Good clinical practice in clinical interventional studies [PDF]
, 2014 Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise ‘frequently asked questions’ format.While ...
Diamant, Zuzana, Pieterse, Herman
core +3 more sources
Trials, 2017 Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor.
Anne Daykin +9 more
doaj +1 more source
Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics. study protocol for a randomized controlled trial [PDF]
, 2015 Background: Ventilator-associated pneumonia (VAP) is one of the most common and severe hospital-adquired infections, and multidrugresistant gram-negative bacilli (MDR-GNB) constitute the main etiology in many countries.
Clara Rosso, Fernández +6 more
core +1 more source
Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs) [PDF]
, 2020 Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few.
Bakker, Jessie +14 more
core +2 more sources
Establishing a data monitoring committee for clinical trials.
Shanghai archives of psychiatry, 2014 A data monitoring committee (DMC) is a group of clinicians and biostatisticians appointed by study sponsors who provide independent assessment of the safety, scientific validity and integrity of clinical trials. In the United States, the Food and Drug Administration requires the formation of DMC in all trials that assess new interventions. DMC are also
LIN, Julia Y, LU, Ying
openaire +2 more sources
Safety of intravenous thrombolysis for acute ischemic stroke in patients receiving antiplatelet therapy at stroke onset [PDF]
, 2010 <p><b>Background and Purpose:</b> Antiplatelets (APs) may increase the risk of symptomatic intracerebral hemorrhage (ICH) following intravenous thrombolysis after ischemic stroke.</p> <p><b>Methods:</b> We ...
Ahmed, N. +10 more
core +2 more sources
Experience and Challenges from Clinical Trials with Malaria Vaccines in Africa. [PDF]
, 2013 Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades ...
A Nyika +67 more
core +3 more sources
Accreditation of human research protection program: An Indian perspective
Perspectives in Clinical Research, 2012 With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can ...
K L Bairy, Pratibha Pereira
doaj +1 more source
PLoS ONE, 2020 While the epidemiologic burden of mental health disorders in the United States has been well described over the past decade, we know relatively little about trends in how these disorders are being studied through clinical research.
Joshua R Wortzel +8 more
doaj +1 more source
Experiences of Establishing an Academic Early Phase Clinical Trials Unit [PDF]
, 2017 Background: Early phase trials are essential in drug development, determining appropriate dose levels and assessing preliminary activity. These trials are undertaken by industry and academia, with increasing collaborations between the two.
Brown S +7 more
core +1 more source