Ahead of the marcus evans Evolution Summit 2016, read here an interview with Sonia Sethi discussing some of the metrics that measure clinical study health beyond the major milestones

1. Why Clinical Studies Should
Look at All the Metrics that
Lead Up to Major Milestones
Interview with:
Sonia Sethi, Executive Director,
Clinical Operations, Topstone
Research, Inc.
“Sponsors and Contract Research
Organisations (CROs) are often driven
by the major clinical study milestones,
but those do not necessarily correlate to
the overall health or success of the
study,” says Sonia Sethi, Executive
Director, Clinical Operations, Topstone
Research, Inc. “Just because a study
hits a milestone, this is not an indicator
of the quality or data integrity of the
study,” she explains.
Topstone Research, Inc. is a solution
provider at the marcus evans
Evolution Summit 2016 taking place
in Cologne, Germany, 9 - 11 November.
Why are sponsors and CROs driven
by the major milestones, and why
should they not be?
The milestones are often tied into their
contract, but in between those
milestones there are many metrics that
are a better indicator of whether the
study is on the right track. They should
not define a study by milestones alone –
they must take a step back, evaluate
and measure all the steps on a regular
basis. If they miss a milestone but other
indicators are on track, the study may
be just fine.
What are some of the metrics they
need to look at?
Having the first patient in is a major
milestone for everyone, but the reality
is you can achieve that by having one
site activated, but this does not mean
that you will hit your last patient in
date. However targeting to have 80
percent of sites activated, measuring
IRB approval processes and using tools
to speed them up is a better indicator of
study health.
For quality of data, individuals look at
overall queries generation, but that
should be broken down further, between
system and non-system generated
queries. A decrease in system gener-
ated queries at a site over time is an
indicator of a well trained and engaged
site.
As a CRO, our job is to train and
maintain sites so that these types of
queries decrease, ensuring a higher
quality of data is being entered.
Additionally most monitoring plans and
metrics are developed to be very linear,
once a site is up and running, the
monitoring plan says the CRO needs to
visit at a fixed interval, but that does
not take into consideration how many
patients are at a site, how much data
there would be to monitor, and the
quality of the site.
Monitoring plans should be more flexible
to allow the Project Manager to
determine the proper amount of
monitoring needed on a site by site
basis.
Other metrics that people should
consider is the conversion of pre-screen
activity to screening and randomisation,
so that we can better support those
activities that would result in evaluable
patient into a study.
Essentially there are many other metrics
and trends that we can look at and need
to look at to ensure that, not only we
reach the major study milestone but
that quality and integrity is also upheld
through the whole study.
What do you consider a well-run
study?
A good study does not mean that there
are no delays or issues, but that you are
well aware of them, and can be
proactive in minimising the impact
rather than reactive.
A
successful
study is
not defined
by major
milestones
alone

2. About the Evolution Summit 2016
The 14th annual Evolution Summit is the premium forum bringing elite buyers and
sellers together. The Summit offers clinical research leaders and global CROs an
intimate environment for focused discussion of key new drivers shaping drug
development strategies. Taking place at the Cologne Marriott Hotel in Germany,
9 - 11 November 2016, the Summit includes presentations on optimal clinical
management, harnessing health IT, individualised healthcare, and deploying digital
tools to better understand and serve patients.
www.evolution-summit.com
Contact
Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com
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About Topstone Research, Inc.
Topstone Research is a unique, multifaceted North American organization comprised of a CRO, clinical trial facilities and medical
clinics with an unwavering commitment to quality and service flexibility. Headquartered in Canada, our team of research
professionals throughout Canada and the USA have extensive clinical research experience working for both sponsors and CROs.
www.topstoneresearch.com
About marcus evans Summits
marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss
strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to
individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
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To view the web version of this interview, please click here:
http://events.marcusevans-events.com/evolution2016-sonia-sethi
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