In 2024, many authors shared their insights on clinical trials in our journal. Their articles published with us have received very well feedback in the field and stimulate a lot of discussions and new insights among the peers.
Hereby, we would like to highlight some of our outstanding authors who have been making immense efforts in their research fields, with a brief interview of their unique perspectives and insightful views as authors.
Outstanding Authors (2024)
Toyoaki Hida, Lung Cancer Center, Central Japan International Medical Center, Japan
Zhonghua Sun, Curtin Medical School, Curtin University, Australia
Savvas Lampridis, Imperial College London, UK
Joseph Dux, Laniado Hospital, Israel
Takehiro Uemura, Graduate School of Medical Sciences, Nagoya City University, Japan
Outstanding Author
Toyoaki Hida
Dr. Toyoaki Hida, MD, PhD, is the Director of Lung Cancer Center at Central Japan International Medical Center, Japan. He spent 2 years in the Biomarkers and Prevention Research Branch of the National Cancer Institute, Maryland. Thereafter, he joined Aichi Cancer Center’s Thoracic Oncology unit in 1996. At Aichi Cancer Center, he was Director of Thoracic Oncology from 2005, and vice president from 2018.
His primary interests are translational medicine in the field of non-small cell lung cancer. In the first period of his career, his work focused on the studies on lung cancer pathogenesis, and then on the personalized cancer therapy using molecular target agents, immune-checkpoint inhibitors, and antibody-drug conjugates.
Dr. Hida emphasized that clinical trials play a crucial role in determining the clinical value of expected treatments. Good clinical trials may need the key elements such as appropriate trial population, adequate sample size, adherence to allocated trial intervention, trustworthy capture of data, monitoring emerging information on benefits and toxicities, thorough follow-up, and appropriate statistical analysis.
When discussing the interpretation of clinical trial results, Dr. Hida provided an in-depth example from the field of non-small cell lung cancer (NSCLC). Durvalumab sequentially administered after platinum-based CRT is the established, global standard of care for the treatment of unresectable, stage III NSCLC based on the results of the PACIFIC trial. The PACIFIC-2 trial was initiated to evaluate concurrent durvalumab administration with CRT, with the aim of addressing patients who progress or discontinue treatment during CRT and are therefore ineligible for the PACIFIC regimen. The PACIFIC-2 trial for durvalumab concurrently administered with CRT did not achieve statistical significance for the primary endpoint of PFS versus CRT alone. While the PACIFIC-2 trial, like the NRG-LUOO5 study of atezolizumab, did not show favorable results, the PACIFIC regimen remains the standard of care for patients with unresectable, stage III NSCLC. These outcomes should guide future research on combining immunotherapy with radiation therapy.
Dr. Hida also introduced some aspects of clinical trials that he is currently following. He mentioned that investigators frequently use analyses of subgroups to extract as much information as possible. These analyses may provide useful information. However, subgroup analyses sometimes may lead to overstated and misleading results. Randomized trials on drugs with positive results obtained more citations than those with neutral results.
In Dr. Hida's view, one aspect of clinical trials that has received insufficient attention is the analysis of late effects of adverse events (such as adverse cardiovascular effects) associated with immune checkpoint inhibitors, molecular targeted agents, or anticancer agents. A prospective study of long-term serial cardiac monitoring after ICI therapy, molecular targeted therapy, or anticancer therapy may be needed.
Conducting clinical trials is not without its challenges, and Dr. Hida has also encountered several in his work. One of key barriers that impede progress in clinical research was the lack of financial resources. Dr. Hida faced a challenge when recruiting participants within the required timeline, and to address this challenge, he proactively established hospital networks to enter potential participants. With this strategy, he successfully enrolled the required number of participants within the scheduled timeline and planned funding limits.
(by Ronnie Wu)
Zhonghua Sun
Dr. Sun is a John Curtin Distinguished Professor in medical imaging at Curtin Medical School, Curtin University, Australia. His research interests include 3D image processing and visualization in cardiovascular disease, mainly focusing on the use of 3D printing, virtual reality and mixed reality, and AI technologies in enhancing the diagnosis of coronary artery disease. His research projects involve the development of Generative AI tools in improving diagnostic assessment of calcified coronary plaques, and the development of personalized 3D printed models for medical education and clinical training. Learn more about him here.
A good clinical trial design, according to Dr. Sun, includes innovative ideas, feasible study design, and reasonable sample size that allows for robust conclusions. This foundation is essential for translating positive results into clinical practice, which directly benefits patient care and outcomes. Instead, negative results often stem from challenges in recruiting patients and following up on clinical outcomes, which can hinder the progress of a trial.
Dr. Sun is actively engaged in the field of clinical trials, with a particular focus on the innovative use of AI models in assisting the diagnosis of coronary artery disease This cutting-edge application of artificial intelligence has the potential to revolutionize how medical professionals approach cardiovascular diagnostics. However, Dr Sun also noted that some areas have not received enough attention in clinical trials, such as 3D printing, virtual reality and mixed reality, as well as AI on patient care and management.
