scholarly journals Letter on Predicting the number of sites needed to deliver a multicentre clinical trial within a limited time frame in the UK

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Rosemary Greenwood ◽  
Julie Pell ◽  
Paula Foscarini-Craggs ◽  
Katharine Wale ◽  
Ian Thomas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Cost Effective ◽  
Fixed Time ◽  
Time Frame ◽  
Recruitment Rate ◽  
Limited Time ◽  
Multicentre Clinical Trial ◽  
Ethical Approval ◽  
The Uk

Abstract When planning a multicentre clinical trial, it can be difficult to predict the time needed to open individual sites, and this in turn impacts on the total number of sites needed, the budget and the time frame for a clinical trial to be delivered successfully. This is of particular importance for funding applications with a limited time frame and budget such as NIHR RfPB. It is more efficient and cost-effective to open the total number of sites needed at the outset of a trial, rather than to respond later to slow site opening and recruitment. Here, we share our experience of successfully delivering a multicentre clinical trial for a rare disease within a limited time frame and budget by approximately doubling the number of sites initially predicted to be needed. We initially predicted 20 sites would be needed to deliver the clinical trial, but early on in the trial, the number of sites was more than doubled to allow successful recruitment of the target sample size within the desired time frame. Of the 48 ethically approved sites, the median time from ethical approval of a site to opening for recruitment was 182 days (95% confidence interval [143 to 245 days]) and ranged from 18 to 613 days. In four (9%) of these sites, part of the delay was due to pharmacy sign off not being given when R&D had issued capacity and capability (C&C). Delays due to pharmacy sign off varied from 10 days to over 3 months delay in two sites (94 days and 102 days). A mathematical solution to the problem of planning a study with a short recruitment window has been given to support the planning and costing of grants with fixed time constraints: number of sites = required sample size divided by (number of eligible patients per site per month times recruitment rate times (the number of months accrual minus 6 months)). We expect these results to help others who are planning multicentre clinical trials in the UK. Ethical approval from NRES Committee South West (IRAS number 225959). Trial registration EudraCT Number 2017-001171-23. Registered on 26 June 2017

Technological Approach of Bioremediation Using Microbial Tools

2017 ◽  
pp. 134-154 ◽  
Author(s):  
Mostafa M. El-Sheekh ◽  
Yehia A-G. Mahmoud
Keyword(s):  
Natural Resources ◽  
New Technologies ◽  
Environmental Pollutants ◽  
Cost Effective ◽  
Time Frame ◽  
Genetically Engineered ◽  
Limited Time ◽  
Chlorinated Pesticides ◽  
Great Stress

Bioremediation is applied to eliminate various contaminants, such as organic, inorganic or other pollutants from the environment. Environment worldwide is under great stress due to industrialization and human interfering on the limited natural resources. The release of chemicals pollution needs several techniques to treat some of these chemicals, but due to their cost, new technologies should be developing in order to create cost-effective and eco-friendly bioremediation technologies for environmental conversions. Bioremediation is an increasingly popular using microbial and algae strains for degrading waste contaminants. It is using of microorganisms and its enzymes to protect the environment from severe pollution. Bioremediation may be employed in order to eliminate specific contaminants, such as chlorinated pesticides or other pollutants from the environment. Microorganisms degrade the different pollutants in a natural environment but some modifications can be done to enhance its degradation efficiency at a faster rate in a limited time frame by using the genetically engineered microorganisms and microalgae. In this chapter, the role of the bacteria, fungi and algae in bioremediation of different environmental pollutants was highlighted.

Liposomal Cytarabine (DepoCyte™Injection) Is Cost-Effective Compared with Standard Cytarabine for the Intrathecal Treatment of Patients with Lymphomatous Meningitis.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 267-267 ◽  
Author(s):  
Karen Moeremans ◽  
Lieven Annemans ◽  
James Morris
Keyword(s):  
Clinical Trial ◽  
Effective Treatment ◽  
Cost Effective ◽  
Health State ◽  
Liposomal Cytarabine ◽  
Effective Treatment Option ◽  
Lymphomatous Meningitis ◽  
Health States ◽  
Cost Effective Treatment ◽  
The Uk

