The research studies run by the Therapeutics Development Network (TDN), the largest clinical trials network in the world devoted to cystic fibrosis (CF) research, generate a lot of data. Missy Cianciola, manager, Clinical Data Management and Programming, is one of the people tasked with managing all of this information. She sometimes functions as a Clinical Data Manager for a specific study, but more often her time revolves around supervising and managing staff members who work with clinical data.
Cianciola and her team, along with TDN statisticians, work closely with CF researchers to ensure they are collecting the appropriate data required to reach their study objectives. This involves creating documents and electronic databases and datasets for analysis. Her team is also responsible for “cleaning” data; in other words, her team helps ensure data collected for a study are complete, consistent and as accurate as possible. This translates in tangible terms into creation of quality control checks that are implemented and addressed before data are used in final statistical analyses.
Cleaning the data can involve programming the electronic database to automatically check that dates of all completed study procedures for a study participant are completed on or after the date the participant provided informed consent for the study. In some instances, these checks can be programmed directly into the electronic database; other times, and for more complex checks, these checks are created programmatically outside of the database and are applied to data extracted from the database. When such quality control checks identify data that might be inaccurate, these questions about the data are presented to the study site where the participant was seen.
Her team also generates multiple various reports based on the collected data. These reports are used to help data-cleaning processes and also are provided as needed to various oversight committees, such as data safety monitoring boards. Her team also helps to ensure adverse events and medication data are coded consistently and accurately so that these data can be used in analyses. “At the end of the day, after thousands of hours of effort and work from participants, study site staff, researchers and TDN staff, what you’re left with is the study data,” she explains, “so we want to do everything possible to ensure the data are complete and accurate and that people have the utmost confidence in the answers the data provide.”
For Cianciola, every day brings different challenges. She thrives on being able to find solutions to problems or issues, and being a resource for others if they have questions. “There is a value and a pleasure in helping others does their work better,” she says.
Currently she’s working on a multicenter study funded by the National Institutes of Health’s National Heart, Lung and Blood Institute that aims to determine if children with CF who are on culture-based inhaled tobramycin therapy fare better in terms of pulmonary exacerbation events when randomized to continuous oral azithromycin use versus continuous oral placebo (the Optimize Study). “We’re creating and maintaining systems to facilitate clinical research,” she explains. Anyone who has worked with large amounts of data is grateful that there are people like Cianciola and her team who enjoy managing and handling all this information.
In the future she envisions data from research participants flowing directly into study databases, either via wearable devices or by participants entering information on their health status directly into study databases. Work is also being done to bridge the gap between data stored in electronic medical records and research databases such that manual data entry into electronic study database is not required, thus reducing errors and increasing efficiency. Though not in place at the moment, once implemented, these changes will, of course, bring their own set of concerns and challenges — for example, security of personal health information.
Before joining Seattle Children’s in 2013, Cianciola was a program manager at Fred Hutch managing an NIH-funded clinical trials network focused on developing microbicides for use in the prevention of HIV acquisition. Prior to that, she worked for the University of Washington’s Harborview Medical Center at an HIV clinical research site where she was the data manager. As part of these HIV projects, she travelled to five countries in Africa, as well as numerous clinics treating HIV-infected participants, both in Africa and the U.S. “Seeing how and where people receive care for HIV treatment and prevention was so valuable and educational,” she says. “I observed and learned things on those trips that continue to influence my work, even though my focus is now on CF.”
To learn more about the Therapeutics Development Network Coordinating Center, visit their website.
– E. Kuwana