scholarly journals Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov

2015 ◽  
Vol 18 (8) ◽  
pp. 796-805 ◽  
Author(s):  
Alexandre Vivot ◽  
Jacques Li ◽  
Jean-David Zeitoun ◽  
Samia Mourah ◽  
Perrine Crequit ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Targeted Drugs ◽  
Inclusion Criteria

scholarly journals On the design of early-phase Alzheimer’s disease clinical trials with cerebrospinal fluid tau outcomes

2021 ◽  
pp. 174077452110344
Author(s):  
Michelle M Nuño ◽  
Joshua D Grill ◽  
Daniel L Gillen ◽  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cerebrospinal Fluid ◽  
Phosphorylated Tau ◽  
Inclusion Criteria ◽  
Eligibility Criteria ◽  
Total Tau ◽  
Prodromal Alzheimer’S Disease ◽  
Study Power

Background/Aims: The focus of Alzheimer’s disease studies has shifted to earlier disease stages, including mild cognitive impairment. Biomarker inclusion criteria are often incorporated into mild cognitive impairment clinical trials to identify individuals with “prodromal Alzheimer’s disease” to ensure appropriate drug targets and enrich for participants likely to develop Alzheimer’s disease dementia. The use of these eligibility criteria may affect study power. Methods: We investigated outcome variability and study power in the setting of proof-of-concept prodromal Alzheimer’s disease trials that incorporate cerebrospinal fluid levels of total tau (t-tau) and phosphorylated (p-tau) as primary outcomes and how differing biomarker inclusion criteria affect power. We used data from the Alzheimer’s Disease Neuroimaging Initiative to model trial scenarios and to estimate the variance and within-subject correlation of total and phosphorylated tau. These estimates were then used to investigate the differences in study power for trials considering these two surrogate outcomes. Results: Patient characteristics were similar for all eligibility criteria. The lowest outcome variance and highest within-subject correlation were obtained when phosphorylated tau was used as an eligibility criterion, compared to amyloid beta or total tau, regardless of whether total tau or phosphorylated tau were used as primary outcomes. Power increased when eligibility criteria were broadened to allow for enrollment of subjects with either low amyloid beta or high phosphorylated tau. Conclusion: Specific biomarker inclusion criteria may impact statistical power in trials using total tau or phosphorylated tau as the primary outcome. In concert with other important considerations such as treatment target and population of clinical interest, these results may have implications to the integrity and efficiency of prodromal Alzheimer’s disease trial designs.

Parkinson's disease and convergence insufficiency: a mini-review

2021 ◽  
Vol 1 (3) ◽  
pp. 108-111
Author(s):  
Mashael Al-Namaeh
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Clinical Trials ◽  
Control Group ◽  
Healthy Controls ◽  
Inclusion Criteria ◽  
Medline Search ◽  
Convergence Insufficiency ◽  
Eye Examination ◽  
The Relationship

Background: A key manifestation of Parkinson’s disease (PD) is visual impairment. Cognitive impairment has been found to overlap with convergence insufficiency (CI) in patients with PD and is associated with significantly greater near point convergence (NPC) distance. Difficulty in reading and diplopia were the most common symptoms of CI in PD. The prevalence of CI is greater among patients with PD. Therefore, this study aimed to assess the relationship between PD and CI. Methods: Studies that had included data on CI, NPC, or both were selected by searching PubMed/MEDLINE and clinicaltrails.gov, without any timeline or language limitation. The following terms were used in PubMed/MEDLINE search: ‘Clinical Trials’, ‘Parkinson’s Disease’, and ‘Convergence Insufficiency’. For clinical trials.gov database, the terms ‘Parkinson’s Disease’, ‘Convergence Insufficiency’, and ‘Completed Studies’ were used. Only those studies with control subjects were included. PubMed/MEDLINE search yielded 1,563 articles, but no article was found in the clinical trails.gov search. Twelve articles met the inclusion criteria, among which nine articles were selected as they had data on CI or NPC distance (cm), and PD.   Results: Overall, there were 1,563 articles; among them, 12 articles met the inclusion criteria. Nine articles were selected based on their data concerning CI or NPC distance (cm) and PD. Relative to the control group, the PD group had high CI. In addition, PD group showed increase in NPC distance than the control group. Conclusions: These data suggest that the patients with PD had an increased likelihood of developing CI visual symptoms, and increased NPC distance than healthy controls. These findings indicate that regular eye examination is very important for patients with PD.

scholarly journals Canadian Recommendations for Clinical Trials of Pharmacologic Interventions in Rheumatoid Arthritis: Inclusion Criteria and Study Design: Table 1.

