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Journal of Clinical Trails Market Analysis Advances in Clinical Research and Clinical Trials 2020
Journal of Clinical Trails Market Analysis Advances in Clinical Research and Clinical Trials 2020 Raymond Chong The research report on Global Clinical Trials Market 2019 Other prominent players in the value chain include Mednet keenly analyzes significant features of the industry. The Solutions, Arisglobal, eClinForce Inc., DZS Software Solutions, DSG, analysis servers market size, latest trends, drivers, threats, Inc., Guger Technologies Inc., ICON, Plc., ChemWare Inc., and opportunities, as well as key market segments. It is based on iWeb Technologies Limited. past data and present market needs. Also, involve distinct business approaches accepted by the decision makers. Those intensify growth and make a remarkable stand in the industry. The Clinical Trials market will grow with a significant CAGR between 2019 to 2028. The report segregates the complete market on the basis of key players, geographical areas, and segments. Increasing demand for new medical equipments and medicines among end users, coupled with growing investment for research and development activities for development of effective medicines are major factors driving growth of the global clinical trials market. In addition, increasing number of individuals suffering from chronic diseases as well as changing The clinical trials market is projected to arrive at USD 1.76 conditions and nature of certain types of chronic diseases is billion by 2025, from USD 1.04 billion in 2017 growing at a another factor anticipated to support growth of the global CAGR of 6.7 percent from 2018 to 2025. An upcoming clinical trials market to significant extent. market report contains data for historic year 2016, and the base year of calculation is 2017. -
Using a Study on Arsenic Ingestion and Bladder Cancer As an Example How-Ran Guo1,2,3
Guo BMC Public Health 2011, 11:820 http://www.biomedcentral.com/1471-2458/11/820 RESEARCHARTICLE Open Access Age adjustment in ecological studies: using a study on arsenic ingestion and bladder cancer as an example How-Ran Guo1,2,3 Abstract Background: Despite its limitations, ecological study design is widely applied in epidemiology. In most cases, adjustment for age is necessary, but different methods may lead to different conclusions. To compare three methods of age adjustment, a study on the associations between arsenic in drinking water and incidence of bladder cancer in 243 townships in Taiwan was used as an example. Methods: A total of 3068 cases of bladder cancer, including 2276 men and 792 women, were identified during a ten-year study period in the study townships. Three methods were applied to analyze the same data set on the ten-year study period. The first (Direct Method) applied direct standardization to obtain standardized incidence rate and then used it as the dependent variable in the regression analysis. The second (Indirect Method) applied indirect standardization to obtain standardized incidence ratio and then used it as the dependent variable in the regression analysis instead. The third (Variable Method) used proportions of residents in different age groups as a part of the independent variables in the multiple regression models. Results: All three methods showed a statistically significant positive association between arsenic exposure above 0.64 mg/L and incidence of bladder cancer in men and women, but different results were observed for the other exposure categories. In addition, the risk estimates obtained by different methods for the same exposure category were all different. -
Experimental Evidence During a Global Pandemic
