Clinical trials serve as the backbone of Drug development, ensuring the Safety and efficacy of new medications before they are made available to the general public. Drug safety, the study of which is known as pharmacovigilance, is of paramount importance in these trials for sponsors and contract research organizations (CROs), as it directly affects the well-being of participants and the subsequent use of the drug in the wider population.

Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality worldwide, estimated to rank among the top ten causes of death in many countries. With the increasing complexity of drug development and the need for robust safety monitoring, several innovative solutions have emerged to enhance drug safety. Read on to discover the top five drug safety solutions optimizing pharmacovigilance in modern clinical trials!

5 Drug Safety Solutions Optimizing Pharmacovigilance in Clinical Trials

1 | Artificial Intelligence (AI) in Pharmacovigilance

One of the most promising advancements in drug safety is the integration of artificial intelligence (AI) methods, such as deep learning (DL) and machine learning (ML) algorithms. For example, DL methods are well-suited for post-marketing safety, wherein they can help monitor real-world use, support regulatory updates and clinical decision-making, and enable better comparative safety analysis between different products.

On the other hand, ML techniques are invaluable in preclinical toxicity studies because they can help predict drug toxicity, model diversity in patients, elucidate mechanisms of action, and influence certain components of a drug candidate’s trial design to accommodate the preclinical safety findings. By leveraging AI and ML, drug safety professionals can proactively identify and manage safety risks by evaluating common trends in large pools of patient data, leading to more effective and safer clinical trials.

2 | Real-World Evidence (RWE) and Drug Safety Real-World Data (RWD)

Traditionally, clinical trials have relied on controlled environments and selected patient populations; however, real-world evidence (RWE) and the value of real-world data (RWD) have gained significant importance in recent years. RWE refers to the patient health status data collected from real-world settings, such as electronic health records, claims databases, and patient registries. By analyzing RWD collected from these types of sources, pharmacovigilance professionals can identify and monitor less common adverse events (AEs) that may occur in specific patient subgroups or under certain real-world conditions. RWE and RWD also support pharmacovigilance by providing insights into the long-term safety of drugs, as clinical trials typically have a limited duration and may not capture the full spectrum of long-term safety concerns. This information allows for timely updates to drug labels and prescribing information, ensuring that healthcare professionals and patients have the most up-to-date safety information.

3 | Electronic Health Records (EHRs) and Data Integration

Electronic health records (EHRs) have become increasingly prevalent, providing a wealth of patient data that can be used to enhance drug safety. By integrating EHR data with clinical trial databases and pharmacovigilance systems, drug safety professionals can gain a more comprehensive view of a patient’s medical history and identify potential safety concerns. There are several benefits to enabling clinical trial data platform integration with EHRs, including the following:

1. They allow for real-time monitoring of clinical trial participants, allowing clinicians and sponsor/CRO research teams to promptly detect and respond to any adverse events or drug-related problems that may arise during the trial.
2. EHRs provide access to long-term follow-up data, which is crucial for monitoring the safety of drugs beyond the duration of clinical trials, such as in RWE studies.
3. Integrating data from EHRs with pharmacovigilance systems and claims databases allows researchers to identify potential safety issues and make informed drug safety decisions in a timely manner.

4 | Digital Health Technologies as a Drug Safety Solution

The advent of digital health technologies, such as wearable devices and mobile applications, has opened up new avenues for drug safety monitoring. These technologies can collect real-time data on patient vital signs, medication adherence, and AEs throughout clinical trials and during the post-marketing surveillance phase. For example, poor medication adherence is a significant issue in pharmacovigilance, as it increases the risk of AEs, morbidity, increased costs of care, and compromised treatment outcomes. Wearable devices offer a solution by providing real-time monitoring and reminders for medication intake. Although there is a need to develop more rigorous data standards in this growing market, digital health technologies provide a method for sponsors and CROs to detect safety alerts earlier, while simultaneously minimizing the burden on patients participating in clinical trials.

5 | Collaborative Efforts and Pharmacovigilance Data Sharing

Effective drug safety solutions require collaboration and data sharing among various stakeholders, including pharmaceutical companies, regulatory agencies, healthcare providers, and patients. Collaborative efforts facilitate the sharing of safety data, post-marketing surveillance findings, and AE reports across multiple platforms. Such a collective body of knowledge not only enhances drug safety by enabling more efficient pharmacovigilance processes, but they also serve as valuable sources of data for RWE studies, particularly in therapeutic areas with limited patient populations or when placebo arms are not possible. More importantly, collaborative efforts promote transparency and trust between various stakeholders within the medical and clinical research industries, which are essential for ensuring the timely dissemination of safety information to healthcare professionals and patients.

Regulatory Guidance for Pharmacovigilance Services

In addition to the aforementioned solutions, the establishment of robust regulatory frameworks and adherence to compliance standards is crucial for ensuring drug safety in clinical trials and pharmacovigilance. Such standards, referred to as Good Pharmacovigilance Practices (GVP), are typically set forth by regulatory agencies, including the United States Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA). These regulatory bodies play a vital role in setting guidelines and monitoring the safety of drugs throughout their life cycle. Compliance with these guidelines helps to ensure that drugs are developed, tested, and marketed in a manner that prioritizes human safety, while promoting accountability in the pharmaceutical industry and improving patient safety outcomes.

Vial

Vial is a full-service CRO that recognizes the role of technology in the future of drug development and is paving the way for modernized clinical trials and pharmacovigilance data collection through digital innovation. Trusted by leading sponsors, our specialized teams deliver shorter study timelines, quality affordable services, and a clinical trial experience that puts you first.

Contact a Vial representative today to discover how we can help!