2011 ◽  
Vol 38 (10) ◽  
pp. 2095-2104 ◽  
Author(s):  
JACOB KARSH ◽  
EDWARD C. KEYSTONE ◽  
BOULOS HARAOUI ◽  
J. CARTER THORNE ◽  
JANET E. POPE ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Activity ◽  
Study Design ◽  
New Drugs ◽  
Nominal Group ◽  
Consensus Method ◽  
Inclusion Criteria ◽  
Design Features

Objective.Current clinical trial designs for pharmacologic interventions in rheumatoid arthritis (RA) do not reflect the innovations in RA diagnosis, treatment, and care in countries where new drugs are most often used. The objective of this project was to recommend revised entry criteria and other study design features for RA clinical trials.Methods.Recommendations were developed using a modified nominal group consensus method. Canadian Rheumatology Research Consortium (CRRC) members were polled to rank the greatest challenges to clinical trial recruitment in their practices. Initial recommendations were developed by an expert panel of rheumatology trialists and other experts. A scoping study methodology was then used to examine the evidence available to support or refute each initial recommendation. The potential influence of CRRC recommendations on primary outcomes in future trials was examined. Recommendations were finalized using a consensus process.Results.Recommendations for clinical trial inclusion criteria addressed measures of disease activity [Disease Activity Score 28 using erythrocyte sedimentation rate (DAS28-ESR) > 3.2 PLUS ≥ 3 tender joints using 28-joint count (TJC28) PLUS ≥ 3 swollen joint (SJC28) OR C-reactive protein (CRP) or ESR > upper limit of normal PLUS ≥ 3 TJC28 PLUS ≥ 3 SJC28], functional classification, disease classification and duration, and concomitant RA treatments. Additional recommendations regarding study design addressed rescue strategies and longterm extension.Conclusion.There is an urgent need to modify clinical trial inclusion criteria and other study design features to better reflect the current characteristics of people living with RA in the countries where the new drugs will be used.

scholarly journals Critical Appraisal on the Selection Criteria for Evidence-based Healthcare

2021 ◽  
Author(s):  
Paulo Cesar Morales Mayer ◽  
Caroline Amélia Gonçalves ◽  
Franz Porzsolt
Keyword(s):  
Cervical Cancer ◽  
Clinical Trials ◽  
Selection Criteria ◽  
Human Subjects ◽  
Evidence Based ◽  
Inclusion Criteria ◽  
Pragmatic Trials ◽  
Exclusion Criteria ◽  
Policy Makers ◽  
Evidence Based Healthcare

Abstract Background: Evidence-Based healthcare deals basically with published clinical trials to guide the decision making on what treatment to use for any specific conditions.Aims: The present paper assessed the inclusion and exclusion criteria used in clinical trials of cervical cancer aiming at establishing a clear distinction between each criterion.Methods: We performed a bibliographical search in pubmed with the terms cervical cancer and treatment or therapy filtered for clinical trials with human subjects for the last ten years. A total of 30 papers were used extracting and classifying the inclusion and exclusion category according to the characteristic they described. Results: We found no clear parameter to establish which criteria could exclusively serve as inclusion or exclusion across the papers, about 56% of the categories identified were found either listed as inclusion or exclusion criteria or even as both in some cases.Conclusions: The key issue of selection criteria is not in its form but in its function, the first point to consider is if the trial is experimental (focused on efficacy and proof of principle) or observational (pragmatic trials, focused on effectiveness and real world conditions). We suggest, inclusion criteria should be broad, focused on the investigated condition; exclusion criteria should apply only to the subset of this “included” population, and do not take part in observational studies. These conclusions do not serve only for researchers but should affect practitioners and policy makers to correctly compare the results of investigated treatment.

Repurposing Ruxolitinib in Combating COVID-19: a mini review

2021 ◽  
Vol 02 ◽  
Author(s):  
Inshia Begum ◽  
Fathima Murthuza ◽  
Juwairiya Syed Iqbaluddin ◽  
Hafsah Fatima Arsal
Keyword(s):  
Clinical Trials ◽  
Severity Of Illness ◽  
Current Evidence ◽  
Public Healthcare ◽  
Inclusion Criteria ◽  
Research Papers ◽  
Exclusion Criteria ◽  
Mixed Treatment ◽  
Marked Selectivity ◽  
Insight Into