Original research BMJ Glob Health: first published as 10.1136/bmjgh-2020-004222 on 23 October 2020. Downloaded from Is health politically irrelevant? Experimental evidence during a global pandemic Arnab Acharya,1 John Gerring,2 Aaron Reeves3 To cite: Acharya A, Gerring J, ABSTRACT Key questions Reeves A. Is health politically Objective To investigate how health issues affect voting irrelevant? Experimental behaviour by considering the COVID-19 pandemic, which What is already known? evidence during a global offers a unique opportunity to examine this interplay. pandemic. BMJ Global Health Political leaders in democracies are sensitive to cues Design We employ a survey experiment in which ► 2020;5:e004222. doi:10.1136/ from the electorate and are less likely to implement treatment groups are exposed to key facts about the bmjgh-2020-004222 unpopular policies. pandemic, followed by questions intended to elicit attitudes Electoral accountability is not automatic, however, toward the incumbent party and government responsibility ► Additional material is and it only exists if citizens connect specific policies ► for the pandemic. published online only. To view, to politicians and vote accordingly. Setting The survey was conducted amid the lockdown please visit the journal online ► We know little about how public health attitudes af- period of 15–26 April 2020 in three large democratic (http:// dx. doi. org/ 10. 1136/ fect voting intention or behaviour. bmjgh- 2020- 004222). countries with the common governing language of English: India, the United Kingdom and the United States. Due What are the new findings? to limitations on travel and recruitment, subjects were ► The majority of our respondents believe health is an Received 15 October 2020 recruited through the M-T urk internet platform and the important policy area and that government has some Accepted 16 October 2020 survey was administered entirely online. -
A Beginner's Guide to Conducting Reproducible Research
1 A Beginner’s Guide to Conducting Reproducible 2 Research 1,2 1,3 3 Jesse M. Alston and Jessica A. Rick 1 4 Program in Ecology, University of Wyoming, 1000 E University Dr., Laramie, WY 82072 USA 2 5 Department of Zoology and Physiology, University of Wyoming, 1000 E University Dr., Laramie, WY 6 82072 USA 3 7 Department of Botany, University of Wyoming, 1000 E University Dr., Laramie, WY 82072 USA 1 8 Abstract 9 Reproducible research is widely acknowledged as an important tool for improving science and 10 reducing harm from the “replication crisis”, yet research in most fields within biology remains 11 largely irreproducible. In this article, we make the case for why all research should be 12 reproducible, explain why research is often not reproducible, and offer a simple framework that 13 researchers can use to make their research more reproducible. Researchers can increase the 14 reproducibility of their work by improving data management practices, writing more readable 15 code, and increasing use of the many available platforms for sharing data and code. While 16 reproducible research is often associated with a set of advanced tools for sharing data and code, 17 reproducibility is just as much about maintaining work habits that are already widely 18 acknowledged as best practices for research. Increasing reproducibility will increase rigor, 19 trustworthiness, and transparency while benefiting both practitioners of reproducible research and 20 their fellow researchers. 21 Key words: data management, data repository, software, open science, replication 22 Introduction 23 Replication is a fundamental tenet of science, but there is increasing fear among scientists that too 24 few scientific studies can be replicated. -
A Randomized Control Trial Evaluating the Effects of Police Body-Worn
A randomized control trial evaluating the effects of police body-worn cameras David Yokuma,b,1,2, Anita Ravishankara,c,d,1, and Alexander Coppocke,1 aThe Lab @ DC, Office of the City Administrator, Executive Office of the Mayor, Washington, DC 20004; bThe Policy Lab, Brown University, Providence, RI 02912; cExecutive Office of the Chief of Police, Metropolitan Police Department, Washington, DC 20024; dPublic Policy and Political Science Joint PhD Program, University of Michigan, Ann Arbor, MI 48109; and eDepartment of Political Science, Yale University, New Haven, CT 06511 Edited by Susan A. Murphy, Harvard University, Cambridge, MA, and approved March 21, 2019 (received for review August 28, 2018) Police body-worn cameras (BWCs) have been widely promoted as The existing evidence on whether BWCs have the anticipated a technological mechanism to improve policing and the perceived effects on policing outcomes remains relatively limited (17–19). legitimacy of police and legal institutions, yet evidence of their Several observational studies have evaluated BWCs by compar- effectiveness is limited. To estimate the effects of BWCs, we con- ing the behavior of officers before and after the introduction of ducted a randomized controlled trial involving 2,224 Metropolitan BWCs into the police department (20, 21). Other studies com- Police Department officers in Washington, DC. Here we show pared officers who happened to wear BWCs to those without (15, that BWCs have very small and statistically insignificant effects 22, 23). The causal inferences drawn in those studies depend on on police use of force and civilian complaints, as well as other strong assumptions about whether, after statistical adjustments policing activities and judicial outcomes. -
