scholarly journals National control laboratory independent lot testing of COVID-19 vaccines: the UK experience

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nicola J. Rose ◽  
Paul Stickings ◽  
Silke Schepelmann ◽  
Marc J. A. Bailey ◽  
Chris Burns
Keyword(s):  
Clinical Trials ◽  
Vaccine Development ◽  
Regulatory Approval ◽  
Safety Measures ◽  
Discovery Research ◽  
Innovative Products ◽  
The Uk ◽  
Vaccine Availability ◽  
And Control

AbstractThe past 18 months have seen an unprecedented approach to vaccine development in the global effort against the COVID-19 pandemic. The process from discovery research, through clinical trials and regulatory approval often takes more than 10 years. However, the critical need to expedite vaccine availability in the pandemic has meant that new approaches to development, manufacturing, and regulation have been required: this has necessitated many stages of product development, clinical trials, and manufacturing to be undertaken in parallel at a global level. Through the development of these innovative products, the world has the best chance of finding individual, or combinations of, vaccines that will provide adequate protection for the world’s population. Despite the huge scientific and regulatory achievements and significant investment to accelerate vaccine availability, it is essential that safety measures are not compromised. Here we focus on the post regulatory approval testing by independent laboratories that provides an additional assurance of the safety and quality of a product, with an emphasis on the UK experience through the National Institute for Biological Standards and Control (NIBSC), an expert centre of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

scholarly journals GCT-61. CORRELATION OF PATTERNS OF DISEASE RECURRENCE WITH RADIOTHERAPY TECHNIQUES AND DOSE IN INTRACRANIAL GERM CELL TUMOURS (icGCT): LESSONS FROM THE UK COHORT OF SIOP GCT96 STUDY

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii340-iii340
Author(s):  
Thankamma Ajithkumar ◽  
Henry Mandeville ◽  
Fernando Carceller ◽  
Milind Ronghe ◽  
Tina Foord ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Recurrence ◽  
Germ Cell Tumours ◽  
Prospective Data ◽  
Data Collection And Analysis ◽  
Radiotherapy Techniques ◽  
The Uk ◽  
A Prospective Study ◽  
Patterns Of Recurrence

Abstract BACKGROUND There are global variations in radiotherapy approaches for icGCT. An understanding of patterns of disease recurrence correlated with radiation techniques and doses is important in standardising and improving the quality of radiotherapy using high-precision techniques. METHODS AND RESULTS Data from 20 patients with tumour recurrence after treatment within the SIOP GCT96 study in the UK were analysed. Seven (35%) patients had germinoma and 13 (65%) had non-germinoma. Twelve patients had local recurrence, 5 had metastatic and 3 had local and metastatic disease. Radiotherapy details were retrieved in only 8 patients (40%). Six patients had received focal radiotherapy and two craniospinal radiotherapy. Of the patients who received focal radiotherapy, 4 had recurrence within the radiation portal, one had periventricular recurrence and one had marker-positive recurrence with no radiological lesions. Both patients who received CSI recurred within the CSF space. The main reasons for poor retrieval of treatment details were difficulty in retrieving archived information and that the study was conducted during a period before PACS or electronic radiotherapy records. CONCLUSION This study highlights the importance prospective data collection and analysis to understand the patterns of recurrence in icGCT. Even within a prospective study, radiotherapy techniques varied between centres. There is therefore an urgent need for centralised radiological review and prospective radiotherapy quality assurance measures in future clinical trials.

PAciFy Cough – A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough

2021 ◽  
Author(s):  
Zhe Wu ◽  
Winston Banya ◽  
Nazia Chaudhuri ◽  
Ira Jakupovic ◽  
Toby Maher ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Pulmonary Fibrosis ◽  
Crossover Trial ◽  
Randomised Trial ◽  
Morphine Sulfate ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Uk

