scholarly journals NIH Tobacco Research and the Emergence of Tobacco Regulatory Science

2021 ◽  
Author(s):  
Helen I Meissner ◽  
Kriti Sharma ◽  
Rachel J Mandal ◽  
Mary Garcia Cazarin ◽  
Kay L Wanke ◽  
...  
Keyword(s):  
Evidence Base ◽  
Tobacco Product ◽  
Regulatory Science ◽  
Treatment Interventions ◽  
Time Period ◽  
Multiple Levels ◽  
Regulatory Decisions ◽  
Research Domains ◽  
Continue Monitoring ◽  
Support Research

Abstract Introduction This study explores how the emergence of FDA-funded Tobacco Regulatory Science (TRS) research complements and perhaps influenced the direction of tobacco research supported by NIH. Methods New NIH- and FDA-funded tobacco projects awarded in fiscal years (FY) 2011-2020 were identified using internal NIH databases of awarded grants. Project abstracts and research aims were coded by the authors to characterize research domains and tobacco products studied. Results Between FY 2011 and 2020, NIH funded 1032 and FDA funded 322 new tobacco projects. For the years and grant activity codes studied, the number of new NIH tobacco projects declined while FDA’s increased; combined the number of new projects held steady. Much of NIH research included smoking combustibles (43.7%). The most common products in FDA research were cigarettes (74.8%) and e-cigarettes/ENDS (48.1%). Most NIH (58.6%) and FDA (67.7%) projects included research on the determinants of tobacco use. Another area of apparent overlap was health effects (29.5% NIH and 30.1% FDA). Projects unique to NIH included treatment interventions (33.3%), disease pathology/progression (17.8%) and neurobiology (18.9%). A minority of both NIH and FDA projects included populations particularly vulnerable to tobacco product use. Conclusions In total, support for new tobacco research supported by NIH and FDA combined remained steady for the time period covered, though there was a concomitant decline in NIH tobacco projects with the increase in FDA-funded TRS projects for the activity codes studied. Despite apparent overlap in some areas, both NIH and FDA support research that is unique to their respective missions. Implications NIH continues to support tobacco research that falls within and outside of FDA’s regulatory authorities. This research still is needed not only to bolster the evidence base for regulatory decisions at the national and state levels, but also to advance a comprehensive scientific agenda that can inform multiple levels of influence on tobacco control, use and addiction. It will be important to continue monitoring FDA-funded TRS and NIH-funded tobacco research portfolios to ensure that the level of support for and focus of the research is sufficient to address the burden of tobacco-related morbidity and mortality.

scholarly journals Health Informatics in Developing Countries: Systematic Review of Reviews Contribution of the IMIA Working Group Health Informatics for Development

2013 ◽  
Vol 22 (01) ◽  
pp. 28-33
Author(s):  
C. Otero ◽  
A. Marcelo ◽  
D. Luna
Keyword(s):  
Systematic Review ◽  
Developing Countries ◽  
Systematic Reviews ◽  
Health Informatics ◽  
Evidence Base ◽  
Search Term ◽  
Manual Search ◽  
Time Period ◽  
Different Types ◽  
Review Of Reviews

Summary Objectives: An evidence-base is important for medicine and health informatics. Despite numerous publications showing the benefits of health informatics, the emergence of health information systems in developing countries has been slower than expected. The aim of this paper is to identify systematic reviews on the domain of health informatics in developing countries, and classify the different types of applications covered. Methods: A systematic review of reviews was conducted. The literature search spanned the time period between 2000 and 2012 and included PubMed, EMBASE, CINAHL, Scopus, Cochrane Systematic Reviews, LILACS, and Google Scholar. The search term was ‘systematic reviews of health informatics in developing countries’, and transparent and systematic procedures were applied to limit bias at all stages. Results: Of the 982 identified articles, only 10 met the inclusion criteria and one more article was added in a second manual search, resulting in a total of 11 systematic reviews for the analysis. Conclusions: Although it was difficult to find high quality resources on the selected domain, the best evidence available allowed us to generate this report and create an incipient review of the state of the art in health informatics in the developing countries. More studies will be needed to optimize the results.

scholarly journals Not Quite the Rule, But No Longer the Exception: Multiple Tobacco Product Use and Implications for Treatment, Research, and Regulation

2019 ◽  
Vol 22 (11) ◽  
pp. 2114-2117
Author(s):  
Lauren R Pacek ◽  
Andrea C Villanti ◽  
F Joseph Mcclernon
Keyword(s):  
United States ◽  
Cigarette Smoking ◽  
Tobacco Dependence ◽  
The United States ◽  
Tobacco Product ◽  
Regulatory Science ◽  
Tobacco Products ◽  
The Past ◽  
Product Use ◽  
Treatment Research

