FEATURE
types of patients who enter and stay on trials
reflect those we see in practice,” he said.
CROs share the same goal, Mr. Feldman
noted, but the solution to relieve some of
the burden of clinical trials will have to
involve all responsible parties, including
pharmaceutical sponsors, regulatory agen-
cies, and research sites. “There are many
ways for clinical investigators – individually
and as a group – to engage in the dialogues
around facilitating a research enterprise
that is more appealing to patients and less
burdensome to investigators,” he said.
In a report reviewing the present and
future states of clinical trials, ACRO recom-
mended several policy changes “to ensure
that there remains an atmosphere conducive
to innovation and medical research and
development.” 1 These include:
• updating ClinicalTrials.gov (the U.S.
National Library of Medicine’s database
of trials) to be more user-friendly
• integrating electronic health records
with the federal database of clinical
trials to assist patient recruitment
• extending research-and-development
tax credits
• clarifying regulations identifying which
party is responsible for compliance
One of the recommendations emphasizes
CROs’ desires to improve working relation-
ships with regulators and sponsors: “[Make]
it explicitly clear ... that regulators, trial
sponsors, and CROs may communicate
before and during trials will improve trial
outcomes, advance the adoption of adaptive
trial designs, and promote a culture of in-
novation within the FDA itself.”
“For more trials to be successful and for
investments in trials to pay off, regulations