The business challenge: Looming drug shortage and a wasteful packaging strategy
The sponsor of a women’s health trial had succeeded in enrolling just over half of its target number of patients when it foresaw a major problem: the existing drug supplies would be reaching their expiration date before new supplies could be made available.
The sponsor had developed its own supply plan for the complex trial (which involved two patient cohorts and multiple treatment arms in each) and was following a block randomization scheme. There was potential to create unnecessary wastage if 1) a patient were to drop out of the trial early and 2) if the product expired mid-way through the patient’s treatment, in which case, it would have to be replaced with another year’s supply.
That second possibility became a reality when enrolment was slower than anticipated and existing supplies were due to expire before they could be used. At that point, the trial had enrolled 1,100 patients — 800 of whom were still dosing and would have to be provided with replacement Investigational Medicinal Product (IMP).
To make matters worse, the product was in short supply and would take months to replenish the stock. Meanwhile, the trial still needed to enrol another 700 subjects to reach its target randomization.
Recognizing that they needed help, the sponsor sought the advice of a solution provider with expertise in forecasting, packaging, labeling and distribution and they sought out the services of an IRT provider.
Download Almac Group’s latest case study to learn how every patient was dosed on schedule, and no new patient randomizations were delayed.