Comparative studies

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 worth of their new drug products or an existing drug product's new indication. Comparative effectiveness is determined by a clear evaluation or 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.

	A comparator provides a clear evaluation of the impact of different options available for treating a given medical condition for a particular set of patients.

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, and 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 needed 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 using 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. This will lead to a successful clinical trial outcome. 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.

Company profile

Multipharma

For further information, visit: www.multipharma.com