Comparator and co-therapy sourcing practices
Overall, the clinical supply function is managing varying levels of comparator sourcing using a variety of approaches. The
average clinical supply chain function has 246 full-time employees with three full-time staff dedicated to comparator and
co-therapy sourcing. Participating companies note that clinical supply functions typically report into clinical operations.
Clinical supply functions have increased the number of personnel dedicated to working with other biopharmaceutical companies
and third party buyers. Participating companies indicate that they have added on average one new FTE between 2009 and 2012
to work with wholesalers, for example.
Participating companies indicate that there is wide variation year-over-year in their comparator and co-therapy sourcing costs.
Few organizations are routinely collecting metrics on the specific use and expense of comparator and co-therapy drugs. Estimated
participating company spending on comparators in 2012 alone ranged from as little as $10 million to as much as $120 million.
On average, participating companies spent a total of $50 million per year on clinical supplies with half of the entire clinical
supply budget spent on comparator drugs and co-therapies. For several participating companies, 2011 forecasts for budget planning
purposes fell in the $150 or $200 million range, but actual spending was typically lower. Participating companies were unable to breakdown spending by clinical research phase.
Less than 40 percent of clinical trials did not include a comparator or co-therapy in 2012—a proportion that has been gradually
declining during the past four years. During that same period, the proportion of studies involving head-to-head comparator
drug trials has been rising to nearly 60 percent of clinical studies in 2012. (Figure 1). And the percentage of studies using
non-commercial presentations (e.g., bulk supplied or active and placebo) supplied by the competitor and co-medication commercial
comparators (e.g., HIV cocktail) has increased from 0 percent to 5 percent of clinical studies between 2009 and 2012. The
total proportion of comparators and co-therapies represents nearly two-thirds of all clinical studies in 2012.
Figure 1: Percentage of studies conducted using various comparators from 2009 to 2013.
The study results indicate that a growing proportion of comparator and co-therapy drugs are centrally sourced (Figure 2).
Whereas participating companies locally (via investigator) sourced 66 percent of their studies involving comparators and co-therapies
in 2009, only 30 percent did so in 2012. At this time, participating companies report centrally sourcing comparators and co-therapies
for 70 percent of clinical studies that require them.
Figure 2: Percentage of studies conducted using centrally and locally sourced comparators.
A number of factors reportedly influence whether to source comparator and co-therapies locally or centrally. Commercial availability
within a given market, risk of counterfeits, and local regulations and infrastructure are top factors dictating which sourcing
strategy is required.
Branded comparator and co-therapy drug use in clinical trials is far more common. Nearly 90 percent of all studies are sourced
with higher-priced branded co-therapies and comparator drugs. This proportion has not changed between 2009 and 2012.
Data on the amount of comparator and co-therapy drug wasted or unused in clinical studies could not be gathered. Participating
companies are unable at this time to reliably provide this metric. But anecdotal reports based on conversations with senior
sourcing managers suggest that a substantial proportion—ranging between 30 percent and 55 percent—of purchased comparator
drugs and co-therapies are leftover and unused when clinical studies are completed or terminated.