Defining and securing a comparator for clinical drug trials is an essential component for a successful operational outcome. Multipharma outlines the principles involved.
Traditionally, pharmaceutical and biotechnology companies have incorporated comparators within their clinical trials to demonstrate the safety, effectiveness and value of their new drug products or an existing drug product’s new indication. Comparative effectiveness is determined by a clear evaluation of the impact of different options available for treating a given medical condition for a particular set of patients. Generally, comparative effectiveness looks at the following areas:
- comparing similar treatments or competing drugs
- analysing different approaches; for example, surgery or drug therapy
- assessing the benefit/risk options and/or cost.
As such, sponsor organisations conduct global clinical trials using comparators to facilitate the evaluation of their comparative effectiveness. Comparators are commercial products or placebos used as references in clinical trials. They are also referred to as investigational medicinal products when the drugs are intended to be further manufactured, repackaged or used outside of their registered indications.
Comparator sourcing
Sourcing authentic comparators becomes more complicated when trying to secure material based on the clinical trial’s requirements, which can vary from needing multiple lots, short and long-dated inventory, to small and large quantities. Having access to information is one of the most critical strategy components needed, and the following should be considered: determine the complexity of comparator sourcing in the clinical trial; develop an executable yet flexible strategy; and select a sourcing option that best suits the clinical trial.
Although comparator sourcing is a small part of the overall clinical trial supply chain, it can be complex. Determining the complexity of the trial is arguably the biggest initial stumbling block. Thus, it is worth considering the following:
- identify which product is available in each region where the trial will be conducted
- assess the availability of the comparator and the forecasted quantities required in each region
- confirm product lead times and expiry dates
- understand the availability of and access to the necessary supporting documentation
- research the requirements needed for further manufacturing of the comparator
- recognise the source of the comparator
- strategically identify practical alternatives for any potential restrictions to supply.
Teams typically approach comparator sourcing by finding out what is available, seeking consultation to plan the best ways to secure the product, sourcing the material and managing the delivery of the comparator through the appropriate supply chain.
Sourcing decisions
Sourcing the comparator can be managed internally, outsourced or a combination of the two. Many teams source internally through on-site resources or through their trial sites, while others outsource the procurement of the comparator and associated activities to specialised comparator providers. But if the sourcing is not being managed within the sponsoring organisation, a bit of control and disclosure of trial information will have to be relinquished in order to take full advantage of a comparator provider.
When deciding who will source the comparator, first determine in-house capabilities and then evaluate core business functions and see if the team is willing to take on the task of sourcing the comparator and its associated activities. After evaluating these two items inquire about accessibility to information to facilitate the sourcing of the comparator, and consider how the project and time-management of the comparator and its associated activities will affect the overall clinical trial timeline.
The goal is to ensure that clinical trials are effectively executed with sound delivery of the comparator product and its associated requirements. Thus, after completing the comparator need assessment, ensuring that authentic material can be obtained, and using a secure, direct, safe and efficient supply chain, then the ultimate goal of supporting the comparator supply chain from receipt to reconciliation can be attained.
Chain reaction
As the number of clinical trials being conducted worldwide increases, so does the need to choose the best partner-providers. Lekishia Moffett White of Multipharma advises on how to secure every link in the supply chain.
Perhaps due to recent legislation, efforts to standardise regulations and the public attention being given to healthcare, it is acknowledged that clinical trials are increasing in number.
In addition, there is an overall industry requirement to compare the best-in-class competing pharmaceuticals so that the market is supplied with the best therapeutic remedy available, which is of high quality, safe, effective and affordable.
It has even been speculated that, by 2020, the number of clinical trials being conducted within the emerging markets of Asia, Eastern Europe and Latin America will be equal to that of the US and European Union combined. As a consequence, management option assessment for global clinical trials supply is now a requirement.
As a result of mergers and acquisitions, the number of partnerships that need to be developed within the industry has also increased. This has and will continue to amplify the complexity of managing the clinical trial supply chain.
Business plans and core business functions are being evaluated and strategic partnerships are being formed to ensure that all necessary capabilities required to manage such supplies are being fulfilled by the most qualified organisation.
The ‘five Rs’
Finding a partner with sufficient global reach and the ability to demonstrate a secure, reliable and repeatable supply chain will ensure delivery of the commonly identified ‘five Rs’ of getting the right material in the right amount to the right place at the right time in the right manner.
Unfortunately, the details surrounding the logistics and distribution of clinical trials supplies are often ignored. As a result, if not planned for appropriately, supplies will not be delivered to the patient as necessary. Point-to point and just-in time distribution as well as proof of supply pedigree are but a few of the characteristics of the supply chain that should be tested as reliable and traceable.
Consequently, adequate depot management and distribution of inventory should be verified and compliance to all applicable regulations and controls should be audited periodically.
A thought process to consider prior to entering into a partnership for the full logistical support of clinical trial supply management is as follows:
As a guide, consider the following requirements when assessing the capabilities of a partner to fulfil its duties as a provider of logistical support. Ask yourself:
- is clinical trial supply management a core competency and business function?
- Is the provider appropriately licensed/accredited?
- Does the facility have an international presence?
- Are appropriate procedures in place and can they be executed effectively?
- Does the site have adequate temperature and security monitoring systems?
- Does the facility have generator back-up capabilities?
- Are communication, emergency response and disaster recovery plans developed?
- Was the site visit/overall audit favourable?
Fortunately, there are several global organisations that can assist the industry by providing full logistical support of warehousing and distribution activities for clinical trial supplies. It is recommended that after confirming the complementing capabilities of the organisations involved, you further evaluate if a potential partner can:
- gather information and present flexible options via a global network
- provide transparency
- mitigate and control costs
- offer services in terms of project management
- give unbiased clinical trial supply advice
Each clinical trial should have its own distribution network that can securely deliver clinical trial supplies without incident to destination points. Therefore, in summary, have a standard requirement where policies, processes and procedures are in place and are being performed accordingly, and if a partnership with a specialised competent provider is required, ensure that they can deliver on the five Rs. Last but not least, have a viable back-up and an exit plan.