As clinical trials continue to improve their operational efficiencies,
R&D must keep pace to move forward with their prodigious output of new
products and to insure commercial success, says Kenneth Kaitin, director of the
US Tufts Center for the Study of Drug Development (Tufts CSDD), which produced
the study, Tufts CSDD Outlook 2014.
To give you an idea of just how slow pharma moves, Kaitin pointed out that
the drug development model has not fundamentally changed since 1962, when U.S.
Senator Estes Kefauver and Representative Oren Harris’s Drug Efficacy Amendment
established the current standard for clinical testing of investigational drugs
in the U.S.
Chances are the name Estes Kefauver is not familiar to the majority of
people reading this blog. But in his day, Senator Kefauver was a mover and
shaker in the power corridors of the nation’s capital. Beloved by progressive
Democrats, he was also famous for wearing his trademark coonskin cap, which
prompted the Davy Crockett craze of the 1950’s (I had one).
To move forward from the past and to be in sync with today’s clinical
design improvements and pharma’s new, progressive partnership models “will
depend on the development of industry best practices, which will enable
companies to maximize their formidable R&D investment and help ensure
future commercial success,” suggests Kaitin.
Kaitin also pointed out the other highlights from the outlook for the
coming year, including:
• A growing concern over expensive, late-stage clinical development
failures will lead firms to reassess their use of meta-analyses and subgroup
analysis and make more realistic assessments about the likelihood of candidate
success.
• Adoption of adaptive clinical trial designs will accelerate, particularly
in earlier clinical phases, as cross-functional teams within sponsor companies
look to increase program success rates while lowering costs and disruptions
from protocol amendments.
• The U.S. Food and Drug Administration will foster greater use of
patient-reported outcomes to support labeling claims in drug applications and
make greater use of social media and the Internet to communicate with patients,
caregivers, and patient advocates.
• Sustaining the recent pace of investments in new biotech companies will
be a major challenge in 2014, spurring further development of alternative
financing approaches, e.g., industry based venture capital groups and patient
support foundations.
• More approvals of co-developed companion diagnostics and therapeutics are
likely, but diagnostics without evidence of positive impact on health outcomes
will continue to face reimbursement challenges.