Why Replications Do Not Fix the Reproducibility Crisis: a Model And
1 63 2 Why Replications Do Not Fix the Reproducibility 64 3 65 4 Crisis: A Model and Evidence from a Large-Scale 66 5 67 6 Vignette Experiment 68 7 69 8 Adam J. Berinskya,1, James N. Druckmanb,1, and Teppei Yamamotoa,1,2 70 9 71 a b 10 Department of Political Science, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, MA 02139; Department of Political Science, Northwestern 72 University, 601 University Place, Evanston, IL 60208 11 73 12 This manuscript was compiled on January 9, 2018 74 13 75 14 There has recently been a dramatic increase in concern about collective “file drawer” (4). When publication decisions depend 76 15 whether “most published research findings are false” (Ioannidis on factors beyond research quality, the emergent scientific 77 16 2005). While the extent to which this is true in different disciplines re- consensus may be skewed. Encouraging replication seems to 78 17 mains debated, less contested is the presence of “publication bias,” be one way to correct a biased record of published research 79 18 which occurs when publication decisions depend on factors beyond resulting from this file drawer problem (5–7). Yet, in the 80 19 research quality, most notably the statistical significance of an ef- current landscape, one must also consider potential publication 81 20 fect. Evidence of this “file drawer problem” and related phenom- biases at the replication stage. While this was not an issue 82 21 ena across fields abounds, suggesting that an emergent scientific for OSC since they relied on over 250 scholars to replicate the 83 22 consensus may represent false positives. -
Coffee Consumption and Its Inverse Relationship with Gastric
nutrients Communication Coffee Consumption and Its Inverse Relationship with Gastric Cancer: An Ecological Study Luis G. Parra-Lara 1 , Diana M. Mendoza-Urbano 2 , Juan C. Bravo 3, Constain H. Salamanca 4 and Ángela R. Zambrano 5,* 1 Facultad de Ciencias de la Salud, Universidad Icesi, Cali 760032, Valle del Cauca, Colombia; [email protected] 2 Centro de Investigaciones Clínicas (CIC), Fundación Valle del Lili, Cali 760032, Valle del Cauca, Colombia; [email protected] 3 Department of Pathology, Fundación Valle del Lili, Cali 760032, Valle del Cauca, Colombia; [email protected] 4 Laboratorio de Diseño y Formulación de Producto, Departamento de Ciencias Farmacéuticas, Facultad de Ciencias Naturales, Universidad Icesi, Cali 760032, Valle del Cauca, Colombia; [email protected] 5 Department of Hemato-Oncology, Fundación Valle del Lili, Cali 760032, Valle del Cauca, Colombia * Correspondence: [email protected]; Tel.: +57-314-888-39-72 Received: 3 August 2020; Accepted: 21 September 2020; Published: 2 October 2020 Abstract: Coffee is the second most popular drink worldwide, and it has various components with antioxidant and antitumor properties. Due to its chemical composition, it could act as an antitumor substance in the gastrointestinal tract. The objective of this study was to explore the relationship between coffee consumption and the incidence/mortality of stomach cancer in the highest-consuming countries. An ecological study using Spearman’s correlation coefficient was performed. The WorldAtlas’s dataset of coffee consumption and the incidence/mortality rates database of the International Agency for Research were used as sources of information. A total of 25 countries were entered to the study. -
The Financing of Drug Trials by Pharmaceutical Companies and Its
