Inceptua Q&A: Comparator Sourcing for Clinical Trials

What is a comparator?

A comparator is an investigational or marketed product (active control) or placebo (inactive control) used as a reference in a clinical trial. The term also refers to investigational medicinal products when the drugs are intended to be manufactured, repacked, or used outside of their registered indications.

Comparators are used in clinical trials to compare the efficacy of an investigational drug to the efficacy of an existing treatment. An active control might be used in conjunction with a placebo, or instead of it, depending on the type of clinical trial.

What is comparator sourcing?

Comparator sourcing is a strategic operation for the procurement of clinical trial materials worldwide: it requires a robust supply chain, forecasting operations, and logistics expertise.

Identifying and qualifying a broad enough sourcing network to meet the needs of a global trial can be prohibitively costly for sponsors. Thus, many clinical trial project teams require additional, specialized sourcing support, particularly when operating in emerging markets. Many choose to outsource their procurement activities to a partner who can provide greater insight and expertise.

Adding this additional link to the supply chain can add additional risk, thus choosing a reliable partner is essential. A good partner will work with the sponsor from the early stages of the project to create a robust sourcing plan, with contingency plans built in to ensure supply chain integrity, minimize the risk of disruption to the supply chain, and, most importantly, provide continuity of treatment for patients enrolled in the trial.

What are the key challenges associated with comparator sourcing for clinical trials?

Accessing Supply

Increasingly complex clinical trials mean increasingly complex sourcing plans. With multi-country studies involving large patient populations, ensuring comparators are available in the right quantity at the right time is both critical, and difficult to ensure. Adequate planning to take account of possible delays is essential.

To obtain large quantities of a product, a dedicated production can be necessary in order to meet requirements such as single batch and maximum shelf life, and manufacturers need time to plan this into their production schedules. Likewise, possible resupply for ongoing trials should be considered early to ensure manufacturers can guarantee supply.

Taking these lengthy timescales into account early on will help to minimize any delay to your trial.

Regulatory understanding

Regulations vary between countries and regions, and this can mean significant work for sponsors of multi-country trials.

For example, if a comparator drug isn’t commercially available in the country where the trial is taking place, there may be restrictions on importing it. Local regulators may require additional paperwork or licenses, and access to locally qualified staff can be essential to keeping supply chains moving. Products which are repackaged and blinded for control purposes may add even more complexity, with the regulatory approach shifting again.

Gaining a clear understanding of these possible hurdles early on will strengthen the supply chain, allowing sponsors to ensure their comparator supply isn’t disrupted or delayed.

Logistics (import/export)

Moving goods across borders is a complicated task in any industry, but the added concern over medicinal products destined for human consumption is substantial.

Trials are increasingly held in remote locations, so supply chains are often stretched across varied geographies and climates. Particularly where temperature-sensitive biologics are involved, logistics expertise is required to ensure that valuable comparator supply is able to reach the trial site without incident. Managing a large network of third-party logistics providers is often unrealistic for sponsors, thus working with a partner who has an existing network and can provide this support is often essential.

Cost implications

The cost of running a clinical trial is enormous. With sponsors under pressure to meet cost and waste targets, making sure the cost of comparators is within a reasonable limit is crucial.

A reliable source, a secure supply chain, and advance planning can all help sponsors work within budgetary limits and avoid the pitfalls which can lead to ballooning costs and unnecessary waste.

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