Abstract Background: Idiopathic pulmonary fibrosis (IPF) is a progressive disease that leads to lung scarring, Cough is reported by 85% of patients with IPF and can be a distressing symptom with a significant impact on patients’ quality of life. There are no proven effective therapies for IPF related cough. While morphine is frequently used as a palliative agent for breathlessness in IPF, its effects on cough have never been tested. PAciFy Cough is a multicenter, double-blind, placebo-controlled, crossover trial of morphine sulfate for the treatment of cough in IPF. Methods: We will recruit 44 subjects with IPF prospectively from three interstitial lung disease units in the UK, namely the Royal Brompton Hospital, Manchester University NHS Foundation Trust (MFT) and Aintree University Hospital NHS Foundation Trust. Patients will be randomized (1:1) to either placebo twice daily or morphine sulfate 5mg twice daily for 14 days. They will then crossover after a 7 day washout period. The primary endpoint is the percent change in daytime cough frequency (coughs per hour) from baseline as assessed by objective cough monitoring at Day 14 of treatment.Discussion: This multicentre, randomised trial will assess the effect of opioids on cough counts and cough associated quality of life in IPF subjects. If proven to be an effective intervention, it represents a readily available treatment for patients.Trial registration: The study was approved by the UK Medicines and Healthcare Regulatory Agency (Ref: CTA 21268/0224/001-0001 – EUDRACT 2019-003571-19 – Protocol Number RBH2019/001) on 08 April 2020, in compliance with the European Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004 and its subsequent amendments. The study was provided with ethical approval by the London Brent Research Ethics Committee (Ref: 20/LO/0368) on 21 May 2020 and is registered with clinicaltrials.gov (NCT04429516) on 12 June 2020, available at https://clinicaltrials.gov/ct2/show/NCT04429516

The Effect of Press Fit and Viscoelasticity on the Seating of a Percutaneous Endoprosthesis

2013 ◽  
Author(s):  
Garrett J. Noble ◽  
Matthew J. Allen ◽  
Noel Fitzpatrick ◽  
Richard T. Hart
Keyword(s):  
Clinical Trials ◽  
Nervous Tissue ◽  
Direct Transfer ◽  
Residual Limb ◽  
Prosthetic Limb ◽  
Press Fit ◽  
Prosthesis Control ◽  
The Uk ◽  
And Control ◽  
Direct Attachment

Problems with the current, stump-socket method of prosthetic attachment for amputees include general discomfort, rashes, sores, and pain in the residual limb [1]. To alleviate these and other problems with prosthetic attachment, methods of securing a prosthetic to a skeletally-anchored percutaneous endoprosthesis are currently being developed [2]. These skeletally-anchored prosthetics provide a more direct transfer of load between a prosthetic limb and the residual limb, preventing bone resorption. This method allows patients to better sense and control their prosthesis [3, 4] and alleviates problems inherent to a prosthetic that attaches to the skin. Because the endoprosthetic device penetrates the skin, this method could also allow the direct attachment of nervous tissue to the implant which could be an important step in the future development of neuronal prosthesis control. Human clinical trials are currently underway in Sweden and the UK to test these devices in both human and animal patients.

Supporting people to self-manage their allergic rhinitis

2021 ◽  
Vol 32 (7) ◽  
pp. 264-268
Author(s):  
Viv Marsh
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Health Professionals ◽  
Hay Fever ◽  
Self Management ◽  
Nasal Allergy ◽  
The Uk ◽  
And Control ◽  
The Impact

Allergic rhinitis is common in the UK and can cause significant symptoms and reductions in quality of life. Viv Marsh considers how health professionals can support self-management of these patients Many of us look forward to the spring and summer months with warmer weather, longer days and more opportunity to spend time outdoors. But for hay fever sufferers these months can be truly miserable. For others, the winter months can be equally challenging as, with more time spent indoors, exposure to indoor allergens is greater. Hay fever is the term commonly used to describe seasonal nasal allergy triggered by pollen. It affects many children and adults in the UK, causing significant symptoms and reduction in quality of life. Often, people with allergic rhinitis try to manage the condition themselves using home or over-the-counter remedies to reduce and control symptoms. However, effective management may not be straightforward and guidance from knowledgeable and experienced health professionals can lead to improved outcomes. Taking an evidence-based approach, this article will explore the impact of allergic rhinitis on those who experience it, and will consider how health professionals can support self-management to enable people with the condition to manage their symptoms and minimise its impact on their lives.

