Enrollment Challenges

Why Don’t Clinical Trials Finish On Time?

More than 90% of clinical study sites delay enrollment. Increased regulatory requirements, complex protocols, and a global patient population make clinical trial recruitment increasingly difficult to manage. Many trials fail to enroll enough patients and to finish on time.

As a result, biotech companies must delay regulatory approval submissions and, ultimately, product launch. Budget and cost overruns combined with launch delays can cost a company hundreds of millions of dollars.

Do your trials finish on time? Here are four key questions to help you understand why most clinical trials sites delay enrollment:

1. How standardized is your planning process?

A good enrollment plan is critical to finishing a trial on time. Because tools like Microsoft Excel, business intelligence tools, and transactional CTMS systems require extensive customizations, study teams often rely on intuition, good fortune, and budget overruns to meet subject and timeline targets. In addition, enrollment management varies from study manager to study manager, making it difficult to share best practices.

2. How do you predict problems before recruitment goes off track?

Study managers often miss valuable insights and fail to spot potential problems because they lack the tools to quickly identify clinical study enrollment trends. Home-grown spreadsheet models provide some assistance, but can’t visualize and predict potential problems. Instead of seeing problems before they occur, most study managers rely on contingency planning to address enrollment issues.

3. How are you positioned to respond when enrollment goes off track?

Even good plans need to be adjusted from time to time. Subject availability, study protocol complexity, and drug reactions can all delay recruitment.

Without the ability to predict, simulate, and model different scenarios, study managers can’t effectively adjust the plan to keep enrollment on track.

In addition, aggregating data from multiple sources takes up to 10% of a study manager’s time--time that can be better spent analyzing data and making decisions.

With spreadsheets, study managers can’t view and drill down into data to diagnose problems or to track progress. Without simulation and modeling tools, study managers may over-invest in activities that contribute to over-enrollment, such as advertising campaigns, new centers, and other costly initiatives.

Hobson & Co. study

4. How do you encourage transparency between global teams?

Many global study teams have difficulty collaborating because they lack timely data across numerous countries and centers. This lack of transparency impedes communications across multiple time zones and delays decisions.

Not only does the absence of a transparent system reduce staff efficiency and increase enrollment and data clean-up problems, but it also allows companies to repeat costly mistakes. When companies can’t track each site’s historical performance, they also can’t identify top performers or weed out underperformers for future trials.

Continue to Best Practices in Clinical Trial Enrollment.