scholarly journals Clinical trial publication trends within neurology

2019 ◽  
Vol 10 (1) ◽  
pp. 233-234
Author(s):  
Phan Q. Duy ◽  
Anirudh Sreekrishnan ◽  
Wyatt David ◽  
Manish D. Paranjpe ◽  
Ishan Paranjpe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Large Body ◽  
Clinical Decision ◽  
Timely Manner ◽  
Publication Trends ◽  
Publication Rates ◽  
Dissemination Of Results ◽  
Timely Dissemination

Abstract Timely dissemination of results from clinical studies is crucial for the advancement of knowledge and clinical decision making. A large body of research has shown that up to half of clinical trials do not publish their findings. In this study, we sought to determine whether clinical trial publication rates within neurology have increased over time. Focusing on neurology clinical trials completed between 2008 to 2014, we found that while the overall percentage of published trials has not changed (remaining at approximately 50%), time to publication has significantly decreased. Our findings suggest that clinical trials within neurology are being published in a more timely manner.

scholarly journals Ethics of Mandatory Research Biopsy for Correlative End Points Within Clinical Trials in Oncology

2010 ◽  
Vol 28 (15) ◽  
pp. 2635-2640 ◽  
Author(s):  
Jeffrey Peppercorn ◽  
Iuliana Shapira ◽  
Deborah Collyar ◽  
Teresa Deshields ◽  
Nancy Lin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Predictive Biomarkers ◽  
Clinical Decision ◽  
Cancer Tissue ◽  
End Points ◽  
Research Participants ◽  
Group B ◽  
Treatment Alternatives

Clinical investigators in oncology are increasingly interested in using molecular analysis of cancer tissue to understand the biologic bases of response or resistance to novel interventions and to develop prognostic and predictive biomarkers that will guide clinical decision making. Some scientific questions of this nature can only be addressed, or may best be addressed, through the conduct of a clinical trial in which research biopsies are obtained from all participants. However, trial designs with mandatory research biopsies have raised ethical concerns related to the risk of harm to participants, the adequacy of voluntary informed consent, and the potential for misunderstanding among research participants when access to an experimental intervention is linked to the requirement to undergo a research biopsy. In consideration of the ethical and scientific issues at stake in this debate, the Cancer and Leukemia Group B Ethics Committee proposes guidelines for clinical trials involving mandatory research biopsies. Any cancer clinical trial that requires research biopsies of participants must be well designed to address the scientific question, obtain the biopsy in a way that minimizes risk, and ensure that research participants are fully informed of the risks, rationale, and requirements of the study, as well as of treatment alternatives. Further guidelines and discussions of this issue are specified in this position paper. We feel that if these principles are respected, an informed adult with cancer can both understand and voluntarily consent to participation in a clinical trial involving mandatory research biopsy for scientific end points.

Time to symptomatic progression: An emerging clinical trial endpoint in oncology

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19529-19529
Author(s):  
N. Aronson ◽  
L. Melilli ◽  
D. Cella ◽  
K. Gondek
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Disease Progression ◽  
Clinical Decision Making ◽  
Progression Free Survival ◽  
Symptom Assessment ◽  
Clinical Decision ◽  
Cooperative Group ◽  
Clinical Value ◽  
Oncology Clinical Trials

19529 Background: One of the critical challenges in oncology today is assessment of clinical trial results to inform clinical decision making. Because trials typically focus on overall survival, it is often difficult to determine individual patient benefits early on treatment. Surrogate endpoints such as time to disease progression and progression-free survival may not correlate with survival. Based on a growing body of evidence, cancer symptom assessment has been shown to provide immediate treatment responses and to predict long-term outcomes_including tumor response, disease progression and survival. Methods: Results from a comprehensive literature review of oncology clinical trials and observational studies with symptom endpoints to date are provided. Analyses methods are described including potential biases. To illustrate the potential clinical value of time to symptomatic progression (TTSP) in longitudinal clinical trials, a retrospective analysis of data from a three-arm (cisplatin/etoposide versus two dosage regimens of cisplatin/paclitaxel arms) randomized cooperative-group clinical trial in non-small-cell lung cancer (NSCLC) was conducted. Results: In a three-arm randomized cooperative group clinical trial of NSCLC, TTSP was significantly associated with best clinical response (p<0.01) and survival (p<0.05). Conclusion: The utility of cancer symptom response for comparing cancer treatments has been well documented. This endpoint has been shown to act as an early signal of disease progression and death. Opportunities for refinement include methods for more accurate assessment, reduction in the number of symptoms evaluated, and refined statistical methods for reducing bias due to missing data. Given the success demonstrated in clinical trials, clinicians may consider ongoing cancer symptom evaluation in clinical practice. No significant financial relationships to disclose.

