How to Speed Up the FDA Drug Approval System: Interview with: Bruce Thompson, President, Clinical Trials & Surveys Corp, a solution provider at the marcus evans Evolution Summit 2013, on how clinical trial data need to be managed for a speedy FDA approval.

1. How to Speed Up the
FDA Drug Approval System
those particular domains from which the
FDA drives all of its analyses. The goal
is to have as few iterations back and
forth with reviewers as possible.
What level of insight does Clinical
Trials & Surveys Corp have into
what information the FDA requires?
It is not
We have a good track record working
with the FDA and were responsible for
converting 51 HIV clinical trial
submissions (with multiple data sets)
so much
Interview with: Bruce Thompson, into a common set that FDA staff could
President, Clinical Trials & Surveys review on a meta-analysis basis.
Corp
The FDA has a 45-day period to respond
Chief Medical Officers (CMOs) must look
at how the data of their clinical trials
are going to be reviewed by the US
to the sponsor whether it will accept the
data as they were submitted. C-TASC
staff actually wrote software for the FDA
that helps FDA staff make that
the trial
Food and Drug Administration (FDA)
and ensure that the data they submit
can be analyzed quickly and efficiently,
assessment within the stated time
period. but the
way that
says Bruce Thompson, President, This means we know exactly what the
Clinical Trials & Surveys Corp. FDA reviewers are looking for and what
will speed things up. This innovation
From a clinical research company and insight goes beyond simple
data are
attending the marcus evans Evolution checking of the data set for outliers or
Summit 2013, in Palm Beach, Florida, consistency checks, which are mainly an
May 8-10, as a solution provider, Information Technology function, but
Thompson shares his insights into what ac t u a l ly b r i ng s i n a s ta t i s t i c al
FDA reviewers look for and how the
data submission process can improve.
component. This increases the likelihood
analyses will be approved on a first-pass
basis.
organized
that slows
How can CMOs speed up the FDA
approval process? What causes the most delays?
The FDA is moving its submission We have found that what delays FDA
down FDA
process towards the Study Data reviews the most are the ways adverse
Tabulation Model (SDTM), so CMOs events are reported and grouped with
need to be on board with the new MedDRA codes. Those data must be
methodologies in place for submitting organized from the start to the end of
approval
their data. the adverse event, with all the history
involved during the event, so that
The information needs to be collected statistical analysis can be done quickly.
and organized in a specific way. There
are 18 domains of data that the FDA When an adverse event is detected,
reviews, so the forms and data CMOs have to look at the specific
management systems have to be clearly elements of what happened during the
mapped into the SDTM format. CMOs treatment. That is difficult to do well
can utilise software packages that can within the SDTM framework, and it
map out their relational database into seems to hold reviews up quite a bit.

2. The Pharma Network – marcus About the Evolution Summit 2013
evans Summits group delivers
peer-to-peer information on This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May
strategic matters, professional 8-10, 2013. Offering much more than any conference, exhibition or trade show, this
trends and breakthrough exclusive meeting will bring together esteemed industry thought leaders and
innovations. solution providers to a highly focused and interactive networking event. The
Summit includes presentations on improving trial performance, establishing
strategic alliances, site selection and e-recruitment.
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Please note that the Summit is a
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About Clinical Trials & Surveys Corp
C-TASC, a CRO with extensive Statistical and IT services, has been coordinating studies, (especially pulmonary, cardiovascular, and
HIV studies) for nearly 25 years. C-TASC staff have also used their expertise to assist the FDA with the review, mapping and
analysis of new and legacy NDA datasets. Their award-winning rapid review system for NDA submissions is such an example.
www.c-tasc.com
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To view the web version of this interview, please click here: www.evolutionsummit.com/BruceThompson