While it's an issue that's not limited to the pharmaceutical industry, miscommunication between the "doers" - those actually performing clinical trials - and the "planners," who set and monitor the budget, is particularly prominent. While research and development in a non-pharmaceutical business can often be put on indefinite hold while funding is secured, clinical trials don't share that luxury. Variables such as timing, resources, and the ability to make adjustments if obstacles arise are freedoms all crucial to a given trial's success. This means, in turn, that "holding" isn't really a viable option. So how can the behind-the-scenes program teams work in tandem with those on the front lines?
Look At What's Worked Before
Both the "doers" and the "planners" are likely to view proposed budgets with a bias for their own teams, so common ground is a great way to break the stalemate. Get data on other clinical trials of the same approximate size and scope, either from within your company or externally, if no comparisons are readily available. Those performing the trial should prepare a list of how their trial differs from this example, as well as reasons why extra budget may be needed to overcome those differences.
Form a Plan for Contingencies
If budget teams are hesitant to release funds above a certain figure, ask what benchmarks might persuade them to increase the budget. Agreeing to a set amount at the start and a small infusion of additional money if and when certain goals are reached is a fair compromise. Proactively offering transparency that tracks spending before and during the trial is another step in the right direction for managerial and budget collaboration. Confirm which individual or department is the right person to come to with budget questions or concerns - this will keep communication clear and accurate throughout the budget planning and expenditure phases of your clinical trial.
Strategies for Cost-Savings
While the temptation may be to get new equipment, facilities, and so on for each new clinical trial, the "doers" have a responsibility to keep costs down, just as much as the "planners" do. Consider what equipment could be rented, if any fees paid to study participants are above the average for the industry, and if any relatively unskilled support labor could be supplemented with interns or graduate students in exchange for credits or recommendations. While this won't apply to every trial, it could still serve as a cost-saving measure for more routine trials, or the beginning stages of multi-part studies.
Striking the right balance between the needs of your budgeting and managerial oversight teams and the demands of trial implementation teams is difficult, but it's not impossible. If your negotiation and forecasting skills could use a touch-up, visit the Clinical Trial Budgeting and Forecasting conference in Philadelphia, PA, held May 2-3. This 10th annual gathering promises to deliver the knowledge, networking and skill-sets you need to make clinical trial budgeting an easier process for all involved - and that's the most positive test results any researcher can hope for.