The multi-disciplinary meeting as a tool to identify patients for clinical trials and translational research.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14001-e14001
Author(s):  
H Winter ◽  
David Rea
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Translational Research ◽  
Solid Tumour ◽  
Outcome Data ◽  
Team Meetings ◽  
Proactive Approach ◽  
The Uk

e14001 Background: Cancer multi-disciplinary team meetings (MDTs) were established with one of the core aims to increase participation in clinical research. However, a recent Cancer Research UK study observing 624 patient MDT discussions revealed only 8 (1.3%) patients included a discussion on clinical trials. Current work in the UK looking at MDT effectiveness has explored the quality of discussions and team dynamics. However, recruitment to clinical trials has not been promoted as an indicator of an effective MDT. This study explored the role of MDTs in identifying patients for research across all solid tumour MDTs in a tertiary cancer centre. Methods: This study explored the outcome data from solid tumour MDTS; reports on the observation of solid tumour MDTs and completion of a trials and translational proforma about patient discussions on research; exploration of MDT members views on the role of MDTS in identifying opportunities for patients to participate in clinical trials and translational research. Results: MDT outcomes from all solid tumour MDTs were reviewed. Out of 7000 local MDT outcomes from Avon Cancer Registry April 2019- Set 2019. Only 409 discussions included an outcome registered with “Clinical Trial y/n” (5%). In the majority there was no mention of any consideration of clinical trial or an explicit trial documented. Conclusions: We report on the exploration of the MDT as integral to identifying patients for clinical trials and translational research. This requires input and buy in from MDT members and the identification of research champions attending MDTs. The integration of genomics data into MDTs will require a proactive approach to access clinical trials for patients with identified potential actionable targets.

scholarly journals Outcome of multifaceted interventions for improving the quality of antenatal care in Nigerian referral hospitals

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Friday Ebhodaghe Okonofua ◽  
Lorretta Favour Chizomam Ntoimo ◽  
Bola Ekezue ◽  
Victor Ohenhen ◽  
Kingsley Agholor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Trial Registration ◽  
Central Hospital ◽  
Referral Hospitals ◽  
Registration Number ◽  
Multifaceted Interventions ◽  
Clinical Trials Registry ◽  
And Control

Abstract Background The study was designed as quasi-experimental research to investigate the effectiveness of multifaceted interventions for improving the quality of antenatal care in referral hospitals in Nigeria. Two referral hospitals (the Central Hospital in Benin City, South-South Nigeria, and the General Hospital in Minna) served as intervention sites, while two hospitals in comparable locations, (the Central Hospital Warri and the Suleja Hospital Abuja) were the control hospitals. Methods Intervention activities consisted of the introduction of a strategic plan with the shared vision of reducing maternal mortality by 50% in 1 year in the hospitals; staff training and re-training; the establishment of an automated appointment system; composite health education involving couples and providers; advocacy with policymakers; and the implementation of maternal death reviews and surveillance. These activities were implemented in the intervention hospitals over 21 months (October 2017 to June 2019). Exit interviews of pregnant women at intervention and control sites by trained interviewers were used to assess the quality of antenatal care after their visit, A total of 777 women were interviewed (427 in the intervention sites and 350 in the control sites). Data were analyzed with univariate and multivariate Poisson and logistic regression to determine the extent to which health providers in the clinics completed the 18 signal functions identified in the WHO assessment tool. Results The regression analyses showed the interventions were effective in improving six quality indicators (QIs) for counseling and information sharing. The difference between intervention and control sites on these QIs was significant at < 0.05. On the contrary, the interventions were less effective for maternal and fetal measurements; and disease testing and management QIs. Conclusion The positive effects of the interventions are likely due to the effectiveness of the training and health education components. The lack of intervention impact observed for maternal and fetal measurements may be due to the high workload of care staff and inadequate clinic supplies, which we did not address. We conclude that interventions that address the quality of antenatal care in low-resource settings should focus on improving all elements of care, including adequate staffing and mobilization of material resources. Trial registration This study was registered in the ISRCTN on August 14th, 2020. Trial Registration Number. SRCTN17985403. Retrospective registration. The reason for the retrospective registration is the current non-recognition of the Nigeria Clinical Trials Registry (NCTR); which is currently not an ICMJE or WHO ICTRP approved registry. (This study was registered in the Nigeria Clinical Trials Registry on April 14th, 2016. Trial Registration Number NCTR No: 91540209).

scholarly journals Are we addressing the top 10 research priorities in IBD?

