By Ed Miseta, Chief Editor, Clinical Leader
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Can having the right drug distribution strategy help to significantly reduce the cost of clinical trials? A study conducted by eClipseCRO has shown that it can, with quite impressive results. The study, released earlier this year, was designed to provide a comparative analysis between two identical Phase 3 studies, each with a total enrollment of 300 patients. According to Leslie Bihari, president and CEO of eClipseCRO, both studies were conducted with identical study designs, drug administration schedules, clinical technologies, and sites. The only variation in the studies was due to persistence of the disease condition (chronic versus acute) and the strategy used for the packaging and delivery of the drugs.
“One of our goals in comparing the two studies was to figure out a way to bring down the overall cost,” says Bihari. “But at the same time we saw the opportunity to use technology to also improve both product quality and patient safety. Those were the critical factors on which we focused.”
The acute study followed a traditional warehousing approach while the chronic study leveraged integrated distribution with on-demand packaging. The warehousing approach meant a predefined amount of kits were packaged and shipped to each site on activation. A fixed amount was then stored in a warehouse for site resupply. Unfortunately, that approach also creates complications if sites accrue at a rate that is different from what was predicted. Since medication kits are manufactured and packaged with a predetermined overage, this will add to the trial cost and lead times. Therefore, a different model was desired.
Control Product And Control Costs
|Leslie Bihari, president and CEO, eClipseCRO
The integrated distribution model (integrating the EDC and the IRT) and leveraged on-demand packaging for unbiased selection criteria that enrolled responders and excluded non-responders. It also accommodated custom dosing for each patient based on genetic and/or metabolic profiles. For this study, the cost of a kit was $1,250 with an additional $57 for ancillary supplies. The drug was a specialized dose with three stratification layers.
The integrated model provided many benefits to the client. “We were able to keep track of when patients enrolled,” says Bihari. “This enabled us to greatly reduce the amount of product that was shipped. If they had followed the traditional model, they would have put 300% more product on the shelf. The total savings resulting from the integrated model ended up being just under $1.3 million.”
One of the benefits of this method is that product does not have to be packaged for a specific trial, and a trial specific label does not have to be placed on the product. Product was being delivered across 12 different studies, with no labeling applied to any package until it was required for a specific study. This ended up saving a lot of product, since several trials ended up starting in a different order than what was expected. “Trial A ended up being the fifth trial to get started,” says Bihari. “If we had packaged and labeled all that product, it would have been wasted because of the short expiry date.”
The Changing Aspect Of Trials
How trials are being supplied is changing for many reasons. Adaptive trials and the use of genetic information are impacting models. Today, business processes are being integrated along with the technologies. “Never before have we been so involved with the functions of packaging and labeling,” notes Bihari. “Patient screening information coming out of EDC can now automatically go to a lab partner where the results are run overnight. The very next morning a specialized product can automatically be shipped out to the patient based on those lab results. If you are still trying to use the traditional shipping model, the permutations of the amount of product you would have to ship and have on the shelves would be ridiculous.”
While Bihari is encouraged by the amount of money saved, he is quick to note that the takeaway he is most excited about is the ability to now enable tailored treatments to go out to patients. We can now put four units on a shelf versus the traditional model that required 20 to 25 units. This is what results in a much smaller bill for the sponsor to foot.
When working with a lab, patient safety is also enhanced. With the amount of information available to the lab, potential drug/drug and gene/drug interactions which could negatively impact the health of the patient are noted. A medical monitor can then make a call to the primary investigator at the site. These conversations could result in additional tests and/or drug or dosage changes. This has resulted in a code being put in place, which must be obtained before the medicine can be delivered to the patient.
For the 800 patients in this study, three required interaction from the medical monitor. Two required no additional interaction, but the third one involved a drug/drug interaction that could have caused a problem. After closer review, it was decided the patient would not be included on the study. In a traditional provisioning model, that product would have already been delivered to the patient.
As far as the costs are concerned, most of the savings were in the area of waste (56%), ancillary supplies (13%), and routine monitoring (7%). The majority of the waste was the result of returned product, damage, and expiry. The integrated distribution system resulted in less waste in all areas measured, with 100% savings on waste due to expiry and relabeling.