PPD Review: Don’t be too aggressive with timelines for FIH.

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Don’t be too aggressive with timelines for FIH.

Overall: 4 stars

Date: May 1, 2014

Proposal Quality:
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Service Description

this was a full service study consisting of a single ascending dose study with multiple cohorts to enroll at one CRO site. A standard PK, safety study.

What Went Well

CRO provided a very competently run and organized study with almost machine like timing and precision. IRB process was timely and smooth, study start and cohort timing was precise and on schedule. Subjects were promised and delivered, study went off without a hitch.

What Could Be Improved

Most aspects of the study went very well. However, due to the machine like precision of the CRO, sometimes the flexibility is limited. For example, an FDA required protocol amendment threatened to disrupt the entire timing of the study due to lack of scheduling flexibility with the CRO. It is understood that the CRO has other clients and other studies to keep on schedule. If there was a way to allow for slight adjustments due to these type of unanticipated delays without 'losing your slot', it would be a positive and potentially save time.

Lessons Learned from the Experience

The lesson we learned is to not be too aggressive with our timelines for a first in human study. It is perhaps not the best idea not to schedule study start up on day 31 of the 30 day IND review. This is not a fault of the CRO, but as described earlier, if the CRO had the ability to be more flexible with timing it would be a major positive. Other than that, it was quite impressive the way the study once underway, progressed on schedule. I would not hesitate to use them again for additional similar studies.