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.