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Matza L.S.,Evidera Inc. | Margolis M.K.,Patient-Centered Outcomes Research Institute | Deal L.S.,Pfizer | Farrand K.F.,Shire Pharmaceuticals | Erder M.H.,Shire Pharmaceuticals
Value in Health | Year: 2017

Background: Informant-reported outcome measures, usually completed by parents, are often administered in pediatric clinical trials with the intention of collecting data to support claims in a medical product label. Recently, there has been an emphasis on limiting these measures to observable content, as recommended in the US Food and Drug Administration guidance on patient-reported outcomes. This qualitative study explores the concept of observability using the example of childhood attention deficit/hyperactivity disorder (ADHD). Methods: Concept elicitation interviews were conducted with children (aged 6-12 years) diagnosed with ADHD and parents of children with ADHD to identify concepts for a potential parent-reported measure of functional impact of childhood ADHD. The observability of each concept was considered. Results: Of the 30 parents (90% females; mean age = 42.0 years), 24 had a child who was also interviewed (87.5% males; mean age = 9.6 years). Areas of functional impact reported by parents and/or children included the following: 1) functioning within the home/family, 2) academic performance, 3) school behavior, 4) social functioning, 5) emotional functioning, and 6) decreased self-efficacy. Parents cited many examples of direct observation at home, but opportunities for observation of some important areas of impact (e.g., school behavior and peer relationships) were limited. Conclusions: Findings illustrate the substantial functional impairment associated with childhood ADHD while highlighting the challenges of developing informant-reported outcome measures limited to observable content. Because ADHD has an impact on children's functioning in a wide range of contexts, a parent-report measure that includes only observable content may fail to capture important aspects of functional impairment. Approaches for addressing this observability challenge are discussed. © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced the creation of a dedicated unit combining its medical affairs research operations (MARO) team and Evidera, the provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. PPD acquired Evidera last year, uniting two best-in-class research companies to create transformative opportunities for biopharmaceutical clients. The new dedicated unit, retaining the Evidera name, will provide customers with global comprehensive and integrated solutions, including modeling and simulation, interventional studies (including expanded access/compassionate use and extended access), observational studies (including registries), health economics, outcomes research, market access, epidemiology, real-world evidence, safety and risk management. “Our clients are seeking better evidence to satisfy the requirements of both regulators and payers, and we have a tremendous opportunity to meet that need by delivering real-world evidence that bridges the gaps between efficacy, safety and value,” said William Sharbaugh, chief operating officer of PPD. “Through this new business unit we will be able to help our clients seamlessly integrate and align regulatory and peri- and post-approval research efforts, improving their ability to meet the evidence demands of both regulators and payers.” The new business unit will retain the executive and scientific leadership of both the Evidera and MARO organizations. Jon Williams, who has served as president and CEO of Evidera since 2013, will lead the new unit. “Bringing together Evidera’s scientific and consulting expertise with PPD’s global operations infrastructure creates an unparalleled ability to partner with and serve our clients in optimizing their product value and market access,” Williams said. Experts from the new unit will be present at the annual meetings of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Boston in May, and the Drug Information Association (DIA) in Chicago in June, where they will contribute more than 50 research presentations, posters, short courses and other research activities. PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com. Any statements made in this news release that are not statements of historical fact, including statements about the combination of PPD’s medical affairs research operations and Evidera, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements. Additional factors that might materially affect the forward-looking statements include, but are not limited to: the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to recruit, retain and motivate key personnel; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors. PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.


Eremenco S.,Evidera Inc. | Coons S.J.,Critical Path Institute | Paty J.,Quintiles | Coyne K.,Evidera Inc. | Bennett A.V.,University of North Carolina at Chapel Hill
Value in Health | Year: 2014

The objective of this report was to address the use and mixing of data collection modes within and between trials in which patient-reported outcome (PRO) end points are intended to be used to support medical product labeling. The report first addresses the factors that should be considered when selecting a mode or modes of PRO data collection in a clinical trial, which is often when mixing is first considered. Next, a summary of how to "faithfully" migrate instruments is presented followed by a section on qualitative and quantitative study designs used to evaluate measurement equivalence of the new and original modes of data collection. Finally, the report discusses a number of issues that must be taken into account when mixing modes is deemed necessary or unavoidable within or between trials, including considerations of the risk of mixing at different levels within a clinical trial program and mixing between different types of platforms. In the absence of documented evidence of measurement equivalence, it is strongly recommended that a quantitative equivalence study be conducted before mixing modes in a trial to ensure that sufficient equivalence can be demonstrated to have confidence in pooling PRO data collected by the different modes. However, we also strongly discourage the mixing of paper and electronic field-based instruments and suggest that mixing of electronic modes be considered for clinical trials and only after equivalence has been established. If proceeding with mixing modes, it is important to implement data collection carefully in the trial itself in a planned manner at the country level or higher and minimize ad hoc mixing by sites or individual subjects. Finally, when mixing occurs, it must be addressed in the statistical analysis plan for the trial and the ability to pool the data must be evaluated to then evaluate treatment effects with mixed modes data. A successful mixed modes trial requires a "faithful migration," measurement equivalence established between modes, and carefully planned implementation to minimize the risk of increased measurement error impacting the power of the trial to detect a treatment effect. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Schuetz C.A.,Evidera inc | Ong S.H.,Novartis | Bluher M.,University of Leipzig
ClinicoEconomics and Outcomes Research | Year: 2015

