Due to a great amount of data in clinical trials, the data cleansing needs to adopt a variety of measures, including the latest developed visual check approach. According to the different types of clinical data and the different stages in the course of clinical data management, this study reviews 8 types of visual graphics that show the relevance and trend among the data. The series of graphics can rapidly detect abnormal data, monitor clinical research in real-time, make the data management process much easier and improve the clinical trial efficiency and data quality.

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.

Objective To compare the difference region of interest volume (ROI) calculation method between Pinnacle and Eclipse treatment planning system. Methods To acquire CT image with 3 of slice thickness (1 mm, 3 mm, and 5 mm). Delineate 1, 2 and 5 slices square and circle contours in Pinnacle treatment planning system. Meanwhile 15 cases that include 5 cases with head neck tumor, 5 with thorax tumor and 5 with abdomen tumor were selected. Those image and ROI were transfer to Eclipse treatment plan system by DICOM RT protocol . The ROI volume was compared between two TPS . Results For ROI with small volume, the volume difference between TPS was obvious (for small volume ROI have 12 times difference, for big volume ROI almost same). The volume difference between TPS was influenced by many factors. The number of ROI slice and the magnitude of ROI was related with the difference between TPS (R2 = 1. 000, P = 0. 000). The CT thickness (R2 = 0. 200, P = 0. 972 ) and the shape of ROI ( R2 =0. 200, P = 0. 089) were not significant factors. The center of ROI on different axis was not affect the volume calculation in Pinnacle, which cause 3% different in Eclipse. The CT thickness was proportional to the ROI volume ( Pinnacle R2 = 0. 548, P = 0. 011; Eclipse R2 = 0. 502, P = 0. 027 ). In clinical case, optic chiasm and Len averagely have more than 35% volume difference between those two TPS. Conclusions We should pay more attention about the difference volume calculation algorithm between Pinnacle and Eclipse,especially when transfer small volume ROI to another TPS, which may have significant difference.

Objective The positron generated at the dose deposition site by using high-energy carbon ions to hit the material annihilate with the negative electron in the material to release the gamma photon.The positron-emitting isotope (PEI) distributions in the target volume are activated significantly by carbon ions.Therefore, the mean values of positron emission tomography (PET) activity could be related to the delivered doses to the clinical target volume from carbon ion.This specialty can be used for the image registration fusion of the carbon ion treatment planning computed tomography (CT) and treatment verification PET-CT.After radiation in the almost same decay period, the relationship between the different target volume and the PET-CT SUV of different every single fraction dose can be found, then the range of SUV for the radiation target could be decided.So this PET-CT standardized uptake value (SUV) range can also provide a reference for the correlation and consistency in planning target dose verification and evaluation for the clinical trial.Methods The head phantom was used as a simulation of the real human body, the 1 cc, 4 cc, and 10 cc cube volume target contouring were done in the TPS, the 90 degree fixed carbon ion beams were delivered in different single fraction effective dose of 2.5 GyE, 5 GyE, and 8 GyE.After the beam delivery, later the PET-CT scanning was performed and parameters of scanning followed the trial regulation.The MIM Maestro software was used for the image processing and fusion to determine the maximum, minimum, average, and total values of SUV in the virtual clinical target volumes for the different single fraction dose.Results The results showed that for the same target volume, the SUV range of target had an approximate linear correlation with effective dose of target (P=0.000).The same effective dose for the different target volumes got the same SUV range (P>0.05).Conclusions For the carbon ion treatment plan, the SUV range from image registration and fusion of planning CT and PET-CT after treatment can be used to make an evaluation for accuracy of the dose distribution.And this method also could be used in the hyper-fraction treatment plan.In the SUV range research of different decay periods, the similar method can be performed for the exploration.