Background: The pandemic caused by Coronavirus Disease 2019 (COVID-19), also known as Severe Acute Respiratory Syndrome-Related Coronavirus (SARS-CoV-2), is believed to be one of the greatest threats to global health in the 21st century. Recent collective evidence has warranted Ruxolitinib as a potential agent in recovery. Ruxolitinib is a potent and selective inhibitor of Jack kinase (JAK) 1 and 2 with modest to marked selectivity against tyrosine kinase two and JAK3. Objective: The review aims to outline the current evidence regarding the repurposed treatment for COVID- 19 and give insight into the clinical trials. There has been considerable interest in introducing existing therapeutic agents against COVID-19 to reduce the severity of illness and ease the burden on public healthcare systems. Method: A literature search was conducted using keywords like ‘Ruxolitinib trial’ and ‘COVID-19 Ruxolitinib’ on PubMed, Google Scholar, Science Direct, and Cochrane databases to select research papers and articles on the topic published from January to October 2020. Inclusion criteria were restricted to articles on Ruxolitinib and COVID. In contrast, the exclusion criteria stipulated that any study done on COVID-19 involving a mixed treatment regimen with Ruxolitinib and other drug/s or any studies not pertinent to the purpose of the study would be omitted. Conclusion: Based on the successful outcomes of various researches conducted and clinical trials performed, the use of Ruxolitinib has shown significant improvement and faster clinical recovery among COVID-19 patients of varying severity of infection, advanced age, and multiple comorbidities. This review provides an overview of various such studies with their promising outcomes.

Abstract 16784: Under-Enrollment of Real-World Heart Failure With Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Joban Vaishnav ◽  
Lisa R Yanek ◽  
Virginia S Hahn ◽  
Eunice Yang ◽  
Rishi Trivedi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Outcomes ◽  
Real World ◽  
Loop Diuretic ◽  
Nyha Class ◽  
Clinic Visit ◽  
Inclusion Criteria ◽  
Pulmonary Capillary ◽  
Number Of Patients ◽  
Wedge Pressure

Introduction: Inclusion criteria for enrollment in HFpEF clinical trials vary considerably and often exclude patients with co-morbidities such as obesity. We tested the hypotheses that: 1) a large number of patients with clinical and hemodynamic evidence of HFpEF are excluded from major HFpEF clinical trials; and 2) there is no difference in clinical outcomes between patients excluded versus those who met enrollment criteria by evaluating reasons for exclusion from HFpEF clinical trials and comparing clinical outcomes in a real-world HFpEF cohort. Methods: Patients referred to the Johns Hopkins HFpEF Clinic with clinical and hemodynamic evidence of HFpEF (pulmonary capillary wedge pressure [PCWP] ≥ 12 mmHg on a loop diuretic or PCWP ≥ 15 mmHg) were assessed for inclusion into 4 major HFpEF trials (TOPCAT, I-PRESERVE, PARAGON-HF, and RELAX). Cumulative hazard of HF hospitalization or death at 2 years from index clinic visit was compared between patients included and excluded by each trial. Results: Of 132 HFpEF patients, the median PCWP was 19 mmHg (IQR: 15-22 mmHg). Forty-four (33%) of patients met enrollment criteria for TOPCAT, 39 (29%) for I-PRESERVE, 21 (16%) for PARAGON-HF, and 50 (38%) for RELAX. The top 5 criteria that would have excluded patients included low natriuretic peptide level, obesity, elevated blood pressure, young age, and low hemoglobin (Figure 1A) . There was no difference in HF burden (hospitalizations, diuretic dosing, or NYHA class), or in clinical outcomes including HF hospitalization or death between patients who did or did not meet inclusion criteria for each clinical trial (Figure 1B ). Conclusion: We demonstrate that in a real-world cohort of hemodynamically-proven HFpEF few patients would have met criteria for enrollment in major HFpEF clinical trials, yet HF burden and outcomes were no different. Given the lack of proven therapies in HFpEF, consideration should be given to unifying and broadening enrollment criteria in HFpEF clinical trials.

scholarly journals Opioid-induced constipation in palliative care: state of the art

2020 ◽  
pp. 1116-1124
Author(s):  
Erlania do Carmo Freitas ◽  
Geslaney Reis da Silva ◽  
Rudval Souza da Silva ◽  
Rita Narriman Silva de Oliveira Boery ◽  
Maria Patricia Milagres
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Exploratory Study ◽  
Adverse Reactions ◽  
State Of The Art ◽  
Meta Analysis ◽  
Life Quality ◽  
Limited Data ◽  
Inclusion Criteria

OBJECTIVE: The study’s purpose has been to address the state of the art in investigations such as clinical trials, systematic reviews with meta-analysis and case studies, which report how to minimize opioid-induced constipation in patients undergoing palliative care. METHODS: This is an exploratory study through an integrative review of four databases addressing published articles from 2013 to 2017. RESULTS: A total of 117 publications were presented, which 17 presented the inclusion criteria. The studies describe the prevalence of constipation rates induced by the use of opioids. CONCLUSION: Although these drugs alleviate pain, the adverse reactions may generate discomfort and loss of the patient’s life quality. There are limited data on the treatment of constipation. It was observed that few authors mentioned diet as a helper on this situation, emphasizing the use of medications. Further studies should be encouraged aiming to find the balance between analgesia and reduction of adverse effects.

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