TRENDS AND CONSIDERATIONS IN GLOBAL CARDIOVASCULAR DRUG DEVELOPMENT | Page 10

percent in Argentina (to 112 trials).

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Lower investigator fees and rapid enrollment

opportunities may be offset by higher costs for investigator and site training, for
post-trial medications, and for operational costs such as language translations,
requirements for clinical trial insurance, and import/export fees.
Regulatory Considerations. Despite regulatory harmonization and wide
acceptance of ICH/GCP standards in emerging countries, variations in regulatory
requirements still pose challenges for multinational programs. Key considerations
for sponsors include local ethical standards, study approval timelines, and
requirements to conduct trials in local patient populations for product registration.
Compared to North American and European sites, emerging nations often have
stricter ethical standards aimed at protecting large populations that are vulnerable
due to poverty and illiteracy.
In Latin America, for example, sponsors must provide clinical trial insurance to
compensate subjects in the event of harm resulting from the administration of
study drug or from study procedures. Sponsors also must continue to provide
study medications that have demonstrated benefits for subjects who have
participated in research after the study is completed; this provision includes, for
example, marketed comparator drugs required by the study protocol and used
during the trial. Informed consent processes are rigorously scrutinized,
particularly in those countries that require involvement of ethical approval boards.
In Brazil, for example, the wording of the sections on confidentiality and
compensation for injury are commonly questioned by the National Ethics
Committee during the study approval process.
Start-up times from final protocol to regulatory approval are notoriously slow and
tend to be less predictable in some emerging countries. Approval times can range
between 3 to 9 months in Russia, for example. Average approval times range from
3 months in Georgia, to 5.5 months in Belarus and 6.5 months in Croatia. Approval
takes from 6 to 8 months in Brazil. In India, overall timelines average 5 months for
study start-up. By comparison, approval times average 3.5 months in Canada and 5
months in EU nations. In emerging countries, rapid patient enrollment often