Clinical trials are not without challenges, and Dr. Sun also encountered them during clinical trials, including ethics approval from HREC, and clinical support. “Well prepared for these challenges with sufficient time allocated to work on them,” says Dr. Sun.
(By Ronnie Wu)
Savvas Lampridis
Dr. Savvas Lampridis is a cardiothoracic surgeon at the 424 General Military Hospital in Greece, where he serves as a Major in the Army Medical Corps, and is also a Researcher at Imperial College London, UK. His clinical and research interests include minimally invasive surgery, thoracic trauma, translational cardiovascular medicine, surgical education, and health policy. He trained in Greece and the UK, including at the Royal Brompton Hospital and University College London Hospitals, and worked at Guy’s Hospital and Hammersmith Hospital in London. Dr. Lampridis completed master’s degrees in Translational Cardiovascular Medicine and Health Policy and Planning, both with Distinction. He is a member of the Royal College of Surgeons of Edinburgh and the European Association for Cardio-Thoracic Surgery, where he serves on the Solitary Pulmonary Nodules Task Force. He holds positions on editorial boards of several peer-reviewed journals, has guest-edited multiple special issues, and has reviewed more than 1,000 manuscripts for over 200 biomedical journals. Dr Lampridis is also active in medical education, authoring teaching materials and organizing surgical courses. Learn more about him here and on ORCID, and connect with him on LinkedIn.
According to Dr. Lampridis, it's crucial to understand the basic components of a well-designed clinical trial. Dr. Lampridis thinks it starts with being very clear about what question the researchers are trying to answer and who exactly should be included in the study. Proper randomization and the right sample size ensure that the results are genuinely meaningful. When possible, blinding helps prevent bias from creeping in, and strict adherence to ethical standards and regulations keeps patient welfare at the forefront. Ultimately, the goal is to create a setup where the data generated can be trusted—both by the researchers and by the clinicians who may use the results to guide patient care.
In terms of the positive and negative results of a clinical trial, Dr. Lampridis thinks it’s important to recognize that both positive and negative findings have real value. Positive results, such as a lung cancer therapy shown to improve survival in a randomized trial, can reshape clinical guidelines and influence patient care. At the same time, negative results are not failures; instead, they tell us what doesn’t work. For example, if a much-anticipated treatment shows no meaningful improvement, that result can save time, resources, and patients from unnecessary interventions. In other words, both positive and negative data points help refine our understanding of what genuinely benefits patients, ensuring that future research efforts are focused and productive.
In addition, Dr. Lampridis shares some of the clinical trials that he is following. He has been following several key aspects of clinical trials, especially those related to surgical approaches and perioperative systemic therapies for lung cancer. For example, he pays close attention to how trials incorporate new endpoints—like patient-reported outcomes—and how they determine who qualifies for more limited resections, such as segmentectomy or wedge resection, instead of standard lobectomy. Dr. Lampridis is also interested in trials exploring the integration of immunotherapy before and after surgery, as well as how these studies are adapting to evolving regulatory guidelines and ethical standards. By keeping track of these various elements, Dr. Lampridis gains a clearer picture of how clinical trials can influence real-world care.
Nevertheless, Dr. Lampridis points out that not all aspects of clinical trials receive the attention they deserve. A few examples include patient experience and long-term quality-of-life measures. Researchers spend a lot of time focusing on short-term clinical endpoints, but understanding how treatments affect daily life, mental well-being, and overall health over the long haul can be just as important. Also, issues like patient diversity and broader real-world applicability sometimes feel underexplored. Making sure trials incorporate these elements from the start could help generate results that speak more directly to the varied patient populations we actually treat.
Conducting clinical trials is not without its challenges, and Dr. Lampridis has also encountered several in his work. “One of the biggest challenges is ensuring consistent patient enrollment, especially when dealing with complex eligibility criteria or rare conditions. To address this, I’ve found it helpful to work closely with referring physicians, invest time in clear patient communication, and, when possible, collaborate with multiple centers. Another issue can be protocol adherence—making sure everyone involved follows the study plan precisely. Regular training sessions, open communication channels, and having a dedicated coordinator can keep everyone aligned. These measures help maintain the integrity of the trial and ultimately lead to more reliable results”, says Dr. Lampridis.
(By Ronnie Wu)
Joseph Dux
Dr. Joseph Dux specializes in breast surgery and breast cancer patient care, with a particular focus on oncoplastic surgery and tailored surgical approaches for patients. His clinical expertise spans all aspects of breast cancer care, including surgery and collaboration with medical and radiation oncology teams to provide comprehensive, patient-centered treatments. On the research front, Dr. Dux is dedicated to improving diagnostic imaging and advancing methodologies to enhance the precision and effectiveness of breast cancer diagnostics and therapies. He is also actively pioneering innovations in breast cancer surgery and exploring novel surgical approaches to improve outcomes for a broad range of patients. Learn more about him on LinkedIn.
