Pharmaceutical drugs are designed to work wonders — alleviating pain and curing illnesses. But a lot can go wrong without a complete understanding of all the side effects a drug can have on each person.
It’s a problem that’s long plagued the pharmaceutical industry. Nearly one-third of all drugs approved by the US Food and Drug Administration between 2001 and 2010 had a safety event after reaching market, according to the Journal of the American Medical Association. Clinical trials can only measure so much, so pharmaceutical companies rely heavily on analyzing patient outcomes after a drug goes to market to make necessary adjustments along the way.
Today, all that is changing. SAP partner Deloitte has developed an innovative new platform with SAP HANA, ConvergeHEALTH Safety, that monitors patient outcomes and provides drug makers with early detection of potential anomalies that may necessitate further action from the companies.
“We can deliver advanced analytics that make treatments and drugs in the market much more beneficial,” said Monali Kamadolli, vice president of Product Management for Deloitte. “Deloitte provides the tools and analysis — the Intelligent Enterprise — necessary to improve the quality of a patient’s life and make sure they are taking a safer product.”
Protecting Patients, Improving Drugs
While clinical trials are designed to test for a wide variety of patient outcomes and conditions, it’s impossible to cover every possible scenario. For that reason, pharmaceutical companies continue to monitor their products in the market.
The result of that monitoring can lead to anything from changing the labeling, adding information about side effects, to pulling the drug from the market in extreme cases. In recent years, several longtime drugs on the market increased their warnings after new adverse effects were detected. An example of an extreme instance is when Vioxx was removed from the market in 2004.
“That’s the scenario everyone wants to avoid,” said George Pushchinsky, senior manager and ConvergeHEALTH safety solution owner at Deloitte. “Every product has a risk profile. No product has zero risk. We help pharmaceuticals understand what is a true risk profile and what action they should be taking.”
“Reacting to an unexpected outcome in the market historically has been a relatively slow process for drug makers. It takes time to investigate and determine an appropriate reaction. ConvergeHEALTH is helping to transform the way data is collected and processed, accelerating response time and providing more accurate information,” Kamadolli said.
ConvergeHEALTH allows users to identify early indicators of an issue with a specific drug or set of users, quickly identifying the factors that could cause an adverse effect.
“Today, it’s a ‘one size fits all’ approach with how analysis is done. Companies spend millions on safety monitoring, but they’re not spending in the most efficient way possible,” Kamadolli said. “Our clients’ objective is to increase safety, faster, which actually results in saving money.”
“One Deloitte ConvergeHEALTH client has streamlined its process from four disparate systems into a single global platform that provides improved efficiencies and a global view of safety monitoring. Deloitte expects the company to realize 20 to 30 percent savings while making its drugs safer,” Pushchinsky said.
Transformational Approach to Data Analysis
ConvergeHEALTH can also help pharmaceuticals accelerate the process to get drugs approved for alternative or secondary purposes than their original intent, Pushchinsky said. After all, Rogaine was originally used to treat high blood pressure. Then it was discovered that hair growth was a side effect. Meanwhile, after hitting the market Viagra was found to help with some heart issues.
“Today, if you want to get reapproved for secondary indications, you have to go through a costly and time-consuming process. But if you can take data you’ve already collected and repackage it and go back to the U.S. Food and Drug Administration, you may not need to do three more years of clinical trials,” Pushchinsky said. “You already have real-world data to effectively demonstrate the secondary indication, along with the safety data to back it up.”
“That is a fundamental shift in data analysis and gets us from a reactive mode to a predictive mode,” Kamadolli said. “ConvergeHEALTH identifies new insights that lead to better patient outcomes, health care providers and drugs. Ultimately, this can benefit all of us as we are all patients at some time in our lives.”
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