TOP TEN RISKS FOR CLINICAL TRIALS

The top ten risks will vary in each trial based on many factors, so that a composite list for all trials cannot be accurate. This list also reflects the author’s views and experience, which will not mesh completely with those of each of his readers.

These risks are presented in reverse order of importance.

10. Too many patient visits are scheduled and/or too much time and effort of
patients are required at some or all visits
9. Outsourcing to CROs and vendors is not done correctly or efficiently (e.g., CROs
are not carefully monitored, communication plans among all groups in a trial are
incomplete or inefficient)
8. The patient retention strategy is inadequate, so that too many patients leave
the study and follow-up for important data from those who drop out or are
discontinued is not adequately planned in advance
7. The trial is stopped too early after an interim analysis and the data are
inadequate to convince regulators and/or practicing physicians about the
product’s safety or efficacy
6. Too many procedures and/or tests are conducted at some or all patient visits.
This often results from simply adding new procedures and/or tests to the last
protocol performed with the agent
5. The primary trial objectives either represent a baby step forward from the
previous trial or too great a giant step from the previous trial (i.e., the
primary objectives may not be the best ones to choose)
4. The investigators chosen to conduct the trial are not the most appropriate ones
for any of dozens of important reasons, including lack of adequate due diligence
3. The trial design chosen to address the objectives is not the most appropriate
nor efficient one
2. The inclusion/exclusion criteria are too restrictive and have limited the
potential population more than is necessary
1. The recruitment strategy is not adequate to obtain the necessary enrollment at
the necessary speed

To learn more about these and other risks refer to “Guide to Drug Development: A Comprehensive Review and Assessment” by Bert Spilker. Published by Lippincott, Williams and Wilkins (Philadelphia), 2009.