Abstract Background and Objective : The clinical benefit of liposomal cytarabine (DepoCyteTM injection) for the intrathecal treatment of lymphomatous meningitis has been demonstrated in a randomised controlled trial (Glantz M. et al. J Clin Oncol 1999;3110-3116 ). Liposomal cytarabine has recently become available in the UK at a cost considerably above that of standard cytarabine (1,250GBP per dose compared to 4GBP). A cost-utility analysis (CUA) comparing liposomal cytarabine versus standard cytarabine was conducted from the perspective of the UK National Health Service to determine whether or not liposomal cytarabine is a cost-effective treatment option for patients with lymphomatous meningitis. Methods: Using data from the clinical trial, each patient’s survival time was partitioned according to the presence of progressive neurological disease. Utility estimates for two health states, progression and non-progression, were derived from clinical experts using a time-tradeoff exercise and assigned to each patient according to the period of time they remained in each health state. Observed response rates from the clinical trial were used to model expected quality adjusted life year (QALY) estimates for each treatment arm. Health care costs were estimated using resource data from the clinical trial and unit costs from the literature. Probabilistic analyses were used to estimate the expected cost per QALY gained with liposomal cytarabine, taking into account the uncertainty surrounding model input parameters. Results: From a total of 33 randomised patients, response status was available for 29. 13 of 16 patients treated with liposomal cytarabine responded to treatment compared to 3 of 13 patients treated with standard cytarabine (81 vs. 23%; p=0.003). The mean total expected healthcare cost per patient was estimated to be 8,275GBP (+/−796) for patients treated with liposomal cytarabine and 3,238GBP (+/−494) for those treated with standard cytarabine. Patients treated with liposomal cytarabine accrued on average 0.27 (+/−0.027) QALYs compared to 0.15 (+/−0.025) QALYs in the standard cytarabine arm. The mean expected incremental cost per QALY gained with liposomal cytarabine was 47,764GBP (95%CI = 22,921–95,676). This estimate of cost-effectiveness was particularly sensitive to the health state utilities for progression and non-progression. Conclusion : The results of this analysis suggest that liposomal cytarabine is a cost-effective treatment option for patients with lymphomatous meningitis. Although the incremental cost-effectiveness ratio (ICER) is close to the probable willingness-to-pay threshold, the results of this analysis should be evaluated in the context of a severe disease with few effective treatment options. Further research into patient preferences for the health states modelled here would be valuable given the sensitivity of QALY estimates to this variable.

Planning the Size of Clinical Trials with Allowance for Patient Noncompliance

1990 ◽  
Vol 29 (03) ◽  
pp. 243-246 ◽  
Author(s):  
M. A. A. Moussa
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sample Size ◽  
Event Rate ◽  
Survival Functions ◽  
Time Intervals ◽  
Patient Noncompliance ◽  
Event Rates ◽  
Larger Sample

AbstractVarious approaches are considered for adjustment of clinical trial size for patient noncompliance. Such approaches either model the effect of noncompliance through comparison of two survival distributions or two simple proportions. Models that allow for variation of noncompliance and event rates between time intervals are also considered. The approach that models the noncompliance adjustment on the basis of survival functions is conservative and hence requires larger sample size. The model to be selected for noncompliance adjustment depends upon available estimates of noncompliance and event rate patterns.

Exploring the Benefits of Early Contractor Involvement (ECI) and the Mechanism for Automated 5D BIM Quantification Process in Offsite Modular Construction

2016 ◽  
Author(s):  
Tochukwu Moses ◽  
David Heesom ◽  
David Oloke ◽  
Martin Crouch
Keyword(s):  
Effective Means ◽  
Cost Effective ◽  
Modular Construction ◽  
Automated Quantification ◽  
Building Information ◽  
Project Risks ◽  
Value Add ◽  
The Uk ◽  
The Impact ◽  
Level 2