Objective To introduce and evaluate the characteristics of a GyroKnife Digital Cobalt-60 System for stereotactic radiotherapy and radiosurgery in mechanical aspect.Methods To test the radiation safety,the dose rate required for radiation protection was measured by using an ionization survey meter ( Inovision Model 451 B,Cleveland,OH ).Micrometer was used to verify the accuracy of the table in movement and protractor to verify the rotation movement range.The 160 mm diameter polystyrene spherical phantom and film were used in measurement of the radiation Full Width at Half Maximum.And the difference between radiation isocenter and mechanical isocenter was also verified.Results Clinical requirement in radiation protection was met.The maximum error of table movement accuracy was 0.2 cm at Z axis; the maximum error of gantry movement accuracy was 0.1°.For all the collimators,radiation Full Width at Half Maximum ( FWHM ) was 2.55,5.40,10.50,and 18.55 mm and average penumbra was 5.0,12.4,30.1,and 51.5 mm,respectively.The maximum difference between mechanical center and radiation center was 1.41 mm.Conclusions Stereotactic radiotherapy and radiosurgery has good mechanical characteristics and is suitable clinic applications.

Objective To introduce and evaluate the dosimetric characteristics of a GyroKnife cobalt-60 system for radiosurgery.Methods0.015 cm3 and 0.600 cm3 ionization chamber,EDR2 film and semiconductor dosimeter were used to measure the dose rate of center point for the four collimators.The diameter of the four collimators were 5 mm,12 mm,30 mm and 50 mm,respectively.0.015 cm3 ionization chamber was used to test the dose-time linear relationship and dose stability.0.015 cm3 ionization chamber and semiconductor was used to measure the dose error of phantom between treatment planning system (TPS)calculation and measurement.The film was used to measure the error of TPS calculation isodose lines width.ResultsThe results from the four measurement methods have no significant difference for the collimator 50 mm.But for collimator 5 mm great discrepancy appeared.The error between calculation by TPS and the measurement by semiconductor was biggest and the value was 4.8％.Most of the error was within 3.0％.The error of the 50％ isodose line along x-axis was biggest and the value was 4.9 mm,others are all within 2.0 mm.ConclusionThe dosimetric character of this system is suitable for stereotactic radiotherapy.

Objective To retrospectively review the history and development of radiotherapy quality assurance ( QA) in the Affiliated Cancer Hospital of Fudan University, and to report the primary experience and evolvement of an entire QA workflow management. Methods The multidisciplinary QA team has implemented an entire QA workflow management process in the Radiotherapy Center using the failure modes and effects analysis ( FMEA) and plan?do?check?act ( PDCA) tool since April 2015. Treatment data of approximately 6000 patients before and after implementation were compared. Results The error rate was reduced from 17% to 09% after using the entire QA workflow management. Conclusions Entire QA workflow management effectively improves the accuracy and safety of radiotherapy.

With the wide application of electronic data management (EDC), the data management is shifting to a new mode. In order to recognize the advantages of EDC, we choose 20 representative registered clinical trials, which involve 5 404 subjects and 321 sites. We found that EDC has many beneficial impacts on the course of clinical trial data management, including the process of data collection, data cleaning, data quality control and clinical trial decision-making. The result also provides a reference for the adoption of EDC in clinical trials.

Comparative pharmacokinetic (PK) analysis is often carried out throughout the entire period of drug development, the common approach for the assessment of pharmacokinetics between different treatments requires that the individual PK parameters, which employs estimation of 90% confidence intervals for the ratio of average parameters, such as AUC and Cmax, these 90% confidence intervals then need to be compared with the pre-specified equivalent interval, and last we determine whether the two treatments are equivalent. Unfortunately in many clinical circumstances, some or even all of the individuals can only be sparsely sampled, making the individual evaluation difficult by the conventional non-compartmental analysis. In such cases, nonlinear mixed effect model (NONMEM) could be applied to analyze the sparse data. In this article, we simulated a sparsely sampling design trial based on the dense sampling data from a truly comparative PK study. The sparse data were analyzed with NONMEM method, and the original dense data were analyzed with non-compartment analysis. Although the trial design and analysis methods are different, the 90% confidence intervals for the ratio of PK parameters based on 1000 Bootstrap are very similar, indicated that the analysis based on NONMEM is a reliable method to treat with the sparse data in the comparative pharmacokinetic study.

To study the anti-inflammatory effects of the combinations of active components of Painong powder, a compound traditional Chinese herbal medicine, and the quantitative analysis of their interactions.