This contribution to 52 Perspectives comes to us from John Burnett, CEO of JaPa Associates Inc. John shares his perspectives on the study startup process and points out the growing need for companies to gather metrics during the startup phase.
When I was asked to write a blog regarding the study startup process and how I felt about it, I admit that I just didn’t know where to begin. There are so many aspects to it that make it what it is, a process that requires Herculean effort to get done in a way to ensure study enrollment hits timelines set by senior management. Despite these efforts, enrollment timelines seem to always be crunched, and enrollment rescue initiatives have to be implemented to complete the trial on time even if over budget.
Clinical Trial Planning
When I think of this process, invariably the scene usually plays out in a way similar to this: Senior management targets either a submission date or a date that they would like reportable data on a study. The timeline is then built backwards determining a date for database lock, last patient out (LPO), and last patient in (assumed desired treatment period is known) gets calculated backwards from LPO. With the date of LPI, and a discussion with some form of advisory board, assumptions/expectations are set about enrollment rate (patients per site per month) and the number of sites is usually determined that with the assumed enrollment rate, will give the LPI in the time or budget allotted.
Planning for Startup is Often Overlooked
The biggest problem with this methodology is that very little consideration is given to the time it takes to get sites started. While people know it takes time and effort, there is a great desire to have all sites up as quickly as possible. To some people in operations, it begins the game of identifying the bottle-necks in the process, is it legal and contracts at the sponsor or the site, is it the IRBs or Ethic Commitees, is it the study coordinator being not responsive, is it the Investigator not being fully engaged, or is it something else. There is an atmosphere of “let’s grind our way through it” because we don’t have time to think of a way to make things more efficient let alone find a repeatable method of projecting site activation that can show if our study goals can be met. Usually, operations does not have the “luxury” of time to figure out what to do about the bottle-necks, it’s more about identifying them and working within the current system to loosen them up a bit.
It may well be that this is more of an issue for smaller companies than bigger ones because of a perceived (correct or incorrect) notion of the high costs of tools that would enhance this process. And in today’s economy, nobody wants to hear about spending more money no matter the context and or benefits. I still believe that there can and should be a way to make this process more efficient by applying metrics to measure the process against industry benchmarks or company goals. We have to first know and see how we are being inefficient and wasting money before we will take the time to invest in things that will make us more efficient.
About JaPa Associates Inc:
JaPa Associates Inc. was founded in 2009 to focus on applying clinical trial metrics to clinical trials at study start through completion allowing trial managers to assess their trials, notice trends, and make course corrections to ensure trials are completed successfully.
With 15+ years of experience in the field of clinical research and trial management, starting from being a Research Associate and a Clinical Research Monitor rising to a Program Manager level with direct communication with Executive / Senior Management, the reports are built from the end-user perspective. This perspective enabled the development of a tool to organize the managerial and working environment in a more efficient manner. These include the organization of reporting results from clinical trials in a manner that permits the ease of interpretation, the projection of continuing tasks, project time-line control, along with any remedial action.
The reports are built from the user-perspective, with the inside knowledge of how clinical trials are executed, and do not require an investment of non-standard IT infrastructure.
The reports enable decision makers to have faster decision-making during the life-cycle of a clinical trial(s)as they are able to forecast not only timeline, but budgetary implications of their current efforts toward the completion of the trial(s).