Response as a Measure of Treatment Efficacy in Clinical Trials: Should RECIST Be Abandoned?

2013 ◽  
pp. 91-100
Author(s):  
Michael Friedlander ◽  
James Tate Thigpen
Keyword(s):  
Clinical Trials ◽  
Treatment Efficacy

International Dermatology Outcome Measures Initiative as Applied to Psoriatic Disease Outcomes: An Update

2016 ◽  
Vol 43 (5) ◽  
pp. 959-960 ◽  
Author(s):  
Joseph F. Merola ◽  
April W. Armstrong ◽  
Ami Saraiya ◽  
John Latella ◽  
Amit Garg ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Outcome Measures ◽  
Treatment Efficacy ◽  
Regulatory Agencies ◽  
Washington Dc ◽  
Patient Centered ◽  
Psoriatic Disease ◽  
Disease Outcomes ◽  
Dermatologic Disease

Previous publications have described the International Dermatology Outcome Measures (IDEOM) group, comprising patients, physicians, health economists, participating pharmaceutical industry partners, payers, and regulatory agencies. The goal of IDEOM is to create patient-centered, validated measures of dermatologic disease progression and treatment efficacy for use in both clinical trials and clinical practice. We provide an update of IDEOM activities as of our 2015 IDEOM meeting in Washington, DC, USA.

scholarly journals Comparative clinical trials in psychotherapy: Have large effects been replicated?

2020 ◽  
Vol 29 ◽  
Author(s):  
Nickolas D. Frost ◽  
Thomas W. Baskin ◽  
Bruce E. Wampold
Keyword(s):  
Clinical Trials ◽  
Treatment Efficacy ◽  
Literature Search ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Depression And Anxiety ◽  
Inclusion Criteria ◽  
Average Quality ◽  
Meta Analyses

Abstract Aims The purpose of this review is to examine the replication attempts of psychotherapy clinical trials for depression and anxiety. We focus specifically on replications of trials that exhibit large differences between psychotherapies. The replicability of these trials is especially important for meta-analysis, where the inclusion of false-positive trials can lead to erroneous conclusions about treatment efficacy. Methods Standard replication criteria were developed to distinguish direct from conceptual replication methodologies. Next, an exhaustive literature search was conducted for published meta-analyses of psychotherapy comparisons. Trials that exhibited large effects (d > 0.8) were culled from these meta-analyses. For each trial, a cited replication was conducted to determine if the trial had been subsequently replicated by either ‘direct’ or ‘conceptual’ methods. Finally, a broader search was conducted to examine the extent of replication efforts in the psychotherapy literature overall. Results In the meta-analytic search, a total of N = 10 meta-analyses met the inclusion criteria. From these meta-analyses, N = 12 distinct trials exhibited large effect sizes. The meta-analyses containing more than two large effect trials reported evidence for treatment superiority. A cited replication search yielded no direct replication attempts (N = 0) for the trials with large effects, and N = 4 conceptual replication attempts of average or above average quality. However, of these four attempts, only two partially corroborated the results from their original trial. Conclusion Meta-analytic reviews are influenced by trials with large effects, and it is not uncommon for these reviews to contain several such trials. Since we find no evidence that trials with such large effects are directly replicable, treatment superiority conclusions from these reviews are highly questionable. To enhance the quality of clinical science, the development of authoritative replication criteria for clinical trials is needed. Moreover, quality benchmarks should be considered before trials are included in a meta-analysis, or replications are attempted.

scholarly journals Development and reliability of a structured interview guide for the Montgomery-Åsberg Depression Rating Scale (SIGMA)

2008 ◽  
Vol 192 (1) ◽  
pp. 52-58 ◽  
Author(s):  
Janet B. W. Williams ◽  
Kenneth A. Kobak
Keyword(s):  
Clinical Trials ◽  
Treatment Efficacy ◽  
Interrater Reliability ◽  
Rating Scale ◽  
High Reliability ◽  
Intraclass Correlation ◽  
Structured Interview ◽  
Interview Guide ◽  
Test Retest Reliability ◽  
Improve Reliability

