The Joys and Woes of Clinical Trial Startup | Page 10

appropriate qualifications, staff, motivation, support, and patient population
for a particular study may slightly delay site initiation, but this time will be
recouped with more consistent enrollment.
•  onsider global differences in resources. For studies that need specialized
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equipment (eg, -80°C freezer, centrifuge, laptop for data entry), the sponsor
must decide early in the process whether to provide the equipment or require
the sites to provide it. Such issues may be particularly important in developing
countries where resources are limited.
•  tick to the point. Trying to put too much into a single protocol (eg, including
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tests with no clear bearing on the study or study outcomes) may delay start-up
due to numerous questions from the IRB/EC and unreasonable demands made
on study participants.
•  emember that informed consent belongs to the site, not the sponsor. IRBs/ECs
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often have their own language requirements, and in Latin America, they may reject

Practical Advice for Sponsors

•  esearch selected sites. Taking the time to ensure that selected sites have the
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Embrace planning and preparation
Seek feedback
Clearly spell out
eligibility/ineligibility criteria
Research selected sites

Consider global differences
in resources

trials if the sponsor insists on using their own wording. Sponsors should provide
an informed consent template to the sites but expect that it will be changed.4,22
•  e flexible on terms. Sites, particularly large institutions, ofte