The Joys and Woes of Clinical Trial Startup | Page 9
knowledge cannot be underestimated. For example, Spanish is spoken in many
countries on several continents, but subtle differences in grammar, lexicon, and
idiomatic expressions can result in the same word or phrase having several
meanings depending on context and global location.
Ideally, documents are translated by certified local experts. At minimum, translated
documents should be reviewed by a native speaker residing in the target country.
Local resources are also invaluable in facilitating communication between the site
and CRO/sponsor when questions arise, particularly in cases where translations fail
to capture the essence of a document.
Practical Advice for Sponsors »
Sponsors can influence site start-up times in a variety of ways. Based on our
experience, we offer some suggestions for streamlining the start-up process.
• mbrace planning and preparation. Efforts to shorten study start-up
E
timelines are only productive if the study also finishes in less time. Taking a
few extra days or weeks up-front to ensure that all documents are in order may
reduce later setbacks resulting from, for example, drug importation delays, slow
patient enrollment, or the need for a protocol amendment.
• Seek feedback. A well-thought out protocol that has been “field tested” or,
at least, reviewed by physicians with experience in the indication of interest
may identify issues early in the process and decrease or eliminate the need for
amendments. Ideally, there should be at least one practicing physician reviewer
from each country participating in the trial.
• learly spell out eligibility/ineligibility criteria, including as much detail
C
as possible. While trials with more restrictive criteria are often more difficult
to enroll, clear specifications will help the site better estimate the number of
potential patients in their population and decrease the screening failure rate.
Loosely-defined criteria are also more likely to generate questions from sites
and IRBs/ECs and require time-consuming and costly protocol amendments.
On average, it takes 61 days and costs $450,000 to resolve an amendment.19
clinipace.com
8