OP223 A Semi-Automated Process To Monitor The Clinical Development And Regulatory Approval Pathway Of Innovative Medicines

2021 ◽  
Vol 37 (S1) ◽  
pp. 7-7
Author(s):  
Georgina Wilkins ◽  
Fernando Zanghelini ◽  
Kieran Brooks ◽  
Oladapo Ogunbayo
Keyword(s):  
Regulatory Approval ◽  
Data Availability ◽  
Active Monitoring ◽  
Regulatory Pathways ◽  
Gene Therapies ◽  
Department Of Health ◽  
Ongoing Work ◽  
Review Period ◽  
Health And Social Care ◽  
Monitoring Framework

IntroductionEarly identification of innovative medicines is crucial for timely health technology assessment (HTA) and efficient patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies, monitors and notifies key HTA stakeholders in England of ‘technologies’ (innovative medicines) within three to five years of regulatory approval. Increasing numbers of innovative medicines and significant uncertainties in clinical and regulatory pathways are major challenges in the monitoring and notification process. An active monitoring framework using pre-defined predictive criteria has previously been developed. This framework provides a standardized and consistent process, but is highly resource-intensive, requiring manual review of individual records.MethodsUsing the previous active monitoring framework, a scoring matrix was calculated and used to prioritize individual technologies using available data in the NIHRIO database: estimated regulatory timelines, regulatory awards/designations, innovative medicine type (for example gene therapies) and clinical trial phase, completion dates and results. A threshold for automatic and manual reviewing of technologies was developed and tested by NIHRIO analysts.ResultsThe scoring system identified approximately ninety percent of technologies meeting the threshold for semi-automated reviewing. The review period for these technologies are set automatically according to predefined criteria depending on data availability. The review periods are updated automatically until the record reaches the threshold that triggers manual reviewing. The remaining ten percent had estimated regulatory timelines necessitating the need for manual reviewing and early engagement with companies to verify regulatory timelines and/or notify HTA stakeholders.ConclusionsPreliminary analysis indicates that each technology is routinely and automatically updated. The semi-automatic updating represents a significant improvement in the efficiency of the monitoring of the large volume of technologies on the NIHRIO database. Ongoing work is being undertaken to further refine, pilot and test the system.This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

OP491 Beyond Horizon-Scanning And Early Identification Of Innovative Technologies – Development Of An Active Monitoring Framework

2020 ◽  
Vol 36 (S1) ◽  
pp. 11-11
Author(s):  
Patricia Aluko ◽  
Fernando Zanghelini ◽  
Oladapo Ogunbayo
Keyword(s):  
Evidence Synthesis ◽  
Regulatory Approval ◽  
Sensitive Information ◽  
Active Monitoring ◽  
Health Technologies ◽  
Horizon Scanning ◽  
Monitoring Process ◽  
Advanced Therapies ◽  
Monitoring Framework ◽  
Completion Date

IntroductionWhile horizon-scanning systems aim to identify innovative and potentially disruptive health technologies in development, a key challenge is variation in information collation and tracking of the pace of change prior to regulatory approval. An active and efficient monitoring process is crucial for timely notification of health technology assessment (HTA) stakeholders to enhance faster market and patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies and notifies its key HTA stakeholders in England of technologies that are within three to five-year timeframe to regulatory approval. Regular review of each technology is required to meet this remit.MethodsA standardized monitoring framework was developed based on the knowledge and experience of the evidence synthesis specialists in NIHRIO, supplemented by literature to ensure consistency of setting review periods. This framework used predefined criteria that integrated the technology innovation (advanced therapies, orphan status, regulatory awards), trial data (phase, status, completion date, preliminary results) and estimated approval timelines obtained from the company or other sources (for example, press releases).ResultsThe framework has been piloted and early findings showed improved consistency in the monitoring process between different analysts. It ensures that each technology is reviewed at least once a year; review timelines are set at three, six, nine or twelve months based on the predefined criteria. Estimated timeframes obtained from the companies are used to triangulate and streamline review periods, improving efficiency of the monitoring process.ConclusionsFindings from the pilot work with the framework demonstrated improved consistency and efficiency of the technology monitoring process, which can be easily implemented to provide early awareness in an accurate and timely manner for HTA. This framework was designed using a systematic and transparent approach that integrated different data sources to set review periods. While most of the data used in defining the criteria are publicly available, commercially sensitive information provided by companies were also used which may not always be readily available. Implications for horizon-scanning organizations will be discussed.