MEDICINE ORIGINAL ARTICLE The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences Part 1: A Qualitative, Systematic Review of the Literature on Possible Influences on the Findings, Protocols, and Quality of Drug Trials Gisela Schott, Henry Pachl, Ulrich Limbach, Ursula Gundert-Remy, Wolf-Dieter Ludwig*, Klaus Lieb* Arzneimittelkommis - SUMMARY linical drug trials funded by pharmaceutical sion der deutschen companies yield favorable results for the spon- Ärzteschaft, Berlin: Background: In recent years, a number of studies have C Dr. med. Schott, sor’s products more often than independent trials do. Dipl.-Biol. Pachl, shown that clinical drug trials financed by pharmaceutical This has been demonstrated by a number of studies in Prof. Dr. med. companies yield favorable results for company products recent years (1–4). Various ways have been described Gundert-Remy, more often than independent trials do. Moreover, Prof. Dr. med. Ludwig in which pharmaceutical concerns exert influence on pharmaceutical companies have been found to Klinik für Hämatologie, the protocol and conduct of drug trials, as well as on influence drug trials in various ways. This paper Onkologie und the interpretation and publication of their results (1, 3, Tumorimmunologie, provides an overview of the findings of current, 5, 6). HELIOS Klinikum systematic studies on this topic. Berlin-Buch: Two important reviews on this topic were published Prof. Dr. med. Ludwig Methods: Publications retrieved from a systematic in 2003 (7, 8): Klinik für Psychiatrie Medline search on this topic from 1 November 2002 to und Psychotherapie, Bekelman et al. carried out a quantitative analysis Universitätsmedizin 16 December 2009 were independently evaluated and of 37 studies to investigate the extent and the Mainz: selected by two of the authors. -
Supreme Court of the United States ______
No. 15-1525 IN THE Supreme Court of the United States ____________________ SERGEANTS BENEVOLENT ASSOCIATION HEALTH AND WELFARE FUND, NEW ENGLAND CARPENTERS HEALTH BENEFITS FUND, ALLIED SERVICES DIVISION WELFARE FUND, Petitioners, v. SANOFI-AVENTIS U.S. LLP., SANOFI-AVENTIS U.S., INC. Respondents. ____________________ On Petition for a Writ of Certiorari to the United States Court of Appeals for the Second Circuit ____________________ BRIEF OF AARP, AARP FOUNDATION, COMMUNITY CATALYST, AND PUBLIC CITIZEN, INC. AS AMICI CURIAE IN SUPPORT OF PETITIONERS ____________________ Julie Nepveu Jason L. Lichtman AARP FOUNDATION Counsel of Record LITIGATION LIEFF CABRASER HEIMANN 601 E Street NW & BERNSTEIN, LLP Washington, DC 20049 250 Hudson Street, 8th Floor New York, NY 10013 Andrew R. Kaufman (212) 355-9500 LIEFF CABRASER HEIMANN [email protected] & BERNSTEIN, LLP 150 Fourth Ave N., Suite 1650 Nashville, TN 37219 i TABLE OF CONTENTS Page STATEMENT OF INTEREST................................... 1 SUMMARY OF THE ARGUMENT........................... 2 ARGUMENT .............................................................. 3 I. PHARMACEUTICAL MANUFACTURERS AGGRESSIVELY MARKET TO DOCTORS TO BOLSTER SALES................................................... 3 II. PHARMACEUTICAL MARKETING IS FREQUENTLY MISLEADING. ..................................... 6 A. Unlawful promotion of drugs is commonplace................ 7 B. The use of biased clinical studies as marketing tools is highly misleading and corrupts the information process doctors rely upon to -
Overview of Epidemiological Study Designs
University of Massachusetts Medical School eScholarship@UMMS PEER Liberia Project UMass Medical School Collaborations in Liberia 2018-11 Overview of Epidemiological Study Designs Richard Ssekitoleko Yale University Let us know how access to this document benefits ou.y Follow this and additional works at: https://escholarship.umassmed.edu/liberia_peer Part of the Clinical Epidemiology Commons, Epidemiology Commons, Family Medicine Commons, Infectious Disease Commons, Medical Education Commons, and the Quantitative, Qualitative, Comparative, and Historical Methodologies Commons Repository Citation Ssekitoleko R. (2018). Overview of Epidemiological Study Designs. PEER Liberia Project. https://doi.org/ 10.13028/fp3z-mv12. Retrieved from https://escholarship.umassmed.edu/liberia_peer/5 This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in PEER Liberia Project by an authorized administrator of eScholarship@UMMS. For more information, please contact [email protected]. Overview of Epidemiological study Designs Richard Ssekitoleko Department of Global Health Yale University 