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In the past project managers handled most of the data flowing into a trial. And that was fine when studies relied on weekly site visits and a handful of scans. But today’s clinical studies generate volumes more data than they ever did in the past.
Even small studies capture a steady stream of inputs every day from wearable devices, e-diaries, electronic clinical outcomes assessments (ePROs), and other digital tools. Combine that with data from scans, MRIs, natural history comparators, electronic health records (EHRs), and dozens of other potential sources of patient journey information, and clinical teams quickly become overwhelmed.
They accumulate data sets on different timelines and in different formats that can’t be easily combined or analyzed in any quick or meaningful way. As a result, project managers and team members spend hours manually cleaning, combining data for review which can delay time to analysis. By the time the data is captured, cleaned and combined with other data sets for analysis, its value has already diminished.
To evolve with the times, trials now need a data strategist on the team to orchestrate the end-to-end data environment.
The data strategist serves a vital role at every stage in the trial. As soon as the protocol is defined, they begin working with the IT and clinical design teams to select the necessary data technology and vendors and to establish rules and standards for data collection and management.
Once the technology is selected, they will work with the trial team to map that data flow. At this stage they test every connection running real world scenarios of patients sharing data and site staff accessing those systems.
This step is critical to creating a seamless data collection environment and eliminating bottlenecks or errors that could negatively impact the patient experience.
Once the trial is ready to launch, the data strategist will maintain the collaborative data environment. In this role, they ensure end users can access and understand all relevant data while still adhering to all regulatory data requirements. And if problems arise, the data strategist can help to solve it so site teams can stay focused on the science and patient care.
Much of the big work of the data strategist occurs pre-trial when they build and test the data environment. However, in our data flow ecosystem, the strategist stays engaged with the trial until the end, acting as a curator, coach and consultant to the sponsors and site teams. They ensure the data continues to flow as expected and that users continue to gain value from these assets to benefit patients.
For larger trials, the data strategist may be a dedicated full-time role, with a senior data strategist overseeing a junior data strategy team dedicated to a specific portfolio; whereas organizations that run many smaller trials could have one strategist overseeing multiple studies or portfolios. The key is ensuring someone takes charge of managing the data flow.
This role will soon become essential to generating the most value from clinical trial data, ensuring clinical teams can meet database locks and validate results with quality under accelerated delivery timelines.
It means life sciences teams may have to build from within or create a data strategy team that brings these skills together as they wait for academia to catch-up with industry needs. The most promising candidates will have experience over a range of clinical trial activities including technical/programming, clinical data management, biostatistics and analysis, standards, and the regulatory environment. While no one individual is likely to have all of these pre-requisites, a strong candidate can be trained to fill gaps, eventually evolving into more senior data strategist positions.
As a data strategist myself, I began as a BIOS programmer, but worked with several different clinical groups on a variety of projects. In those roles I learned about EDC programming and SDTM/ADaM, spending time as a heads-down programmer before moving into managing wider bios and data management groups, cross-functional initiatives, and large sponsor portfolios. That exposure gave me the foundation of skills and knowledge to grow outwards to view the end-to-end data flow model, which is the level of visibility needed to excel in this new role.
One day in the future, we believe university degrees, certification programs, and clinical trial career paths will align with the unique requirements of a data strategist. In the meantime, IQVIA is building teams from a variety of these backgrounds to support our projects, sharing knowledge to increase our end-to-end data flow expertise, and mentoring our clients as they build their own data strategy capabilities. This first generation of experts will set the stage for a future where clinical trial data strategy is treated as an essential component of the research environment, giving sponsors the expertise they need to navigate the growing data flow running through their trials.
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.
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