The increased use of novel, accelerated regulatory pathways, along with a growing interest in safety information from a range of stakeholders, has had a dramatic impact on the role of pharmacovigilance in drug development. Specifically, it has led to more post-approval safety commitments and a rapidly expanding volume of reported safety events that has forced the industry to urgently consider new approaches to managing pharmacovigilance throughout the product lifecycle.  

During the past decade, increased use of various expedited review approaches and other improvements have led to a decrease in time taken to bring new drugs to market. While this acceleration has led to more rapid access for patients, it also increases the risk of adverse drug reactions being detected for the first time when the product is already in the market, leading to higher demand for post-approval safety surveillance studies and related activities.

In addition, the move from paper to electronic formats, along with increased vigilance from various stakeholders, has increased the amount and velocity of safety information in the environment. Spontaneous reports from all sources need to be managed with a full understanding of the role even a single case can play in changing the perceived benefit risk profile of a product. The evaluation of cases at point of initial entry needs to be undertaken at the highest standard of both quality and timeliness—despite ever-increasing volumes.

Both of these dynamics drive higher costs and create a more complex environment in which to maximize patient safety. In turn, biopharmaceutical companies have been forced to implement a range of innovative approaches to managing safety.   

The first area of active innovation is the greater inclusion of real-world safety considerations in the overall clinical plan. Launching pre-approval disease registries that roll into post-approval surveillance are becoming more frequent—both to identify safety signals as well as to generate other sources of valuable baseline data to support market access imperatives.

The second area is an expanded role for post-approval pragmatic or ‘real world’ studies to cost-effectively improve upon the understanding of safety in a clinical setting. These studies often blur the line between observational and interventional research and require new ways of thinking about various elements like protocol development and site management. Building studies that reduce effort for the clinic and the patients while generating safety and other forms of relevant data has become a discipline in its own right, different from traditional interventional study design or typical observational studies. These studies are also beginning to take advantage of third-party data assets to perform database studies or, more recently, hybrid studies where the third-party data sources provide key background information, with primary data collection modalities filling in data quality gaps or improving timeliness of key safety information.

Third, the large majority of biopharmaceutical companies have begun to leverage outsourced providers as a cost-effective solution to growing pharmacovigilance demands. Several best practices can make these relationships less transactional, including:

1. Reducing internal costs by grouping outsourced activities to minimize hand-offs and the costs of managing multiple vendors (e.g., working with a single provider across multiple compounds and/or a set of related activities);
2. Using ‘partnership’ best practices to focus the relationship on multiple types of value creation such as refined oversight, proactive capability development, technology linkages and sharing lessons learned/best practices from other relationships;
3. ‘Future proofing’ the outsourcing relationship by choosing partners that can flex in scope and volume as needs change;
4. Working with providers that have experience leveraging lower cost locations while maintaining high-quality standards; and
5. Incorporating local affiliates into the pharmacovigilance approach using a “hub and spoke” model.

The biopharmaceutical industry is experiencing the most dynamic period of pharmacovigilance evolution in its history. Responsibly managing safety has become more complex and more expensive.  With a growing range of innovative tools and approaches, the industry now has new avenues to enable drug development. The advances in pharmacovigilance allow industry to continue advancing drug development timelines without sacrificing patient safety.

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Imad Alsayed is vice president, global head late stage interventional and drug safety, Parexel.

Sahil Bansal is associate director, pharmacovigilance operations, Parexel.