Avoiding budget creep with metrics and forecasting

Creating a realistic study budget can be difficult, especially when it comes to recruiting patients. Even if you do it right, it may look as though you're overestimating costs, because on the surface, it appears that you are taking into account more patients than the study needs. But underestimating the true number of patients required to flow through the course of a study can lead to "budget creep," or outspending the budget allotment later, when patients drop out of a study and additional enrollment is required.

There are three keys to developing an accurate budget and keeping the study within its budget parameters. The first two, which need to occur up front, are detailed recruitment forecasting and accurate estimation of patient recruitment requirements. The third, occurring during implementation, is real-time performance metrics, which allow you to quickly cut ties with non-performing sites and invest in only those sites that are recruiting and screening patients. Using all three keys permits you to manage fiscal risk effectively.

Using accurate data during the budgeting process to determine what is spent where helps build more accurate, transparent budgets. Even though the budget of one recruitment provider may be higher than those of competitors, the cost difference can be justified by specifically projecting the number of subjects to be delivered and by committing to the prevention of budget creep later in the study. This should be a powerful motivation for budget approval.

Budget creep occurs in situations when companies are bidding on price. Recruitment vendors deliver a price that is going to be competitive, but the price will increase after the project is awarded, because the study will fail to deliver the required number of patients. This scenario occurs all the time, and can be frustrating to vendors who planned correctly, but whose proposal was overlooked, and to clinical teams, who wonder why the vendor they selected failed to deliver. Companies that are focused only on price fail to realize that they are getting what they pay for-budgets based on the delivery of fewer patients and/or budgets that fail to be tied to any projection forecasts.

Forecasting

Patient forecasting is essential to accurate budgeting. MediciGroup's Leaky Pipe(r) model has become an industry standard as it considers the patient flow through the study and is the foundation of the budgeting process. If recruitment companies and clinical teams do not know how many patients will flow through the study given its particular protocol specifications, then an accurate plan and budget cannot be developed. This recruitment Leaky Pipe model accounts for the loss of subjects for a variety of reasons―from health problems, to not granting informed consent, to moving away from the research site.

If a study needs 150 patients to produce sufficient results, clinical operations and project managers may need to recruit 1,500 patients. This 10:1 ratio may seem high, but it can be affected by many factors, some of which include the prevalence of the condition, the risk involved in participating in the study, and the competition for the type of patients in the study. If clinical teams only budget for 150 recruited patients, the study will run into problems, miss its timeline, expend its budget, and come to a standstill.

Recruitment vendors and clinical teams alike need to plan for attrition under all circumstances. However, the process of recruiting patients can be even more difficult when the study protocol demands low-population types, such as people with migraine headaches who are on certain kinds of pain relievers, or advanced Alzheimer's patients who are treatment naive. For example, if the study calls for drug-naive, advanced Alzheimer's patients, about 75% of callers will be screened out.

Every single study requires its own Leaky Pipe model that drives the budget. Without having that picture up front and agreed to by the clinical team, the budget is meaningless. Without accurate planning, significant budget creep is inevitable.

Market-by-market budget

A major patient recruiting expense is advertising in local newspapers, radio, and other media. Clinical teams must also take into account the cost of buying advertising in different markets. One size budget does not fit all sites. The classic mistake companies make is to allot a fixed amount for each site, such as $2,000 or, usually, the "magic" $5,000. This is a major error. What advertising buys for $5,000 in Birmingham, Alabama, is quite different from what it buys in Los Angeles, California.

Instead of making an average-based estimate of advertising costs, a recruitment budget must determine how many patients each market is projected to deliver, and then estimate how much advertising will be required to reach this number of patients. This must be done on a market-by-market basis, until the big picture equals the number of patients needed-Leaky Pipe and all.

Account for nonperformance

In any given clinical trial, one third of the study sites will not perform. This fact must be accounted for in recruitment budgets and plans. Another third will overachieve, turning in more results and recruiting more patients than projected, possibly ahead of schedule. And finally, a third of the study sites will perform as expected.

Create realistic budgets by assuming that support will be given to 100% of the study sites selected. Within two or three weeks, however, real-time performance metrics will guide continued recruitment investment decisions to two thirds of the sites, those that are meeting or exceeding projected results. However, MediciGroup's experience for many years across all therapeutic areas tells us that one third of sites never perform. Severing ties by not investing further recruitment dollars in these non performing sites before preserves the budget and eliminates wasted spending.

Fiscal risk management for recruitment requires clinical teams to not grant a site all or part of its advertising budget until staff at that site have at least done some groundwork on their own by recruiting from the site's patient database, even if this has involved screening without a patient yet enrolled. This effort demonstrates study commitment, a characteristic that is likely to continue over the course of the study.

Competing for recruitment resources

If a study is set up for "competitive enrollment," it only makes sense to have "competitive recruitment resources." With only a limited recruitment budget, clinical teams cannot afford to invest in non performers who have zero or limited returns. Those who enroll are rewarded with additional support to help them get to the finish line faster. It means targeting the recruitment budget for the greatest return on investment.

Understanding the big picture

Using the Leaky Pipe model to more accurately estimate patient recruitment needs will initially inflate the recruitment budget. However, with real-time metrics, the budget is often decreased by weeding out non performers early-which requires the daily monitoring of study sites. Clinical procurement teams need to understand the big picture when considering recruitment budget proposals and the differences between them.

For example, budgets with comprehensive planning and forecasting and budgets based on these models are more likely to complete recruitment on time. As a result, these sites are much less likely to incur unbudgeted costs for extra time and monitoring as they compensate for patients who drop out.

Smaller companies appear to be more understanding of the zero-based budget approach. They understand the budget's composition, and clearly understand how financial consequences for ill-planned studies can affect their ability to stay in business. They understand that time is money-often venture capital money and they cannot afford to exceed their projected burn rate.

The cost of a comprehensive recruitment plan and budget focused on completing the study on time is considerably less than the cost of maintaining a delayed study with ongoing contract research organization costs for monitoring. Biopharmaceutical clinical teams and procurement management can benefit from using forecasts to model recruitment scenarios and carefully compare competing recruitment budgets accordingly. You get what you pay for.