the drug, device or procedure in a real life situation. We must account for human behavior and the ‘hassle factor’ but we shouldn’t add to it and cause additional biases to influence our clinical trial results. In the end, people, companies and patients want to do the ‘right’ thing and we should provide an adequate and elegant vehicle and process to support that mindset.

Stay tuned for Part 3: Implementation and Communication

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

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