News Article | June 19, 2017
"Mapi has been the industry innovator and leader in Patient Centered Research longer than most CROs have existed " said Will Maier, Chief Scientific Officer of Mapi. "Through this new business unit we help our clients seamlessly integrate and align Patient Centered Sciences; developing the most complete understanding of patients, their behaviour and preferences, integrating relevant Clinical Outcomes to support endpoints and value based treatment, as well as execute on these combined insights with the industry's most experienced Direct to Patient Contact experts. Mapi is considered the regulatory and peri- and post-approval research experts, enabling our clients to meet the evidence demands of both regulators and payers for over four decades." Experts from the new unit will be presenting at the annual June meeting of the Drug Information Association (DIA) in Chicago. About Mapi: Patients are at the heart of our research Mapi Group has over 40 years of experience supporting Life-Science companies in developing and implementing strategies for commercializing novel treatments through Strategic Regulatory Services, Pharmacovigilance, Market Access, Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologics, and Medical Devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics. Visit http://www.mapigroup.com for more information. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mapi-creates-dedicated-patient-centered-sciences-unit-by-combining-patient-centered-outcomes-patient-insights-and-engagement-and-direct-to-patient-contact-services-300475033.html
News Article | June 2, 2017
LYON, France, June 2, 2017 /PRNewswire/ -- Mapi Research Trust, the leading curator and license distributor of Clinical Outcome Assessments (COAs) and Mapi Language Services, the most trusted provider of linguistic validation of COAs, will present three posters at the 21st International...
News Article | July 10, 2017
Register and learn more about Bridge the gap – SYNGAP, Syngap1 and the progress of the recent global registry click here The incidence of SYNGAP1 mutations reported are 1-4/10,000 individuals or approximately 1-2% of all cases of ID. A mutation in the SYNGAP1 gene results in non-syndromic intellectual disability in children ranging from mild to severe with attention deficits, impulsivity, and/or mood disorders. Seventy to eighty percent of children with SYNGAP1 also have some type of epilepsy. "We are eager to talk with Monica Weldon and learn more of the challenges Rare Disease advocacy and driving research collaborations from the patient and care giver perspective in SYNGAP1," Commented Elan Josielewski, Mapi's VP of Strategy and Global Marketing. "Rare disease research comes with unique complexities that can delay or prevent valuable treatments from reaching patients. Engaging and working with Advocacy groups such as Bridge the Gap is critical to advancing research to improve the lives of children and their caregivers. Mapi is honored to host this webinar with Monica and promote all the amazing work she and the Bridge the gap team brings to life." About Mapi: Patients are at the heart of everything we do™ Mapi Group has over 40 years of experience supporting Life-Science companies in developing and implementing strategies for commercializing novel treatments through Strategic Regulatory Services, Pharmacovigilance, Market Access, Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologicals, and Medical Devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics. Visit http://www.mapigroup.com for more information About Bridge the Gap – SYNGAP Education and Research Foundation Bridge the Gap – SYNGAP Education and Research Foundation 501(c)(3) is a non-profit organization whose mission is to serve, educate and fund research for families coping with the effects of SYNGAP1 mutations. Most children benefit from occupational, physical and speech therapy emphasizing that early diagnosis and developmental intervention is important to ensure that affected children reach their full potential. Currently there are no treatments as researchers and clinicians are still trying to understand the biology of the disease. Our international outreach for SYNGAP1 children gathers critical information, which is needed to drive research towards more immediate therapeutic solutions. Our mission is to improve the quality of life for people affected by SYNGAP1 and provide family support, accelerating research and raising awareness. Every child with SYNGAP1 provides information that can guides us to a cure.
