The Joys and Woes of Clinical Trial Startup | Page 2

The Joys and Woes of Clinical Trial Start-Up:
A Global Perspective
With the ever-increasing pressure on pharmaceutical and biotechnology companies
to bring more products to market faster, many in the industry have turned their
focus to streamlining study start-ups.
With an estimated 65% of FDA-regulated clinical trials running outside of the US2,
these factors become globally important. This paper reviews several key areas
that can significantly affect study start-up, each with region- and country-specific
information and examples, and concludes with a section that offers practical advice
for sponsors aiming to decrease their start-up timelines.

Regulatory and Ethical Approvals »
The number of countries involved in clinical trials more than doubled between
1995 and 2005,3 and there is little harmonization in trial approval processes. It is
tempting to consider some areas, including the European Union or Latin America,
as homogenous entities, but each autonomous nation still has its own regulations,
experience, and history. A few countries, such as Australia, regulate trials mostly at

2009

A
survey by
CenterWatch identified
five factors that are most
likely to delay study
starts in the US1:
1.  nstitutional review board (IRB) or
I
ethics committee (EC) review and
approval
2. Contract and budget negotiation

and approval
3. Availability of an appropriate

patient population

the state/territorial/provincial level, resulting in considerable heterogeneity even

4.  Protocol design and refinement

within the same nation.

5. Legal review

In almost every country, permission from the competent regulatory authority is
needed to run a clinical trial. A handful of countries, such as Chile, rely solely on ECs
to review and approve trials and require only that the Ministry of Health (MoH) or
other designated body receive notification.4 Timelines for regulatory approval vary
widely from a few weeks to more than 12 months (Table 1). Sponsors can help the
authorities meet these timelines by submitting only finalized documents, as the multiple
changes that often occur following the initial submission of a dossier can significantly
slow the process. Documents also should be complete, clear, and error-free.
clinipace.com

1