scholarly journals Introducing the Care Certificate Evaluation: Innovative practice

Dementia ◽  
2017 ◽  
Vol 19 (2) ◽  
pp. 512-517
Author(s):  
Elaine Argyle ◽  
Louise Thomson ◽  
Antony Arthur ◽  
Jill Maben ◽  
Justine Schneider ◽  
...  
Keyword(s):  
Staff Development ◽  
Social Care ◽  
Policy Research ◽  
Research Programme ◽  
Direct Care ◽  
Care Staff ◽  
Care Provision ◽  
Front Line ◽  
Department Of Health ◽  
Health And Social Care

Although investment in staff development is a prerequisite for high-quality and innovative care, the training needs of front line care staff involved in direct care have often been neglected, particularly within dementia care provision. The Care Certificate, which was fully launched in England in April 2015, has aimed to redress this neglect by providing a consistent and transferable approach to the training of the front line health and social care workforce. This article describes the early stages of an 18-month evaluation of the Care Certificate and its implementation funded by the Department of Health Policy Research Programme.

scholarly journals How effective are governmental and university campaigns for increasing meningitis vaccine uptake?

2021 ◽  
Author(s):  
Ayushi Ramjee ◽  
Chloe Ogilvie ◽  
Africa Couto ◽  
Teresa Matini ◽  
Claudia Anaele ◽  
...  
Keyword(s):  
Student Perceptions ◽  
Vaccine Uptake ◽  
Disease Spread ◽  
Awareness Campaigns ◽  
Department Of Health ◽  
Behavioural Patterns ◽  
Health And Social Care ◽  
Catchment Areas ◽  
Student Cohorts ◽  
E Mail

ObjectivesUniversity student cohorts have a potential for significant impacts on public health policies. Health impacts arise from wide geographic catchment areas and behavioural patterns that enhance infectious disease spread and occasional cases of meningococcal meningitis and septicaemia, measles and mumps. Universities and the Department of Health and Social Care have tackled these serious problems through advertising campaigns and by offering free MenACWY and MMR vaccines to university students. Our study aimed to assess the engagement of universities with these vaccine campaigns and student awareness of this information. Study DesignInformation was accrued by a combination of e-mail and telephone interactions with welfare officers at universities. Student perceptions of meningitis vaccine campaigns were studied through use of questionnaires with University of Leicester students. ResultsInformation provided by 17 universities indicated that all universities run meningitis awareness campaigns whereas on campus meningitis campaigns were infrequent and of variable penetration into student cohorts. Assessment of 272 students from a 2019-2020 cohort found that 17.5% and 58% of students did not know or had not had the MMR and MenACWY vaccines. Only 37% of students were aware that these vaccines were free and available from a university-linked GP practice with lack of this knowledge being significantly associated with uncertainty or perceived absence of immunisation. This latter group were significantly associated with a preference for on campus immunisation. DiscussionThis information is important for understanding how to target a critical cohort with effective campaigns for uptake of meningitis, MMR and COVID-19 vaccines.

VP74 Orphan Black Box: Explanatory Principles

2019 ◽  
Vol 35 (S1) ◽  
pp. 92-93
Author(s):  
George Wang ◽  
Richard Macaulay
Keyword(s):  
Market Access ◽  
Economic Value ◽  
Orphan Drugs ◽  
Regulatory Approval ◽  
Marketing Authorization ◽  
European Medicines Agency ◽  
Reimbursement Mechanisms ◽  
Regulatory Pathways ◽  
Small Patient ◽  
Pricing And Reimbursement

