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Objective:To analyze the registration status of acute pancreatitis-related clinical studies registered on the Chinese Clinical Trial Registry (ChiCTR) and USA ClinicalTrials.gov database.Methods:The ChiCTR and ClinicalTrials.gov database were searched to collect, sort and analyze the clinical studies related to acute pancreatitis registered from the establishment of the database to December 31, 2020. The clinical trials were manually grouped, and the features of clinical researches were compared based on different registered data (2007-2014 vs 2015-2020) and different financial sources (self-support, enterprise support or public support). Results:A total of 157 registered clinical studies related to acute pancreatitis have been included (ChiCTR n=99; ClinicalTrial.gov n=58). The top three areas with the greatest number of registered clinical studies were Sichuan (28.0%), Shanghai (14.6%) and Jiangsu (12.1%), totally accounting for 54.7%. There were 91 interventional studies, 41 observational studies and 25 other type studies. Masking was performed in 34 studies (21.6%). Randomized parallel controlling was performed in 84 studies (53.5%). 30 trials (19.1%) were at Ⅳ phase, and 7 trials (4.4%) were at Ⅱ or Ⅲ phase. 2007-2014 group tended to use randomized parallel controlled design (68.3% vs 45.4%, P=0.005) and randomization grouping (76.7% vs 47.4%, P=0.001). 2015-2020 group tended to use relatively large sample (72.6% vs 47.4%, P=0.002)and data management committee (53.6% vs 25.0%, P=0.001). The differences between the two groups were statistically significant. Of 92 trials from ChiCTR database, 48 were self-supported, 5 was supported by enterprise, and 38 was supported by the public. The percentage of self-support and public support was 86.9%. Conclusions:The number of acute pancreatitis-related clinical studies registered on ChiCTR was generally on the increase. Most registered studies were funded by public finances or by the researchers' institutions self. There was a lack of phaseⅡ or phase Ⅲ.
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BACKGROUND: There is an imbalance between supply and demand for tissues and organs. Therefore, it is crucial to actively carry out basic research regarding tissue engineering and accelerate relevant clinical transformation. OBJECTIVE: To analyze the status of clinical trials registrations in tissue engineering and to provide reference and evidence support for clinical transformation research in tissue engineering. METHODS: Clinical trial data from the ClinicalTrials.gov were collected. Bibliometrics and mathematical statistics methods were adopted to analyze the status of clinical trial registration in tissue engineering from various aspects, including registration quantities, indications, sponsors, and stages. RESULTS AND CONCLUSION: There were 434 records of clinical trial registrations regarding tissue engineering worldwide, 65 of which were in China. Over half of the records were randomized controlled trials in China or in the world, and no Chinese institutions have participated in the 18 international multi-center clinical trials worldwide. These clinical trials covered a total of 57 indications all over the world and 37 indications in China, mainly concentrated in the fields of bone and cartilage, teeth, and skin. There were 275 sponsors all over the world, 33 of which were in China. Most of the clinical trials were in phase 1/phase 2. Through analyzing the status of clinical trial registrations regarding tissue engineering, there were less clinical transformation applications in tissue engineering. Although China had the second largest number of registrations in the world, there was still a certain gap with the United States. There were a certain number of clinical trials with high evidence levels, but no products with high potential value in the international market. More concerns were paid onto clinical transformation research in research institutions and medical institutions. Clinical applications mainly focused on the treatment of defects or functional defects in bone and cartilage, teeth and skin, which were mainly in the stage of safety or efficacy evaluation.
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PURPOSE: PubMed is not only includes international medical journals but also has a registration site for the ongoing clinical trials, such as ClinicalTrials.gov, under the supervision of US National Institutes of Health. We analyzed current status of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. MATERIALS AND METHODS: As of October 2012, there are total of 72 trials found on registry of vaccine clinical trials conducted by Korean investigators in database of ClinicalTrial.gov. These trials were analyzed and classified by conditions of vaccine clinical trials, biologicals or drugs used in vaccine clinical trials, status of proceeding research, and list of sponsor and collaborators. RESULTS: Total 72 trials of vaccine clinical trials conducted by Korean investigators are classified by groups of infection (64 trials), cancer (4 trials), and others (4 trials). Infections group shown are as follows: poliomyelitis, pertussis, diphtheria, tetanus, and Haemophilus influenzae type b (10), influenza (9), human papillomavirus infection (8), pneumococcal vaccine (6), herpes zoster (4), smallpox (4), hepatitis B (4), etc. One trial of each in lung cancer, breast cancer, prostate cancer, and colorectal cancer are shown in cancer group. One trial of each in Crohn's disease, ulcerative colitis, renal failure, and rheumatoid arthritis are shown in other group. CONCLUSION: Vaccine clinical trials conducted by Korean investigators in ClinicalTrial.gov reflects the current status of Korean research on vaccine clinical trials at the international level and can indicate research progress. It is hoped that this aids the development of future vaccine clinical trials in Korea.