FEATURE
therapeutic prevention and treatment
options.” The CTTI’s strategic plan involves
“transformative and incremental change” in
evidence generation, patient recruitment,
and protocol development. 10
Since its founding in 2008, it has com-
pleted more than 25 projects, supported in
part by funding from the FDA, that explore
new practices that could correct the inef-
ficiencies in the research enterprise. These
projects have produced several official
recommendations, outlining actions regu-
lators, CROs, and investigators can take to
improve the clinical trials enterprise.
The first official recommendations,
issued in May 2011, tackled improving AE
reporting – one of the most pressing con-
cerns cited by Dr. Wei and other researchers
who spoke with ASH Clinical News. Their
recommendations include decreasing the
volume of uninterpretable and irrelevant
safety reports to investigators (through
changes to FDA policy) and supplying
investigators with meaningful reports that
would improve their understanding of a
drug’s safety profile. 11
Dr. Khorana echoed these sentiments,
deeming it important for the monitors
“to focus only on AEs that are relevant [to
the investigational drug], rather than on
every AE a patient experiences.” Because
of the pay-by-query incentive models most
organizations use, CRO associates also feel
compelled to escalate issues to the trial’s
principal investigator on a whim.
Abolishing these financial incentives is
at the top of Dr. Wei’s CRO wish list, too. He
believes any effort to address the concerns of
research teams would go a long way toward
improving the clinical trials process – and
the validity of its results.
Today, CROs are a multibillion-dollar
industry. Their market was worth $25.3
billion in 2013, about one-fifth of the $130
billion that pharmaceutical companies
spent on clinical research and develop-
ment that year. Projections estimate
that CROs will take over 70 percent of
clinical trials by 2020. 12
Clearly, CROs are here to stay, and
the entire research community needs to
figure out how to work with each other,
Dr. Wei agreed. “I’m not interested in
eradicating or bashing CROs. I’m worried
that financial rewards are driving bad
behavior,” he said. “I accept that we need
CROs, because regulators need to have
confidence in the results being produced,
but I want to emphasize that we need a
balance between quantity and quality of
clinical trial data.” —By Nicole Lou ●
REFERENCES
1. Association of Clinical Research Organizations. “Clinical
Research: A Legacy of Innovation, A Future of Trans-
formed Medicine.” Accessed February 21, 2018, from
www.acrohealth.org/wp-content/uploads/2014/10/
acro-white-paper-tah10.pdf
2. U.S. Food and Drug Administration. “FDA and clinical drug trials:
a short history.” Accessed January 20, 2018, from www.fda.gov/
AboutFDA/WhatWeDo/History/ucm304485.htm.
3. Roberts DA, Kantarjian HM, Steensma DP. Contract
research organizations in oncology clinical research: chal-
lenges and opportunities. Cancer. 2016;122:1476-82.
4. Pleiss D. “CROs: a universal problem.” ASH Clinical News,
January 2018. Accessed January 20, 2018, from www.ash
clinicalnews.org/perspectives/cros-universal-problem.
5. U.S. Food and Drug Administration. “Pediatric clinical
investigator training: GCP, BIMO, monitoring tips on
preparing for FDA inspection.” Accessed January 15, 2018,
from www.fda.gov/downloads/NewsEvents/Meetings
ConferencesWorkshops/UCM519807.pdf.
6. U.S. Food and Drug Administration. “Bioresearch monitor-
ing (BIMO) metrics – FY’16.” Accessed January 15, 2018,
from www.fda.gov/downloads/ScienceResearch/Special-
Topics/RunningClinicalTrials/UCM561049.pdf.
7. Le Gouill S, Rule S, et al. “Advocating for a return to com-
mon sense in clinical research.” ASH Clinical News, July
2017. Accessed January 11, 2018, from www.ashclinical
news.org/perspectives/advocating-return-common-
sense-clinical-research.
8. TransCelerate BioPharma. “Our Mission.” Accessed Febru-
ary 21, 2018, from www.transceleratebiopharmainc.com/
our-mission.
9. Outsourcing Pharma. “Updated common protocol tem-
plates align clinical trial objectives, endpoints.” Accessed
February 21, 2018, from www.outsourcing-pharma.com/
Article/2017/05/08/Common-protocol-templates-align-
clinical-trial-objectives-endpoints.
10. Clinical Trials Transformation Initiative. “Strategic Plan.”
Accessed February 21, 2018, from www.ctti-clinicaltrials.
org/who-we-are/strategic-plan.
11. Clinical Trials Transformation Initiative. “CTTI Recom-
mendations: Improving Reporting of Unexpected Serious
Adverse Events (SAEs) to Investigational New Drug (IND)
Investigators.” Accessed February 22, 2018, from www.
ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/
recommendations/saereporting-recommendations.pdf.
12. Vantage Partners. “Sponsor-CRO collaboration study:
executive summary.” Accessed January 27, 2018, from
www.vantagepartners.com/uploadedFiles/Consulting/
Research_And_Publications/Smart_Form_Content/
Publications/Articles/Sponsor-CRO_Collaboration_Study_
Executive_Summary_(2013-11-19).pdf.
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