The Cellular and Molecular Pathology Biobanking Sample Quality Improvement Tool: A Guide for Improving the Quality of Tissue Collections for Biomedical Research and Clinical Trials in Cancer

Author(s):  
Valerie Speirs ◽  
Harriet Foden ◽  
Jane Hair ◽  
Raffaella Tate ◽  
Helen Pitman ◽  
...  
2019 ◽  
Author(s):  
Liran Chen ◽  
Huafang Chen

Abstract Background: The China food and drug administration (CFDA) issued the Announcement of Self-examination and Inspection of Clinical Drug Trial Data on July 22, 2015. Great changes have taken place since the launch of the most stringent drug registration self-examination and inspection in history; the cost of clinical trials is one of the important changes. Methods: The paper compares the changes in the cost of clinical drug trials on both the number and the structure of the trials 3 years before and 3 years after self-examination and inspection were initiated by the CFDA,analyzes the impact on the cost of the clinical research coordinator ( CRC ), the labor service of researchers, audit companies, institutional drug management and quality control on the quality improvement of clinical drug trials. Conclusions: According to the article, the emergence and increase in most clinical trial costs are conducive to the quality enhancement of clinical drug trials,However, the emergence and continued increase of CRC costs can improve the quality of clinical drug trials in some ways and hinder it in others..To improve the quality of clinical trials, China must regulate the booming site management organization ( SMO ) market and actively formulate industry standards and qualification certifications for CRCs.


2018 ◽  
Vol 8 (5) ◽  
pp. 456-461 ◽  
Author(s):  
Anup D. Patel ◽  
Joseph V. Fritz ◽  
David A. Evans ◽  
Karen B. Lundgren ◽  
Katie Hentges ◽  
...  

In 2015, the American Academy of Neurology began development of a clinical quality data registry now known as the Axon Registry®. The data collected by the Axon Registry and reported back to participants include performance on a number of quality measures relevant to neurology practice. While the Axon Registry may serve any number of needs for neurology practices, the essential function of the registry is to inform neurologists regarding the quality of their care and provide them with a tool to establish not only performance baselines but progress toward improved quality of care. This article includes 2 case studies of how the Axon Registry has been implemented in neurology practices to date. In the future, implementation of patient-reported outcome data and additional outcome measures will be necessary to expand the reach and effectiveness of the Axon Registry as a quality improvement tool.


2018 ◽  
Vol 15 (10) ◽  
pp. 1443-1447 ◽  
Author(s):  
Shlomit Goldberg-Stein ◽  
Oleg Kaplun ◽  
Meir H. Scheinfeld ◽  
Judah Burns ◽  
Todd Miller ◽  
...  

2015 ◽  
Vol 8 (1) ◽  
pp. 1
Author(s):  
Afriantoni Afriantoni ◽  
Ibrahim Ibrahim

This study aimed to describe in depth between the link of school policy and the school quality improvement. The method in this study is a qualitative method using the case study presented descriptively. This research was conducted at SMA Negeri 2 Babat Tomat Kabupaten Musi Banyuasin. Based on this study it was found that the First, free school policy can help the economy / ease the burden of school costs to be incurred by the parents. Second, the policy constraints of the application for free school educa-tion at SMAN 2 Babat Toman is not very effective, so that the students' interest is not increasing, infrastructure is one of the obstacles in the implementation of free school education, how the quality of schools will be increased if it is not supported by facilities and complete infrastructure. Third, the quality of school education free SMAN 2 Babat Toman already realized well with regard to input, input turns unselected maximum, that is the students. Fourth, the implementation of free school education in Banyuasin, the quality of school SMAN 2 Babat Toman Muba Sumsel was not increased. This means that the implementation for free school education quality of school SMAN 2 Babat Toman was not increased.Keywords : free schools, school quality, case studies


Author(s):  
Hendri Wasito ◽  
Hening Pratiwi ◽  
Adi Wibowo ◽  
Nia Kurnia Solihat

Drugs are an important component of health services that are the needs of the community. There is still a lack ofcommunity knowledge of medicines and management especially for family members, hence an educational effort as well asimprovement of quality of drug management in family through training program and mentoring by pharmacist. Thiscommunity service activity aims to determine the knowledge and attitude of the community in managing drugs in the familyand improve the quality of drug management by the community in the family. The activity was conducted in SidasariWetanKubangkangkung Village Kawunganten Cilacap. The workshop on drug management in family was conducted by pharmaciststo the 33 participants. Data collection was done by using questionnaire and observation through home visit. The result of theactivity shows that the increase of knowledge and attitude of the society in managing drugs in the familywere 10% and 7%,respectively. Workshop activities and mentoring by pharmacists can provide benefits and behavioral changes in family drugsmanagement.


2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ismail Zul Khairul Azwadi ◽  
Mohd Noor Norhayati ◽  
Mohd Shafie Abdullah

AbstractAcute obstructive uropathy is associated with significant morbidity among patients with any condition that leads to urinary tract obstruction. Immediate urinary diversion is necessary to prevent further damage to the kidneys. In many centres, the two main treatment options include percutaneous nephrostomy (PCN) and retrograde ureteral stenting (RUS). The purpose of this study if to compare the efficacy and safety of PCN and RUS for the treatment of acute obstructive uropathy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE, the World Health Organisation International Clinical Trials Registry Platform and ClinicalTrials.gov. We also searched the reference lists of included studies to identify any additional trials. We included randomised controlled trials and controlled clinical trials comparing the outcomes of clinical improvement (septic parameters), hospitalisation duration, quality of life, urinary-related symptoms, failure rates, post-procedural pain [measured using a visual analogue scale (VAS)] and analgesics use. We conducted statistical analyses using random effects models and expressed the results as risk ratio (RR) and risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes, with 95% confidence intervals (CIs). Seven trials were identified that included 667 patients. Meta-analysis of the data revealed no difference in the two methods in improvement of septic parameters, quality of life, failure rates, post-procedural pain (VAS), or analgesics use. Patients receiving PCN had lower rates of haematuria and dysuria post-operatively and longer hospitalisation duration than those receiving RUS. PCN and RUS are effective for the decompression of an obstructed urinary system, with no significant difference in most outcomes. However, PCN is preferable to RUS because of its reduced impact on the patient’s post-operative quality of life due to haematuria and dysuria, although it is associated with slightly longer hospitalisation duration.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.


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