Driving Drug Innovation and Market Access – Part 3: Implementation and Communication

This is Part 3 and the final blog of a three-part blog series that highlights 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 and Utilizing Technology and Maximizing Resources in Part 2. In Part 3 we’re going to look at how best to implement and communicate (aka publish) this data to your audience.

The end first – “If I had asked people what they wanted, they would have said faster horses.” Henry Ford

The question that begs to be answered is:  Are we really tied into a legacy model of doing things or should we explore and evolve to transform our industry and patient healthcare?

Where are we now? Let’s start with Table 1 where the average ten cost centers have been broken down into our two therapeutic area examples. We can see here that clinical sites account for approximately 45% of clinical trial costs; physician services account for 6% to 8 % and other administrative staff add on another 20%. Is it possible that a good percentage of these funds and efforts could be better spent by redirecting them to the patient or reallocating to other projects of the sponsor company?

Table 1- Breakdown of Average Cost Center	Phase 2			Phase 3
	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 are the alternative options? Wearing the hat of the pragmatic manager and conservative decision-maker, my stance would be, a 50% savings in any clinical trial is great. I would however question if such a savings is realistic and if the trial could be smoothly implemented through completion. The good news: the answer to both questions is yes. How? The direct-to-patient process using a site-less CRO.

How much do advanced clinical trials cost today? As you can see in Table 2 below, the more advanced the clinical trial, the greater the cost using traditional trial models and CROs. And these costs continue to rise for various reasons. The only way to reverse this trend without cutting corners is to enlist the direct-to-patient site-less CRO approach.

In short, this is a truly patient-centric model; clinical medicines are delivered directly to the patient’s home and where a specially trained clinical trial research pharmacist (CTRP®) coordinates all communication between the patient and the healthcare team. A combination of technology and personal contact ensures that the patient is engaged, knowledgeable and empowered to succeed within the trial protocol parameters. In addition, a strategic set of SOPs are followed to ensure compliance with all regulations, patient privacy and to generate robust and unbiased data.

Table 2 – 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

 

Closing Thoughts – The standard continues to be the data of the randomized controlled trial (RCT). As we all know from experience, it is becoming more difficult to enroll patients and then to retain these patients in ongoing studies. As an industry, we need to explore ways to ensure that the clinical trial process is as simple and cost-effective as possible. This benefits the health and well-being on our trial patients, and also contributes to the quality of life for all patients that may benefit from the drug discovery process.

You may also want to consider a prospective or retrospective medical database review and analysis to supplement your brand documentation in the future. There are many benefits to conducting a retrospective database review that include, decreased time, increased cost-effectiveness, specific population analysis and the ability to address that critical question for a decision-maker. Best Wishes and Good Hunting!

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