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.

Yoona Choi and Jung-Hyun Won attended the 65th Annual Meeting & Exposition of the American Society of Hematology (ASH), which took place from December 9 to 12, 2023, in San Diego, USA. Annually, the ASH conference brings together healthcare professionals, researchers, clinicians, and academics from around the globe to explore advancements in hematology. This prestigious event not only focuses on the study, diagnosis, treatment, and prevention of blood disorders but also features a variety of social events and opportunities for collaboration and the sharing of insights among experts in the field. Official photos from ASH are available here.

At the 'Outcomes Research—Lymphoid Malignancies: Poster II' session, Yoona Choi, serving as the first author and representing the entire research team, presented a study titled 'Evaluating the Effectiveness and Safety of Prephase Steroid Treatment before Remission Induction Chemotherapy in Pediatric Acute Lymphoblastic Leukemia: A Common Data Model-Based Real-World Data Approach.' This study investigated steroid pretreatment in pediatric acute lymphoblastic leukemia (ALL) patients undergoing remission induction chemotherapy (RIC), with the aim of reducing complications such as tumor lysis syndrome (TLS). Analyzing data from Seoul National University Hospital and Catholic University Seoul St. Mary’s Hospital, the study compared patients who received steroid pretreatment at least seven days before RIC with those who did not. The findings indicated a significant reduction in TLS incidence in the pretreated group. While overall survival rates were higher in this group, the difference was not statistically significant. These results provide important real-world evidence for the effectiveness of steroid pretreatment in reducing TLS risk in pediatric ALL patients.

This study was part of a larger project, funded by a grant from the Ministry of Health and Welfare, aiming to develop a disease registry database for pediatric ALL using real-world data in the clinical data warehouse (CDW) of Seoul National University Hospital and Catholic University Seoul St. Mary’s Hospital, thereby generating real-world evidence for pediatric ALL. 

Prof. Howard Lee gave a talk at the 17th JSCPT-KSCPT Joint Symposium, Kobe, Japan, on December 15, 2023. In his presentation entitled 'Real-World Data Analysis as a Clinical Pharmacologist: Experience and Some Thoughts', Prof. Lee. introduce the audience to the RWD research works CCADD has performed for the past 3 or so years, all of which have been published in reputable journals or under review shown below. Prof. Lee stressed, "With RWD landscape fast growing, clinical pharmacologists should leverage the potentials of RWD/RWE in drug development by furthering its scientific innovation!" 

Prof. Lee's speech was well received by the audience followed by a welcome reception by JSCPT colleagues, whom he and other delegates have not seen in person for the past three years because of the COVID-19 pandemic. The night was full of talking, drinking, and singing! Both teams promised to meet again next year in Jeju, Korea, for the Spring Conference of 2024 KSCPT. 

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.

Yesol Hong won the Excellent Research Award at the 30th Annual Conference of the Korean Society for Clinical Pharmacology & Therapeutics (KSCPT), December 1-3, 2022, held at Bexco, Busan, South Korea. The title of YeSol's presentation was "One-year follow-up of patients with COVID-19: Analysis of new-onset disease after COVID-19 diagnosis using Real-World Data". She discussed the results of an analysis of the occurrence of disease in patients with COVID-19 over a year using two different real-world data sets. One of her analysis results was a nation-wide study, which was significant in that it included the largest number of study subjects among the studies analyzing the post-COVID-19-condition in Korea. Jung Hyun Won equally contributed to this study with Professor Howard Lee serving as the principal investigator.

Additionally, Siun Kim, Yoona Choi, David Seung U Lee also presented their research through poster exhibition at the conference. 

Full presentations can be watched at the following YouTube links: 

YeSol had the honor to deliver oral presentation and won the Excellent Research Award at 2022 fall conference hosted by the Korean Society of Medical Informatics(KOSMI). YeSol has presented her work entitled "Effectiveness and safety of sodium-glucose cotransporter-2 inhibitors(SGLT2i) added to mono, dual or triple treatment in patients with type 2 diabetes mellitus(T2DM)". She discussed the additive efficacy in glycemic control and the tolerability of SGLT2i in T2DM patients when combined with other antihyperglycemic agents, such as metformin, sulfonylureas, and dipeptidyl peptidase-4 inhibitors using real-world data. Yoona Choi, TaeKyu Chung, and Yoomin Jeon also contributed to this study as co-researchers, with Professor Howard Lee serving as the principle investigator.

The conference was a three-day event (from Nov 23rd, 2022 to Nov 25th, 2022) and was held at The International Convention Center, Jeonbuk National University, Jeonju, Jeonbuk, South Korea. This conference, the host(KOSMI) organized the event around the theme, "The Power and Value of Healthcare Data Linkage". The conference was full of enlightening speeches that reflected the progress made in the field of medical informatics. With a total of 1,039 participants, this conference was held on the largest scale ever among KOSMI conferences. 

Yujin Kim is a bio-medical engineering major at the department of Integrative Engineering, Chung-Ang University. She became an undergraduate student researcher at CCADD after successfully completing the 2022 Summer Internship program. Before this, she studied the fundamentals of drug development while participating in AMIST Drug Development Online Summer School program in 2021. At CCADD, she intends to explore diverse ways to integrate her engineering and biological knowledge with artificial intelligence (AI) technology and discover solutions to overcome limitations in medical data.