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W-11: Innovations in the Management of Study Drug Inventory Through a Web-Based System

Poster Presenter

Nigel Scott

Analyst
Centers For Disease Control and Prevention (CDC)
United States

Objectives

Describe an innovative solution to the management of study drug inventory for an international clinical trial, using a combination of statistical simulations, knowledge of approval requirements for drug importation, and a web-based system, all set in an environment of limited human resources.

ORAL PRESENTATION: 12:30PM

Method

Collaboration of an interdisciplinary team to implement a technological solution to the cyclical process of stocking sites with study drugs to: submit online restock requests; estimate study drug stock-out times; account for local approval/delivery times; send sites reminders to submit next request.

Results

Tuberculosis Trials Consortium (TBTC) Study 31/AIDS Clinical Trials Group (ACTG) A5349 is a phase 3 clinical trial evaluating shortened regimens for treatment of drug-susceptible tuberculosis (TB) at 31 domestic and international sites. Prior to May 2017, a 3-person team at the TBTC Data and Coordinating Center (DCC) manually managed study drug inventory. Drug management challenges in large international trials include: navigating import permit regulations at international sites; tracking study drug supply, and their expiration dates, at study sites to maintain steady recruitment; and providing an easy and reliable platform for sites to manage local drug supply and request re-supply. Recognizing these challenges, the DCC assembled an interdisciplinary team to design and implement a more efficient approach to drug management. The team developed an online Drug Management Module (DMM) that 1) provides automatic restock reminders, based on statistically simulated study drug stock-out dates, and accounts for local shipment approval times; 2) supports restock requests via a user-friendly web-based system; and 3) provides data entry screens for confirmation of study drug receipt and real-time status updates, allowing study drugs to be immediately available for assignment to study participants. We compared 89 completed shipments processed using the new DMM (May 2017 - December 2017), to 81 shipments processed manually in the 8-month period prior to DMM deployment (September 2016 - April 2017). Of these shipments, 6.7% resulted in a stock-out under the DMM, compared to 18.5% with the manual process. The average days between restock request and submission to shipper are 2.2 and 6.8, for DMM and manual processes respectively. This translates to a 68% decrease in time spent by DCC drug management personnel on shipment processing. On average, study drugs were available on the same day received at site using DMM process, compared to 2.9 days after receipt under manual process.

Conclusion

Effective study drug management procedures are critically important in the conduct of large clinical trials. Efficient supply procedures allow clinical sites to recruit consistently, without pauses or losses in enrollments. Lack of such procedures, results in extended enrollment periods, increases clinical trial costs, and may reduce confidence in the study, for both study site personnel and potential study participants. The combination of simulations to estimate the timing of study drug stock-outs at clinical sites, use of import approval timelines provided by international site pharmacists, and a user-friendly online system, provides a unique and innovative solution to the management of study drug inventory. The design and implementation of the DMM improved our drug management process through addressing targeted challenges identified. The DMM also allows timely re-supply of study drugs to clinical sites in S31/A5349, reducing the proportion of shipments linked to site shut-downs because of stock-outs by 64%. The development of the DMM has contributed to overall cost reductions and increased productivity with improved efficiency in drug inventory management, allowing DCC personnel more time to focus on other drug management issues. The design and implementation of the DMM provides TBTC DCC with more efficient procedures in the management of study drug inventory in S31/A5349, and has set a new standard for these processes in future TBTC studies. The underlying concepts implemented in the DMM can be applied to clinical studies outside TBTC, for which there is a need for management of study drug inventory, in settings of limited human resources.