BackgroundThe Montgomery-Åsberg Depression Rating Scale (MADRS) is often used in clinical trials to select patients and to assess treatment efficacy. The scale was originally published without suggested questions for clinicians to use in gathering the information necessary to rate the items. Structured and semi-structured interview guides have been found to improve reliability with other scales.AimsTo describe the development and test-retest reliability of a structured interview guide for the MADRS (SIGMA).MethodA total of 162 test-retest interviews were conducted by 81 rater pairs. Each patient was interviewed twice, once by each rater conducting an independent interview.ResultsThe intraclass correlation for total score between raters using the SIGMA was r = 0.93, P < 0.0001. All ten items had good to excellent interrater reliability.ConclusionsUse of the SIGMA can result in high reliability of MADRS scores in evaluating patients with depression.

scholarly journals Comparing the Effects of Intracellular and Extracellular Magnetic Hyperthermia on the Viability of BxPC-3 Cells

Nanomaterials ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. 593
Author(s):  
Gary Hannon ◽  
Anna Bogdanska ◽  
Yuri Volkov ◽  
Adriele Prina-Mello
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Treatment Efficacy ◽  
Magnetic Hyperthermia ◽  
Oxide Nanoparticles ◽  
Solid Malignancies ◽  
Hyperthermia Therapy ◽  
Underlying Mechanisms ◽  
Alternating Magnetic Fields ◽  
Clinical Advances

Magnetic hyperthermia involves the use of iron oxide nanoparticles to generate heat in tumours following stimulation with alternating magnetic fields. In recent times, this treatment has undergone numerous clinical trials in various solid malignancies and subsequently achieved clinical approval to treat glioblastoma and prostate cancer in 2011 and 2018, respectively. However, despite recent clinical advances, many questions remain with regard to the underlying mechanisms involved in this therapy. One such query is whether intracellular or extracellular nanoparticles are necessary for treatment efficacy. Herein, we compare the effects of intracellular and extracellular magnetic hyperthermia in BxPC-3 cells to determine the differences in efficacy between both. Extracellular magnetic hyperthermia at temperatures between 40–42.5 °C could induce significant levels of necrosis in these cells, whereas intracellular magnetic hyperthermia resulted in no change in viability. This led to a discussion on the overall relevance of intracellular nanoparticles to the efficacy of magnetic hyperthermia therapy.

Treatment Efficacy Differences of Sorafenib for Advanced Hepatocellular Carcinoma: A Meta-Analysis of Randomized Clinical Trials

Oncology ◽  
2015 ◽  
Vol 88 (6) ◽  
pp. 345-352 ◽  
Author(s):  
Yu-Yun Shao ◽  
Wen-Yi Shau ◽  
Soa-Yu Chan ◽  
Li-Chun Lu ◽  
Chih-Hung Hsu ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trials ◽  
Treatment Efficacy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Advanced Hepatocellular Carcinoma

scholarly journals PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Yiqin Zhou ◽  
James H-C. Wang
Keyword(s):  
Clinical Trials ◽  
Sport Medicine ◽  
Treatment Efficacy ◽  
Basic Science ◽  
Orthopaedic Surgery ◽  
Science Studies ◽  
Platelet Rich Plasma ◽  
Tendon Injuries

Platelet-Rich Plasma (PRP) has been widely used in orthopaedic surgery and sport medicine to treat tendon injuries. However, the efficacy of PRP treatment for tendinopathy is controversial. This paper focuses on reviewing the basic science studies on PRP performed under well-controlled conditions. Bothin vitroandin vivostudies describe PRP’s anabolic and anti-inflammatory effects on tendons. While some clinical trials support these findings, others refute them. In this review, we discuss the effectiveness of PRP to treat tendon injuries with evidence presented in basic science studies and the potential reasons for the controversial results in clinical trials. Finally, we comment on the approaches that may be required to improve the efficacy of PRP treatment for tendinopathy.

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