Empirical Evaluations of Clinical Trial Designs.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA network open"
DOI: 10.1001/jamanetworkopen.2022.11620
Abstract: present an insightful comparison of 2 clinical trial designs: (1) the actual study design that was implemented in the Stroke Hyperglycemia Insulin Network Effort (SHINE) trial 2 and (2) an alternative nonimplemented design. This comparison… read more here.
Keywords: trial designs; empirical evaluations; trial; design ... See more keywords
New clinical trial designs in the era of precision medicine
Sign Up to like & getrecommendations! Published in 2019 at "Molecular Oncology"
DOI: 10.1002/1878-0261.12465
Abstract: Cancer treatment has made significant strides towards the promise of personalized medicine. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing… read more here.
Keywords: medicine; drug development; trial designs; oncology ... See more keywords
Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2528
Abstract: Global regulatory agencies have transformed their approach to approvals in their processes for formal review of the safety and efficacy of new drugs. Opportunities for innovation have expanded because of the coronavirus disease 2019 (COVID‐19)… read more here.
Keywords: innovative trial; designs orphan; trial designs; trial ... See more keywords
Trial designs using real‐world data: The changing landscape of the regulatory approval process
Sign Up to like & getrecommendations! Published in 2019 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4932
Abstract: There is a need to develop hybrid trial methodology combining the best parts of traditional randomized controlled trials (RCTs) and observational study designs to produce real‐world evidence (RWE) that provides adequate scientific evidence for regulatory… read more here.
Keywords: real world; designs using; trial; trial designs ... See more keywords
Trial designs and results supporting treatment de-escalation and escalation.
Sign Up to like & getrecommendations! Published in 2017 at "Breast"
DOI: 10.1016/j.breast.2017.06.020
Abstract: Trials for escalation and de-escalation of treatment aim to improve patient care, but from different sides of the same coin with respect to disease control and burdens of treatment. De-escalation of therapy is inherently a… read more here.
Keywords: trial designs; treatment escalation; treatment; designs results ... See more keywords
Opportunity for efficiency in clinical development: An overview of adaptive clinical trial designs and innovative machine learning tools, with examples from the cardiovascular field.
Sign Up to like & getrecommendations! Published in 2021 at "Contemporary clinical trials"
DOI: 10.1016/j.cct.2021.106397
Abstract: Modern data analysis tools and statistical modeling techniques are increasingly used in clinical research to improve diagnosis, estimate disease progression and predict treatment outcomes. What seems less emphasized is the importance of the study design,… read more here.
Keywords: adaptive designs; efficiency; machine learning; trial designs ... See more keywords
Advancing Effective Clinical Trial Designs for Myelofibrosis.
Sign Up to like & getrecommendations! Published in 2021 at "Hematology/oncology clinics of North America"
DOI: 10.1016/j.hoc.2020.12.009
Abstract: Design features of phase I, II, and III clinical trials of pharmaceutical interventions in myelofibrosis (MF) are discussed. Model-assisted and model-based designs for phase I trials are useful for maximizing therapeutic benefit and include novel… read more here.
Keywords: clinical trial; designs myelofibrosis; trial designs; effective clinical ... See more keywords
RCTs and other clinical trial designs in Ayurveda: A review of challenges and opportunities
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Ayurveda and Integrative Medicine"
DOI: 10.1016/j.jaim.2021.06.012
Abstract: Currently, there is a paucity of clinical trial designs that comprehensively evaluate the efficacy of most complementary and alternative systems of medicine (CAMs) like Ayurveda. Several factors such as complex interventions, individualized therapy, etc., make… read more here.
Keywords: clinical trial; medicine; trial; trial designs ... See more keywords
Adaptive trial designs for spinal cord injury clinical trials directed to the central nervous system.
Sign Up to like & getrecommendations! Published in 2020 at "Spinal cord"
DOI: 10.1038/s41393-020-00547-8
Abstract: STUDY DESIGN Narrative review. PURPOSE To provide an overview of adaptive trial designs, and describe how adaptive methods can address persistent challenges encountered by randomized controlled trials of people with spinal cord injury (SCI). RESULTS… read more here.
Keywords: adaptive trial; trial; trial designs; adaptive methods ... See more keywords
Central concepts for randomized controlled trials and other emerging trial designs.
Sign Up to like & getrecommendations! Published in 2022 at "Seminars in vascular surgery"
DOI: 10.1053/j.semvascsurg.2022.10.004
Abstract: Randomized controlled trials (RCTs) are widely considered to provide the highest-quality evidence for the comparative efficacy and safety of competing clinical strategies. The strength of using RCTs for causal inference is derived from random treatment… read more here.
Keywords: central concepts; trial designs; randomized controlled; controlled trials ... See more keywords
A possible explanation for the contrasting results of REDUCE-IT vs. STRENGTH: cohort study mimicking trial designs.
Sign Up to like & getrecommendations! Published in 2021 at "European heart journal"
DOI: 10.1093/eurheartj/ehab555
Abstract: AIMS We tested the hypothesis that the contrasting results for the effect of high-dose, purified omega-3 fatty acids on the prevention of atherosclerotic cardiovascular disease (ASCVD) in two randomized trials, Reduction of Cardiovascular Events with… read more here.
Keywords: strength; contrasting results; trial designs; reduce strength ... See more keywords