Introduction: Dipeptidyl peptidase-4 (DPP-4) inhibitors are a class of oral antidiabetic agents for the treatment of type 2 diabetes mellitus, which lower blood glucose without causing severe hypoglycemia. However, the frst cardiovascular (CV) safety trials have only recently reported their results, and our understanding of these therapies remains incomplete. Using clinical trial simulations, we estimated the effectiveness of DPP-4 inhibitors in preventing major adverse cardiovascular events (MACE) in a population like that enrolled in the SAVOR-TIMI (the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction) 53 trial. Methods: We used the Archimedes Model to simulate a clinical trial of individuals (N=11,000) with diagnosed type 2 diabetes and elevated CV risk, based on established disease or multiple risk factors. The DPP-4 class was modeled with a meta-analysis of HbA1c and weight change, pooling results from published trials of alogliptin, linagliptin, saxagliptin, sitagliptin, and vildagliptin. The study treatments were added-on to standard care, and outcomes were tracked for 20 years. Results: The DPP-4 class was associated with an HbA1c drop of 0.66% (0.71%, 0.62%) and a weight drop of 0.14 (-0.07, 0.36) kg. These biomarker improvements produced a relative risk (RR) for MACE at 5 years of 0.977 (0.968, 0.986). The number needed to treat to prevent one occurrence of MACE at 5 years was 327 (233, 550) in the elevated CV risk population. Conclusion: Consistent with recent trial publications, our analysis indicates that DPP-4 inhibitors do not increase the risk of MACE relative to the standard of care. This study provides insights about the long-term benefts of DPP-4 inhibitors and supports the interpretation of the published CV safety trial results. © 2015 Schuetz et al.


Abogunrin S.,Evidera Inc. | Di Tanna G.L.,Statistical Advisor to Evidera Inc. | Keeping S.,Sanofi S.A. | Carroll S.,Sanofi S.A. | Iheanacho I.,Evidera Inc.
BMC Cancer | Year: 2014

Background: Infection with human papillomavirus (HPV) is necessary for the development of cervical carcinoma. By contrast, the role of HPV in the pathogenesis of other malignancies, such as head and neck cancers, is less well characterised. This study aimed to address key information gaps by conducting a systematic review and meta-analysis of the prevalence of HPV infection in head and neck cancers, focusing on data for European populations. Methods: MEDLINE, Embase and grey literature sources were systematically searched for primary studies that were published in English between July 2002 and July 2012, and which reported on the prevalence of HPV infection in head and neck cancers in European populations. Studies on non-European populations, those not published in English, and those assessing patients co-infected with human immunodeficiency virus were excluded. Eligible studies were combined in a meta-analysis. In addition, the potential statistical association between the head and neck cancers and certain HPV types was investigated. Results: Thirty-nine publications met the inclusion criteria. The prevalence of HPV of any type in 3,649 patients with head and neck cancers was 40.0% (95% confidence interval, 34.6% to 45.5%), and was highest in tonsillar cancer (66.4%) and lowest in pharyngeal (15.3%) and tongue (25.7%) cancers. There were no statistically significant associations between the HPV types analysed and the geographical setting, type of sample analysed or type of primer used to analyse samples in head and neck cancers. Conclusions: The prevalence of HPV infection in European patients with head and neck cancers is high but varies between the different anatomical sites of these malignancies. There appears to be no association between HPV type and geographical setting, type of samples analysed or type of primer used to analyse samples in such cancers. © 2014 Abogunrin et al.


PubMed | University of Bristol, Evidera Inc. and Guideline
Type: Journal Article | Journal: Systematic reviews | Year: 2016

As more complex meta-analytical techniques such as network and multivariate meta-analyses become increasingly common, further pressures are placed on reviewers to extract data in a systematic and consistent manner. Failing to do this appropriately wastes time, resources and jeopardises accuracy. This guide (data extraction for complex meta-analysis (DECiMAL)) suggests a number of points to consider when collecting data, primarily aimed at systematic reviewers preparing data for meta-analysis. Network meta-analysis (NMA), multiple outcomes analysis and analysis combining different types of data are considered in a manner that can be useful across a range of data collection programmes. The guide has been shown to be both easy to learn and useful in a small pilot study.


Trademark
Evidera Inc. | Date: 2014-01-03

Printed reports featuring medical research and surveys and assessments in the field of medicine and clinical trials. Medical research.


Trademark
Evidera Inc. | Date: 2016-09-07

Books in the field of the healthcare industry; Magazines in the field of the healthcare industry; Printed reports featuring news, information and commentary in the field of the healthcare industry. Providing on-line publications in the nature of e-books in the field of the healthcare industry; Providing on-line publications in the nature of books, magazines, newsletters and reports in the field of the healthcare industry; Providing on-line newsletters in the field of the healthcare industry; Providing on-line publications in the nature of e-books in the field of the healthcare industry; Providing online newsletters in the field of the healthcare industry via e-mail.


Trademark
Evidera Inc. | Date: 2015-07-17

Computer software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields. Providing temporary use of web-based software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields.


Trademark
Evidera Inc. | Date: 2015-07-17

Computer software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; computer software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields. Providing temporary use of web-based software for managing, accessing, and sharing information and data in the healthcare and life sciences fields, namely, information and data in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software featuring predictive analytics in the healthcare and life sciences fields, namely, predictive analytics in the fields of health economics, outcomes research, epidemiological studies, payer research, and market access; providing temporary use of web-based software for managing, accessing and sharing information and data in the fields of performance metrics, data visualizations, and predictive analytics in the healthcare and life sciences fields.

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