atient engagement is defined as inspiring and mobilizing stakeholders beyond clinical research professionals, including patient advocacy groups, healthcare providers, and policy makers, to amplify and incorporate the patient voice in the development and delivery of new medical treatments. While efforts have been undertaken to incorporate the patient voice, the patient engagement movement has remained aspirational and tokenistic. Though there have been calls to grow the patient engagement movement, the number of trials reporting patient engagement remains extremely low. This article briefly discusses the reasons driving this gap and presents potential solutions that organizations can incorporate into their strategies to engage patients.

ealth disparity is defined as the unequal burden of disease in a population due to race, ethnicity, gender, education, socioeconomic status, disability, geographic location, sexual orientation, or cultural or religious beliefs. In this article, the term Latino includes individuals that migrated from Mexico, Central, and South America, and from Latino members of the Caribbean population. These individuals have a diverse racial makeup and heterogenous genetic ancestry that must be considered when studying Latino populations at various levels including clinical trial outcomes.

here is increasing interest in data privacy and data sharing in clinical trials, and most publicly available information is targeted toward individuals with training, experience, or expertise in these areas. In response to the increased misinformation and misconceptions in society about clinical trials during the global pandemic, PHUSE—a global community of data science professionals, founded under the acronym Pharmaceutical Users Software Exchange—began a collaborative project to produce a video series focused on creating engaging content organized into logical sections in the form of bite-sized videos.

he task of promoting the generation and use of meaningful patient-generated data in drug development is a shared one. An interactive DIA Europe 2023 session concluded that collaborations between regulators, industry, academia, and patient advocates will drive patient-focused medicines development.

ecently, Generative artificial intelligence (AI) has emerged as a popular technology that has taken the world by storm. As a prime example, ChatGPT had already crossed 100 million users in January 2023, setting a record in just two months.

t’s been more than five years since FDA issued its first regulatory approval using real-world evidence (RWE), a new indication for a medical device approved exclusively based on data from the electronic health records (EHRs) of patients who actually used the product in “real life” instead of data from randomized clinical trials. This approval was heralded as the onset of a new era in drug and medical device development and regulation: the systematic use of RWE based on data (real-world data, or RWD) from actual use.

n recent years, the data workbench has emerged as a powerful tool for aggregating and reviewing data from multiple study sources. The data workbench—often called the clinical data platform—reduces cleaning cycle times and speeds the preparation of analysis-ready data. With 87% of sponsors and CROs deploying decentralized clinical trials and the volume and variety of non-EDC data expanding, the need for consolidated data management and review will only intensify.

ttempts at improving diversity, equity, and inclusion (DEI) access across US healthcare is a much-welcomed, if not long-overdue, development in recent years. Substantive DEI legislation was signed into US law in December 2022 (and went into effect in February 2023), helping to correct significant disparities (explained below) and holding sponsors responsible for ensuring that their trials include participants from diverse groups. As we learned from vaccine development during the pandemic, clinical trials must address diverse participant populations to determine the real-world impacts on safety and efficacy for novel therapies. Data analytics tools can help.

ransformation is defined in the Cambridge Dictionary as “the process of changing completely the character or appearance of something in order to improve it.” This definition will also tell you that transformation is a noun — but it is much more. As industry continues to extend the frontiers of science, the interactions and information exchange between regulators and the regulated is relatively unchanged. A paradigm shift from a document-centric mindset to a data-driven approach is needed to get therapies to patients more quickly and efficiently. It is time to turn digital transformation into a verb by reimagining the way these entities collaborate and exchange data.

Our 2023 EMEA Regional Inspire Award Winners

IA thanks Regulatory Affairs Community Chair Linda Bowen, who has stepped down after more than a decade of service to this DIA Community.

“I started in the biopharmaceutical industry in 1983 in the laboratory (as many people do), then moved to various roles in quality assurance. I moved into regulatory affairs in 1993, so I have been in regulatory for 30 years, and am currently Chief of Staff and lead the Centers of Regulatory Excellence at Seagen, Inc., a medium-sized oncology biotech company,” Linda explains.

What aspects of regulatory affairs improved the most during her career?