I work on a lot of multi-protocol, multi-country, multi-language campaigns. Over the last four years or so, I’ve uncovered the top five MUST-HAVES for running said campaign. In order of importance…
1. Clear communication maps with clear role/ownership designation.
Clearly define who is responsible for decision making across functional roles (e.g., vendor managers can make decisions on invoices, clinical trial managers can approve copy for materials, etc.). This will reduce review and approval timelines for patient recruitment materials, program decisions, etc.. You’ll also experience a reduction in the amount of “noise” or water cooler/hallway conversations about projects that are dragging on or delayed based on inability to finalize products.
Clear goals need to be set to accurately measure the impact of your role in the campaign. Whether it’s a precise metric you’re trying to attain or level of control on activity within the campaign, the goals need to be clearly articulated for the entire team to understand what their performance will be measured on. The clearer the goal, the easier it will be to measure, analyze, adjust, and redeploy campaign strategies and tactics.
3. TrialCentralNetSM (TCN) – a study portal with the ability to report on the goals you’ve set.
You need a common ground for all sites, vendors, and team members to work within. TCN provides a user-class, password-protected, HIPAA-compliant platform to store reports on aggregated, de-identified data, site activity, campaign results, and so much more. The more data you can capture in a common system (or import – we import IVRS/EDC data and report on commonly overlooked patient recruitment metrics to analyze site, country, and campaign performance), the easier it will be to set goals and measure your success against them.
4. Flexible materials with a contingency budget.
Have innovative and flexible messaging that has the ability to react to the marketplace. You may have a print or banner advertisement that needs to be manipulated into a train ad in Germany. A print ad might become an online classified ad. Your messaging needs to be effective across a variety of media. Go into the material development process with an open mind and be ready to adapt. Be sure to include language in your IRB/EC submissions to indicate various uses of the materials to avoid limiting the use of your study’s materials to one tactic. Build a cushion for additional submissions into your budget so that you can implement changes and get them out in the field quickly.
Don’t cut corners on the budget at the start of the program. Be realistic, and know that cost savings are more likely to be achieved once the campaign is running on all cylinders. It is often more costly (time and money) to process change orders while waiting to implement a tactic that could reduce the last-patient-in date. Adding a few more dollars in the beginning can increase your study’s ROI in the end.