Online Adverse Event Monitoring Could Guide Ph IV Spending say Researchers

By Gareth Macdonald

- Last updated on GMT

Related tags Clinical trial

Scientists Say Net-Based Monitoring Could Guide Phase IV Trials
Scientists Say Net-Based Monitoring Could Guide Phase IV Trials
Researchers behind a new automated adverse drug event monitoring method say it could act as an early warning system and guide Phase IV trials. 

The system – presented in the journal of medical internet research last week​ – is intended as a low cost, automated means of monitoring adverse reactions by tracking queries submitted to internet search engines.

The team applied its method – known as the query log reaction score – to the US version of Yahoo’s web search engine, logging adverse event-related queries about the top 20 selling drugs in the US submitted by 174 million annonymized users during a 6-month period in 2010.

Lead author Elad Yom-Tov, from Yahoo Research, told that: “Our method differs from Phase IV trials in several ways. First, it covers a very large population, compared to most Phase 4 trials.

Second, whereas most trials require patients or care providers to make the association between drug and side effect, we can identify such side effects even if the user does not make them​.”

While the approach is not likely to replace Phase IV studies – people who suffer drug-related heart attacks are more likely to head to the emergency room than their internet browser – it could aid detection and show sponsors and CROs where to focus their efforts according to Yom-Tov.

I tend to think of the adverse events we discover as a guide for what Phase 4 trials may want to look at and where to focus. If we ran this system on a daily basis, it could also serve as an early detection system, simply because it observes what people are currently searching for.”

I think drug companies should see this as an opportunity to receive useful information which would otherwise be difficult for them to obtain​,” he continued, stressing that any events identified using this method would need to be assessed in a formal Phase IV trial.

The team is also hopeful regulators will see the potential benefits of this approach to automated adverse drug event monitoring according to Yom-Tov who suggested that: “I suspect that since this is a new way of discovering side effects, regulators will be careful analyzing our results.”

Moving the idea forward is likely to involve the contract research sector. Yom-Tov told us that the researchers would be “interested in validating the side effects we discovered in collaboration with CROs​.”

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