THE ADDED VALUE OF STATE-OWNED HOSPITALS IN CONDUCTING CLINICAL TRIALS

Regulation failing to keep up with India's trials boom

Access to data from clinical trials in the COVID-19 crisis: open, flexible, and time-sensitive

Objective: To understand the current status and characteristics of clinical trials for oral diseases in China, for the purpose of providing a reference for the research and development of oral diseases in China. Methods: Retrieving the information on clinical trials related to oral diseases registered on the"Platforms for drug clinical trial registration and information"of the National Medical Products Administration from the date of the database establishment to December 31, 2024. The number of clinical trials, type of drugs, trial phases, indication, trial scope, design types were statistically analyzed. Results: As of December 31, 2024, a total of 578 drug clinical trials for oral disease were registered, accounting for 2.1% (578/27 905) of the clinical trials disclosed on the platform during the same period. Bioequivalence clinical trials accounted for the highest proportion [73.9% (427/578)], followed by Phase Ⅰ [9.0% (52/578)], Phase Ⅱ [8.0% (46/578)], and Phase Ⅲ [4.5% (26/578)]. The 578 clinical trials involved 149 types of trial drugs, mainly chemical drugs, among which 127 were developed by domestic pharmaceutical enterprises and 27 by international pharmaceutical enterprises (the five investigational drugs have undergone clinical trials by both domestic and international pharmaceutical companies). The project leader units of the 578 drug clinical trials were distributed in 27 provinces, autonomous regions, municipalities, and Hong Kong Special Administrative Region. Excluding 427 bioequivalence clinical trials, the project leader units of 151 new drug clinical trials showed a significant aggregation phenomenon, and only three specialized oral hospitals have served as project leader units for drug clinical trials. Conclusions: The number of drug clinical trials for oral disease in China has generally shown an increasing trend, but there are still problems such as small number of clinical trials, low proportion of investment in new drug development and international multicenter trials, concentrated indications of clinical trials and insufficient clinical trial experience in specialized oral medical institutions. Enhancing the enthusiasm and innovation capabilities of domestic pharmaceutical enterprises in the research and development of oral diseases drugs, exploring the advantages of traditional Chinese medicine/natural medicine resources for oral diseases, and establishing a clinical research system in specialized oral medical institutions are of great significance for the development of oral drugs.

e13549 Background: The oncology clinical trials have grown gradually until 2019. The COVID-19 pandemic led to a marked reduction in clinical trial numbers. To understand the post-pandemic oncology landscape, we analyzed recent clinical trials between 2021 and 2022. Methods: The analytics and insights were obtained from the Kognitic digital platform for 2021 and 2022 (extracted-January 2023). The Kognitic platform applies proprietary Natural Language Processing (NLP) to extract cancer clinical trials from NIH’s clinicaltrials.gov (https://clinicaltrials.gov/ct2/home) and World Health Organization international trials registry ( https://trialsearch.who.int/utn.aspx ). A list of cancer-related synonyms and keywords was used with the NLP algorithm to extract the trials and generate a normalized list which was used for quality check to classify and add to the Kognitic drug database. Results: 14,361 national and international clinical trials launched in 2021 and 2022 were collected and analyzed. Of 14,361 trials, 3906 did not have trial phase information and were excluded from further analysis. We observed a reduction in overall clinical trial numbers in 2022 compared to 2021, with 8000 trials in 2021 and 6361 trials in 2022. In 2021, there were 799 Early Phase trials, 1043 Phase I, 2665 Phase II, 971 Phase III, and 425 Phase IV trials. In 2022, there were 340 Early Phase, 1037 Phase I, 2375 Phase II, 617 Phase III, and 183 Phase IV trials. Of these five Phases, Phase II had the highest number of trials in both 2021 and 2022. Similar to the total number of trials, we observed a general trend of decreasing trial count in all Phases (except Phase I) in 2022 compared to 2021. These trials were distributed across 21 indications, with the highest trial count in gastrointestinal cancer for both years. Out of the total trials, 24.18% of trials in 2021 and 22.93% in 2022 were gastrointestinal cancer trials. Other leading indications were lung cancer, non-Hodgkin lymphoma, breast cancer, and gynecologic cancers. Although the top indications remain the same in 2021 and 2022, there is a general trend of a decreasing number of trials in these indications in 2022. Next, we looked at the targets these trials were focused on. Our results show that Programmed Cell Death Protein 1 (PD-1) was the top target with the highest number of clinical trials, suggesting a continued broadening of the checkpoint inhibitor market. Similar to the total number of trials and the indications, we observed a general trend of decreasing clinical trials in each target in 2022 compared to 2021. Conclusions: Our results show a general trend of decreasing clinical trials in 2022 compared to 2021, suggesting that oncology clinical trials have not resumed pre-pandemic period growth. We observed a reduction in the number of clinical trials collectively and within various categories, namely, trial Phase, indications, and targets.