2020 ◽  
pp. flgastro-2020-101579
Author(s):  
Jeroen Geldof ◽  
Jean-Frédéric LeBlanc ◽  
Laura Lucaciu ◽  
Jonathan Segal ◽  
Charlie W Lees ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Treatment Strategies ◽  
Research Priorities ◽  
Patient Reported ◽  
James Lind Alliance ◽  
Set Up ◽  
The Uk ◽  
And Control

BackgroundSince publication of the top 10 research priorities in inflammatory bowel disease (IBD) based on the James Lind Alliance Priority Setting Partnership, the question remains whether this has influenced the IBD-research landscape. This study aimed to create an overview of the current distribution of research interests of trials in the UK.MethodsThe ClinicalTrials.gov database and European Union Clinical Trials Register were screened for clinical trials set up from 9 August 2016 to 16 November 2019 in the UK involving adult patients with IBD.ResultsOf 20 non-industry-sponsored studies, a quarter investigated treatment strategies considering efficacy, safety and cost-effectiveness (priority 1). Four evaluated the role of diet (priorities 3 and 7). Development/assessment of biomarkers for patient stratification (priority 2) and fatigue (priority 8) were subject of three studies. IBD-related pain and control of diarrhoea/incontinence were each subject of 2 studies (priorities 4 and 6). The effect of gut microbiota (priority 10) and optimal strategy for perianal Crohn’s disease (priority 5) was the focus of 2 studies each. One study evaluated surgery for terminal ileal Crohn’s disease (priority 9). Of 63 industry-sponsored studies, 59 focused on priority 1.ConclusionsThis study presents an impression of the breadth of the IBD-research landscape in the UK, in light of the top 10 research priorities published in 2016. Optimal treatment strategy has been the most studied research priority by academic and industry-sponsored trials. Fewer studies focused on patient-reported outcomes. It remains debatable to what extent the current research landscape adequately represents all stakeholders’ viewpoints on needs for expanded knowledge in IBD, particularly the patients’ perspective.

scholarly journals Progress and Prospects on Vaccine Development against SARS-CoV-2

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 153 ◽  
Author(s):  
Jinyong Zhang ◽  
Hao Zeng ◽  
Jiang Gu ◽  
Haibo Li ◽  
Lixin Zheng ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Severe Acute Respiratory Syndrome ◽  
Infectious Diseases ◽  
Vaccine Development ◽  
Effective Means ◽  
Efficacy Evaluation ◽  
Novel Coronavirus ◽  
And Control

In December 2019, the outbreak of pneumonia caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to a serious pandemic in China and other countries worldwide. So far, more than 460,000 confirmed cases were diagnosed in nearly 190 countries, causing globally over 20,000 deaths. Currently, the epidemic is still spreading and there is no effective means to prevent the infection. Vaccines are proved to be the most effective and economical means to prevent and control infectious diseases. Several countries, companies, and institutions announced their programs and progress on vaccine development against the virus. While most of the vaccines are under design and preparation, there are some that have entered efficacy evaluation in animals and initial clinical trials. This review mainly focused on the progress and our prospects on field of vaccine development against SARS-CoV-2.

