A research article, entitled “Country Contribution to Investigators of Pivotal Clinical Trials and their Primary Publications of New Drugs Approved by the US Food and Drug Administration, 2012–2021”, authored by Yoona Choi, Jung-Hyun Won, Heeju Kim, YeSol Hong, Yujin Kim, and Howard Lee, has been published in Clinical Pharmacology & Therapeutics (CPT) on February 5, 2025. Clinical Pharmacology & Therapeutics (CPT) is one of the most prestigious journals in the field of clinical pharmacology (impact factor of 6.3 in 2023), reflecting its significant influence in translational medicine and regulatory science.

This study investigated the geographical distribution of investigators and authors in pivotal clinical trials (PCTs) for new drugs approved by the U.S. Food and Drug Administration (FDA) from 2012 to 2021 and its association with the racial and ethnic diversity of study participants. While PCTs are often conducted across multiple countries to ensure broad participant enrollment and generalizability of clinical trial findings, the diversity of trial participants remains inadequate, with a predominant representation of White. To address this, the study analyzed 429 new drugs, 734 PCTs, and 718 primary publications (PPubs), extracting data from FDA labels, review s, PPubs, and clinicaltrials.gov. The findings revealed that North America and Western Europe (NAWE) accounted for the largest proportion of PCT investigators (62.9%), PPub authors (81.7%), and lead authors (90.9%). Among 521 PPubs reporting racial and ethnic distribution of participants, the median Diversity Index (DI) was 0.33, with only 16.3% of PPubs exceeding a DI of 0.5.

This study shows that evidence generation for new drug approval has remained concentrated in NAWE, with an even stronger presence in PPub authorship. This study emphasizes that to improve the racial/ethnic diversity of PCT participants, investigators from non-NAWE countries should be encouraged to take on more leadership roles, thereby increasing their likelihood of serving as authors in PPub.

CCADD members attended the Annual Conference of the Korean Society for Clinical Pharmacology and Therapeutics (KSCPT), taking place at Sono Belle, Gyeongju, from November 16th to 17th. In this conference, approximately 300 participants shared their insights and findings in the translational pharmacometrics and new drug development realms. 

Representing CCADD, graduate students Tae Kyu and Yoona have delivered oral presentations on the latest advancements in clinical pharmacology and related scientific disciplines at the Conference.

Tae Kyu's oral presentation, centered around the research entitled "Comparison of Machine Learning and Population Pharmacokinetic Models for Predicting Antiepileptic Drug Concentrations Based on Therapeutic Drug Monitoring Records," acquired substantial attention, particularly from pharmacometricians. During the presentation and subsequent discussions, he shared insights on how the application of machine learning to clinical pharmacology holds the potential to revolutionize drug development, dosage optimization, and personalized medicine. 

Yoona also presented her research topic, entitled "Country Contribution of Investigators to Pivotal Clinical Trials and THeir Primary Publications of New Drugs Approved by the US Food and Drug Administration," emphasizing the need for Korean researchers to take an active leadership role in key clinical trials to secure opportunities to contribute as authors to primary publications. The audience also agreed with her suggestions and provided constructive feedback, e.g., why it is not easy to be the author in the primary publications. After her presentation, she commented that it was a valuable opportunity to gauge the interest of clinical pharmacologists in that subject matter. 

In this conference, Tae Kyu and Yoona were bestowed with the esteemed "Best Presentation Award," marking a significant achievement and recognition for their outstanding presentation skills. Out of around 50 accepted abstracts, only the 7 presentations were deemed worthy of the best presentation title. Tae Kyu and Yoona's work was further celebrated with a cash prize of 100,000 KRW.

After all the programmed sessions were over, attendants eagerly awaited the prize draw. In a moment of drawing for the first gift, Howard emerged as the fortunate recipient. With his jaws on the floor, Howard made his way to claim his prize, a Bluetooth Sony Headphone. The annual conference held by KSCPT was a stage to celebrate the lab's commitment to excellence and an opportunity to showcase our gratitute for the fortune we have experienced.