Over the past 8 years the number of oncology studies SDC has supported has skyrocketed to help meet the needs of the industry. As March is Multiple Myeloma Month we spoke with two of SDC’s clinical data managers, Joanne Gonzalez, Senior Director, Data Management and Vanessa Leverett, Senior Manager, Clinical Data Management, about their experience with Multiple Myeloma studies and the necessary steps needed for successful studies.
What has been your personal experience with Multiple Myeloma studies?
JG: “My first experience with Multiple Myeloma studies was at a biotech company. It was a first in human study and the first oncology study for the company. My background in research prepared me to support Clinical Operations and Statistics to dive deeply into the data requirements as we learned about the indication as an organization. Since it was a FIH study, we continually monitored data for dose limiting toxicities to define the maximum tolerable dose. Together, we tracked when subjects were dosed and eagerly awaited data entry within 24/28 hours. I had never been so deep into the science and laboratory data in my DM management career.”
VL: “ A Multiple Myeloma study was the first big study that I did as a Lead Data Manager. I looked up and read everything I could find about the disease, the unique testing that was done (SPEP, UPEP) to monitor the disease status and progression, and how it affects the patients. Although I never met any of the trial participants, I found myself pulling for them as I watched their journey in the data. I was fortunate to work with a client that was deeply invested in the research and subject base, and was willing to teach me. This was back in the paper study days, so we worked closely with the sites to get the data entered and reviewed. It was a great experience for me, where I was able to blend my clinical laboratory background with data management in a concrete way.
When consulting with a client on a Multiple Myeloma study what questions do you always make sure to ask?
JG: “What are their long-term plans and how do they envision growth and development of the drug? We want to partner with our clients to plan for the future and help guide them for potential challenges.”
Are there any data management considerations when starting a Multiple Myeloma study?
JG: “It’s all about what’s in the protocol and the changes our clients anticipate in protocol amendments. The studies are typically complex, and we need to ensure the database is agile enough to meet the dynamic needs of the indication with quality in mind.”
VL: “Like Joanne said, these studies tend to be complex with a lot of moving parts. Lab and scan data must be collected properly and in a timely manner. Protocol amendments must be considered when building the database, keeping in mind the needs and time of the site personnel, and data quality and completeness.”
In conclusion, Multiple Myeloma may be a rare form of cancer, affecting every 1 out of 132 people in the US, but it also has a far-reaching impact on those affected by it. With the help of SDC’s Oncology focused client based Teams, we are able to provide more comprehensive and specialized support to those who are affected by this condition. We know that with our efforts, we can help improve the lives of those living with Multiple Myeloma, and reduce the number of people impacted by this disease.
If you would like to connect with anyone from our SDC team, please email us here.