Tracking Trial Cost Drivers: The Impact of Comparator Drugs and Co-Therapies - Pharmaceutical Executive

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Tracking Trial Cost Drivers: The Impact of Comparator Drugs and Co-Therapies


Pharmaceutical Executive


Measuring the problem

A three-part data collection tool was designed by Tufts CSDD to collect general company information, overall perceptions about sourcing comparators and co-therapies, and company-specific study data and costs. Tufts CSDD researchers collaborated with participating companies in developing the data collection instrument for the study. Definitions for specific types of trials using comparators were agreed upon by participants and included with the data collection instrument.

General company information included comparator function capacity; the overall reporting structure within R&D or commercial operations; and strategies typically used for sourcing comparators (e.g., the use of central, local, or mixed models).

Participating company perceptions were gathered using open-ended responses and focused on the challenges associated with sourcing comparator drugs and co-therapies. Areas of impact that were explored included regulations concerning IMP versus non-IMP and the use of generics as standards of care. Company practices and approaches to sourcing comparators were assessed as well as strategies for purchasing products from third party buyers or other pharmaceutical companies. Cycle-time data—including the average lead time from order placement to product delivery—was collected. Data on the timing and frequency of receipt of CoAs and CoCs was collected and examined for global differences and by manufacturers.

Specific study and cost data was gathered for clinical trials conducted in 2009, 2010, and 2011. Sponsor companies were also asked to estimate and forecast study time and cost data for clinical trials conducted and planned for 2012 and 2013. Data was gathered for head-to-head; co-medication; and standard of care trials. Study data was also examined for use of branded and generic drugs. Participating company budget data was collected including the total amount spent on clinical supplies and proportion of budgets spent on comparators and co-therapies.

Tufts CSDD also sought to collect data on the total volume and cost of co-therapy and comparator drugs not used during the course of the clinical trial. Additional data included total number of studies and revenue received from other companies (through use of their company's drugs); and total full-time equivalents (FTEs) or number of hours per month dedicated to working with other biopharmaceutical companies and third party buyers. Company strategies regarding purchasing products from third party buyer services and other biopharmaceutical companies were explored, as was company receptivity to selling comparators directly for use in head-to-head clinical trials. Data on 370 studies was collected and analyzed.


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