The landscape of clinical research is evolving. The marriage between clinical research and technology has brought about a positive outcome on clinical trial conduct. As much as maintaining the rights, safety and wellbeing of clinical trial subjects, efficient data management is a key area in clinical trial conduct. But how do we leverage all data to support clinical conduct? As a freelance consultant in the Bay Area since 2006, I was contacted by a new company named, Comprehend Systems in San Francisco, CA, this in 2017. They asked me to consult as their Data Management Advisor while developing their tool. This tool merged all data including lab data into a variety of useful graphs and measures and I got a unique look at how to improve an output that would be useful to all parties, not just DM and not just Clin Ops.
I wondered how this would affect site selection and recruitment of patients and how this data could be leveraged. And given it includes clinical data, would it affect Investigator decisions?
Long ago are the days where we collected data manually, but how do we leverage data that we now collect electronically. Today, clinical data is stored and analysed in bulk and data is a driving factor for effective decision making. Therefore, software such as Comprehend Systems are so not only important but strategic. And systems like this will give companies a competitive edge from those without similar systems. The point being that not only can we look at all data at once we can create efficiencies while increasing site support during conduct. Not to mention increasing the data points used in site selection. Site recruitment will also be influenced while also streamlining workflows, creating automation of time-consuming processes and improving data management. Isn’t this one of our goals? Improving overall clinical operations?
All roads lead back to Clinical Operations and R&D.
But having the Clinical Project Manager’s view be easy and make sense, from our perspective, is what will really determine if this type of tool is really value-added.
Sponsor companies have had rising budgets and have had to face obstacles and delayed timelines, perhaps leading to a reduced number of studies, therapies being studied. Optimizing data insights and observing trends and patterns, in addition to trial data, can ultimately help with better decision making in clinical trial conduct.