August 25, 2020
Can a single missed drug safety reference be a billion dollar problem? If it’s been missed in literature monitoring for pharmacovigilance, it can. A missed drug safety reference can have serious consequences, with PV professionals making the wrong conclusions and patients being harmed, prompting lawsuits, regulatory action and precipitous share price falls. But when marketing authorisation holders are expected to monitor a vast volume of literature at least weekly, how is it possible to catch every relevant article?
In the context of tight reporting deadlines, ever-increasing literature volumes and rigorous compliance demands, the literature monitoring aspect of pharmacovigilance can create the ultimate in information overload. It’s perhaps no surprise that “Collection and collation of adverse drug reactions” is the #1 minor finding in audit reviews by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
If researchers are able to start by narrowing down the universe of results – without, of course, running the risk of eliminating relevant references – then the subsequent tasks of reviewing and monitoring can become significantly less costly and time consuming. Yet in even the most precise search, only five percent of references will be relevant; and only one in 1,000 references (Dialog Solutions estimate) are likely to trigger a signal evaluation.
However, precision searching reduces by 30-50 percent the volume of results from the regular “alert” searches that are the main task of medical literature monitoring. This not only makes monitoring less time-consuming and costly – it also reduces the need to carry out the many subsequent tasks in screening.
So what does best practice look like in precision search? In a nutshell, it’s about balancing the universe of sources used with the best search strategy. Our six points for best practice search, which we unpack further in our new whitepaper, Better Relevance: How precision search reduces the cost, effort and risk in medical literature monitoring, are:
- Define the question
- Choose the right sources
- Define an optimal search strategy that balances precision with recall
- Review search results and refine the search strategy as needed
- Maintain an audit trail
- Manage duplicates
If searches are correctly set up and fit for purpose, regularly reviewed and documented, pharmaceutical firms can be confident that regulatory audits are not going to reveal compliance issues or result in time-consuming remedial work.
When the consequences of missed drug safety references can cost billions, best-practice search is a valuable investment.
Download Better Relevance for deeper examination of this topic, which concludes with a checklist to benchmark your own medical literature process.
Click here to get hold of your copy of Better Relevance
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