Even if you are already satisfied with the results of your current clinical trials, there’s always room for improvement. And the investment you make now in improving your study management processes will pay big dividends as every future trail delivers cleaner data, in less time, and at lower cost. So, how do you tune up your study machine? Here are some tips from the trenches.
Lean, Leaner, Leanest, Never Let It Rest, ‘Til your Lean is Leaner, And Your Leaner Leanest.
My paraphrasing of the old grade school poem doesn’t flow off the tongue quite as smoothly as the original, but it makes the same point. Even if you are relatively satisfied with the results of your current clinical trials, there’s always room for improvement. And the investment you make now in improving your study management processes will pay big dividends as every future trial delivers cleaner data, in less time, and at lower cost.
So, how do you tune up your study machine? Here are some tips from the trenches:
1. Uncap the bottlenecks.
Before the study actually starts or, even better, before site training, role-play the study process from site initiation through close-out. Have your study team take the protocol and a full set of CRFs and run several hypothetical cases through the full visit sequence. You’ll be surprised by how many glitches and inefficiencies you uncover. Fixing those before actual cases start enrolling at the study sites will save you lots of headaches later on.
Don’t allow project team members to use different methods to track study progress for their respective responsibilities. Once you develop a workable format that includes all of the information needed for each report, deploy it across all study teams. In addition, insist that all study monitors employ the same report template. Being consistent in every step of your study processes minimizes the possibility that something will fall through the cracks. It also allows team members to jump from one project to another with little difficulty.
3. Manage with metrics.
Before the first subject enrolls, define your expectations for every key aspect of the trial. Then, develop a series of benchmarks and schedules against which you can measure your progress. The more frequently you compare your actual results to your metrics, the sooner you will spot errant performance and the more likely you are to meet your objectives.
4. Explode enrollment.
Many investigators overestimate their ability to meet their enrollment targets. Don’t just accept that fact or, worse, ignore it. Instead, plan around it. Brainstorm strategies to recharge subject recruitment and closely track enrollment at each site so you know in advance when to deploy those strategies. Lagging enrollment is the principal cause of study delay. So, stay on top of it!
5. Catalog the queries.
Many study teams view data queries as the unavoidable nuisances of any clinical trial. But there is hidden value in queries. If you track queries by site, by investigator, by CRF, and by data field, you’ll spot patterns or trends. The sooner you can identify the cause of the queries, the sooner you can implement a solution that will eliminate them (at least from that cause). Then retrain all study personnel in the new procedure, and watch your data start to shine!
Remember, knowledge is power. Therefore, if you make an improvement at one site, implement it at all sites. If one investigator makes a useful observation that can be incorporated in the study process, pass it along to all of the other investigators. Even if an owner comes up with a good idea, share it with everybody on the project team. By growing the collective knowledge base, you give everyone the power to produce better results.
7. Get techie.
Integrate technology whenever and wherever possible. As important as humans are to the design, planning, and conduct of every clinical trial, computers, specialized software, communications systems, and other digital tools can streamline your processes, provide real-time status reports, boost data quality, accelerate your timelines, and lower your development costs better, faster, and more reliably than humans can. The more technology you use, the more you can leverage your existing human capital to produce ever-greater results.
After the last data form has been checked, the last query answered, and the database has been locked, poll every member of the study team to document what went right, what went wrong, and what could have been done better…while the study is still fresh in everyone’s mind. This is very valuable information that can dramatically improve future studies. It’s also information that almost no one captures because they are too busy starting their next project. Don’t miss this golden opportunity.
When things are getting done, even with a problem here and there, we often are reluctant to change the status quo. “If it ain’t broke, don’t fix it” becomes the rule. But, in today’s competitive, time-sensitive world, such a rule leaves us vulnerable to getting passed on the road to market success by a competitor that has taken the time to tune up their study processes. So, stay ahead of the competition by supercharging yours!