Good clinical practice guidance and pragmatic clinical trials: balancing the best of both worlds
RJ Mentz, AF Hernandez, LG Berdan, T Rorick… - Circulation, 2016 - Am Heart Assoc
Randomized, clinical trials are commonly regarded as the highest level of evidence to
support clinical decisions. Good Clinical Practice guidelines have been constructed to …
support clinical decisions. Good Clinical Practice guidelines have been constructed to …
[PDF][PDF] Ethical and scientific implications of the globalization of clinical research
SW Glickman, JG McHutchison, ED Peterson… - N Engl J …, 2009 - researchgate.net
Ethical and Scientific Implications of the Globalization of Clinical Research Page 1 sounding
board The new england journal of medicine n engl j med 360;8 nejm.org february 19, 2009 …
board The new england journal of medicine n engl j med 360;8 nejm.org february 19, 2009 …
Characteristics, Progression, and Output of Randomized Platform Trials: A Systematic Review
A Griessbach, CM Schönenberger, AT Heravi… - JAMA Network …, 2024 - jamanetwork.com
Importance Platform trials have become increasingly common, and evidence is needed to
determine how this trial design is actually applied in current research practice. Objective To …
determine how this trial design is actually applied in current research practice. Objective To …
Sensible approaches for reducing clinical trial costs
EL Eisenstein, R Collins, BS Cracknell… - Clinical …, 2008 - journals.sagepub.com
Background Over the past decade, annual funding for biomedical research has more than
doubled while new molecular entity approvals have declined by one third. Objective To …
doubled while new molecular entity approvals have declined by one third. Objective To …
Acetylcysteine in the prevention of contrast-induced nephropathy: a case study of the pitfalls in the evolution of evidence
During the past 5 years, 19 randomized controlled trials, 4 prospective nonrandomized
studies, and 11 meta-analyses that explored the role of acetylcysteine for prevention of …
studies, and 11 meta-analyses that explored the role of acetylcysteine for prevention of …
[HTML][HTML] Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013
Abstracts Background Clinical trial globalization is a major trend for industry-sponsored
clinical trials. There has been a shift in clinical trial sites towards emerging regions of …
clinical trials. There has been a shift in clinical trial sites towards emerging regions of …
Clinical trials bureaucracy: unintended consequences of well-intentioned policy
RM Califf - Clinical trials, 2006 - journals.sagepub.com
Background As randomized controlled trials have become the 'gold standard'for medical
research, a complex regulatory structure for the conduct of clinical trials has emerged …
research, a complex regulatory structure for the conduct of clinical trials has emerged …
[HTML][HTML] Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013
Background Industry-sponsored clinical trials, in the past performed almost exclusively in
more developed countries, now often recruit participants globally. However, recruitment from …
more developed countries, now often recruit participants globally. However, recruitment from …
Tenecteplase use in patients with acute ischaemic stroke
Physicians have always faced uncertainty when making clinical decisions. 1 Clinical
research seeks to reduce such uncertainty by generating more evidence. The more …
research seeks to reduce such uncertainty by generating more evidence. The more …
[HTML][HTML] New approaches to rewarding pharmaceutical innovation
Aspects of the drug patent system make it challenging for companies to earn the sales
revenues needed to recoup costs of research and development. First, the time between …
revenues needed to recoup costs of research and development. First, the time between …