News Article | July 7, 2017
The Disease Activity Score (DAS-28) was developed by Piet Van Riel and aims at following and predicting disease activity in patients with rheumatoid arthritis (RA). Since its publication in Prevoo et al., Arthritis Rheum in 1995, it has become a reference tool used in almost every clinical practice and clinical research projects in RA. It includes swollen and tender joint counts, assessment of disease activity and erythrocyte sedimentation rate (ESR), providing a 0-10 disease activity score. "Collaborating with Mapi will lead to the production of high quality and harmonized translations and electronic versions of the DAS-28 and their dissemination within the scientific community, while respecting the integrity of the original instrument," said Piet van Riel. "The distribution of the DAS-28 by Mapi Research Trust will facilitate the access to the official original questionnaire and all its derivatives such as translations and electronic versions through an easy and controlled access," said Katrin Conway, Managing Director of the Mapi Research Trust. "The DAS-28, largely used both in clinical research and practice for twenty years, deserves the highest linguistic validation and electronic migration standards established by Mapi, for the benefit of the whole scientific community," added Ana Bayles, Global Director – Mapi Language Services. Mapi is organizing an author webinar on the DAS-28 on July 13rd during which Prof Dr Piet van Riel will present the instrument and its advantages for clinical practice and research. To register for free to this webinar, please consult http://mapigroup.com/eventcalendar/author-webinar-disease-activity-score-das-28/ For any request about the DAS-28 or to view the DAS-28's description, please consult https://eprovide.mapi-trust.org/ Mapi Language Services is the worldwide leader in medical translation and Linguistic Validation of COAs for nearly 3 decades. Mapi has first-hand knowledge of local languages and cultures, regulations, and healthcare practices. We work in close collaboration with developers, assure conceptual equivalence and international harmonization of all language versions. Mapi Language Services' experience represents more than 40,000 translated versions of 2,500 Questionnaires in 170 languages. Visit http://www.mapigroup.com for more information. Mapi Research Trust is a Non-Profit arm of Mapi Group and works in collaboration with Academic Researchers, Life-Science Companies and Regulatory bodies. It is the largest curator of Clinical Outcomes Assessments (COA) and their translations, the largest single COA licensing provider and the most trusted name in distribution of COA instruments exclusively representing over 300 questionnaires. Visit http://mapi-trust.org/ for more information. Professor Dr Piet van Riel is Rheumatologist at the Radboud University Nijmegen, the Netherlands. Some of his current activities are President of the DREAM-RA registry and practicing rheumatologist at Bernhoven, Uden, The Netherlands. Prof Dr van Riel is an active member of many professional societies, including the Dutch Society of Rheumatology, of which he was Chairman from 2003 up to 2009, the American College of Rheumatology and the British Society of Rheumatology. From 1999 to 2003 he was Chairman of the EULAR Standing Committee for International Clinical Studies Including Therapeutic Trials. Prof Dr van Riel's research interests include clinical research in rheumatology, clinical pharmacology and clinimetrics. He is on the editorial board of a number of journals, and has authored or co-authored several books and over 700 international publications. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mapi-research-trust-appointed-as-exclusive-distributor-and-mapi-language-services-as-exclusive-translator-of-the-disease-activity-score-das-28-300484190.html
Santagostino E.,Maggiore Hospital Policlinico |
Lentz S.R.,University of Iowa |
Busk A.K.,Novo Nordisk AS |
Regnault A.,Mapi |
Iorio A.,McMaster University
Haemophilia | Year: 2014
Haemophilia and its treatment interfere with patients' life, so health-related quality of life (HRQoL) should be assessed when evaluating treatments. This study investigated the HRQoL of patients with haemophilia A treated prophylactically with a new recombinant factor VIII. Two phase 3 trials investigated turoctocog alfa in patients with severe haemophilia A: one in children, one in adults and adolescents. HRQoL was a secondary endpoint assessed by the HAEMO-QOL age-specific, self-administered questionnaires. Parent-completed versions were also included for parents of children and adolescents. All HAEMO-QOL questionnaires allow the calculation of domain-specific and total scores ranging from 0 to 100, lower scores indicating better HRQoL. Mean change in all scores was described for 25 children aged 4-7 years, 21 children aged 8-12 years, 18 adolescents aged 13-18 years and 129 adults, overall, and according to the treatment regimen received prior to the study (on-demand; prophylaxis; mixed). Mean changes in HAEMO-QOL total score were 1.4 for children aged 4-7 years, -2.6 for children aged 8-12 years, -5.8 for adolescents and -1.6 for adults. In parent-completed versions, mean changes in total score were -6.0 for children aged 4-7 years, -4.7 for children aged 8-12 years, and -10.0 for adolescents. Patients receiving on-demand treatment before the trial showed greater improvement in HRQoL scores than patients already on prophylaxis. HRQoL of patients remained fairly stable over the course of the trials. However, improvements were observed for adolescents. Switching to prophylaxis was identified as a potential driver of improvement of HRQoL in patients with haemophilia A. © 2014 The Authors. Haemophilia published by John Wiley & Sons Ltd.
Takizawa C.,Nestlé |
Thompson P.L.,Mapi |
Van Walsem A.,Mapi |
Faure C.,Mapi |
Journal of Alzheimer's Disease | Year: 2014
Background: Alzheimer's disease (AD) weighs heavily on health expenditure and is strongly associated with increasing age. Due to population aging, increasing global prevalence of AD will pose huge challenges to public health and elderly care systems in all countries across the world.Objectives: This study aimed to better understand the burden of AD from a healthcare perspective.Methods: A systematic literature review of journal articles published between January 2002 and December 2012 was performed for studies conducted in France, Germany, Italy, The Netherlands, Spain, the United Kingdom (UK), and the United States of America (USA), using Medline, Embase, and the NHS Economic Evaluation Database.Results: 3,288 references were initially retrieved, and 39 epidemiological and 66 economic publications were selected for data extraction. AD incidence rates greatly varied between countries; however, prevalence was more consistent across all included countries, ranging between 3-7%. Overall, medical costs were lower in France compared to other included countries and increased with AD severity, e.g., direct medical costs per year for mild AD ranged from 5,476 int$ in France to 27,380 int$ in Spain. Limitations, such as heterogeneous methodology and missing data, prevented the comparison of results across studies between countries or the conclusion of any trend over time.Conclusion: This review corroborates previous understanding that AD burden is high for both society and healthcare providers. Limitations regarding study heterogeneity restricted conclusions; further research is required. Stakeholders could benefit from new healthcare strategies addressing both epidemiological and economic aspects of AD. © 2015 - IOS Press and the authors.
