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 Almost half of references in reports on new and emerging nondrug health technologies are grey literature

2019 ◽  
Vol 107 (1) ◽  
Author(s):  
Kelly Farrah ◽  
Monika Mierzwinski-Urban
Keyword(s):  
Medical Devices ◽  
Laboratory Tests ◽  
Evidence Synthesis ◽  
Grey Literature ◽  
Regulatory Agencies ◽  
Literature Searching ◽  
Health Technologies ◽  
Clinical Trial Registries ◽  
Horizon Scanning ◽  
The Us

Objective: The research investigated how frequently grey literature is used in reports on new and emerging nondrug health technologies, which sources are most cited, and how grey literature searching is reported.Methods: A retrospective review of references cited in horizon scanning reports on nondrug health technologies—including medical devices, laboratory tests, and procedures—was conducted. A quasi-random sample of up to three reports per agency was selected from a compilation of reports published in 2014 by international horizon scanning services and health organizations.Results: Twenty-two reports from 8 agencies were included in the analysis. On average, 47% (288/617) of references listed in the bibliographies of the horizon scanning reports were grey literature. The most frequently cited type of grey literature was information from manufacturers (30% of all grey literature references), regulatory agencies (10%), clinical trial registries (9%), and other horizon scans or evidence synthesis reports (9%). The US Food and Drug Administration (FDA) and ClincalTrials.gov were the most frequently cited specific sources, constituting 7% and 8% of grey literature references, respectively. Over two-thirds (15/22) of the analyzed reports provided some details on search methodology; all 15 of these reported searching some grey literature.Conclusions: In this sample, grey literature represented almost half of the references cited in reports on new and emerging nondrug health technologies. Of these grey literature references, almost half came from three sources: the manufacturers, ClinicalTrials.gov, and the FDA. There was wide variation in the other sources cited. Literature search methodology was often insufficiently reported for analysis.

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.

scholarly journals Data Protection by Design in the E-Health Care Sector

2021 ◽  
Author(s):  
Giorgia Bincoletto
Keyword(s):  
Health Care ◽  
Data Protection ◽  
Medical Information ◽  
Health Care Sector ◽  
Design Stage ◽  
Personal Health ◽  
Sensitive Information ◽  
Primary Concern ◽  
Health Technologies ◽  
Data Subject

In the digital age, e-health technologies play a pivotal role in the processing of medical information. As personal health data represent sensitive information concerning a data subject, enhancing data protection and security of systems and practices has become a primary concern. This book explores how an e-health system could be developed and how data processing activities could be carried out to apply data protection principles and requirements from the design stage. There is currently a lack of clarity and knowledge on the topic among developers, data controllers and stakeholders. The research attempts to bridge the gap between the legal and technical disciplines on DPbD by providing a set of guidelines for the implementation of the principle in the e-health care sector.

scholarly journals Rapid qualitative evidence syntheses (rQES) in health technology assessment: experiences, challenges, and lessons

2020 ◽  
pp. 1-9
Author(s):  
Umair Majid ◽  
Laura Weeks
Keyword(s):  
Qualitative Research ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Evidence Synthesis ◽  
Health Technology ◽  
Lessons Learned ◽  
Qualitative Evidence Synthesis ◽  
Health Technologies ◽  
Related Data ◽  
Qualitative Evidence

Abstract Healthcare decision makers are increasingly demanding that health technology assessment (HTA) is patient focused, and considers data about patients' perspectives on and experiences with health technologies in their everyday lives. Related data are typically generated through qualitative research, and in HTA the typical approach is to synthesize primary qualitative research through the conduct of qualitative evidence synthesis (QES). Abbreviated HTA timelines often do not allow for the full 6–12 months it may take to complete a QES, which has prompted the Canadian Agency for Drugs and Technologies in Health (CADTH) to explore the concept of “rapid qualitative evidence synthesis” (rQES). In this paper, we describe our experiences conducting three rQES at CADTH, and reflect on challenges faced, successes, and lessons learned. Given limited methodological guidance to guide this work, our aim is to provide insight for researchers who may contemplate rQES. We suggest several lessons, including strategies to iteratively develop research questions and search for eligible studies, use search of filters and limits, and use of a single reviewer experienced in qualitative research throughout the review process. We acknowledge that there is room for debate, though believe rQES is a laudable goal and that it is possible to produce a quality, relevant, and useful product, even under restricted timelines. That said, it is vital to recognize what is lost in the name of rapidity. We intend our paper to advance the necessary debate about when rQES may be appropriate, and not, and enable productive discussions around methodological development.

