The Joys and Woes of Clinical Trial Startup | Page 8

the inspection of sites, IRBs/ECs, and CROs.
»»Brazil has never had a negative result from an FDA audit.23
•  sian sites tend to be large hospitals that take enrollment quotas seriously, and
A
investigators often informally compete to see who can enroll the largest number
of qualified patients.
Investigators in “pharmerging” areas are often engaged in the science behind the
clinical trials, welcoming the chance to participate and, when possible, be involved
in the protocol development. These investigators, and their site personnel, are
usually enthusiastic, invested in the patient and the study, and very likely to strictly
adhere to the protocol (eg, inclusion/exclusion criteria) and perform administrative
tasks, such as returning required regulatory documents, on time.
Contracts
While some sites accept contracts from sponsors without making any changes, many
countries/regions/sites have specific requirements that must be met. For example, in Latin
America, sponsors usually are expected to cover anything that is considered standard
of care (background medications, routine lab work, etc.), not just the investigational
medication and any additional tests required by the protocol. Country-specific issues also
can arise when investigators want to keep biological samples, such as tumor or tissue
blocks, for their own work. Depending on national law, language detailing the ownership
of the samples, and under what conditions they may be used, may be included in the

Did you know?
In the last 10 years, the
number of FDA-regulated
investigators outside of
the US has increased by

15

%

3

contract. To simplify the process, some larger CROs have preferred provider agreements
with major hospitals, institutions, and physician practices.
Language Differences
With this global growth comes the need to translate clinical trial materials, often into
several different languages. Depending on the country and the IRB/EC, translation
may be needed for all or a subset of materials (eg, protocol synopsis, patient
questionnaire, packaging for the investigational drug, import/export permits).
While the translation process is generally efficient, the importance of local

clinipace.com

7