Drugmakers are beginning to pay more attention to pharmacovigilance and are relying on signal detection technologies “to aid in the costly act of identifying and managing adverse drug events”, a new report claims.
The report from Datamonitor is called Addressing Key Challenges in Drug Safety and its author Ruchi Mallya says it is crucial that “pharma companies and regulatory agencies develop comprehensive pharmacovigilance strategies to intelligently analyse the risks and benefits of each drug”. She adds that advanced computerised systems and IT solutions to help with drug safety monitoring “are a must for companies that want to survive in this predictive and proactive pharmacovigilance environment”.
Ms Mallya notes that companies need to communicate safety issues related to a drug in every country where it is legally marketed and the adoption of advanced pharmacovigilance tools, “specifically signal detection and management technology solutions, data management tools, and adverse event reporting systems” will greatly help them do so.
She adds that given the current business environment, characterised by declining product pipelines and increasing R&D costs, “a company can no longer afford to go through the entire drug development process, only to have the drug be rejected by the regulatory agencies, or worse, be removed post-market, due to safety concerns”. Drug safety issues not only affect a company’s business portfolio, Ms Mallya says, but can lead to high lawsuit payouts.
The report states that in order for pharmacovigilance to be effective, “a radical change must take place in the signal detection and management process”. The use of data mining and signal detection during post-market surveillance is not unheard of, Datamonitor argues, but using these technologies in clinical trials “is a relatively new concept”. In the past, analysis of data required a ‘back-and-forth discussion’ between researchers and statisticians, “and could take anywhere from a few days to a few weeks to complete the analysis”.
Ms Mallya concludes by saying that “the newer, more sophisticated pharmacovigilance solutions, such as signal detection technology, are still in the nascent stages, and so pharma companies have been reluctant to welcome them with open arms”. However, as they see the benefits of “the substantial time and cost savings” will provide, the IT industry will see an accelerated growth in the adoption of pharmacovigilance technologies which “will play an essential role in promoting and protecting public health”.