A good clinical trial, according to Dr. Dux, starts with identifying the real, practical questions that clinicians face every day. These questions should be relevant and address challenges that impact patient care. It’s also crucial to include a diverse patient population, covering all ages and races. For instance, breast cancer studies often focus on older-postmenopausal patients, which can leave younger populations underrepresented. A more inclusive approach ensures that the findings apply broadly and benefit everyone.
In evaluating the positive and negative results of a clinical trial, Dr. Dux thinks both positive and negative results are valuable. Positive results are encouraging, but it’s important to analyze them critically to fully understand their implications and ensure they are applied appropriately. For example, the recent publication in the New England Journal of Medicine about avoiding lymph node surgery in breast cancer patients offers promising insights, but it requires careful consideration before being widely adopted. Negative results, on the other hand, often lead to progress by showing us what doesn’t work and guiding us toward better solutions. A good example is the Alliance 1071 trial, which revealed higher false-negative rates in certain lymph node surgeries. While disappointing at first, these findings led to the development of targeted axillary surgery, which has greatly improved patient care.
Furthermore, Dr. Dux introduced some clinical trials he is following. He is currently involved in clinical trials that aim to improve breast cancer care, particularly through tailored surgical approaches and new technologies. One area he’s focusing on is how artificial intelligence can enhance mammogram interpretation by integrating patient-specific factors. This kind of innovation has the potential to make diagnostics more accurate and personalized, bridging the gap between technology and clinical care.
However, Dr. Dux points out that some aspects of clinical trials are not receiving the attention they deserve. One area that needs more focus is the integration of new technologies, like artificial intelligence, into clinical trials. AI can help streamline trial processes and improve data analysis, but it’s still underutilized. Another challenge is demonstrating meaningful outcomes in early-stage breast cancer trials. With high survival rates and low recurrence risks, it’s hard to show significant differences in treatment approaches without huge patient populations, which are often difficult to recruit. We need to explore alternative trial designs and statistical methods to address this issue and still get valuable insights.
Conducting clinical trials is not without its challenges. “Recruiting both patients and staff for clinical trials has been a significant challenge. With the heavy clinical workload, it can be hard to find the time and resources to dedicate to research. Another difficulty is securing enough support for study design and execution, like getting help from statisticians or research assistants. What has helped us overcome these challenges is the enthusiasm of the team. Everyone shares a strong commitment to improving patient care, and that passion motivates us to push through even when things get tough,” says Dr. Dux.
(By Ronnie Wu)
Takehiro Uemura
Dr. Takehiro Uemura, a lecturer in the Department of Respiratory Medicine, Allergy, and Clinical Immunology at the Graduate School of Medical Sciences, Nagoya City University, Japan. Dr. Uemura earned his M.D. in 2003 and his Ph.D. in 2010, both from Nagoya City University. His research primarily focuses on drug sensitivity and resistance in lung cancer therapy. Additionally, he is actively engaged in the design, proposal, and participation in clinical trials exploring innovative therapeutic strategies for lung cancer treatment.
A good clinical trial design, as Dr. Uemura points out, should be tailored to address the clinical question relevant to the new therapeutic intervention. It should ensure the reliability, validity, and ethical soundness of the study while enabling the generation of actionable data to inform clinical practice.
In the view of positive and negative outcomes in clinical trials, Dr. Uemura provides some examples. Positive results from clinical trials are pivotal in driving transformative changes in clinical practice. For example, trials demonstrating the efficacy of immune checkpoint inhibitors revolutionized the treatment of advanced lung cancer. However, it is equally important to critically assess such results to ensure their robustness and reproducibility. Negative results, while disappointing, are not without value; they provide an opportunity to investigate the reasons behind the failure and explore modifications to improve the likelihood of success in future studies.
Additionally, Dr. Uemura shares some of the clinical trials that he is following. Currently, he is closely monitoring trials investigating novel approaches in lung cancer treatment, including the use of antibody-drug conjugates (ADCs) and bispecific antibodies. These innovative strategies have the potential to address unmet clinical needs and significantly improve patient outcomes.
However, it is evident that not all aspects of clinical trials receive the attention they deserve. One area that Dr. Uemura believes requires more attention is the integration of real-world evidence (RWE) into clinical trials. While randomized controlled trials (RCTs) remain the gold standard, incorporating RWE can provide complementary insights into the efficacy and safety of interventions in broader, more diverse patient populations. Additionally, the long-term follow-up and quality-of-life assessments in trial design often remain underemphasized, despite their critical importance for patient-centered care.
Conducting clinical trials is not without its challenges. “Proposing new clinical trials can be challenging, particularly when working independently. Collaborating with experienced clinicians and biostatisticians is essential to overcome these hurdles. Their expertise can help refine trial designs, address logistical issues, and ensure statistical rigor, enabling the successful execution of complex studies,” says Dr. Uemura.
(By Ronnie Wu)