Zeppetella G.,St. Clare Hospice |
Davies A.,Royal Surrey County Hospital |
Eijgelshoven I.,Mapi |
Jansen J.P.,Mapi |
Jansen J.P.,Tufts University
Journal of Pain and Symptom Management | Year: 2014
Context With many medications available for the management of breakthrough cancer pain (BTCP), physicians may require additional guidance in selecting an appropriate medication to suit an individual patient's needs. Objectives To identify all the evidence and assess the relative clinical value of currently approved BTCP medications. Methods Following a systematic literature search (2007-2010), the results of 10 randomized controlled trials investigating the effects of BTCP medications (intranasal fentanyl spray [INFS], fentanyl pectin nasal spray, fentanyl sublingual tablets, fentanyl buccal soluble film, fentanyl buccal tablets, oral transmucosal fentanyl citrate, and morphine sulfate immediate release) were synthesized using a network meta-analysis. The main outcome was pain intensity difference (PID) relative to placebo up to 60 minutes after the intake of medication. Results INFS, fentanyl pectin nasal spray, fentanyl buccal tablet, and oral transmucosal fentanyl citrate showed greater PIDs relative to placebo than other BTCP medications 15 minutes after intake. All other medications showed greater PIDs relative to placebo at 30 minutes, except morphine sulfate immediate release, which did not show efficacy over placebo until 45 minutes. Only INFS produced clinically meaningful pain relief (absolute PID 2) at 15 minutes. Conclusion From current evidence, although all BTCP medications provided pain relief within the time frames assessed, transmucosal fentanyl medications achieved a greater level of pain relief in a shorter time frame than placebo or oral morphine.
Cope S.,Mapi |
Zhang J.,Novartis |
Saletan S.,Novartis |
Smiechowski B.,Mapi |
And 2 more authors.
BMC Medicine | Year: 2014
Background: The aim of this study is to outline a general process for assessing the feasibility of performing a valid network meta-analysis (NMA) of randomized controlled trials (RCTs) to synthesize direct and indirect evidence for alternative treatments for a specific disease population.Methods: Several steps to assess the feasibility of an NMA are proposed based on existing recommendations. Next, a case study is used to illustrate this NMA feasibility assessment process in order to compare everolimus in combination with hormonal therapy to alternative chemotherapies in terms of progression-free survival for women with advanced breast cancer.Results: A general process for assessing the feasibility of an NMA is outlined that incorporates explicit steps to visualize the heterogeneity in terms of treatment and outcome characteristics (Part A) as well as the study and patient characteristics (Part B). Additionally, steps are performed to illustrate differences within and across different types of direct comparisons in terms of baseline risk (Part C) and observed treatment effects (Part D) since there is a risk that the treatment effect modifiers identified may not explain the observed heterogeneity or inconsistency in the results due to unexpected, unreported or unmeasured differences. Depending on the data available, alternative approaches are suggested: list assumptions, perform a meta-regression analysis, subgroup analysis, sensitivity analyses, or summarize why an NMA is not feasible.Conclusions: The process outlined to assess the feasibility of an NMA provides a stepwise framework that will help to ensure that the underlying assumptions are systematically explored and that the risks (and benefits) of pooling and indirectly comparing treatment effects from RCTs for a particular research question are transparent. © 2014 Cope et al.; licensee BioMed Central Ltd.
Jansen J.P.,Mapi |
Jansen J.P.,Tufts University |
Naci H.,The London School of Economics and Political Science
BMC Medicine | Year: 2013
Background: In the last decade, network meta-analysis of randomized controlled trials has been introduced as an extension of pairwise meta-analysis. The advantage of network meta-analysis over standard pairwise meta-analysis is that it facilitates indirect comparisons of multiple interventions that have not been studied in a head-to-head fashion. Although assumptions underlying pairwise meta-analyses are well understood, those concerning network meta-analyses are perceived to be more complex and prone to misinterpretation.Discussion: In this paper, we aim to provide a basic explanation when network meta-analysis is as valid as pairwise meta-analysis. We focus on the primary role of effect modifiers, which are study and patient characteristics associated with treatment effects. Because network meta-analysis includes different trials comparing different interventions, the distribution of effect modifiers cannot only vary across studies for a particular comparison (as with standard pairwise meta-analysis, causing heterogeneity), but also between comparisons (causing inconsistency). If there is an imbalance in the distribution of effect modifiers between different types of direct comparisons, the related indirect comparisons will be biased. If it can be assumed that this is not the case, network meta-analysis is as valid as pairwise meta-analysis.Summary: The validity of network meta-analysis is based on the underlying assumption that there is no imbalance in the distribution of effect modifiers across the different types of direct treatment comparisons, regardless of the structure of the evidence network. © 2013 Jansen and Naci; licensee BioMed Central Ltd.
News Article | November 15, 2016
NEW YORK, Nov. 15, 2016 /PRNewswire/ -- Nearly half of surveyed manufacturing executives lack confidence their assets are protected from external threats, according to a new study from Deloitte and the Manufacturers Alliance for Productivity and Innovation (MAPI) on "Cyber Risk in...