health care big data (Panchenko Vladimir/

Leveraging big data for pediatric health

While major public health initiatives are getting a boost from the power of big data, pediatric medicine is taking longer to make similar gains.  After the Food and Drug Administration approves a drug for adults, for example, it can take up to six more years for its approval in pediatrics, according to FDA Pediatric Team Leader Dr. Mona Khurana.

At a Sept. 18 FDA event on big data in pediatric studies, Khurana discussed the two questions that must be addressed before pediatric patients can be involved in clinical trials. “Can public health objectives be met if enrollment is left to adults?”  [and] does the risk have the ability to provide enough benefit to expose children to the risks?”

Khurana found child clinical trials are only likely to occur after “considerable study” in adults.  But it can still be hard to determine all of a drug's  side effects on children due to a “limited amount of interest” in the trials.

The FDA keeps track of side effects through the FDA’s Adverse Event Reporting System, a database that supports post-marketing safety surveillance through voluntary reporting  from healthcare professionals and consumers.

“The real world evidence [from FAERS] allows us to capture information" and track  adverse reactions that may not "manifest until years after exposure,” Khurana said.

Several other programs similarly leverage health care-related big data.

The FDA's Sentinel Initiative tracks medical product safety using a distributed data infrastructure approach.  Sentinel has electronic data from over 193 million patients from multiple health care providers.

“Sentinel allows the FDA to systematically determine data, integrity, reliability and reproducibility,” Khurana said.  “The ability to look for adverse reactions in children where toxicity needs to be studied with these large data sets could lead us in the right direction.”

The NIH Collaboratory is a living textbook of pragmatic clinical trials conducted across the United States.  The research is designed to focus on the basic benefits, burdens and risks of a medical intervention rather the outcomes, which allows the trials to be conducted a fraction of the typical cost and time. 

The Centers for Disease Control and Prevention also is involved in big data with the National Health and Nutrition Examination Survey, which collects socioeconomic, health and demographic information for adults and children across the United States and serves a resource for disease prevalence and risk factors. 

About the Author

Sara Friedman is a reporter/producer for GCN, covering cloud, cybersecurity and a wide range of other public-sector IT topics.

Before joining GCN, Friedman was a reporter for Gambling Compliance, where she covered state issues related to casinos, lotteries and fantasy sports. She has also written for Communications Daily and Washington Internet Daily on state telecom and cloud computing. Friedman is a graduate of Ithaca College, where she studied journalism, politics and international communications.

Friedman can be contacted at [email protected] or follow her on Twitter @SaraEFriedman.

Click here for previous articles by Friedman.

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