MAKING PROCESSES RELIABLE: A VALIDATED PUBMED SEARCH STRATEGY FOR IDENTIFYING NEW OR EMERGING TECHNOLOGIES

2012 ◽  
Vol 28 (4) ◽  
pp. 452-459 ◽  
Author(s):  
Leonora Varela-Lema ◽  
Jeanette Punal-Riobóo ◽  
Beatriz Casal Acción ◽  
Alberto Ruano-Ravina ◽  
Marisa López García
Keyword(s):  
Search Strategy ◽  
Emerging Technologies ◽  
Scanning System ◽  
Free Text ◽  
Medline Search ◽  
Health Technologies ◽  
Horizon Scanning ◽  
Wide Range ◽  
Pubmed Search ◽  
Bibliographic Search

Background and Objectives:Horizon scanning systems need to handle a wide range of sources to identify new or emerging health technologies. The objective of this study is to develop a validated Medline bibliographic search strategy (PubMed search engine) to systematically identify new or emerging health technologies.Methods:The proposed Medline search strategy combines free text terms commonly used in article titles to denote innovation within index terms that make reference to the specific fields of interest. Efficacy was assessed by running the search over a period of 1 year (2009) and analyzing its retrieval performance (number and characteristics). For comparison purposes, all article abstracts published during 2009 in six preselected key research journals and eight high impact surgery journals were scanned. Sensitivity was defined as the proportion of relevant new or emerging technologies published in key journals that would be identified in the search strategy within the first 2 years of publication.Results:The search yielded 6,228 abstracts of potentially new or emerging technologies. Of these, 459 were classified as new or emerging (383 truly new or emerging and 76 new indications). The scanning of 12,061 journal abstracts identified 35 relevant new or emerging technologies. Of these, twenty-nine were located within the Medline search strategy during the first 2 years of publication (sensitivity = 83 percent).Conclusions:The current search strategy, validated against key journals, has demonstrated to be effective for horizon scanning. Even though it can require adaptations depending on the scope of the horizon scanning system, it could serve to simplify and standardize scanning processes.

Implementing Early Warning Messages on Emerging Health Technologies

1998 ◽  
Vol 14 (4) ◽  
pp. 663-670 ◽  
Author(s):  
Graham Mowatt ◽  
Mary Ann Thomson ◽  
Jeremy Grimshaw ◽  
Adrian Grant
Keyword(s):  
Health Care ◽  
Early Warning ◽  
Health Care Professionals ◽  
Implementation Strategies ◽  
Care Group ◽  
Health Technologies ◽  
Organisation Of Care ◽  
Warning Messages ◽  
Horizon Scanning ◽  
Active Implementation

AbstractThe purpose of this study was to determine how horizon-scanning organizations can encourage the implementation of recommendations contained in their early warning messages about emerging health technologies. We reviewed the conclusions of the EUR-ASSESS Project Subgroup report on dissemination and impact, an overview of systematic reviews of interventions to promote implementation of research findings by health care professionals, and various Cochrane Effective Practice and Organisation of Care Group protocols and reviews. The evidence on the effectiveness of different implementation strategies aimed at distinct target groups is of variable quality. There is some evidence from rigorous study designs on the effectiveness of strategies designed to influence the behavior of health care professionals; the quality of the evidence relating to policy makers and the general public is more limited. Horizon-scanning organizations can improve the likelihood of their recommendations being acted upon by developing active implementation strategies based on the best available evidence, establishing links with key groups, and directing early warning messages at specific target audiences. Given the relative lack of good quality evidence, it is important that implementation strategies be rigorously evaluated to determine their effectiveness.

OP283 A Pipeline Analysis Of Advanced Therapy Medicinal Products (ATMPs) In Late-Stage Clinical Development

2020 ◽  
Vol 36 (S1) ◽  
pp. 5-5
Author(s):  
James Woltmann ◽  
Rhiannon Teague ◽  
Dapo Ogunbayo ◽  
Dawn Craig
Keyword(s):  
Late Stage ◽  
Medicinal Products ◽  
Active Monitoring ◽  
Advanced Therapy Medicinal Products ◽  
Health Technologies ◽  
Gene Therapies ◽  
Advanced Therapy ◽  
Hematological Cancers ◽  
High Prevalence ◽  
Innovative Therapies