1.1 Objectives • Understand the different epidemiological study types • Get to know what is involved in each type of study • Understand the strengths and Limitations of each study type Key terms • Population • Consists of all elements and is the group from which a sample is drawn • A sample is a subset of a population • Parameters • Summary data from a population • Statistics • Summary data from a sample • Validity • Extent to which a conclusion or statistic is well-founded and likely corresponds accurately to the parameter. Hierarchy of Evidence Study type Observational Interventional Descriptive Experiment Ecological Randomized Controlled Trial Cross-sectional Case-control Cohort Overview of Epidemiologic Study Designs Validity *anecdotes Cost Understanding What Physicians Mean: In my experience … once. -
Is This a Seeding Trial? by Mark Hochhauser
Vol. 5, No. 6, June 2009 “Can You Handle the Truth?” Is this a Seeding Trial? By Mark Hochhauser Seeding trials are clinical studies primarily intended to promote use of the study drug by physicians and/or to convert physicians, especially opinion leaders — and study subjects — into advocates for the study drug. Seeding trials seed the market with product samples. The sponsor hopes that physicians and patients will continue using the drug after the trial. Seeding trials are unethical because they exploit study subjects for commercial purposes, create little or no medically useful knowledge, and deceive researchers, subjects and IRBs. In the interest of protecting human welfare, institutional review boards (IRBs) should not approve seeding trials. A seeding trial can occur only because the sponsor “does not disclose its true purpose to anyone who could say ‘no.’” 1 (p. 279) The question for the IRB thus becomes: Is the study under review a seeding trial? Inexperienced investigators and IRB members may not be familiar with the characteristics of seeding trials. Table 1 summarizes the six seeding trial criteria of Kessler, et al2 and six additional criteria of Sox and Rennie1. These researchers suggested that clinical trials sharing one or more of these flaws might be seeding trials, although some information may be difficult or impossible for the IRB to obtain. With the criteria in Table 1, IRBs can identify most seeding studies. Case Study Our IRB reviewed a Phase IIIb rollover trial (“Study A”) using subjects from a Phase III study. Phase III trials are large, multicenter, randomized controlled trials designed to evaluate a drug’s effectiveness in comparison to the standard treatment. -
Which Findings Should Be Published?∗
Which findings should be published?∗ Alexander Frankel† Maximilian Kasy‡ December 5, 2020 Abstract Given a scarcity of journal space, what is the optimal rule for whether an empirical finding should be published? Suppose publications inform the public about a policy-relevant state. Then journals should publish extreme results, meaning ones that move beliefs sufficiently. This optimal rule may take the form of a one- or a two-sided test comparing a point estimate to the prior mean, with critical values determined by a cost-benefit analysis. Consideration of future studies may additionally justify the publication of precise null results. If one insists that standard inference remain valid, however, publication must not select on the study’s findings. Keywords: Publication bias, mechanism design, value of information JEL Codes: C44, D80, D83 1 Introduction Not all empirical findings get published. Journals may be more likely to publish findings that are statistically significant, as documented for instance by Franco et al. (2014), Brodeur et al. (2016), and Andrews and Kasy (2019). They may also be more likely to publish findings that are surprising, or conversely ones that confirm some prior belief. Whatever its form, selective publication distorts statistical inference. If only estimates with large effect sizes were to be written up and published, say, then ∗We thank Isaiah Andrews, Victoria Baranov, Ben Brooks, Gary Chamberlain, Zoe Hitzig, Emir Kamenica, Matthew Notowidigdo, Jesse Shapiro, and Glen Weyl for helpful discussions and com- ments. †University of Chicago Booth School of Business. Address: 5807 South Woodlawn Avenue Chicago, IL 60637. E-Mail: [email protected]. ‡Department of Economics, Oxford University.