Life Science Leader Magazine Supplements

CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 11 Demo Support & Sandbox Access Co-Marketing Opportunities Bid Defense and Audit Support Flexible Pricing Options +1.440.443.0082 D ATATRAK CONNECT ™ PARTNER PROGRAM D ATATRAK is adding even more value for our CRO Partners. Contact us to see how we can help you optimize your trial investment , from Concept to Cure ® . CRO to improving clinical trials. "If you really want the trial to go quicker, it actually requires more thinking up front," she says. The challenge is the changing of the mindset, because it feels like you are start- ing slower. "It is so much easier to quickly design a trial. Get it all started. Then make amendments one, two, three, and so on along the way," she states. "But how much money did we allocate by making the changes?" Heyrman notes that taking this approach is usually driven by what she describes as the "all-encompassing, first-patient-in syndrome" and doesn't result in the trial being completed any faster. However, it does result in costing more. It may seem cliche, but Anderson advocates spending 90 percent of your time on the planning component of the trial and 10 percent on the execution. In the planning phase, Katz suggests gaining a greater understanding of the practice of medicine in the field when conducting global clinical trials. "On the front end, we need to involve the right people, who may or may not be key opinion leaders, but who know the practice of medicine in the relevant regions and what is really feasible when designing the study from a practical standpoint." Anderson suggests a good place for start- ing the trial design is to begin with the drug label and work your way back. "I've got to make sure I have a good product package insert in order to give me a good drug label," he says. "This is going to allow me to get my product on the market. Further, a good label provides for a point of differentiation, which leads to greater commercial viability." To that end, Krusinska advises you to talk to the commercial side and get them involved early in the process. "Don't apply this approach to individual trials," she states. "You have to involve the commercial team across clinical development plans." Fiore adds, "We also need to think about reimbursement, so as to build in pharmacoeconomic elements as early as practically possible." Katz agrees. "Where we have to get a little smarter is planning for third-party payer involvement. We need to partner with them before we even start Phase 3 trials." The consensus is that the good old-fash- ioned wisdom on how to improve clinical trials can be described by the word simplify and the following principles: • Ask the right questions. • Spend more time on planning so as to come up with designs that make sense. • Gain alignment between industry and third-party payers for reimbursement purposes. • Gain alignment between industry and regulatory agencies so you provide them with what they want (see sidebar "Simplifying Clinical Studies Provides Spirited Debate"). In the words of Katz, "We have to get back to the basics." L 0 3 1 4 _ R o u n d t a b l e _ I m p r o v e . i n d d 6 0314_Roundtable_Improve.indd 6 2 / 1 9 / 2 0 1 4 1 : 4 1 : 5 7 P M 2/19/2014 1:41:57 PM

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