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.

On Friday, December 27, 2024, the 2024 CCADD Year-End Workshop was successfully held at the Seoul National University (SNU) Yongon Campus. The event was attended by Prof. Howard Lee, CCADD members, interns, and alumni. Notably, Research Professor Yoona Choi joined the event in person, while Prof. Asa Johansson and Dr. Tae Kyu Chung participated online, adding an international dimension to the program.

The workshop began with a brief icebreaking session, followed by a series of meaningful presentations. The first presenter, Yunjin Choi, shared her growth and learning experiences over the past six months in her presentation titled “The Serendipitous Road: Lessons from the Past 6 Months.” Next, Yujin Kim reflected on her first year as a graduate student, highlighting her research projects, achievements, and key takeaways. In the afternoon session, Junghyun Won provided a retrospective on her 4.5 years as a graduate student, offering valuable insights into the diverse experiences of graduate life.

The main session reviewed CCADD's accomplishments in 2024, celebrating the research group's growth and achievements. Prof. Howard Lee commended the group’s continued success in research and publications. The workshop then shifted its focus to 2025, with a session outlining a roadmap emphasizing emerging AI concepts and innovative research ideas aligned with the latest trends.

Three special lectures added depth and inspiration to the workshop. Dr. Tae Kyu Chung, a postdoctoral researcher at the University of California San Francisco, delivered a lecture titled “Postdoc Diaries: A Glimpse of Life in the US,” offering a vivid account of his life and research abroad, which resonated strongly with the audience. Research Professor Yoona Choi reflected on her year as a research professor at Child Cancer and Rare Disease Project, Seoul National University Hospital. Her presentation detailed the challenges and achievements of her rigorous research journey, offering valuable insights for fellow researchers. Prof. Asa Johansson from Uppsala University delivered a lecture titled “Pharmacoepidemiology in the Era of Precision Health,” introducing the latest developments in precision medicine and pharmacoepidemiology. Her session provided an opportunity for attendees to exchange ideas with an international expert.

The workshop concluded with an inspiring speech by Prof. Howard Lee, who has been serving as the Dean of the Graduate School of Convergence Science and Technology at SNU. Prof. Lee praised CCADD's remarkable achievements throughout 2024 and expressed his strong support for the group’s ambitious goals in 2025. The 2024 CCADD Year-End Workshop provided members and alumni with a valuable opportunity to strengthen their relationships, exchange ideas, and align on a shared vision for the journey ahead.

On May 30th, CCADD came together to celebrate Teacher's Day, creating a memorable evening for Prof. Howard, graduate students, and CCADD members. The event was graced by the presence of Dr. Hyun A Lee, Dr. Siun Kim, Dr. Yoona Choi, and Dr. Tae Kyu Chung, whose attendance added warmth and significance to the occasion.

The evening was enchanting, with a delightful dinner setting the stage for meaningful conversations. Attendees shared recent updates, discussed various research topics, and exchanged personal experiences. Both graduates and current students found inspiration and motivation in each other's stories, drawing strength from their shared journeys.

A heartfelt farewell for Dr. Tae Kyu Chung marked a special highlight of the event. As he prepares to start a new chapter as a postdoctoral researcher at the University of California San Francisco (UCSF), Dr. Chung expressed his gratitude and hopes for future research endeavors. CCADD members honored Dr. Chung’s new journey with full hearts, celebrating his achievements and new beginning.

The gathering reaffirmed the strong bonds within CCADD and emphasized the importance of interaction and collaboration between alumni and current members. This event was more than just a meeting; it was a moment of growth, support, and envisioning a shared future. We hope such gatherings will continue, creating lasting and meaningful memories for all CCADD members.

The study "Effectiveness and Safety of Sodium-Glucose Cotransporter 2 Inhibitors Added to Dual or Triple Treatment in Patients with Type 2 Diabetes Mellitus," authored by Yesol Hong, Yoomin Jeon, Yoona Choi, Tae Kyu Chung, and Howard Lee, was published in the Diabetes Therapy on December 20, 2023. Conducted at Seoul National University Hospital (SNUH) in South Korea, this research by the CCADD team delved into the use of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i) in Type 2 Diabetes Mellitus (T2DM) treatment. The study, utilizing Real-World Data (RWD) from electronic medical records (EMR) from SNUH's a Common Data Model database, revealed improvements in HbA1c levels and a higher rate of patients achieving targeted HbA1c levels with SGLT2i therapy.

Furthermore, CCADD is dedicated to continuing its use of EMR-based RWD to generate important clinical evidence, particularly in areas where Randomized Controlled Trials (RCTs) may face limitations. This commitment underscores CCADD's role in advancing medical research and improving patient care through innovative data utilization.

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. 

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.