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Comparator local sourcing for clinical trials: Balancing opportunities and challenges

Whitepaper

There are several reasons why the market for comparators is growing. For one thing, more clinical trials are being conducted today than ever before and more of those trials are using active comparators. According to ClinicalTrials.gov, the registry of clinical trials underway in the United States and around the world, 47,448 studies of the 276,190 studies registered on the site were recruiting participants in mid-2018. By contrast, the total number of registered studies in 2008 was 35,742. The proportion of studies using comparators and co-therapies has also skyrocketed.

An estimated two-thirds of clinical trials today involve the use of comparators and co-therapies. The demand for reference drugs or so-called comparators is soaring as the volume, size and complexity of clinical trials reach record levels. Under pressure to source necessary quantities of these products within tight timelines and budget constraints, many supply chain managers are opting to go local. Comparators are increasingly used in clinical trials to establish that an investigational drug is more effective than an existing product, a differentiating factor that can be a prerequisite for licensure, formulary listing and healthcare reimbursement. On average, a sponsor spends a total of $50 million on clinical supplies, half of it for comparators, according to the Tufts Center for the Study of Drug Development.

This growing demand for comparators is causing many supply chain managers to explore available sourcing options. Two out of three polled during a recent webinar by Thermo Fisher Scientific indicated that they have either gone to local markets for sourcing comparators or are considering this as an option for a future trial. Those who have already taken the plunge into local sourcing cited a variety of reasons for their decision, including product availability, timing, obstacles to importing comparators in some countries, and regulatory and clinical requirements. Half of those queried said all of these factors influenced their decision to source comparator locally.

There’s no doubt that local sourcing of comparators can be a highly effective option under the right circumstances, but it’s not a one-size-fits-all solution. In some cases, local sourcing may be neither the best, nor the most economical choice. Savvy supply chain managers say deciding to source locally requires weighing factors that include the preferred comparator, the countries in the trial, and the requirements of the protocol. Furthermore, since executing any local sourcing strategy demands a high level of management throughout the trial, having the right internal resources in place—or the right partner to support local sourcing – is a crucial and often overlooked success factor. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.