Advancing the Science

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August 22, 2019

At Mayo Clinic, one Statistics and Data Management Center oversees hundreds of cancer clinical trials

By Advancing the Science contributor

By Lydia Hansen, undergraduate public affairs intern

The Mayo Clinic Cancer Center’s Statistics and Data Management Center is one of the largest and most highly rated statistics and data management centers working with cancer research in the world. The group has an overall portfolio of 361 cancer-related clinical trials and information on more than 185,000 patients in its database.

Housed within the Department of Health Sciences Research at Mayo Clinic, the Statistics and Data Management Center supports a range of cancer research. This includes clinical trials and associated projects funded through Mayo Clinic Cancer Center and its National Cancer Institute (NCI) Cancer Center Support Grant and Specialized Programs of Research Excellence. The center also supports research conducted through the Alliance for Clinical Trials in Oncology, Academic and Community Cancer Research United, the Cancer Prevention Network and several other large NCI and industry-sponsored cancer research programs. All data collected from the clinical trials funded by these networks passes through the center.

Sumithra Mandrekar, Ph.D.

“When a trial opens, we are responsible for every piece of data coming through that trial,” says Sumithra Mandrekar, Ph.D., group statistician for the Alliance for Clinical Trials in Oncology, and section head for Mayo Clinic Cancer Center Statistics. “It’s a very big machine,” she says.

The Statistics and Data Management Center’s primary focus is to help Mayo Clinic Cancer Center and collaborating researchers design, conduct and analyze data collected on clinical trials. Many of these trials involve testing new drugs.

Statisticians and data managers from the Statistics and Data Management Center get involved with each trial right from the beginning. Working with study investigators, members of the center define the working hypotheses — or research questions — of the trial. That information helps determine how the trial should be conducted, what data should be collected, the number of participants, and the definition of success for the drug or other treatment being tested. The center then designs a database to house all of the data from the trial.

After a trial has been approved and funded, project team members from the Statistics and Data Management Center continue to monitor the trial for patient safety and viability and perform regular cleaning and querying of the data being collected. When the trial closes, the statistical team helps investigators analyze the data collected and write manuscripts, abstracts or presentations on any findings.

“We’re there the whole time, from the birth of a trial to its completion,” Dr. Mandrekar says.

The Statistics and Data Management Center is a massive repository of data collected from both Mayo Clinic-led trials as well as patient data collected from other trials led by international organizations and pharmaceutical companies. Investigators can use these databases to pose additional questions about trials and the effectiveness of different treatments.

“We have the ability to pool data and look across multiple trials to ask questions that are not always possible to be answered using data from a single trial,” says Dr. Mandrekar.

Unlike other data centers, which often divide infrastructure and teams by funding source or research focus, Mayo Clinic’s Statistics and Data Management Center has a consolidated infrastructure. Teams organized by disease specialties oversee all cancer-related trials research. This practice of increased information-sharing is part of how the center keeps hundreds of clinical trials running smoothly and safely.

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Tags: About, cancer, clinical trials, health sciences research, Mayo Clinic Cancer Center, National Cancer Institute, Sumithra Mandrekar

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