Accelerating drug development without sacrificing safety: How pharmacovigilance is keeping pace with COVID-19 clinical research
2020 gave rise to the most devastating pandemic in modern history, but it also prompted remarkable breakthroughs across clinical research and product stewardship.
Just one year after COVID-19 was declared a global health emergency, there were 10 vaccines available for full or limited use and more than 80 vaccines in human trials. This extraordinary and highly anticipated effort was expedited by many factors, including eager trial participants, agile operation strategies and extensive industry collaboration.
Wide interest in the effort also means that clinical trials and their safety have been in the news and the public is paying attention. While many people are eager to receive a vaccine, some have questions about vaccine safety and the speed with which these products were brought to market. Drug development is a complex undertaking. The general public often doesn’t have a nuanced understanding of the process or the critical role pharmacovigilance plays in the development and stewardship of every product.
Pharmacovigilance specialists have been at the forefront of a transformational effort to balance patient safety with product efficacy.
Self-reporting health trackers across mobile devices and platforms play an important role in aggregating data from widely disparate sources. These AI-driven tools, like the Centers for Disease Control and Prevention app that prompts vaccinated patients to disclose any side effects, have not only helped pharmacovigilance teams track adverse events in real time, but also capture post-vaccination adverse event trends as they unfold.
In addition to leveraging self-reported data, pharmacovigilance service providers are wise to invest in tools to streamline research and analysis. Natural Language Processing (NLP)—an AI technology that automates medical literature review, identifies and analyzes facts for contextual information and streamlines data analysis with advanced algorithms—offers huge efficiency gains in pharmacovigilance operations. From accelerating clinical research and reducing transcription error, NLP lessens the strain on clients’ time and resources. Through its recent acquisition of NLP technology assets, Parexel reduced literature handling time by as much as 50 percent with 100 percent accuracy during a six-month pilot with a client.
While demonstrating the need for remote, efficient data capture, the global pandemic also exposed technology, personnel and other resource challenges in clinical research and product stewardship. Many biopharmaceutical organizations with promising vaccines and other treatments lacked flexibility to quickly scale and monitor safety profiles throughout the product life cycle.
Recognizing that health care providers needed to spend their time supporting patients, pharmacovigilance operational teams jumped in and worked with cross functional teams to find quick solutions and adjusted processes almost daily in the early part of the pandemic.
One of the benefits offered by contract research organizations is swift, nimble access to the right resources for end-to-end pharmacovigilance. As adverse event reporting volumes were skyrocketing, COVID-19 disruptions caused some pharmacovigilance service providers to suspend operations. The advantage of outsourcing to a pharmacovigilance partner through a Functional Service Provider (FSP) model is greater flexibility to maintain services—especially amid unforeseen circumstances.
Parexel’s Functional Service Provider (FSP) team quickly transitioned to a remote model with uninterrupted service delivery. Pharmacovigilance teams around the world were able to significantly increase case processing volumes with minimal additional training to ensure partner regulatory commitments were met. Global reach and access to local expertise near strategically located operations across multiple continents is an essential component for Parexel’s agile infrastructure, with experts who recruit and train the most qualified teams with speed and precision.
Agility in pharmacovigilance operations has never been more important than it is now as the industry works to combat and contain a highly contagious, deadly virus.
AI-powered technology and agile infrastructure drive more efficient, effective processes that have helped clinical trial staff, healthcare providers and the patients they serve throughout the COVID-19 crisis.
In the height of COVID-19, Parexel’s pharmacovigilance teams transitioned to user-friendly digital intake forms, devices and tablets for health care workers to provide the important clinical trial data. With trial staff able to input responses into structured, digital formats, clients saved time, cut costs and improved reporting accuracy.
With the recent increase in demand for pharmacovigilance services, adaptive strategies and strategic investments can make significant contributions to current and post-pandemic clinical research—particularly through mobile apps and data analysis platforms for post-approval pharmacovigilance.
When COVID-19 vaccines are delivered through mass immunization campaigns, many individuals will be exposed to the vaccines in a short time, with limited time for adverse events detection and analysis. In such situations, active surveillance will help obtain near real-time surveillance data for all adverse events.
Advances in technology help the industry quickly capture signal detection of the frequency and seriousness of adverse events. Automated, data-driven emails are sent to identified recipients across pharmacovigilance teams, clinical sites, health care providers and general practitioners. These digital platforms will provide real-time monitoring of the occurrence of adverse events following immunization.
In the United States, the COVID-19 initiative “Operation Warp Speed” prompted fear by virtue of its name. However, Parexel and others that specialize in the science of safety continue to work tirelessly on behalf of vaccine sponsors and the patients they serve. Every COVID-19 vaccine sponsor participates in extensive regulatory reviews, thorough data collection and analysis and ongoing safety checks conducted long after vaccines are deployed.
To learn more about how Parexel can turn functional into transformational through comprehensive and scalable solutions, visit Pharmacovigilance: Helping Reduce Patient Risk | Parexel.