As regulations around drug safety increase, pharma companies 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. In a new report just published, independent market analyst Datamonitor predicts the industry will see accelerated growth in the uptake of drug safety monitoring solutions. The report Addressing Key Challenges in Drug Safety, examines the technology solutions that will be integral to streamlining the pharmacovigilance process, thus helping pharma companies reduce costs while promoting and protecting public health.
“It is crucial pharma companies and regulatory agencies develop comprehensive pharmacovigilance strategies to intelligently analyze the risks and benefits of each drug prior to introduction into the mass market and monitor any adverse drug reaction post-market”, says Ruchi Mallya, pharmaceutical technology analyst at Datamonitor and author of this study. “Advanced computerized 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.”
The pharmaceutical industry is a highly regulated global market, and must adhere to not only federal and local rules, but international regulations as well. Companies must adapt to constantly changing government regulations to ensure compliance and eventual approval of their drug products, and response to these new rules is driving the adoption of pharmacovigilance solutions.
“Companies will need to ensure they report and communicate safety issues related to a drug in every country where the drug is legally marketed,” says Mallya. “The adoption of advanced pharmacovigilance tools, specifically signal detection and management technology solutions, data management tools, and adverse event reporting systems, will greatly help companies manage the large amounts of safety data, as well as generate and submit reports to specific countries or regions based on their regulations.”
The business environment for the pharma industry has changed immensely in the past few years. The current “blockbuster” business model is no longer viable for companies to sustain growth. As the industry faces increasing competition from generic drugs, declining product pipelines, and increasing research and development costs, pharma executives are becoming anxious about the state of their companies. 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, but also can lead to high lawsuit payouts.
“It is essential for a pharma company to implement a proactive pharmacovigilance and risk management strategy which encompasses the use of technology to ensure production of a safe and effective drug that will be approved and maintain a favourable risk-benefit ratio post-approval,” says Mallya.
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, but using these technologies in clinical trials is a relatively new concept. In the past, analysis of clinical 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. Using advanced signal detection technologies throughout the clinical trials process allows researchers to perform ad hoc, close to real-time analysis on the data, reducing time in the interchange between researchers and statisticians.
According to Mallya, “for a drug that is deemed ‘safe', this time-saving could lead to a reduction in development costs and a faster time-to-market. On the other hand, early detection of safety issues could also lead to termination of future clinical trials, which protects patients from further suffering, and saves companies money that would be spent on clinical trials, litigation, and regulatory fines.”
Detection of potential safety issues early will allow pharma companies to manage these safety signals throughout the product's lifecycle. Unfortunately, the industry is still sceptical of the benefits provided by advanced signal detection technologies.
“IT vendors must take an active role in educating companies about using pharmacovigilance solutions, and position signal detection technologies as essential tools for developing comprehensive risk management strategies which will not only benefit the company, but ultimately the public.”
Mallya concludes, “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. As they see the benefits of the substantial time and cost savings these efficient drug safety systems will provide, the IT industry will see an accelerated growth in the adoption of pharmacovigilance technologies. These tools will play an essential role in promoting and protecting public health.”
Datamonitor's report, Addressing Key Challenges in Drug Safety, identifies and analyzes the key forces driving and impeding the adoption of pharmacovigilance technology solutions. This report also discusses key functionalities needed for a complete drug safety solution and offers insight into how IT vendors can improve their products.