A survey of the feasibility of developing osteoporosis clinical trials in Duchenne muscular dystrophy: Survey of the opinion of young people with Duchenne muscular dystrophy, families and clinicians

2020 ◽  
pp. 174077452095839
Author(s):  
Sze Choong Wong ◽  
Shuko Joseph ◽  
Nadia Capaldi ◽  
Marina Di Marco ◽  
Jennifer Dunne ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Young People ◽  
Outcome Measures ◽  
Bone Health ◽  
Limited Evidence ◽  
Great Awareness ◽  
The Uk

Background/aims Given the extent of osteoporosis in people with Duchenne muscular dystrophy treated with glucocorticoids and the limited evidence of bone-protective therapies, clinical trials are needed. We conducted surveys to obtain the opinion of young people with Duchenne muscular dystrophy, parents/guardians and neuromuscular clinicians on the feasibility of osteoporosis clinical trials in this population. Methods Online surveys were sent to three groups: (a) people with a confirmed diagnosis of Duchenne muscular dystrophy (≥14 years), (b) parents and guardians and (c) neuromuscular clinicians in the UK NorthStar Clinical Network. Surveys (a) and (b) were distributed via the UK Duchenne muscular dystrophy Registry. Results Survey respondents included 52 people with Duchenne muscular dystrophy with a median age of 17 years (range: 14, 40) and 183 parents/guardians. Fourteen out of 23 (61%) NorthStar centres responded. Of the 52 people with Duchenne muscular dystrophy, 13 (25%) were very concerned about their bone health and 21 (40%) were slightly concerned. Of the 183 parents/guardians, 75 (41%) were very concerned about their son’s bone health and 90 (49%) were slightly concerned. Fractures and quality of life were the top two main outcome measures identified by people with Duchenne muscular dystrophy. Fractures and bone density were the top two main outcome measures identified by parents/guardians and neuromuscular clinicians. Thirty percent of people with Duchenne muscular dystrophy and 40% of parents/guardians would not take part if an osteoporosis trial involved a placebo that was administered parenterally. Only 2 of the 14 NorthStar centres (14%) would enrol people with Duchenne muscular dystrophy if a parenteral placebo was used in an osteoporosis trial in Duchenne muscular dystrophy. Conclusion There is great awareness of bone health and the need for bone-protective trials among people with Duchenne muscular dystrophy and their carers. However, a proportion of people with Duchenne muscular dystrophy and parents are reluctant to participate in a placebo-controlled osteoporosis trial that included a parenteral therapy. A larger proportion of health care experts are unwilling to enrol their patients in such a trial. Our finding is relevant for the design of bone-protective studies in Duchenne muscular dystrophy.

scholarly journals Considerations for bioanalytical characterization and batch release of COVID-19 vaccines

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Gautam Sanyal ◽  
Anna Särnefält ◽  
Arun Kumar
Keyword(s):  
Vaccine Development ◽  
Scale Up ◽  
Novel Technologies ◽  
Technology Platforms ◽  
Successful Vaccine ◽  
Batch Release ◽  
History Of ◽  
And Control ◽  
Selection Of

AbstractThe COVID-19 pandemic has prompted hundreds of laboratories around the world to employ traditional as well as novel technologies to develop vaccines against SARS-CoV-2. The hallmarks of a successful vaccine are safety and efficacy. Analytical evaluation methods, that can ensure the high quality of the products and that can be executed speedily, must be in place as an integral component of Chemistry, Manufacturing, and Control (CMC). These methods or assays are developed to quantitatively test for critical quality attributes (CQAs) of a vaccine product. While clinical (human) efficacy of a vaccine can never be predicted from pre-clinical evaluation of CQA, precise and accurate measurements of antigen content and a relevant biological activity (termed “potency”) elicited by the antigen allow selection of potentially safe and immunogenic doses for entry into clinical trials. All available vaccine technology platforms, novel and traditional, are being utilized by different developers to produce vaccines against SARS-CoV-2. It took less than a year from the publication of SARS-CoV-2 gene sequence to Emergency Use Authorization (EUA) of the first vaccine, setting a record for speed in the history of vaccine development. The largest ever global demand for vaccines has prompted some vaccine developers to enter multiple manufacturing partnerships in different countries in addition to implementing unprecedented scale-up plans. Quantitative, robust, and rapid analytical testing for CQA of a product is essential in ensuring smooth technology transfer between partners and allowing analytical bridging between vaccine batches used in different clinical phases leading up to regulatory approvals and commercialization. We discuss here opportunities to improve the speed and quality of the critical batch release and characterization assays.

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