The UK Construction Industry through its Government Construction Strategy has recently been mandated to implement Level 2 Building Information Modelling (BIM) on public sector projects. This move, along with other initiatives is key to driving a requirement for 25% cost reduction (establishing the most cost-effective means) on. Other key deliverables within the strategy include reduction in overall project time, early contractor involvement, improved sustainability and enhanced product quality. Collaboration and integrated project delivery is central to the level 2 implementation strategy yet the key protocols or standards relative to cost within BIM processes is not well defined. As offsite construction becomes more prolific within the UK construction sector, this construction approach coupled with BIM, particularly 5D automated quantification process, and early contractor involvement provides significant opportunities for the sector to meet government targets. Early contractor involvement is supported by both the industry and the successive Governments as a credible means to avoid and manage project risks, encourage innovation and value add, making cost and project time predictable, and improving outcomes. The contractor is seen as an expert in construction and could be counter intuitive to exclude such valuable expertise from the pre-construction phase especially with the BIM intent of äóÖbuild it twiceäó», once virtually and once physically. In particular when offsite construction is used, the contractoräó»s construction expertise should be leveraged for the virtual build in BIM-designed projects to ensure a fully streamlined process. Building in a layer of automated costing through 5D BIM will bring about a more robust method of quantification and can help to deliver the 25% reduction in overall cost of a project. Using a literature review and a case study, this paper will look into the benefits of Early Contractor Involvement (ECI) and the impact of 5D BIM on the offsite construction process.

scholarly journals Implementation of podiatry telephone appointments for people with rheumatic and musculoskeletal diseases

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
J. L. Palmer ◽  
H. J. Siddle ◽  
A. C. Redmond ◽  
B. Alcacer-Pitarch
Keyword(s):  
Musculoskeletal Diseases ◽  
Cost Effective ◽  
Time Frame ◽  
Teaching Hospitals ◽  
Potential Cost ◽  
Foot Health ◽  
Telephone Consultation ◽  
Face To Face ◽  
Initial Intervention

Abstract Background Foot health problems are common in the general population, and particularly so in people with rheumatic and musculoskeletal disorders (RMD). Several clinical guidelines state that people with RMDs should have access to foot health services, although service capacity is often limited. The current COVID-19 pandemic has increased the need for alternative ways to provide patient care. The aim of this clinical audit was to review a newly implemented telephone follow-up appointment service conducted within the Rheumatology Podiatry Department in Leeds, UK. Methods Fifty-eight patients attending the Rheumatology Podiatry Department at Leeds Teaching Hospitals NHS Trust were contacted by telephone approximately 6–8 weeks following initial intervention. During the telephone consultation, all patients were asked pre-defined questions relating to their symptoms, intervention efficacy, the need for further appointments and their preference for the type of consultation. To assess the cost of the telephone consultation the number of attempts needed in order to make successful contact, the duration of the call and the number of telephone follow-up appointments completed in a working day were also recorded. Results Twenty-five patients (43%) were successfully contacted within the 6–8 weeks stipulated time frame and were included in the analysis. Of the 25 contacted, twelve (48%) patients were successfully contacted on the first attempt. Ten (40%) were successfully contacted on the second attempt. The remaining three patients (12%) required 3 or more attempts to make successful contact. Telephone consultations were estimated not to last longer than 10 min, including notes screening and documentation. Eleven patients (44%) reported an improvement in their symptoms, thirteen (52%) reported no change and one patient (4%) reported their symptoms to be worse. Conclusion Telephone follow-up consultations may be a potentially cost-effective alternative to face-to-face appointments when implemented in a Rheumatology Podiatry Department, and provide an alternative way of providing care, especially when capacity for face-to-face contact is limited. The potential cost saving and efficiency benefits of this service are likely to be enhanced when telephone consultations are pre-arranged with patients.

scholarly journals Healthcare professionals’ views of the use of oral morphine and transmucosal diamorphine in the management of paediatric breakthrough pain and the feasibility of a randomised controlled trial: A focus group study (DIPPER)

2021 ◽  
pp. 026921632110087
Author(s):  
Liz Jamieson ◽  
Emily Harrop ◽  
Margaret Johnson ◽  
Christina Liossi ◽  
Christine Mott ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Healthcare Professionals ◽  
Breakthrough Pain ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Oral Route ◽  
Focus Group Study ◽  
Framework Approach ◽  
Randomised Controlled ◽  
The Uk