Abstract The patterns of tobacco product use in the United States have changed during the past several decades. Currently, a large proportion of tobacco users report using multiple tobacco products (MTPs). The prevalence of MTP use varies significantly by cigarette smoking frequency, as well: nearly half (46.9%) of all non-daily smokers report using other tobacco products within the past 30 days. Despite this, much of extant tobacco dependence treatment efforts, tobacco regulatory science research, and tobacco product research, in general, has focused largely on single product use (ie, cigarette smoking). To effectively design interventions and model the potential impact of regulations on tobacco products aimed at reducing tobacco use, as well as effectively study tobacco users, it is essential to consider actual use patterns in the population of tobacco users. Implications: MTP use is increasingly common in the United States. This commentary highlights the impact that MTP use has for efforts to treat tobacco dependence, tobacco regulatory science efforts, as well as on tobacco research, in general.

A BLUE-PRINT FOR PERFORMING PAEDIATRIC PHARMACOLOGICAL RESEARCH

2015 ◽  
Vol 101 (1) ◽  
pp. e1.63-e1
Author(s):  
Eric Vermeulen ◽  
Debbie Nuytemans ◽  
Timo de Haan ◽  
Robert Flint ◽  
Johanna van der Lee
Keyword(s):  
Cost Efficiency ◽  
Evidence Base ◽  
Basic Study ◽  
Design And Implementation ◽  
Laboratory Techniques ◽  
Population Pk ◽  
Multiple Drugs ◽  
Regulatory Decisions ◽  
Blue Print

IntroductionIn order to develop rational, patient tailored dosing schemes, population PK/PD studies in children and infants are needed. The emergence of new laboratory techniques (LC-MS/MS) and statistical tools (population PK/PD modeling) allows for the analysis of sparse and unbalanced data and has increased the possibilities to perform (observational) PK/PD studies in the paediatric clinic.To improve the quality of future pediatric PK/PD investigations the experience and knowledge about these tools should be shared and a basic study template agreed upon.ObjectiveWe aim to present a possible blue-print to assist paediatricians in the design and conduct of multicentre PK/PD studies in children and infants.MethodsBased on a review of the existing literature and multiple interviews with paediatricians and pharmacologists involved in multicenter paediatric PK/PD research a blue-print is drafted containing recommendations and examples for the design and implementation of PK/PD studies in children. The draft blue-print will be available at the conference and participants are asked for feed-back.ResultsPK/PD research to determine dosing in children and infants is preferably performed in a multi-center infrastructure in order to include a sufficient number of subjects within a reasonable time, covering all covariates relevant for dosage. The multi-center collaboration may also enable the analysis of multiple drugs in one cohort increasing cost-efficiency. Formal monitoring is needed to guarantee the quality of collected data.DiscussionIf performed well, the results of these studies will contribute to the evidence base underlying clinical guidelines and regulatory decisions concerning labeling adjustments.

scholarly journals Emerging technologies and their impact on regulatory science

2021 ◽  
pp. 153537022110522
Author(s):  
Elke Anklam ◽  
Martin Iain Bahl ◽  
Robert Ball ◽  
Richard D Beger ◽  
Jonathan Cohen ◽  
...  
Keyword(s):  
New Technologies ◽  
Emerging Technologies ◽  
Cost Effective ◽  
Assessment Tools ◽  
Regulatory Science ◽  
Science Field ◽  
Regulatory Decision ◽  
Technical Advances ◽  
Novel Approaches ◽  
Regulatory Decisions

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

Cognitive Therapy with an HIV-Positive Depressed Gay Man

1997 ◽  
Vol 11 (1) ◽  
pp. 37-44 ◽  
Author(s):  
Vicki L. Gluhoski
Keyword(s):  
Cognitive Therapy ◽  
Hiv Positive ◽  
Limited Information ◽  
Short Time Period ◽  
Family Coping ◽  
Time Period ◽  
Multiple Levels ◽  
Short Time ◽  
Coping With Illness ◽  
Illness Progression

Clinicians may be increasingly called upon to work with HIV-positive clients. Although cognitive therapy has proven efficacious with a broad range of populations, limited information is available on the application of cognitive therapy to HIV-positive clients. This article will describe the case of an HIV-positive gay man seen for cognitive therapy, as part of a research protocol. This case was chosen for several reasons: (1) to demonstrate how to address specific HIV-related issues in cognitive therapy (e.g., disclosing to family, coping with illness progression), (2) to illustrate how to work with multiple levels of cognitions in a short time period, and (3) to show how to work with long-held beliefs within the context of HIV.

