Prepare for Success: How Advance Planning Keeps Clinical Trials on Track

It’s rare for any large project that involves hundreds of individuals and multiple locations to proceed without some sort of hiccup. Budgets get stretched, schedules run behind, key staff members move on.

Clinical trials are not immune to missed deadlines and cost overruns. However, with proper advance planning, you can up the odds of success and avoid major glitches.

Why Do So Many Clinical Trials Fall Behind?

In our recent trial rescue white paper, we present original research that shows why scientifically sound clinical trials falter. Our studies show that about 33% of all clinical trials are behind schedule at any given moment. These trials underperform due to operational failures; meaning, they’re behind schedule, over budget, or the data produced lacks the quality needed to support an approval.

Just like the most organized executive submits a report a day late, even the smartest clinical research teams can fall behind.

Why? Developing a clinical trial involves more moving parts than a vintage Swiss watch. The more moving parts, the easier it is for one of them to fall out of place.

A few of those moving parts include:

• Tremendous Human Resources. Even a relatively small clinical trial can involve hundreds of people, including sponsor employees, CRO staff, investigators and their staff, IRB members, and (probably most complicated of all) the patients. All those people have to be hired, contracted, evaluated, trained, managed, and paid.
• Intricate Logistics. Moving molecules from lab to site is complicated enough. Moving time-sensitive, fragile, limited production, and possibly hazardous or controlled material takes special skill.
• Multiple Venues. Few modern clinical trials take place in the same state—or country—much less at a single site. Today’s studies span the globe, with possible locations across continents, separated by oceans, regulations, languages, and time zones.
• Financial Expectations. It costs hundreds of millions of dollars to develop a pharmaceutical or biologic. That said, sponsors don’t take liberties with the budget. Because of budget concerns, project managers face pressure to keep costs down and quality high. As a result, they may become overly optimistic when setting the budget, or they cost-cut at the expense of success.
• Protocol and Study Design. Some trials require complex, specialized protocols and study designs. Most don’t. As design complexity goes up, so does the cost, and so does the number of things that can go wrong.

Every one of these challenges has to be closely managed to keep from spiraling out of control. Spiral too long, and the trial may not produce useful results.

How to Overcome Study Planning Challenges

If 33% of clinical trials fall behind, that means about 66% do not. How do these 66% address the complexities of clinical trial planning and stay on time and on budget? Here’s how:

• They err on the side of caution. Investors, executives, and other stakeholders may want to cut expenses beyond reason or set the completion date unrealistically early. Successful trial managers learn to diplomatically push back when needed. They explain what they need in a budget and timeline to avoid compromising risk and quality.
• They reduce complexity where possible. Actively look for opportunities to simplify the study process. Simplification begins with protocol and study design and extends throughout the trial. The more you can simplify each step, the less likely your study will experience unexpected issues.
• They don’t try to do too much with one study. Pick venues in cities or regions that meet your objectives, rather than casting a wide net when it’s not needed. Choose clinical endpoints that move your program forward. Don’t try to accomplish too many goals with one study. Screen patients for critical inclusion and exclusion criteria, and pare down the “nice-to-haves.”
• They don’t oversimplify projections. It’s tempting to project linear growth in patient enrollment, for instance. It’s easy to point to a direct relationship between sites, patients, and budgets. However, these variables have complex interactions and few straight lines. Oversimplifying projections is a sure way to end up in trouble later.

Thorough planning in the early stages will go a long way toward keeping your trial in the “elite” 66%. If your trial does experience a setback, a good plan (which includes contingency planning) can help you get back on track. Take your time, keep things simple, and if you need a hand, call Biorasi for a free study health assessment.