Processes in multicenter study investigating safety and efficacy of combination drugs in patients with locally advanced or metastatic solid tumors amended successfully.
SITUATION
George Clinical was contracted by a small to mid-size biopharmaceutical company to conduct a Phase Ib open-label multicenter study investigating the safety and efficacy of combination drugs in patients with locally advanced or metastatic solid tumors. This trial was conducted over 15 activated sites, with a small patient population designed to be in ongoing expansion. In a trial of this type where peripheral blood mononuclear cells (PBMC) samples are collected from patients, the weight of the trial results depends on the accuracy, precision and reliability of data generated from these samples. The fragile nature of biological samples makes standardization of laboratory procedures an especially important focus, and there are many parameters that can affect data such as the time frame between sampling and processing, and storage/shipping temperature en route to the processing lab.
George Clinical provided a full-service approach to this trial which included the handling of patient samples but also a beginning-to-end support from feasibility and site identification and qualification, to patient concierge services including hotel arrangements, stipends and travel arrangements. This level of hands-on support was crucial in overcoming the many challenges faced.
CHALLENGES & SOLUTIONS
Challenge: Investigational Product (IP) Management
Initially the control drugs were not provided by the sponsor and required patient insurance to cover their cost. Waiting for authorization from patient insurance delayed randomization and added to screen failure rates. In addition, one of the control drugs in the initial batch had a short expiration date which created the potential of sites using expired drugs or not having adequate usable supplies when needed.
Solution:
The team at George Clinical was quick to realize that IP management would be critical to this study, and having established trust and rapport with the sponsor, was able to recommend that they assume responsibility for providing the control/combination drug. The sponsor agreed with the recommendation, and protocol was amended to clarify the IP management cycle of the control/combination drugs.
Our hands-on service also included initiating a system for sending drugs to sites on an “as-needed” basis instead of in batches as originally planned. This operational change increased site efficiency and ensured that all sites had viable supplies at the appropriate time to make the patient experience as convenient and comfortable as possible.
With these few incremental changes, patient financial and stress burdens were eased, sites were functioning in an optimum manner, and screen failures were reduced.
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