Jeffrey Litwin, M.D. of ERT, a solution provider company at the marcus evans Evolution Summit 2012, on better patient recruitment in clinical trials. Interview with: Jeffrey Litwin, M.D. Chief Executive Officer, ERT

1. Overcoming
Patient Recruitment Issues in
Clinical Trials
otherwise be eligible. Criteria are often to ensure that patients have adequate
copied from another study and new information on both the benefits and
exclusion criteria for that particular risks of medications. The centralized
drug are added. Some of the collection of data would contribute to
exclusions that carry over from one better safety databases.
drug to another are inappropriate.
What often happens is a study starts What could CMOs take advantage
and the CMO finds that many people of today, to enhance or nurture
were excluded for an inapplicable innovation in this field?
reason. Re-writing the protocol ends up
being costly and time consuming. They have to look at the big picture,
how the drug or drug development
What is missing in clinical program fits into what is currently
Interview with: Jeffrey Litwin, M.D. development today? available in the marketplace and how
Chief Executive Officer, ERT they can create a marketing or labeling
Companies are not sharing their data. differentiation. What innovation is the
Many are working on similar drug bringing to the marketplace?
“Pharmaceutical companies can have compounds, when others have already
more success in drug development if found that they do not work. There are
they recruit enough of the right few publications of failed studies.
patients into their clinical trials,” says Pharmaceutical companies consider
Dr. Jeffrey Litwin, Chief Executive this information as a competitive
Officer, ERT. More time must be spent
on the inclusion and exclusion criteria,
so that eligible patients are not
advantage, but the reality is that the
industry is spending billions of dollars
on drugs that have proven
Re-writing
unnecessarily excluded, he adds. unsuccessful. Also, if a certain
compound has failed, it does not mean the protocol
ends up
From a solution provider company at that it would not succeed in a better
the upcoming marcus evans designed study or in a different
E v o l u ti o n Su m m i t 2012 , in formulation. At least other scientists
Wheeling, Illinois, April 30 - May 2,
Litwin offers his expertise into
improving patient recruitment, clinical
would have some data to work from.
Large pharmaceutical companies would
all benefit by sharing information on
being costly
trial success and innovation. their failures as much as their
successes. and time
What could improve the success
rate of clinical trials? What should they focus more of
their time on?
consuming
Chief Medical Officers (CMOs) have
to make sure that protocols are well Everyone is focused on drug efficacy
written, so that the inclusion and and labeling. Of course drug approval
exclusion criteria do not eliminate a is based on that data, but drug safety
large number of patients who would and pharmacovigilance are important

2. About the Evolution Summit 2012
The Pharma Network -
marcus evans Summits group
This unique forum will take place at the Westin Chicago North Shore, Wheeling,
delivers peer-to-peer information
Illinois, April 30 - May 2, 2012. Offering much more than any conference, exhibition
on strategic matters, professional
or trade show, this exclusive meeting will bring together esteemed industry thought
trends and breakthrough
leaders and solution providers to a highly focused and interactive networking event.
innovations.
The Summit includes presentations on the future of drug development, developing a
culture of safety and maximizing return on investment.
www.evolutionsummit.com
Please note that the Summit is a
Contact
closed business event and the
number of participants strictly Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits
limited. Division
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About ERT
ERT (www.ert.com) is a global technology-driven provider of health outcomes research services and customizable medical
devices supporting biopharmaceutical sponsors and Contract Research Organizations (CROs) to achieve their drug development
and healthcare objectives. ERT harnesses leading technology coupled with unrivaled processes and scientific expertise to collect,
analyze, and report on clinical data to support the determination of health outcomes critical to the approval, labeling and
reimbursement of pharmaceutical products. ERT is the acknowledged industry leader in centralized cardiac safety and respiratory
efficacy services and also provides electronic Patient Reported Outcomes (ePRO) and Outcomes Assessments for multiple
modalities across all phases.
For more information: www.ert.com
About marcus evans Summits
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For more information, please visit: www.marcusevans.com
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To view the web version of this interview please click here: www.evolutionsummit.com/JeffreyLitwin