
Firas FneishMS Forschungs- und Projektentwicklungs-gGmbH
Firas Fneish
Dr. rer. nat
About
34
Publications
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Introduction
Firas Fneish currently works as a Biostatistician at Multiple Sklerose Forschungs- und Projektentwicklungs-gGmbH
Additional affiliations
Education
September 2019 - May 2023
October 2016 - August 2018
October 2011 - May 2015
Publications
Publications (34)
Background
Regulatory authorities have encouraged the usage of a risk -based monitoring (RBM) system in clinical trials prior to trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM Tools were developed after the International Council for Harmonization (ICH) gave sponsors the f...
Background:
Vaccines offer people with multiple sclerosis (PwMS) an effective protection against severe COVID-19 disease courses. However, representative real-world data on the tolerability of SARS-CoV-2 vaccines in PwMS are limited. We aimed at analysing vaccination reactions (VRs) and MS deterioration following SARS-CoV-2 vaccinations in German...
Monitoring of clinical trials is a fundamental process required by regulatory agencies. It assures the compliance of a center to the required regulations and the trial protocol. Traditionally, monitoring teams relied on extensive on-site visits and source data verification. However, this is costly, and the outcome is limited. Thus, central statisti...
Several studies reported post-SARS-CoV-2-vaccination (PV) symptoms. Even people with multiple sclerosis (PwMS) have concerns about disease activity following the SARS-CoV-2 vaccination. We aimed to determine the proportion of PwMS with PV relapses, the PV annualized relapse rate (ARR), the time from vaccination to subsequent relapses, and identify...
Background
Treatment guidelines recommend early disease-modifying therapy (DMT) initiation after diagnosis of multiple sclerosis (MS). Multinational comparative studies that assess time to DMT initiation in MS may allow detection of barriers inherent to healthcare systems to explain potential adverse systematic delays in commencing DMTs.
Objective...
In pre‐clinical and medical quality control, it is of interest to assess the stability of the process under monitoring or to validate a current observation using historical control data. Classically, this is done by the application of historical control limits (HCL) graphically displayed in control charts. In many applications, HCL are applied to c...
Background
The spectrum of disease-modifying therapies (DMTs) for people with multiple sclerosis (PwMS) has expanded over years, but data on treatment strategies is largely lacking. DMT switches are common clinical practice.
Objective
To compare switchers and non-switchers, characterize the first DMT switch and identify reasons and predictors for...
Economic and political/governmental infrastructural factors are major contributors to the economic development/growth of all sectors of a country, such as in the area of healthcare systems and clinical research, including the pharmaceutical industry. But what is the interaction between economic, political/governmental infrastructural factors and th...
Despite protection from severe COVID-19 courses through vaccinations, some people with multiple sclerosis (PwMS) are vaccination-hesitant due to fear of post-vaccination side effects/increased disease activity. The aim was to reveal the frequency and predictors of post-SARS-CoV-2-vaccination relapses in PwMS. This prospective, observational study w...
Background
Bone demineralization in people living with HIV (PLWH) could be ameliorated by biomechanical loading of the musculoskeletal system which exerts an osteogenic stimulus. Therefore, we determined whether the bone mineral density (BMD) varied in weight-bearing and non-weight-bearing bones in PLWH, and its relationship with some risk factors...
Background: Biomechanical loading exerts an osteogenic stimulus; thus, bone mineral
density(BMD) may vary in weight-bearing and non-weight-bearing bones. Therefore, weight-
bearing activities could modulate sex-, HAART- and HIV-related BMD loss.
Method: A cross-sectional observational study of 503 people living with HIV (PLWH) selected by
conven...
Introductions:
Therapy switches in patients with multiple sclerosis (MS) receiving treatment with fingolimod occur frequently in clinical practice but are not well represented in real-world data. The aim of this study was to identify and characterize treatment switches and reveal sociodemographic/clinical changes over time in fingolimod-treated peo...
Background: The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit. Objectives: This study was designed to compare the development of the...
Background:
The globalization of clinical research should also benefit the population in developing
markets. In this context, the approval of tested medicines and the associated
expansion of medical care beyond clinical studies would be desirable as a possible
long-term benefit.
Objectives: This study is designed to compare the development of the n...
Background: The tailored immunomodulatory treatment strategy for secondary progressive multiple sclerosis (SPMS) depends on disease activity.
Objective: To assess the real-world situation in monitoring disease activity in SPMS patients and to identify associations of resulting subgroups with demographics, symptomatology, and therapy
Methods: This s...
Introduction: Piper crocatum Ruiz & Pav (P. crocatum) has been reported to accelerate the diabetic wound healing process empirically. Some studies showed the benefits of P. crocatum in treating various diseases but its mechanisms in diabetic wound healing have never been reported. In the present study we investigated the diabetic wound healing acti...
Introduction
Piper crocatum Ruiz & Pav (P. crocatum) has been reported to accelerate the diabetic wound healing process empirically. Some studies showed the benefits of P. crocatum in treating various diseases but its mechanisms in diabetic wound healing have never been reported. In the present study we investigated the diabetic wound healing activ...
The globalization of clinical research business is leading to a shift of clinical trials from Western countries to so-called emerging markets. This article should present the temporal development of clinical research business on the African continent. Further information should be gathered on favorite disease categories in which clinical trials are...
Daclizumab was approved by the FDA and the EMA in 2016 for the treatment of relapsing forms of multiple sclerosis (MS). Cases of severe inflammatory brain disease with fatal outcome led to the withdrawal of approval in Europe and the US on March 2, 2018. Approximately 8,000 patients worldwide received daclizumab, but little is known about the furth...
Objective
To assess the feasibility of collaboration and retrospective data harmonization among three multiple sclerosis (MS) registries by investigating employment status.
Methods
We used the Maelstrom guidelines to facilitate retrospective harmonization of data from three MS registries, including the NARCOMS (North American Research Committee on...
Background: Clinical trials are conducted all over the world, including developing economies in Africa. Pharmaceutical companies could easily take advantage of the regulatory situation in these vulnerable countries. This research study examines ethical statements of the 25 top pharmaceutical companies conducting clinical trials in Africa regarding...
Generalized linear models for analyzing binomial count data with logit-link are frequent in controlled experiments in toxicology, plant biotechnology and clinical trials 1 Trials often involve several treatment groups, independent replicates and may involve further structures like blocked replication, secondary factors, or covariates Asymptotic...
Background: Type 2 Diabetes Mellitus (T2DM) is a chronic lifestyle disease. It has become evident that T2DM finds its presence even among the younger age groups. In Lebanon, Type 2 diabetes (T2D) has a major public health impact through high disease prevalence, significant downstream pathophysiologic effects, and enormous financial liabilities. Pur...
Worldwide self-medication is on rise and has different reasons. Prescription of drugs should only be sold by pharmacy shops to the patient with a prescription of the medical doctor. The main ethical problem is that patient wants the drug depending on his own belief of self-medication and the pharmacist is interested in selling his products without...
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparati...
Type 2 diabetes mellitus (T2DM) is a chronic lifestyle disease. It has become evident that T2DM occurs even among the younger age groups.1 In Lebanon, T2DM has a major public health impact through high disease prevalence, significant downstream pathophysiologic effects, and enormous financial liabilities.2
Adult Vaccination in undergraduate students in Ashrafieh, Lebanon. Firas Fneish Faculty III, Hochschule Hannover, Expo Plaza 12, Hannover 30539, Germany. BACKGROUND: Over the years, medicine has improved our health, reaching a level where the human body could be resistant to several life threaten diseases by passive immunization. Vaccination is boo...