The inaugural article in this series of articles (Animal Pharm 690, p 11). “Cutting Delay in Veterinary Clinical Trials,” cited the disturbing statistic that 90% of all clinical trials experience significant delays. Even more disturbing is the economic cost of those delays to the companies that suffer them. The article then described the four main causes of study delay, why these occur, and what can be done to avoid them. In this article, I’d like to be more proactive and suggest ten steps to make your next trial a rousing success.
The ten steps are:
1. Specific expectations and roles
2. Project team communication plan
3. Study team communication plan
4. Well-designed data forms
5. Quality investigators
6. Thorough site training
7. Active subject recruitment
8. Frequent monitoring visits
9. Timely data review
10. Test article controls
These ten steps are easy to list but can be difficult to implement effectively. I can assure you, though, that the effort you invest in these ten steps will pay big dividends.
1. Expectations and Roles
An old saying cautions that we should “never assume” because doing so makes a donkey’s rump out of “(yo)u” and “me.” Yet many project team members fall prey to this trait and experience nasty surprises throughout their study because other team members are operating under different assumptions. To avoid surprises of all types, project team members should meet before a trial begins to have an open and frank discussion about their expectations for the study and the corresponding responsibilities of each team member. Those responsibilities should be agreed upon and then documented in clearly-defined roles.
2. Project Team Communication Plan
Poor project team communications is one of the four main causes of study delay. Avoid that problem by developing a detailed project team communication plan that defines what should be communicated, to whom, in what manner, and at what frequency. There also should be a regular schedule of meetings or teleconferences to discuss study progress, address any problems and plan corrective action.
3. Study Team Communication Plan
There is nothing worse than not knowing what’s happening at your study sites… except, perhaps, knowing too late about problems that could have been solved had you learned about them in a timely manner. Again, a detailed site communication plan that lists what, when, how, and to whom can prevent a multitude of sins that will keep you out of study “hell.”
4. Well-Designed Data Forms
Whether your clinical trial data will be collected on paper or electronically, it is important to test your data forms. Are they consistent with your protocol? Sometimes, protocols dictate that certain data be collected, but no data form contains a field in which to record it. Some data forms include multiple-choice questions but do not allow a “none of the above” or “not applicable” answer. Are your data forms logical? Are they easy to complete? Do they allow enough room for complex answers, long owner or subject names, and investigator signatures? Are fields structured to accept data in the proper format? The list goes on but suffice it to say that the design of your data forms plays a very large role in the quality of the data you will receive.
5. Quality Investigators
“Quality” is a relative term. What I really mean is “research-quality” investigators… veterinarians who have a sincere interest in clinical research, a commitment to follow your protocol, a sufficient patient population with the target indication, the perseverance to deliver, and a dedication to excellence. Not every veterinarian fits that description and therein lies the challenge. Therefore, it is essential that all potential investigators be prequalified before being selected for a trial.
I’d love to finish my list of ten steps, but the editor tells me that I’ve run out of space in this issue. Not to worry, I promise to finish it in my next column. Stay tuned!