IntroductionOrphan legislations over the past thirty years have successfully increased the number of drugs receiving marketing authorization for rare diseases. However, for a therapy to be accessible to most patients, it requires not only marketing authorization, but market access via public reimbursement. In many major markets, the pricing and reimbursement of new therapies is based on an assessment by a national Health Technology Assessment (HTA) body, for which economic value is typically a key consideration. This research evaluates the outcome of HTAs of orphan drugs in Europe.MethodsHTA decision data (to 31/08/2017) was extracted from Gemeinsame Bundesausschuss (G-BA), Haute Autorité de Santé (HAS), National Institute for Health and Care Excellence (NICE), Pharmaceutical Benefits Advisory Committee (PBAC), and Scottish Medicines Consortium (SMC) websites. EC-approval data was extracted from the European Medicines Agency (to 31/08/2017).ResultsOnly a small minority of drugs for orphan diseases received full recommendations for their licensed indication(s) by NICE (3/35, 9%), SMC (8/66, 12%) and PBAC (1/44, 2%). 37% (26/70) of drugs assessed received positive HTA outcome by HAS (ASMR I-III). In Germany, all approved orphan drugs (100/100) received automatic additional benefit post regulatory approval by G-BA.ConclusionsThere have been significant challenges for manufacturers in converting regulatory approval of orphan drugs into commercial success and optimised market access. Attaining positive HTA appraisals for these drugs, which have been approved under expedited regulatory pathways on a less than fully mature dataset, whilst also having high prices, due to small patient populations, limiting commercial returns, may necessitate increased utilisation of alternative reimbursement mechanisms.

scholarly journals Remembering people with dementia during the COVID-19 crisis

2020 ◽  
Vol 3 ◽  
pp. 15 ◽  
Author(s):  
Eamon O'Shea
Keyword(s):  
Family Carers ◽  
Current Crisis ◽  
Department Of Health ◽  
People With Dementia ◽  
Difficult Time ◽  
New Public ◽  
Practical Support ◽  
Health And Social Care ◽  
Information And Communication ◽  
Shared Humanity

This letter argues that we need to pay particular attention to people with dementia during this difficult time of the COVID-19 pandemic. Social distancing rules and cocooning for people aged 70 years and over are now in place in Ireland to slow down the rate of infection and protect vulnerable older people.  This letter argues that we need, more than ever, to assert the personhood of people with dementia at this difficult time. That means more person-centred care and practical support structures for family carers to allow them to continue to care at home in a safe and life-enhancing way. New public broadcasting initiatives could create information and communication channels for people with dementia and their carers, as well as demonstrating empathy and solidarity with their predicament. Government, the Department of Health, the HSE and the voluntary sector have risen to the challenge of COVID-19 in all sectors of society. So too have ordinary citizens. Now we need to unite even more to create an unyielding commitment and adherence to the principles of  decency, justice  and equity in the allocation of scarce  health and social care resources. By doing this, we will demonstrate our caring potential and capacity in a way that reflects our shared humanity, not only in the current crisis, but into the future.

scholarly journals Audit into post diagnostic support in newly diagnosed dementia patients

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S335-S335
Author(s):  
Madhumanti Mitra ◽  
Raghupathy Paranthaman
Keyword(s):  
Support Group ◽  
Random Number Generator ◽  
Patient Choice ◽  
Newly Diagnosed ◽  
Department Of Health ◽  
Dementia Patients ◽  
Health And Social Care ◽  
Diagnosis Of Dementia ◽  
Potential Factors ◽  
Diagnostic Support

AimsThis audit aims to identify whether newly diagnosed dementia patients are offered post diagnostic support and potential factors influencing patient choice.BackgroundA diagnosis of dementia can be life changing and hence post-diagnostic support for dementia is key. Multiple guidelines suggest that post diagnostic support need to be offered to all patients diagnosed with dementia. The Department of Health and Social Care and other national/ local guidelines suggest that post diagnostic support is offered to all patients diagnosed with dementia.MethodData were collected for 40 patients diagnosed with dementia. Using random number generator, patient group was selected from pool of patients diagnosed with dementia between July’ 2017 - December’ 2017. Data included whether they had been offered support during the initial appointment and what post-diagnostic support was offered. Demographic details obtained to identify patterns of support accessed by patients.ResultAll patients were offered post-diagnostic support. Diagnosis was discussed in appointment in about 93% of patients. Medication was discussed in 82% patients. Driving was discussed in only 64% patients and LPA was discussed in only 63% patients. When given choice between Post diagnostic support group (PDSG) and Dementia adviser (DA), slightly more women tend to choose PDSG group. The only 2 ethnic minority patients chose DA. 21% more patients opted for PDSG group when they had a carer.ConclusionThe positive is that some post-diagnostic support is offered to all patients. Although discussion of diagnosis with patients was done well, discussion of medication, driving and LPA can be improved upon. Ethnicity and family structure/ carer may have a bearing on patient choice of post-diagnostic support.

