Contract Research Organizations
for clinical trials must be clear and predict-
able,” the authors noted. “There also must
be even more cooperation, collaboration,
and communication among regulatory
bodies, research sponsors, and CROs.” 1
Mr. Feldman pointed to TransCelerate
BioPharma, a non-profit organization formed
by pharmaceutical industry members, as a
leader in this effort. Since 2012, its mission
has been “to identify, prioritize, design
and facilitate implementation of solutions
designed to drive the efficient, effective and
high-quality delivery of new medicines.” 8
In 2015, TransCelerate released its
first Common Protocol Template (CPT),
a guideline for designing “harmonious”
clinical trial protocols. “Having a CPT will
ease protocol interpretation and review by
sites, IRBs, and regulators,” Dalvir Gill,
PhD, TransCelerate chief executive officer
explained. 9 “Protocols have become increas-
ingly complex and difficult to navigate, with
sponsors providing protocols in their own
structure. Sites spend time deconstructing
and interpreting protocols when that time
would be better spent with patients.”
The latest update to the CPT, issued in
December 2017, aligns with the NIH-FDA
Joint Leadership Council’s protocol tem-
plate, originally designed for NIH-funded
studies. “Following a harmonized template
will also e