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CRO Leadership Awards 2014

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LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2014 15 munications and issue resolution. Some roadblocks include competing incentives existing within traditional models, competing trials from differ- ent sponsors in the same disease area that impede enrollment, soaring costs in Western countries, increasing trial com- plexity, and lack of global harmonization in clinical and regulatory requirements, including study start-up procedures. How would you approach minimiz- ing the impact of these roadblocks on the successful execution of your trials? Regarding the internal roadblocks, the single most important consideration is strategic thoughtfulness. Specifically, there needs to be consideration of the right discovery approach to produce robust, differentiated compounds; the right selection of the initial indication most pertinent to and most likely to be responsive to a given pharmacological intervention into its pathophysiology; and use of the right trial design, power, and selection of dependent variables to detect and define the true effect of the medica- tion on the disease. Essentially, you need to be smart about how you pick the drug to test, the disease to test it in, and the things to measure. The regulatory hurdles reflect political and sociological concerns as well as the career incentive systems of the regulators. Hence, you need to accept that these barriers exist, only undertake programs where those barriers will not be fatal to your chances of success, and work closely with the specific regulators to ameliorate the overall problem as it pertains to your therapy. Every project must have a proper kick- off session to establish shared goals with clear roles and responsibilities agreed upon by sponsor and CRO. Frank, con- structive conversations must occur between all the parties to establish the team, with members agreeing to honor the team objectives. Most start-up ses- sions focus on the tasks to execute, not how the team will work together. In addi- tion, it is critical that both the sponsor and CRO agree to reward team members based on these shared objectives and goals. Each of the roadblocks identified above requires a specific focused approach, but for many of them, the challenges will not be completely overcome until we address the bigger issue relating to the business model for conducting clinical trials. In Western countries, conducting large-scale outcomes trials has become prohibitively expensive and inefficient. Novel approaches to the clinical trial model must be tested and explored, which include moving away from traditional clinical research settings at tertiary care centers to community-based locations that are closer to the patients we have Learn more about Tria OA solutions at CRFHEALTH.COM With Tria OA solutions, it's never been faster or easier to collect Clinical Outcome Assessments. 0 3 1 4 _ C R O _ R o u n d t a b l e _ F u t u r e 3 C . i n d d 4 0314_CRO_Roundtable_Future3C.indd 4 2 / 1 9 / 2 0 1 4 1 : 4 4 : 3 6 P M 2/19/2014 1:44:36 PM

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