Data Manager Sees People Not Numbers

When it comes to clinical trial data, Amy Mirand, PhD, sees the personal contribution behind the numbers.

“When I am reviewing data, I can see the timeline of a person’s health – the ups, the stability, and sometimes the challenges,” says Mirand, Data Manager at the AIDS Clinical Trials Group (ACTG) Network Data Management Center (DMC) in Amherst, New York, USA. “Data are not just numbers. Data represent what individuals have decided to share about themselves towards the goal of a greater good for many. This is humbling. I respect and admire our study participants.”

As a data manager, Mirand breaks down her role into two parts – quality assurance and data cleaning. Throughout the course of the study, she says the data manager works with the study team, enrolling sites and ACTG’s statisticians to maintain quality assurance of the data being collected from participants.

“If the statisticians or I discover a data discrepancy, missing data, or an outlier, we’ll review it, and, if needed, query the participating sites,” Mirand says. “We need to find out if the reported data are accurate. What is the source of this discrepancy? Is it a typo? Is it accurate as reported? It’s an ongoing process that involves a lot of computerized data checks, emails and calls. In addition, each site has its own quality assurance and quality control measures in place. So, together we make sure the data are as accurate as possible. It really is a team effort.”

“If we collect high quality data, we will yield high quality data results. And if we collect poor quality data, our results could be potentially misleading or incorrect,” says Mirand. “This is why we have systems in place to monitor the data at every stage of the trial. The efforts to ensure high quality data are expressions of respect for the study participants.”

For many of her counterparts at the DMC, data management is a second career. Prior to joining the DMC as a data manager eight years ago, Mirand, an epidemiologist, was a researcher at the Roswell Park Cancer Institute in Buffalo, New York, where her research focused on cancer prevention and health behaviors.

“Sometimes I miss being a principal investigator, but all of our jobs within the ACTG are part of the research spectrum. That contribution is still there,” she says. “When individual data are compiled into group data, we can see trends. These are the data that are reported. I am proud to be a part of the ACTG’s contributions to the realm of HIV knowledge and care.”

As an epidemiologist, Mirand confesses she loves observational studies. When she came to the ACTG, she was thrilled to discover she would be the data manager for the Network’s A5001 study, an observational study that has followed nearly 6,000 participants for an average of five years to assess the long-term outcomes of antiretroviral therapy (ART). All participants were enrolled in another ACTG study (parent protocol) prior to A5001 enrollment. Although the median time on study was five years, many study volunteers participated in A5001 for more than 12 years. The study led to the creation of a rich database of information investigators continue to draw from to conduct new HIV studies.

“A5001 looked at more than just a person’s CD4 count. This study looked at all of the factors that make a person whole and can be impacted by the long-term effects of HIV including cognitive, virological and neurological function,” says Mirand. “When I was assigned to this study, it was a good fit. I truly admire the A5001 study participants’ dedication and contributions to the field of HIV research.”

Mirand also serves as the DMC representative to the Women's Health Inter-Network Scientific Committee (WHISC) and ACTG’s Outreach, Recruitment and Retention (OR&R) subcommittee.  Participation on each of these committees reflects her strong interest in clinical trial participation of female and under-served populations. 

“Amy is a dedicated data manager who not only admires the contributions of the A5001 study participants, but she also admires the efforts site study personnel have contributed to high data quality and maintaining a strong relationship with their study participants,” says Kristine Coughlin, Data Manager at the DMC.

The OR&R committee supports study teams to spread the word about an enrolling protocol. During the ACTG’s annual summer meeting three years ago, Mirand attended the OR&R business session.

“Michael Louella, OR&R’s chair, was very welcoming, and I observed camaraderie and commitment from the committee’s members,” Mirand recalls. “All of the ideas they discussed to connect the research with the community had true application and meaning.”

What she saw during the OR&R session years ago inspired Mirand to ask the DMC if she could represent the DMC on the committee. Louella was happy to welcome her to the team.

“Frankly, I was shocked to discover that Amy was a data manager.  Ideas, comments and solutions bubble up from her with a passion you’d not expect if you were to believe the stereotypes we hold about people who work with numbers,” says Louella, who also serves as the Outreach Coordinator at the ACTG’s University of Washington site in Seattle. “The video to thank the participants of A5001 was Amy’s vision. I was pushing my subcommittee members to master elements of social media, and Amy was the first to dive into the deep end. That her dive ended up being a reverse twisting group is a testament to her innate talent for outreach.”  

Mirand said it’s the relationships she has established with her colleagues at the DMC, at the sites, the ACTG’s study teams, WHISC, and other OR&R members that make her job fulfilling.

“All of the data managers have relationships with people from the ACTG’s sites worldwide,” Mirand says. “The relationships I have built with all of the people I have interacted with over the years are my favorite part of my job. I strongly encourage people to pick up the phone and give me a call because email is not always sufficient. It’s nice to take the time during the workday to really ask someone how they are doing. That is what gives the job depth.”