Taking a page from the large CRO’s playbook, the National Football League (NFL), which outsourced injury surveillance to Quintiles in 2011, now has signed a five-year expanded strategic partnership that will use the CRO’s epidemiology capabilities to track and better understand trends in football injuries.

Quintiles’ Real-World & Late Phase Research business unit, which developed the Injury Surveillance System for the NFL as part of its observational research and patient registry services, provides programs for characterizing diseases. The system also evaluates safety and effectiveness of medical interventions and implements risk management programs, in addition to sports industry research. The group’s expertise provides insights about risk factors for sports injuries, including concerns relating to rules, equipment and types of surfaces.

The analytics for the NFL are produced in response to specific requests by the NFL’s teams, health and safety committees, physicians, athletic trainers and the NFL Players Association. The information is shared with these groups in a series of reports and faceto- face meetings. Data from each of the 32 NFL teams is entered by the athletic trainers in consultation with the team physicians.

The partnership expansion comes as the overall number of football injuries has risen despite a decline in the number of concussions, from 173 in 2012 to 111 in 2014—a 36% drop over the three-year span, according to the NFL. The decline follows a series of changes by the NFL meant to cut down on blows to the head, including reduced contact practice time and rules that bar players from leading with the top of their helmets to stop a receiver.

“Players are changing the way they’re tackling,” Jeff Miller, NFL senior vice president of health and safety policy said in a statement. “They’re changing the way they play the game.”

During the just-ended 2014-2015 NFL season, Quintiles took injury surveillance a step further by combining it with each player’s electronic medical record (EMR) under an agreement with the NFL Players Association.

“Using EMRs and other game-related information enables us to conduct analytics, which also broadens our understanding of player safety and health,” said Christina Mack, Ph.D., Quintiles’ associate director of epidemiology. “We work with the league to look at a very comprehensive set of injuries beyond concussions. We look at rule changes that have helped reduce concussions. We also track all other injuries including fractures, bad sprains and torn knees involving the ACL [anterior cruciate ligament] and MCL [medial collateral ligament]. Since we launched the EMR, we are getting more injuries put in the players’ medical records, such as contusions and bruises, which increased the total number of injuries last year.”

Typically, after a Sunday football game, players are checked on Monday or Tuesday by the athletic trainer and team physicians, who enter medical data into their EMRs and, if needed, update later in the week, said Mack. She said this past season’s games had additional onsite medical expertise, with independent neurologists on the sidelines to perform assessments when players were suspected of having concussions.

“Concussions are difficult to diagnose, so these physicians can determine if the player has a concussion and if they think he doesn’t, the player can return to play,” said Mack. “This is an extra safeguard.”

Her team at Quintiles reviews those medical records for accuracy and missing information— even checking with the local media that covers each team—to make sure injuries that occur during both games and practices are not omitted. News reports in the local media of a significant injury that is not noted in the player’s EMR immediately is checked for an explanation, she said.

“We do that kind of resolution on key injuries, along with overall data cleaning with the teams on all medical and surveillance data—which relates to back to clinical trials and observational studies,” said Mack. “Often, it’s something that has to be corrected to complete the medical record. This is the bread and butter of our scientific affairs group, which has epidemiologists, statisticians and data managers, and applies our methods used in clinical trials for successful prospective data collection. Those methods also are used in the NFL electronic medical records for research.”

Asked if she and Quintiles would consider expanding beyond football, Mack didn’t hesitate.

“Absolutely,” said Mack. “We’d look at other professional sports groups.” 

Email comments to Ronald at ronald.rosenberg@centerwatch.com. Follow @RonRCW

This article was reprinted from Volume 19, Issue 06, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »