Table 1.

Recommendations for conducting a multi-center trial in U.S. military hospitals

Obtain commitment for the trial from site investigators and the full chain of command before requesting funding. Initiate CRADA and IRB approval process early and simultaneously, if allowed. Be prepared for military priorities to take precedence over study protocol, especially last minute cancellations of study visits. Include basic research training for trial staff, and anticipate ongoing training due to transitory staff. Provide for redundancy in key personnel. Plan flexible recruitment strategies. For long term studies, make plans for continued care when study participants separate from the military and can no longer be treated at a military hospital. Consider hiring civilian trial staff, but be prepared for lengthy intervals between hiring and clearance. Be prepared for local firewalls on the military hospitals’ internet that may limit access to web-based data systems. Be prepared for the unexpected – furloughs, base closures, and other events.