For World Patient Safety Day 2025, the World Health Organization (WHO) is spotlighting safe care for every newborn and child with this tagline: “Patient safety from the start.” This is an important reminder to protect all patients, including the most vulnerable populations. For those of us in drug development, it also reminds us of our responsibility to ensure patient safety from the start of clinical development.
“Pharmacovigilance is core to one of our most fundamental promises: to protect the wellbeing of those who depend on life-changing therapies. By implementing robust safety monitoring from the earliest stages of development, we create a foundation of trust with patients, regulators and healthcare providers,” says Sanjay Vyas, President, Safety & Logistics and Country Head of India, Parexel. “This proactive approach allows us to identify potential safety signals quickly and take appropriate action to protect those we serve.”
Drug safety programs are essential to any development effort, so pharmacovigilance — the work of monitoring, detecting, assessing, and preventing adverse events (AEs) — should begin early in the drug lifecycle. This allows for a comprehensive approach to safety and product stewardship that identifies and addresses potential safety concerns as expeditiously as possible. A robust and ongoing safety assessment is also critical to earning regulatory approval and to protecting patients once an approved product enters the market.
Pharmacovigilance teams detect new or changing safety concerns by monitoring data from a wide range of sources, then looking for causality — a clear link between the therapy and the reported event — and determining which safety signals require further investigation. Researchers apply statistical methods and data mining techniques to massive datasets that include structured data from clinical trials and post-marketing studies, literature reviews, AE reports from health care providers, study sites, and patients themselves, as well as real-world data ranging from electronic health records to social media posts.
Because the strength of a pharmacovigilance program hinges on the quality and availability of its data, it’s critical that patients report any potential side effects they experience while using a medicine. But research shows that underreporting rates for AEs can exceed 90 percent — an alarming statistic with real consequences for patients.
To address this enormous gap, we need to first understand the barriers to reporting. Sometimes, patients assume that their providers will report all AEs on their behalf, which isn’t always the case. We also hear these common concerns among the patients we work with at Parexel:
- A potential AE will be dismissed as disease progression.
- AE reporting could result in a patient being removed from a trial.
- Reports won’t be heard or won’t make a difference.
- Reporting is difficult or time-consuming.
Every AE report is valued and valuable and this must be our first message to patients. Through face-to-face conversations as well as print, video, and online education, we need to communicate that AE reporting helps us protect other patients and continuously improve critical medicines. When someone reports an AE, they’re doing a service to fellow patients and to everyone involved in developing and prescribing that medicine.
Because every case is investigated and assessed, patients should report any suspected AE, even if they aren’t sure whether it is disease progression or whether their provider might report the AE as well. Recently, the FDA announced that it will begin daily publication of AE data, a modernization we strongly support because it reinforces the value of patient reports. Greater transparency in AE reporting demonstrates to patients that their feedback is being heard and accounted for. This is one way we build trust with patients who need to know that they are participating in a system designed to protect them.
In addition to patient education, drug sponsors and their partners have other ways to ease the burdens of reporting. We can:
- Be clear that AE reporting does not jeopardize clinical trial participation. This should be communicated throughout the course of any study.
- Partner with patient advocacy groups — trusted organizations that also understand the importance of AE reporting and that have unique lines of communication with the patients they serve.
- Make reporting as simple as possible for patients and health care providers. Calling a reporting line should always be an option for patients, but we should offer a range of user-friendly interfaces that make reporting accessible and straightforward. At Parexel, we often turn to focus groups and our patient advisory council to determine which solutions would be best in real-life situations.
“The patient voice is our most important signal,” says Stacy Hurt, Chief Patient Officer, Parexel. “Living with a disease and its treatments can complicate a person’s life immensely. As both a stage IV cancer survivor and a caregiver, I’ve experienced first-hand how incorporating the patient voice can save lives. If sponsors and CROs can reduce that complication in any way, we owe it to patients to do so.”
In the old model of pharmacovigilance, teams primarily worked reactively, focusing on collecting and reporting safety data. But AEs aren’t just data points and we need to fully consider the patients who experienced these events, creating accessible pathways for patients to share their experiences and reassure them that their voice matters.
As much as we work to minimize them, AEs will sometimes occur. But we can help patients report them as easily and expeditiously as possible, knowing that every story we receive helps us uncover and address pressing concerns. Through meaningful engagement, we can minimize patients’ risk of disruption to their lives. We can move from passive monitoring to proactive partnerships in which each patient voice is heard and makes a difference.
About the authors
Sanjay Vyas, President, Safety & Logistics and Country Head of India
Sanjay oversees critical functions that directly impact patient safety and clinical trial success, ensuring patient safety remains paramount throughout the drug development process. His global expertise gives him a deep understanding of diverse patient needs across different health care systems, enabling Parexel to help bring safer and more effective treatments to patients worldwide.
Stacy Hurt, Chief Patient Officer, Parexel
Because of her unwavering commitment to patient safety, Stacy ensures patients and their care partners have meaningful representation in the drug development process, translating their lived experiences into action. Drawing from her personal journey as both a stage IV cancer survivor and a caregiver to her son who has an ultra-rare genetic chromosome abnormality, she brings an authentic patient perspective to safety discussions, advocating for enhanced safety protocols and risk management and trial designs that place the patient first.