Karyopharm Therapeutics, a clinical-stage pharmaceuticals company, needed to transform their processes for global clinical trials of their flagship product, Selinexor, a drug used to treat a type of blood cell cancer called multiple myeloma.
With patient outcomes on the line and stakeholders collaborating across time zones — from Boston to Israel to Europe — Karyopharm’s data analysts needed a better way to organize and streamline the process of capturing and collaborating on data and add visibility for all stakeholders, including data providers and medical professionals administering Selinexor.
Since Karyopharm was already leveraging Smartsheet broadly across the organization, the data analyst team hoped to bring this critical information onto their existing platform for a single, consolidated source of truth for data related to clinical trials.
“We had the problem, we had the solution, and we just needed to put the two of them together,” says Bruce Warren, Clinical Data Analyst at Karyopharm.
Adopting Smartsheet, as well as premium Smartsheet offerings Data Shuttle and Pivot App, created a sea change in how their data analysts trend and find correlations in results. This new process also bolstered employee morale, created an instant return on investment, and helped strengthen the startup company’s position in the market.
The benefits of data automation
In order to assess data, clinical trial sites upload results into an electronic data capture (EDC) software platform. Before Smartsheet, Karyopharm’s data analysts would export the data into Excel spreadsheets in order to record and corroborate their findings. This inefficient, manual entry process led to some major pain points, such as document version-control issues, slower turnaround times, and a lot of repetitive, manual labor.
“All of these things, for all our studies, were being done by hand,” Warren says, and “finding someone to plug all these numbers from one spreadsheet to another is a waste of time and resources, and it’s not quality work for somebody who’s trying to help patients by keeping an eye on the studies.”
“For larger studies, it used to take two people a full day to just enter data,” Warren says. With Data Shuttle automatically importing data from their central database into Smartsheet, “we’re expecting that to maybe take an hour and a half per day for a full study update.”
Data accuracy helps patients
Together Smartsheet, Data Shuttle, and the Pivot App enable Karyopharm to automate much of the manual entry, which cuts down on errors and frees up analysts’ bandwidth to focus on finding important trends and correlations in the patient results.
“The biggest part for us, besides time, is accuracy,” Warren says. “In our world, there could be a huge difference between one-tenth of a decimal spot on a particular value. That could mean the difference between somebody having a higher response rate.” In addition, their new system provides time savings and improved work quality, leading to increased efficiency.
With Data Shuttle, the data analyst team struck gold. “We take a massive amount of data from about 150 patients located anywhere who have been part of the study from a minimum of a month to up to a year or more,” Warren says. “Trying to filter all that was a challenge in itself, and the filters in Data Shuttle were tremendously helpful in getting everything in and organized.”
Prior to Smartsheet, Karyopharm considered building out a full team of data managers focusing on manual entry. “Entering data into [spreadsheet] cells is fine, but that’s not a long-term position here,” Warren adds. The conversation changed from hiring a team to entrusting data automation to Smartsheet and Data Shuttle.
Now data managers are able to eliminate manual work by using automation to import results, and analysts can look for and correlate trends in how individual patients are responding in clinical trials. If they see that a patient’s status is slipping, they can dig deeper into the data.
With added time, Warren’s team can find trends much faster and report those findings to medical professionals running the studies. “And same with side effects,” Warren says. “How are they affecting patient responses? Data Shuttle is giving us the space to do these things,” and ask more targeted questions to make sense of the data they receive.
The benefits of these new efficiencies extend far beyond the obvious business value to a core mission of Karyopharm: creating innovative medicines that improve the quality and duration of patients’ lives.
“At the end of the day,” says Warren, “the only reason we exist is to assess information so that patients are provided with better care."
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