Transforming Governance: How National Policies and Organizations for Managing Disaster Recovery Evolved following the 4 September 2010 and 22 February 2011 Canterbury Earthquakes

2014 ◽  
Vol 30 (1) ◽  
pp. 577-605 ◽  
Author(s):  
Laurie A. Johnson ◽  
Ljubica Mamula-Seadon
Keyword(s):  
Disaster Recovery ◽  
Large Scale ◽  
National Level ◽  
The United States ◽  
Time Period ◽  
The World ◽  
Government Capacity ◽  
Multiple Levels ◽  
Recovery Management ◽  
New Institutions

Large-scale disasters simultaneously deplete capital stock and services which then requires many complex rebuilding and societal activities to happen in a compressed time period; one of those is governance. Governments often create new institutions or adapt existing institutions to cope with the added demands. Over two years following the 4 September 2010 and 22 February 2011 Canterbury earthquakes, governance transformations have increasingly centralized recovery authority and operations at the national level. This may have helped to strengthen coordination among national agencies and expedite policy and decision making; but the effectiveness of coordination among multiple levels of government, capacity building at the local and regional levels, and public engagement and deliberation of key decisions are some areas where the transformations may not have been as effective. The Canterbury case offers many lessons for future disaster recovery management in New Zealand, the United States, and the world.

scholarly journals Survival Following Post-HCT Relapse in Adult Acute Lymphoblastic Leukemia Has Improved in the Era of Novel Immunotherapies: A Single Institution Analysis

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 48-49
Author(s):  
Juliana Craig ◽  
Maria Iglesias ◽  
Kristen Cunanan ◽  
Sally Arai ◽  
Matthew J. Frank ◽  
...  
Keyword(s):  
Research Funding ◽  
Lymphoblastic Leukemia ◽  
Recent Time ◽  
Study Cohort ◽  
Novel Therapies ◽  
Private Company ◽  
Advisory Committees ◽  
Time Period ◽  
Time Periods ◽  
Support Research

Background: Historically, the survival of adult patients with acute lymphoblastic leukemia (ALL) relapsing after allogeneic hematopoietic cell transplantation (HCT) was dismal, with fewer than 10% surviving long-term (Fielding et al Blood 2007). In the last five years, the availability of targeted immunotherapies including blinatumomab (blin), inotuzumab ozogamicin (IO), and chimeric antigen T-cell receptor (CART) therapy has expanded the opportunity for effective salvage of relapsed/refractory ALL. We hypothesized that the expanding therapeutic landscape has resulted in superior survival following post-HCT relapse in adult ALL in the targeted immunotherapy era. Methods: We performed a retrospective analysis of adults receiving first allogeneic HCT for ALL between 2008-2019 at Stanford University; patients were stratified by time period of HCT: 2008-2013 (earlier era) vs 2014-2019 (recent immunotherapy era). Descriptive statistics characterized the study cohort; chi-square test was used to evaluate differences in characteristics and treatments based on time period transplanted. Kaplan Meier method was used to determine overall survival (OS); log-rank tested significance between time periods. Follow-up time of the earlier time period was truncated to 5.4 years to match maximum follow-up time of the more recent time period. Results: Of the 285 adult ALL patients transplanted (N=119, 2008-2013; N=166, 2014-2019), 81 (28%) experienced disease relapse following HCT and represent the analytic cohort. Post-HCT relapse occurred in 39 (33%) transplanted between 2008-2013 and 42 (25%) transplanted between 2014-2019. The median time to relapse following HCT was 7.72 months (95% CI, 3.88-14.0), and did not significantly differ between time periods. Baseline patient and transplant characteristics were similar across the two time periods (Table 1); however, relative to the earlier time period, patients transplanted during the more recent time period were less likely to be transplanted with active disease (26% vs 2%), and more likely to receive cord blood as a stem cell source (0 vs 10%). The median overall survival (OS) for the entire cohort following post-HCT relapse was 9.93 months (95% CI, 7.07-12.73). However, the median OS from relapse was 7.99 months (95% CI, 3.30-11.6) for patients transplanted in the earlier era, while the median OS for patients relapsing in the recent era was 15.75 months (95% CI, 9.24-26.4), P<0.0001 (Figure 1A). Relative to the earlier era, the use of novel therapies for relapse following HCT increased markedly (44% vs 3%), while the use of traditional chemotherapy dropped (70% vs 38%), P<0.001 across therapies during the two time periods based on year of relapse (Figure 1B). Of the novel therapies administered, blin, IO, and CART were used with descending frequency (64%, 41%, 36%, respectively), and 8 patients received at least two novel therapies after relapse. The frequency of patients receiving no therapy for relapse decreased in the more recent time period (18% vs 10%). Donor lymphocyte infusion (DLI) was administered infrequently during both the early (6%) and more recent time periods (2%), and only two patients in the entire study cohort received a second HCT after relapse. Conclusion: In this large cohort of adults transplanted for ALL over the last decade, we show that the OS of ALL patients relapsing after HCT has significantly improved, coinciding with a substantial increase in the availability and utilization of novel therapies in this setting. Additional studies are needed to understand the optimal therapeutic intervention for post-HCT relapse in adult ALL. Disclosures Meyer: Orca Bio: Research Funding. Miklos:Adaptive Biotech: Consultancy, Other: Travel support, Research Funding; Kite-Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel support, Research Funding; Juno-Celgene-Bristol-Myers Squibb: Consultancy, Other: Travel support, Research Funding; Allogene Therapeutics Inc.: Research Funding; Novartis: Consultancy, Other: Travel support, Research Funding; Pharmacyclics: Consultancy, Other: Travel support, Patents & Royalties, Research Funding; Janssen: Consultancy, Other: Travel support; Miltenyi Biotec: Research Funding. Negrin:UpToDate: Honoraria; Biosource: Current equity holder in private company; Amgen: Consultancy; BioEclipse Therapeutics: Current equity holder in private company; Magenta Therapeutics: Consultancy, Current equity holder in publicly-traded company; KUUR Therapeutics: Consultancy. Rezvani:Pharmacyclics: Research Funding. Shizuru:Jasper Therapeutics, Inc: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees. Sidana:Janssen: Consultancy. Shiraz:ORCA BioSystems: Research Funding; Kite, a Gilead Company: Research Funding. Muffly:Amgen: Consultancy; Adaptive: Research Funding; Servier: Research Funding.

