Best Practices For Conducting Multinational Clinical Trials | Page 15

Clinipace Worldwide is positioned to provide advice about other options.
“We were conducting a clinical trial in China with a big sponsor,
and we expected 5-6 PIs to participate in the trial. After completion
of the study, the sponsor sent a global auditor to audit the study, and
he reported a major finding. He said the recruitment speed was too
fast; the investigators must have done something wrong. He hadn’t
seen recruitment that fast in his 30 years of experience. When we
looked into the recruitment, it ended up that over 100 PIs were
mobilized in advance of the study to identify and recruit patients.
This was despite only paying for 5-6 PIs. We believe this was a
reflection of the relationship we built with the site and investigators,
and they wanted to help us have a successful trial.”

The e-clinical, cloud-based software platform, TEMPO™, available
through Clinipace Worldwide, has the ability to store protocols specific
to a country, provides real-time visibility to operational progress, and
allows access to start-up data. Transparent access to data, regardless of
where it’s collected, enables decision-making relating to that data on a
real-time basis, thereby saving time and preventing delays. This applies
to the recruitment progress, monitoring of adverse events/safety issues,
and data trends for the overall trial as well as specific to each site. Upon
trial completion, the platform has the ability to easily meet reporting

Clinipace Worldwide conducts analysis of the sites/PIs during protocol

requirements for all countries involved in the trial.

development to determine which are the most appropriate to include
in the trial. Selection is based on experience and reliability as well as
any potentially competing ongoing clinical trials. Such information is
available through their local investigator networks. The larger hospitals
in a number of these countries are in high demand for clinical trials, and
the competition for patients can be high. Other PIs or smaller facilities

“The ability to monitor your trial through TEMPO
allows decisions to be made regarding the data.
For example, we were able to stop recruitment in
Korea in our multinational trial because we could
monitor the enrollment easily across sites.”

may be just as or more appropriate for the needs of a clinical trial, and
Figure 8.

Cancer: The Leading Cause of Premature Death in Asia

Clinical trials in oncology present particular opportunities in Asia.

Cancer is responsible for:

21%
of all the
deaths in
South Korea

14%
of all the
deaths in
Vietnam

Oncology trials
There are large populations of drug- and clinical trial-naïve oncology

12%
of all the
deaths in
Malaysia

patients. In 2002, approximately one-third of new cancer cases
worldwide were diagnosed in select countries in South, East, and )M