Seattle Children’s Therapeutics Teams Share a Common Goal: Having an Impact on a Child’s Life
When Seattle Children’s launched its first immunotherapy clinical trials for childhood cancer in 2012, it planted the seeds for expanding their impact. Today, Seattle Children’s Therapeutics runs nine different clinical trials, and its resources are similar to what you would find in a biotech company: research and development, technology development, a GMP facility for cell and vector manufacturing, clinical trials development and statistical core, and business operations.
Clinical trial manager Tom Roberts arrived at Seattle Children’s Therapeutics two and a half years ago and has witnessed its tremendous growth. Today, he manages the operations of leukemia and lymphoma trials, four of which are offered at multiple sites across the U.S. and Canada. From a macro level, his job is to ensure the clinical trials are completed within budgets, on time and with the highest quality. On a daily basis, that can include problem-solving with site managers in other states, consulting with the laboratory or therapeutic cell production teams, reviewing reports and generally being the go-to person for problems.
"My role covers the study from the time of inception to the eventual study closure,” said Roberts, “and to ensure that the study runs according to the protocol and regulations. I make sure all of the sites are conducting their studies correctly so that patient safety is maintained, data is accurately collected and important deadlines are met.”
His degree is in biology, but he prefers project management to working on a bench or in a remote jungle. The clinical manager role allows managers like Roberts to keep abreast of scientific fields while focusing on their organizational and managerial strengths.
He works hard to keep all the parts moving in sync and on time. “It’s essential that all the various components of a study are submitted to the FDA, IRB and other committees on time so we’re able to bring new therapies to patients as soon as possible. It’s extremely rewarding to see the tangible differences we make in people’s lives.”
Like Roberts, Elisabeth Alleman is proud that her work “puts the needs of the kids in our trials before anything else.” As a clinical data management specialist at Seattle Children’s Therapeutics, she is responsible for the overall collection and management of the data in each clinical trial. Her work begins at the inception stage of a trial, helping to design how the data should be collected, establishing a database unique to that particular study, and monitoring the data collection throughout the study and for 15 years afterwards. She also develops tools for verification, validation and quality control of the data gathered during the clinical trial. Basically, Alleman ensures the integrity and confidentiality of collected data are maintained at all times.
“It’s important to ensure the integrity of the study data because we want it to be as accurate, reliable and unbiased as possible,” said Alleman. “Better data means we have better information to use in the decision making involved in how these studies are run and how we ultimately can help as many kids as possible. We have to make the safety of clinical trial participants our highest priority, and this includes the safety of their personal health information collected in our studies.”
Alleman worked at for-profit organizations before coming to Seattle Children’s Therapeutics. She prefers her work at Seattle Children’s, “where I get to design a database that will collect and correlate data that helps us improve treatment of the children we serve. Our end goal is not necessarily to take something all the way to commercialization but to help the children we serve.”
The data that Alleman collects, verifies and monitors is passed to the Biostatistics team, of which Prabha Narayanaswamy is a member, for analysis and reporting, Biostatisticians and statistical programmers are part of the clinical trial from start to finish, and they have a long to-do list. They advise on study design, calculate the sample size and ensure the enrolled patients are correctly assigned to specific arms of a trial or specific doses of the investigational product. They help define the analysis design, provide definitions for data analysis, and create tables and figures for reports to the Institutional Review Board and U.S. Food and Drug Administration, as well as providing analysis for publications and conferences.
Put simply, biostatisticians and statistical programmers turn raw clinical trial data into usable knowledge.
“Stats uses this data in various ways, said Narayanaswamy, “such as assessing the safety and efficacy of trials. We compile the data to create Data Monitoring Committee (DMC) reports, where a committee external to Children’s evaluates the safety of the trial. The data is also pulled for IND annual reports and investigators’ brochure that are sent to the FDA for their review of our clinical trial."
Narayanaswamy holds a bachelor’s degree in biotechnology and a master’s degree in biostatistics, but she has evolved her role at Seattle Children’s Therapeutics to become a statistical programmer.
“80 to 90 percent of my job is programming,” said Narayanaswamy. “I get to use my creative brain to find solutions and create regulatory submission-ready information.” Rather than making the clinical researchers infer conclusions from the raw data, she builds programs whose output provides meaningful inferences.
“For example,” said Narayanaswamy, “the Data Monitoring Committee (DMC) and safety assessment committee review patient data to ensure that the kids have no safety concerns. In the event of multiple dose-limiting toxicities, they are carefully reviewed, and the future of the trial is decided at that point. They also use data to look at enrollment rates and project enrollment goals for the next year.” Having good data is very important for opening more trials as well. “Our PLAT-02 leukemia trial gave us several data points that served as a template for opening more leukemia trials. Ultimately, all of our data is used to help children get the treatment they deserve and live to their fullest potential.”
Like any well-oiled machine, most of the things that make clinical trials run successfully are not known to the public. The Seattle Children’s Therapeutics Clinical Development and Integrated Data Science teams work together to ensure the myriad data, reporting, logistical and administrative needs are planned, managed and completed with great care, keeping Seattle Children’s mission of helping every child live the heathiest, most fulfilling life possible at the forefront.
As Narayanaswamy said, “we all share a common goal: having an impact on a child’s life.”
Author: Elizabeth Dimarco