IntroductionAdvanced Therapy Medicinal Products (ATMPs) are innovative biologics (gene, cells and tissue-based products) with the potential to treat diseases with significant unmet clinical need. ATMPs pose distinct regulatory, health technology assessment (HTA) and patient access challenges, hence early identification and prioritization of ATMPs is now recognized as a key concern in England. The National Institute for Health Research Innovation Observatory (NIHRIO) uses a robust methodology to identify and monitor health technologies, including ATMPs that meet the remit of key HTA stakeholders in England. This analysis provides a global overview of the current ATMPs pipeline to administer useful insights for policymakers, funders and innovators.MethodsNIHRIO's database tracks pharmaceuticals from phase I/II onwards, but this analysis focuses on late-stage development. The database (N > 12,000 records) was filtered to identify potential ATMPs using a predefined criteria based on the European Medicine's Agency's classification. Each record is categorized by stage: ‘Active’, (with an estimated three years to European licence); ‘Monitoring’ (in development with no licence date); and ‘Finished’, (output produced/discontinued and no longer tracked). Subsequently, records in ‘Active’ and ‘Monitoring’ were examined further.ResultsAnalysis identified 636 ATMPs: five percent ‘Active’, 40 percent ‘Monitoring’ and 55 percent ‘Finished’. ATMPs in the Active/Monitoring stages included: gene therapies (52%), somatic cells (43%) and tissue-engineered products (5%). Of these, 40 percent were oncological with the majority targeting hematological cancers (lymphomas). Prevalent non-oncology areas included musculoskeletal (10%) and ophthalmology (8%). Over one-third of trials were phase IIs, with almost half of all trials were based in the US.ConclusionsThe overarching findings here indicate increasing development of the ATMP pipeline towards indications with significant unmet clinical need. In oncology, the high prevalence of hematological ATMPs is largely due to recent chimeric antigen receptor T cells (CAR-T) innovation. In non-oncology areas, ATMP development is increasing due to advances in regenerative medicine. With a significant number of ATMPs projected to be licenced within three years, and many more in active late-stage trials, HTA bodies and health systems are challenged to prepare for the entry of these innovative therapies.

scholarly journals Pharyngeal Electrical Stimulation for the Treatment of Dysphagia Associated With Neurologic Conditions

2021 ◽  
Vol 1 (9) ◽  
Author(s):  
Anusree Subramonian
Keyword(s):  
Health Care ◽  
Electrical Stimulation ◽  
Emerging Technology ◽  
Decision Makers ◽  
Health Care Decision ◽  
Health Technologies ◽  
Potential Interest ◽  
Horizon Scanning ◽  
Available Information ◽  
Care Decision

Horizon Scan reports provide brief summaries of information regarding new and emerging health technologies. These technologies are identified through the CADTH Horizon Scanning Service as topics of potential interest to health care decision-makers in Canada. This Horizon Scan summarizes the available information regarding an emerging technology, Phagenyx, a pharyngeal electrical stimulation device for the treatment of difficulty swallowing associated with neurologic conditions.

Health Technology Assessment in Malaysia: Past, Present, and Future

2019 ◽  
Vol 35 (6) ◽  
pp. 446-451 ◽  
Author(s):  
Sarimin Roza ◽  
Sabirin Junainah ◽  
Mudla Mohamed Ghazali Izzuna ◽  
Ku Abdul Rahim Ku Nurhasni ◽  
Mohd Aminuddin Mohd Yusof ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Impact Evaluation ◽  
Quantitative Description ◽  
Health Technology ◽  
Health Technologies ◽  
The Past ◽  
Horizon Scanning ◽  
Report Quality

AbstractObjectivesThe aim of this study was to provide a comprehensive overview of the evolution of health technology assessment (HTA) in Malaysia over the past decade.MethodsWe described the evolution of HTA program in Malaysia based on review of administrative data, publicly available information and quantitative description of impact evaluation.ResultsHealth Technology Assessment HTA was formalized in Malaysia in 1995 as a central structure within the Ministry of Health, Malaysia in 1995. Expansion of activities demonstrated over the years including Horizon Scanning of health technologies and implementation of evidence-based Clinical Practice Guidelines. Improvement on the processes in terms of types of report, quality, monitoring, and impact evaluation as well as accessibility was also carried out. Examples of impact/influence of the reports have also been demonstrated.ConclusionsHTA program in Malaysia has evolved over the past decades. Its role in policy formulation and decision making of health technologies has become more significant over the years and is foreseen to be bigger in the future. As a trusted source of evidence, HTA in Malaysia will continue to strengthen the health system by advocating informed decision making and value-based medicine. As other countries in this region is trying to establish their own HTA processes and procedures, this review on the evolution of the HTA program in Malaysia might give some insights on developing a sustainable HTA program.

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