Background: Oral morphine is frequently used for breakthrough pain but the oral route is not always available and absorption is slow. Transmucosal diamorphine is administered by buccal, sublingual or intranasal routes, and rapidly absorbed. Aim: To explore the perspectives of healthcare professionals in the UK caring for children with life-limiting conditions concerning the assessment and management of breakthrough pain; prescribing and administration of transmucosal diamorphine compared with oral morphine; and the feasibility of a comparative clinical trial. Design/ participants: Three focus groups, analysed using a Framework approach. Doctors, nurses and pharmacists ( n = 28), caring for children with life-limiting illnesses receiving palliative care, participated. Results: Oral morphine is frequently used for breakthrough pain across all settings; with transmucosal diamorphine largely limited to use in hospices or given by community nurses, predominantly buccally. Perceived advantages of oral morphine included confidence in its use with no requirement for specific training; disadvantages included tolerability issues, slow onset, unpredictable response and unsuitability for patients with gastrointestinal failure. Perceived advantages of transmucosal diamorphine were quick onset and easy administration; barriers included lack of licensed preparations and prescribing guidance with fears over accountability of prescribers, and potential issues with availability, preparation and palatability. Factors potentially affecting recruitment to a trial were patient suitability and onerousness for families, trial design and logistics, staff time and clinician engagement. Conclusions: There were perceived advantages to transmucosal diamorphine, but there is a need for access to a safe preparation. A clinical trial would be feasible provided barriers were overcome.

scholarly journals Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Helda Tutunchi ◽  
Majid Mobasseri ◽  
Samira Pourmoradian ◽  
Hamid Soleimanzadeh ◽  
Behnam Kafil ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Complete Blood Count ◽  
Controlled Clinical Trial ◽  
Medical Sciences ◽  
Boron Compounds ◽  
Double Blind ◽  
Link Type ◽  
Nutrition Research ◽  
Full Protocol

Abstract Objectives In this study, we investigate the effect of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19. Trial design The current study is a single-center, randomized, double-blind, placebo-controlled clinical trial with parallel groups. Participants The inclusion criteria include male and female patients≥18 years of age, with a confirmed diagnosis of SARS-CoV-2 infection via polymerase chain reaction (PCR) and/or antibody test and with written informed consent to participate in this trial. The exclusion criteria include regular use of any other supplement, severe and critical COVID-19 pneumonia, pregnancy and breastfeeding. This study is being conducted at Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran. Intervention and comparator Patients are randomly assigned to four groups. The first group (A) will take one capsule containing 5 mg of boron compounds twice a day for two weeks. The second group (B) will take one capsule containing 200 mg oleoylethanolamide twice a day for two weeks. The third group (C) will take one capsule containing 5 mg boron compounds with 200 mg oleoylethanolamide twice a day for two weeks, and the fourth group (D) does not receive any additional treatment other than routine treatments. Boron-containing compounds and oleoylethanolamide capsules will be synthesized at Nutrition Research Center of Tabriz University of Medical Sciences. Main outcomes The primary end point of this study is to investigate the recovery rate of clinical symptoms, including fever, dry cough, and fatigue, as well as preclinical features, including complete blood count (CBC), the erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) profiles within two weeks of randomization. Randomisation Patients are randomized into four equal groups in a parallel design (allocation ratio 1:1). A randomized block procedure is used to divide subjects into one of four treatment blocks (A, B, C, and D) by a computer-generated allocation schedule. Blinding (masking) The participants and investigators (enrolling, assessing, and analyzing) are blinded to the intervention assignments until the end of the study and data analysis. Numbers to be randomised (sample size) The calculated total sample size is 40 patients, with 10 patients in each group. Trial Status The protocol is Version 1.0, May 17, 2020. Recruitment began May 19, 2020, and is anticipated to be completed by October 19, 2020. Trial registration This clinical trial has been registered by the title of “Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in Patients with COVID-19: A double-blind randomized placebo-controlled clinical trial” in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20090609002017N35”, https://www.irct.ir/trial/48058. The registration date is 17 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Microdose intravaginal levonorgestrel contraception: A multicentre clinical trial

Contraception ◽  
1990 ◽  
Vol 41 (2) ◽  
pp. 151-167 ◽  
Author(s):  
S. Koetsawang ◽  
Ji Gao ◽  
U. Krishna ◽  
A. Cuadros ◽  
G.I. Dhall ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multicentre Clinical Trial
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