scholarly journals Recent advances in psychological therapies for eating disorders

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 702 ◽  
Author(s):  
Glenn Waller
Keyword(s):  
Eating Disorders ◽  
Evidence Base ◽  
Behavioural Therapy ◽  
Psychological Therapies ◽  
Time Period ◽  
Cognitive Behavioural ◽  
Novel Approaches ◽  
Family Based Treatment ◽  
Family Based ◽  
Further Development

Recent years have seen substantial consolidation and development of the evidence base for psychological therapies for eating disorders. This review summarises the key changes over that time period. Specific forms of cognitive behavioural therapy and family-based treatment have consolidated and extended their positions as treatments of choice despite the development of novel approaches. However, there is still a significant need for further development and testing to improve recovery rates, particularly in anorexia nervosa.

Daring discourse: should the ESP block be renamed RIP II block?

2020 ◽  
Vol 46 (1) ◽  
pp. 57-60 ◽  
Author(s):  
PA Lonnqvist ◽  
Manoj Kumar Karmakar ◽  
Jonathan Richardson ◽  
Bernhard Moriggl
Keyword(s):  
Nerve Block ◽  
Meta Analysis ◽  
Analysis Data ◽  
Evidence Base ◽  
Erector Spinae ◽  
Turn Of The Millennium ◽  
Nerve Blockade ◽  
Erector Spinae Plane Block ◽  
Time Period ◽  
Regional Anesthetic

During the time period 1984 to the turn of the millennium, interpleural nerve blockade was touted as a very useful regional anesthetic nerve blockade for most procedures or conditions that involved the trunk and was widely practiced despite the lack of proper evidence-based support. However, as an adequate evidence base developed, the interest for this type of nerve block dwindled and very few centers currently use it—thereby to us representing the rest in peace (RIP) I block. Unfortunately, we get a deja-vù sensation when we observe the current fascination with the erector spinae plane block (ESPB), which since 2019 has generated as many as 98 PubMed items. This daring discourse point out the lack of a proper evidence base of the ESPB compared with other established nerve blocking techniques as well as the lack of a proven mechanism of action that explains how this nerve block technique can be effective regarding surgical procedures performed on the front of the trunk. Emerging meta-analysis data also raise concern and give cause to healthy skepticism regarding the use of ESPB for major thoracic or abdominal surgery. Against this background, we foresee that ESPB (and variations on this theme) will end up in a similar fashion as interpleural nerve blockade, thereby soon to be renamed the RIP II block.

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