scholarly journals On the possible tools for the prevention of non-performing loans. A case study of an Italian bank

2015 ◽  
Vol 12 (3) ◽  
pp. 133-145 ◽  
Author(s):  
Elena Bruno ◽  
Giuseppina Iacoviello ◽  
Arianna Lazzini
Keyword(s):  
Data Availability ◽  
Decision Making Process ◽  
Integrated Process ◽  
Quality Of Information ◽  
Active Monitoring ◽  
Real Time Information ◽  
Credit Portfolio ◽  
Time Information

This work analyzes the contribution of an Information Systems (IS) to the implementation of credit monitoring as a new integrated process to prevent non-performing loans in a small bank. The study focuses on the process of active monitoring of the entire credit portfolio, aimed at guiding the best migration between risk classes. This is understood as a set of integrated activities, in which the quality of information becomes a major determinant of the outcome. Such tools support risk management in the decision-making process and aiding performance evaluation. The purpose of this work is to highlight the possibility of an IS to support this new integrated process of credit monitoring, providing increasingly reliable data, availability on demand and real-time information

scholarly journals Monitoring populations at increased risk for SARS-CoV-2 infection in the community

2021 ◽  
Author(s):  
Emma Pritchard ◽  
Joel Jones ◽  
Karina Vihta ◽  
Nicole Stoesser ◽  
Philippa C Matthews ◽  
...  
Keyword(s):  
Public Health ◽  
Real Time ◽  
Multiple Testing ◽  
Reverse Causality ◽  
Screening Process ◽  
Department Of Health ◽  
Increased Risk ◽  
Behavioural Surveillance ◽  
Geographical Regions ◽  
Health And Social Care

Background: The COVID-19 pandemic is rapidly evolving, with emerging variants and fluctuating control policies. Real-time population screening and identification of groups in whom positivity is highest could help monitor spread and inform public health messaging and strategy. Methods: To develop a real-time screening process, we included results from nose and throat swabs and questionnaires taken 19 July 2020-17 July 2021 in the UK's national COVID-19 Infection Survey. Fortnightly, associations between SARS-CoV-2 positivity and 60 demographic and behavioural characteristics were estimated using logistic regression models adjusted for potential confounders, considering multiple testing, collinearity, and reverse causality. Findings: Of 4,091,537 RT-PCR results from 482,677 individuals, 29,903 (0.73%) were positive. As positivity rose September-November 2020, rates were independently higher in younger ages, and those living in Northern England, major urban conurbations, more deprived areas, and larger households. Rates were also higher in those returning from abroad, and working in healthcare or outside of home. When positivity peaked December 2020-January 2021 (Alpha), high positivity shifted to southern geographical regions. With national vaccine roll-out from December 2020, positivity reduced in vaccinated individuals. Associations attenuated as rates decreased between February-May 2021. Rising positivity rates in June-July 2021 (Delta) were independently higher in younger, male, and unvaccinated groups. Few factors were consistently associated with positivity. 25/45 (56%) confirmed associations would have been detected later using 28-day rather than 14-day periods. Interpretation: Population-level demographic and behavioural surveillance can be a valuable tool in identifying the varying characteristics driving current SARS-CoV-2 positivity, allowing monitoring to inform public health policy. Funding: Department of Health and Social Care (UK), Welsh Government, Department of Health (on behalf of the Northern Ireland Government), Scottish Government, National Institutes of Health Research.

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