2022 年 2 月 18 日

Reducing Drug Management Costs: IRT-Enabled Medication Pooling

We have talked on many occasions about how IRT can help sponsors reduce the cost of drug management, by applying clever settings that reduce the amount of drug shipped to sites. One of those advanced IRT settings enables the management of pooled medication across trials that use the same compound(s).

Medication pooling is possible when more than one protocol operating at the same depot and/or clinical sites uses the same medication. Not only is it a good way to reduce medication wastage, but it is also an effective solution to address availability (scarcity) concerns or other restrictions that affect the supply of medication. When considering sharing medication across trials, sponsors have the option to apply medication pooling at depot level or at site level.

Sylvain Berthelot - Increase your Chance of Diverse Clinical Trial Enrollment through IRT

“Medication pooling is a good way to reduce medication wastage and to address availability concerns that affect the supply of medication.”

— Sylvain Berthelot, Technical Solutions Director, Calyx

仓库与研究中心层面的集中

Depot and site-level pooling have different supply chain and IRT setup considerations. The level where the pooling takes place will impact on kit labelling, depot supply management, and site supply management. Both levels also provide different savings potentials, site pooling offering the highest medication savings.

In simple terms, depot medication pooling consists of managing medication across trials at the depot but having protocol-specific medication at the site (even if the kit types are identical). On the other hand, site medication pooling results in managing medication across trials both at depot and site levels. 后一种解决方案始终被视为最佳方法,但在确定一组研究中用于所有事件的集中库存的大小方面可能会非常复杂。

How does IRT help?

Considering that it controls what medication is shipped from depot to sites, IRT plays a crucial part in the setup of medication pooling. In fact, IRT is one of the key enablers of medication pooling: it allows the use of the same medication across multiple trials, and it ensures each single trial “sees” the same pooled stock quantities, statuses, and locations. Maintaining those records accurately and in real-time is crucial to avoiding conflicting information and orders between trials. As such, IRT is a safeguard preventing issues in a medication pooling context.

Clinical supply managers will be wondering how supply strategies are managed in IRT. It will depend on the type of pooling applied for the program:

Depot-level pooling


When the IRT generates a new shipment request for a certain site, the medication selected to fulfil that shipment request is not pooled anymore, it becomes protocol-specific. This means that site supply strategies are applied at each trial independently and the IRT does not consider if the site already has medication of the same type that may have been shipped for another trial.

Site-level pooling


Shipment requests from depot to site take into account the needs across all the trials for which medication is pooled, so supply strategies should be built with this concept in mind. Supply strategies do not need to be identical across trials, although it may be useful to define the same strategy that works across the program. Our recommendation is to consult with an IRT expert to define the right strategy depending on the trial and/or program needs. With site-level pooling, adding a trial to the pooled program may require amending existing strategies for other trials in the program depending on how they have been setup.

在这两种情况下,补给算法仍可包括以患者为中心的预测性供应,以满足整个计划内持续的患者需求。

如果方案同时包括集合药物和方案特定的药物组合类型,或如果药物组合类型间的采购策略不同(一些药物在当地采购,而另一些则集中采购),则供应策略的界定会变得愈加复杂。凭借在临床库存管理方面的丰富经验,凯理斯供应管理专家不但深谙其中的最佳做法,并能灵活应用,进而帮助申办方满足各类不同要求。

结论

Both depot level and site level pooling options can help reduce drug wastage and study-specific supply management oversight, the site level solution being the most effective. These solutions will not apply to all programs, as there is a need to have sufficient overlap in same kit type requirements across protocols for it to be beneficial.

Sponsors also need to consider the impact on labeling and should refer to regulations in force across all countries included in each trial to make sure they follow the right recommendations. Having multiple labels on kits can become confusing to depots and sites, specific labeling solutions are likely to be required to reduce both confusion and risk of error.

Looking to the future, solutions such as e-labeling should help support medication pooling strategies, as an integration between IRT and the e-label could automatically update the protocol at the right time, reducing depot and site burden, and increasing compliance.


获取最新消息

不错过任何精彩内容。立即注册,接收涵盖行业新闻和其他相关信息的电子邮件,帮助您推进临床开发。

  • 此字段用于验证目的,应保持不变。
Powered by Translations.com GlobalLink OneLink Software