Recently, while reading back issues of Applied Clinical Trials, I came across a shocking statistic: 90% of all clinical trials experience substantial delays. I almost didn’t believe my eyes, so I read that sentence again. 90%…9 out of every 10… almost every study takes much longer than expected. As I pondered those numbers, the economic impact of such a percentage struck me. While there are different causes for study delay, the results are always the same: lost revenues and diminished market share.
Consider a new veterinary product that is projected to generate first-year sales of $12 million or more. For every month that this product’s clinical trial is delayed, its sponsor loses at least $1 million in revenues. As the months drag on, these losses mount. And what’s the cost if a more nimble competitor beats you to market with a similar product? Which sponsor would you rather be?
In my experience, there are four main causes of study delay: slow enrollment; poor data quality; lax test article controls and weak project team communications
Choosing the right investigator often determines how fast you hit your numbers…or whether you hit them at all. Some investigators don’t have the requisite patient population. Others really don’t have the time to follow through on their study responsibilities. A few just lose interest. In addition, a strong field monitor gets enrollment off to a fast start and helps maintain site staff awareness of potential study subjects. Thorough protocol training before the study starts minimizes ineligible subjects, and creative recruitment strategies accelerate the pace of enrollment at all sites.
Poor Data Quality
Believe it or not, the sponsor is sometimes at fault. For example, protocol requirements can be vague, contradictory, or incomplete. Or, data forms are inconsistent with the protocol. Or they are poorly designed. A little extra scrutiny before the study documents are finalized can greatly reduce data error once the study is underway. Of course, most data error comes from the sites. Data form entries can be incomplete, inconsistent, illegible, or suspicious. All of these errors must be corrected before the database can be locked. Comprehensive site training and detailed data form guidelines reduce data form error and related delays.
Lax Test Article Controls
Keeping track of test article is nothing more than a simple accounting procedure… with some very strict controls. The sponsor counts the test article when shipped. Each site counts the test article when received. Those two numbers should match. Then, the site counts the test article when it is dispensed, and counts it again when unused test article is returned. The difference should equal what was administered to the study subjects. At the end of the study, each site counts unused test article before returning it to the sponsor. The sponsor counts returns upon their receipt. Those numbers should match. Pretty simple, right? Not without those very strict controls.
Weak Project Team Communications
Every member of the study team must understand the importance of complete, accurate, and timely communication of all study activities… both good and bad. Every study has problems. The time to solve them is when they occur, and everyone should be informed and involved in the solution. Detailed communication plans are critical elements of successful trial management, and clear expectations are integral to effective communication plans. So, express yourself!
No one likes nasty surprises… especially at the end of a trial.
So, how do you avoid these four causes of study delay? First, choose investigators who have the experience and dedication necessary to follow the protocol plus the enthusiasm and patient population to quickly enroll the required number of study subjects. Second, think like an investigator when designing data forms. Then, test them against the protocol. Third, develop strict controls for test article accountability. And, fourth, create communication plans for all members of the study team that incorporate all of their expectations for successful study completion.
If you follow these steps, I guarantee that your next study will be in the top 10%… the ones that don’t suffer significant delays.