The Clinical Research Information Service (CRIS) in South Korea provides a clinical trial registry platform in which all clinical trials should be mandatorily and prospectively registered. However, to date, the registration status of clinical trials in the field of dentistry has not been investigated. Therefore, this study aimed to provide an overview of the methodological design and trends of the registered clinical trials over a period of nine years. Information about registered clinical trials in the field of dentistry from the CRIS was comprehensively collected from 2013 to 2021. The details assessed from the collected trials include: type of sponsors, recruitment status, study design, randomization, allocation concealment, single or multi-centric, retrospective or prospective registration, and publication status. A total of 65 registered clinical trials were identified. The number of clinical trials in dentistry in South Korea was found to be less; however, an increasing trend was observed in the recent three years. A majority of the trials were interventional (81.5%), single-centered (86.2%), and conducted on patients (81.5%) and in private hospitals (55.4%). A considerable number of trials had an unclear phase, were retrospectively registered, and rarely published. Regarding the quality, most trials have inadequately reported the method of randomization and allocation concealment. The number of clinical trials in dentistry is still low in South Korea, and most of them were registered retrospectively. A poor-quality reporting of methods at several specific areas was observed. It is necessary for dental investigators to raise awareness of the need to register clinical trials.

Characteristics of dermatology clinical trials 2007-2018: Insights from a systematic analysis of ClinicalTrials.gov

Although 85% of patients with cancer are diagnosed and treated in the community setting, only 3% are enrolled onto clinical trials. Lack of adequate time, infrastructure, resources, incentives, and reimbursement adversely affect clinical trial participation. In July 2007, Saint Francis Cancer Treatment Center (SFCTC) in Grand Island, Nebraska, was selected as one of the initial 16 sites for the National Cancer Institute Community Cancer Centers Program (NCCCP). Clinical trial and related activities data at SFCTC 5 years before and 5 years during the NCCCP were gathered and compared. Data included information on patients in clinical trials, number and type of trials, ratio of underserved patients, staffing, collection and storage of tissue samples, availability of new cancer services, and organizational infrastructure and linkage to National Cancer Institute-designated cancer centers. The number and percentage of patients enrolled onto clinical trials increased from 89 (3.2%) to 640 (23%; P<.001). All enrollees were rural Nebraskans, with 70%age > 65 years. Available treatment and nontreatment (eg, prevention, biospecimen,cancer control) trials increased from eight and three per year to 28 and 12 per year (P=.012), respectively. Staffing increased from 1.2 to 3.9 full-time equivalents (P=.012). A genetic counselor, smoking cessation counselor, and outreach project coordinator and two nurse navigators were hired. The number of tissue samples collected and/or stored increased from 26 (19%) to 320 (52%; P<.001). NCCCP participation had a direct and positive impact on all activities, with enhanced access to expanded types of trials and cancer care services. Our data demonstrate the feasibility of successful implementation of an expanded spectrum of clinical trials and programs in a rural community.

Human stromal (mesenchymal) stem cells (hMSC) represent a group of non-hematopoietic stem cells present in the bone marrow stroma and the stroma of other organs including subcutaneous adipose tissue, placenta, and muscles. They exhibit the characteristics of somatic stem cells of self-renewal and multi-lineage differentiation into mesoderm-type of cells, e.g., to osteoblasts, adipocytes, chondrocytes and possibly other cell types including hepatocytes and astrocytes. Due to their ease of culture and multipotentiality, hMSC are increasingly employed as a source for cells suitable for a number of clinical applications, e.g., non-healing bone fractures and defects and also non-skeletal degenerative diseases like heart failure. Currently, the numbers of clinical trials that employ MSC are increasing. However, several biological and biotechnological challenges need to be overcome to benefit from the full potential of hMSC. In this current review, we present some of the most important and recent advances in understanding of the biology of hMSC and their current and potential use in therapy.

Background and Objective:The Asian continent appears to be a growing destination for conducting cost-effective clinical trials, utilizing the available pool of treatment naïve subjects. This study aims to determine the growth rate of clinical trials in Asia.Methods:A database review was conducted. Registered clinical trials conducted in selected countries in Asia, Europe, Australia, and North America between 2008 and 2017 were searched from the International Clinical Trial Registry Platform. Compound Annual Growth Rate was determined for registered clinical trials.Results:During the 10-year period, a total of 125,918 registered clinical trials were conducted in Asia. There was a 7-fold increase in the number of registered clinical trials in Asia. More trials were registered in Japan than any other Asian country (30.8%). The average annual increase in the number of registered trials was generally higher in Asia than the United States of America, Canada, EU countries, or Australia. Iran recorded the highest average annual increase in the number of all clinical trials in Asia (41.9%). The number of pediatric clinical trials in Iran also increased annually by an average of 30.4%, more than any other country included in this study.Conclusions:Clinical trials recruitment in Asia is increasing faster than Europe, North America, and Australia. Lower trial cost and large patient pool may be contributory to this increase.

