TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 9

face committee meetings. Ideally, integrated IT platforms enable work with
international review committees using the best physicians for a therapeutic area,
and reduce cycle time for review committees to conduct assessments. Integrated
platforms can improve data quality using eCRFs and online edit checks. Sponsors
can access adjudication results instantly. Another advantage of integrated
platforms is the capability to use the same data system for safety and monitoring.

Considerations in the Conduct of Multinational CV Trials
When selecting sites for multinational cardiovascular development programs,
sponsors must address a constellation of factors in addition to disease prevalence
and the availability of appropriate patient populations. Country-by-country
considerations should include the impact of local regulatory requirements,
standards of care, and operational infrastructure pertaining to clinical trial
supplies and Internet-based technology platforms.
Site Selection: Mature vs. Emerging Venues. Key considerations in international
site selection include the availability of experienced cardiovascular investigators,
recruitment incentives, and regulatory costs. Mature regions offer high levels of
investigator experience but also require higher investigator and submission fees.
Wide access to treatment and reimbursement tend to discourage patient
participation, resulting in high recruitment costs and slow enrollment. Emerging
countries offer less CV research experience, but physicians have strong incentives
to participate in trials, both to gain experience and to offer patients treatment that
is not otherwise available.
In many emerging markets, compensation is not permitted for subjects, but
compensation for participating institutions is a strong incentive. High population
density and centralized national healthcare systems facilitate rapid patient
enrollment in cities such as Sao Palo, Brazil, and Mexico City. Latin American
countries are gaining recognition for increasing numbers of trials and high data
quality. For example, between 2005 and 2009, the number of trial starts increased
58 percent in Brazil (to 241 trials), 49 percent in Mexico (to 158 trials), and 16