The Joys and Woes of Clinical Trial Startup | Page 5

Some countries also require import/export permits or material transfer agreements for
drug, lab kits, equipment, blood and tissue samples, etc. While the permitting process
is occasionally bundled with the regulatory approval, typically it involves a separate
application that requires about 1 month to process.4,12,13 Identifying, gathering, and, if
needed, translating the required documents as far in advance as possible will help keep
timelines on track.

When in doubt about approval requirements,
it’s best to ask.
The regulatory agencies in most countries, particularly those with a
developing clinical trial infrastructure, are usually amenable to presubmission meetings and will offer advice and insight into the process.
However, there is no substitute for employees or partners with local
experience and good working relationships with the regulatory agencies.

Patient Population »
With sponsors attributing at least 30% of all phase III early study terminations to
enrollment difficulties,19 identifying sites with sufficient populations of appropriate
patients is vital to success. Investigators have a tendency to over-estimate the
number of patients they can enroll into a specific protocol, so it is beneficial for the
sponsor or contract research organization (CRO) to have strong pre-study site visit
(PSSV) team and, when possible, a history of successful collaboration with the site.
However, there is a push to globalize clinical trials that is due, in large part, to the
fact that nearly 90% of the world’s population lives outside of North America and
Western/Central Europe.
clinipace.com

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