Tomorrow’s drugs: Improving lives through clinical trials

Well-designed and performed pivotal trials are critical in providing the efficacy and safety of a new drug for regulatory approval. The success of clinical drug development relies on the ability of clinical trial leaders to design and conduct international clinical studies. Physicians can do good clinical practice quality trials by following the protocols accurately but may not be able to design a complicated trial or lead an international clinical trial team. Clinical trial leaders are rarely born but have to be trained and learn through clinical research experience. Academic centers and drug industries have identified this need and proactively designed programs to nurture the clinical trial leaders of tomorrow via multidisciplinary programs. Using Taiwan as an example, the government has set up a Center of Excellence for Clinical Trials and Research (CECTR) in four medical centers. These national CECTRs complete a nationwide clinical trial network; strengthen clinical trial and clinical research infrastructure; set up national clinical trial and translational research centers; provide education and training for clinical researchers, doctors, nurses, and pharmacists; and improve quality, capacity, capability, and results of clinical trials. They are among the best in the world. Major pharmaceutical companies sponsored 200 international clinical trials for New Drug Applications in Taiwan in 2007. Our clinical investigators showed their clinical trial leadership by chairing many international clinical trials in Asia and worldwide. A Clinical Trial Academy for the training of clinical research leaders in Asia-Pacific is held regularly at the National CECTR at National Taiwan University Hospital. In collaboration with distinguished speakers from the industry, academia, and the local regulatory agency, promising young physicians from Asia-Pacific are trained in practical small-group workshops. Topics selected included how to perform international investigator meetings, how to write principal investigator (PI)-initiated clinical trial protocols, the concept of new drug development from the perspective of industry, experience in the institutional review board review of investigational new drug protocols, and so on. These investments in human resources have been well reflected in the number of clinical trials performed in Taiwan. Other than Australia, Taiwan has the highest number of PI-initiated clinical trials in Asia. We believe a good clinical research environment can attract young physicians to develop careers in clinical research and become clinical trial leaders of tomorrow.

Relevance. The number of international multicenter clinical trials and patient recruitment varies across countries, influenced by a variety of external factors such as the availability of experienced research centers, a sufficient patient pool, convenient logistics, the presence of competing studies, cost, political situation in the country, the timing of clinical trial approval by the regulator and ethics committee, the availability of a regulatory framework for clinical trials harmonized with ICH GCP, etc. At the same time, the speed of patient recruitment, along with the quality of data, remains one of the leading reasons for changes in the number of clinical trials in countries around the world. Clinical trials are usually conducted in cities where there is the necessary equipment to conduct the protocol, and the patient can get to the clinical center without special efforts. The authors emphasize that living close to a clinical center increases the motivation of patients to participate in a clinical trial. Many authors have also studied the relationship between patient recruitment and income. Objective. Calculate the quantitative impact of country, city (infrastructure), and income on patient recruitment. Materials and methods. The data were obtained for a period of 13 years from July 2008 to July 2021 during 4 international multicenter clinical trials of phases II–III. A retrospective analysis was conducted on the recruitment of patients depending on the influence of various factors — country, city (infrastructure) and income. Using the odds ratio method, a quantitative calibration of the influence of the selected factors was carried out. Conclusions. For the first time, the impact of external factors on patient recruitment in clinical studies was calibrated — country, city (infrastructure) and income. It was shown that the country, as an external factor, has a medium and weak impact on patient recruitment. Residence in the cities of Moscow, St. Petersburg and Kyiv has almost the same impact on patient recruitment as the country of residence. Clinical centers located in locations with high incomes of the population, as a rule, are characterized by lower patient recruitment.

Does orthopaedics need randomized controlled trials?

Objective: Clinical trials are essential tools for improving scientific knowledge and public health. With this work, it is aimed to evaluate the clinical trials landscape in Turkey. Method: To evaluate the landscape of clinical trials in Turkey, all clinical trials registered on or before the date of 20.06.2019 in the ClinicalTrials.gov database were used. The registered clinical trials were filtered by study type, study phase, funder type, current status of clinical trials, and location. In addition, the number of clinical trials in Turkey was compared with some countries which were selected based on population and number of trials. Results: In Turkey, the total number of registered clinical trials was 3880. The majority of these trials (%79.4) were interventional studies. The majority of phase trials were phase III studies, of which the vast majority were sponsored by industry. The numbers of completed and currently participants recruiting trials were 2245 and 722, respectively. Not only in Turkey, but in all countries, the numbers of clinical trials with unknown status and phase studies without defined phases were higher in trials were not funded by industry. When the numbers of first registered clinical trials were evaluated between the years of 2009 and 2018, a considerable increase was seen. The number of clinical trials in Turkey was 5 or 6 fold less than in developed countries with a comparable population such as Germany, France, and United Kingdom. Conclusion: With this work, it was shown that the number of clinical trials in Turkey is still not as expected. In order to take its rightful place in the world, Turkey should continue to make improvements, use its potential and increase awareness in the field of clinical trials

MP75-12 UROLOGIC CLINICAL TRIALS ARE UNDER-CONDUCTED IN LOW AND LOWER-MIDDLE INCOME COUNTRIES