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Let's Get SMART on Adverse Events

Automation may be the key

The National Cancer Institute defines an Adverse Event as “an undesired effect of a drug or other type of treatment, such as surgery. Adverse events can range from mild to severe and can be life-threatening. Also called adverse effect and adverse reaction.”

One of the biggest risks to a medical product or company is the underreporting of adverse events. Every decade there seems to be one blockbuster drug that ends up being pulled from the market because the drug’s adverse events were not properly understood from the initial clinical trials.

From the 1950s-60s, there was the drug Thalidomide, which was later discovered to cause birth defects. The 1990’s had the famous weight loss drug Fen-Phen. This drug was pulled off the market after a few years due to heart and lung issues caused in some patients. Then in the early 2000’s, there was the drug Vioxx. Vioxx promised to be a new painkiller with fewer gastrointestinal problems than the others on the market. It had reached over $2.5 billion in sales but was eventually taken off the market due to increased risk of strokes and heart attacks. After Vioxx was taken off the market, the value of the company’s stock value dropped by 33+ percent.

These tales from the recent past show the high stakes of properly reporting adverse events in clinical trial studies. But what causes underreporting in the first place? A study showed that there are five core reasons that lead to most adverse events underreporting.

Five causes of underreporting of adverse events in clinical trials

  1. Ignorance – Thinking only serious adverse events need to be reported
  2. Lethargy – Due to overbearing workload of adverse event reporting
  3. Complacency – Belief that if drug is on market, it must be safe
  4. Diffidence – Fear of over reporting adverse events
  5. Insecurity – Unable to isolate one drug to an adverse event

In a world of burned out clinical researchers, what can be done? This is where technology comes into play. One of the goals of the SMART on FHIR framework was precisely to reduce some of the overbearing data entry workload on health professionals that is mentioned above. With this framework, health data should seamlessly flow from one health system to another without the burden of extra manual data entry.

Automated AE reporting framework supported by White House initiative

As many of you know, the form used by the FDA to report adverse events is the Medwatch Form 3500. Most of the information needed on this form for reporting an adverse event on a particular participant can be found in the patient’s health record or their participant record in the clinical database. Therefore, in a world of seamless health data sharing, this form can be filled out automatically and sent over electronically to the FDA instead of manually. In a world of automated adverse event reporting, imagine how many drug failures we would prevent and imagine how many more safe medicines we would have.

This vision of the future of clinical research may seem like a pipe dream, but the White House wants to join us on this journey as well. In October, the White House’s Office of Science and Technology agreed to bolster the clinical trial infrastructure in America and one of their number one outlets is investing in the development of the SMART on FHIR framework. OpenClinica is aligned with the White House’s initiative to make the U.S. a world leader in clinical trial innovation. Also, in order to meet that goal, the White House agreed that seamless sharing of health data is necessary.

Automated AE reporting is closer than you might think

In October, OpenClinica participated in a Connectathon as part of our membership in the Vulcan FHIR Accelerator. The focus of this event was the Adverse Event FHIR standard. During this event, OpenClinica showed how close to automated electronic adverse reporting we already are.

OpenClinica recreated the Medwatch Form 3500 using our configurable form engine and our eSource solution – Unite – to pull in the demographic, laboratory, medication and condition data from a sample patient. This data from the EHR was automatically pulled into the Medwatch Form 3500, dramatically reducing the number of fields to be filled out manually. We were also able to transform this form in the clinical trial database into an outline of a FHIR-based adverse event that was sent to a simulated FDA FHIR-based server.

If you squint your eyes enough when reading the post above, you can see the bright future we have ahead of us in clinical research and OpenClinica will be right there pushing forward with you.

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