Drug supply professionals concur that the increasing use of comparator drugs and co-therapies in clinical studies acts as
a strong counter to company efforts to rein in the rapid growth in drug development spending. TransCelerate Biopharma, a consortium
of 10 Big Pharma companies committed to improving the overall efficiency of the R&D process, is putting new focus on the high
cost and incidence of comparator drugs and co-therapies in clinical trials.
The current climate reflects intensifying market competition and regulatory reform as more trials are being conducted to compare
the safety and efficacy of investigational treatments against a standard of care. Although comparative effectiveness studies
of new drugs are still relatively new, sponsor companies are including commercial comparator drugs in their clinical studies
to position their drug against a competitor. In some cases, regulatory authorities still require comparisons with a placebo.
However, as sponsor companies target more difficult chronic and terminal illnesses, comparisons with a placebo may be unethical,
making a commercial comparator drug necessary. Moreover, many clinical trials now test the efficacy and benefits of co-therapies
on diseases that have historically not responded well to single therapies (e.g., HIV and oncology).
Based on a decade of experience, investigational drug supply chain professionals note that sourcing and managing comparator
drugs and co-therapies is difficult, risky, and costly. The cost to acquire comparator drugs and co-therapy drugs is high
as study sponsor companies often must pay retail prices instead of wholesale or discounted prices. In many instances, sponsor
companies are unable to secure comparators and co-therapies directly from a competitor. As a result, sponsors must rely on
vendors/wholesalers and the principal investigators at each research center to purchase comparator and co-therapies, and also
through local pharmacies. As newer and more sophisticated therapies enter the market (e.g., biotherapeutics and stem cells),
the cost for comparator and co-therapies is expected to escalate sharply. Also, the supply of these products will likely be
curtailed due to the complex manufacturing processes.
Sourcing comparator drugs and co-therapies often results in substantial delays and increased study cycle time. Planning and
managing decentralized global sourcing activity poses logistical challenges—particularly with comparator drugs and co-therapies
requiring unusual storage and shipping requirements. Obtaining comparator and co-therapy product documentation, handling resupply
shortages and delays, and maintaining supply chain security particularly against counterfeit drugs are but a few of the many
challenges introduced by comparator and co-therapy sourcing.
Despite mounting concern and increased attention to the rising prevalence of comparator and co-therapies in clinical trials,
little data exists that quantifies current practices and characterizes the current situation and key trends. In response,
the Tufts Center for the Study of Drug Development (CSDD) conducted a study among 11 major pharmaceutical companies in late
2012 to gather benchmark metrics.