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.