Is the Deductive Falsification Approach a Better Basis for Clinical Trial Appraisal?

2019 ◽  
Vol 14 (3) ◽  
pp. 224-228
Author(s):  
Steffen Mickenautsch
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Empirical Evidence ◽  
Clinical Decision Making ◽  
Inductive Reasoning ◽  
Clinical Decision ◽  
Future Trial ◽  
Grading Systems ◽  
Component Scores ◽  
Current Clinical Trial

Background: Inductive reasoning relies on an infinite regress without sufficient factual basis and verification is at any time vulnerable to single contrary observation. Thus, appraisal based on inductive verification, as applied in current clinical trial appraisal scales, checklists or grading systems, cannot prove or justify trial validity. Discussion: Trial appraisal based on deductive falsification can identify invalid trials and give evidence for the recommendation to exclude these from clinical decision-making. Such appraisal remains agnostic towards corroborated trials that pass all appraisal criteria. The results of corroborated trials cannot be considered more robust than falsified trials since nothing within a particular set of complied trial criteria can give certainty for trial compliance with any other appraisal criterion in future. A corroborated trial may or may not reflect therapeutic truth and may thus be the basis for clinical guidance, pending results of any future trial re-appraisal. Conclusion: Trial grading following appraisal based on deductive falsification should be binary (0 = Invalid or 1 = Unclear) and single component scores should be multiplied. Appraisal criteria for the judgment of trial characteristics require a clear rationale, quantification of such rationale and empirical evidence concerning the effect of trial characteristics on trial results.

scholarly journals ALK inhibitors, resistance development, clinical trials

2018 ◽  
Vol 25 ◽  
pp. 59 ◽  
Author(s):  
J.M. Rothenstein ◽  
N. Chooback
Keyword(s):  
Clinical Trials ◽  
Patient Outcomes ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Current Treatment ◽  
Resistance Development ◽  
Ongoing Research ◽  
Alk Positive ◽  
Emergence Of Resistance ◽  
Key Questions

The treatment of advanced non-small-cell lung cancer (nsclc) has undergone a paradigm shift since the early 2000s. The identification of molecular subtypes of the disease, based on oncogenic drivers, has led to the development of personalized medicine and the ability to deliver molecularly targeted therapies to patients. In the 10 years that have elapsed since the discovery of the ALK gene in a patient with nsclc, several active drugs have moved rapidly from bench to bedside, and multiple others are currently in clinical trials. Those developments have led to important improvements in patient outcomes, while simultaneously raising key questions about the optimal treatment for ALK-positive nsclc. The inevitable emergence of resistance to alk-directed therapy is central to ongoing research and daily clinical practice for affected patients. In the present review, we highlight the current treatment landscape, the available and emerging clinical trials, and the evolving clinical decision-making in ALK-positive nsclc, with a focus on Canadian practice.

Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials—Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?

2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.

The role of experience and clinical decision support in clinical trial accrual within oncology.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1527-1527
Author(s):  
Waqas Haque ◽  
Ann M. Geiger ◽  
Celette Sugg Skinner ◽  
Rasmi Nair ◽  
Simon Craddock Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Decision Support ◽  
Clinical Decision Support ◽  
Clinical Decision ◽  
Principal Investigator ◽  
Physician Practices ◽  
The Past ◽  
The Future ◽  
Clinical Trial Accrual

1527 Background: Patient accrual for cancer clinical trials is suboptimal. The complexity of applying eligibility criteria and enrolling patients may deter oncologists from recommending patients for a trial. As such, there is a need to understand how experience, training, and clinical decision support impact physician practices and intentions related to trial accrual. Methods: From May to September 2017, we conducted a survey on clinical trial accrual in a national sample of medical, surgical, and radiation oncologists. The 20-minute survey assessed barriers and facilitators to clinical trial accrual, including experience (e.g., “In the past 5 years, have you been a study or site PI of a trial?”), training (e.g., “Did you receive training about trial design and recruitment as part of medical school, residency, or fellowship? After fellowship?”), and clinical decision support (e.g., “What kind of clinical decision support has your practice implemented?). We used logistic regression to identify factors associated with frequency of discussing trials (with ≥25% of patients) and likelihood of recommending a trial to a patient (likely or very likely) in the future. Results: Survey respondents (n = 1,030) were mostly medical oncologists (59%), age 35-54 years (67%), male (74%), and not in academic practice (58%). About 18% of respondents (n = 183) reported discussing trials with ≥25% of their patients, and 80% reported being likely or very likely to recommend a trial to a patient in the future. Prior experience as principal investigator of a trial was associated with both frequency of discussing trials (OR 3.27, 95% CI 2.25, 4.75) and likelihood of recommending a trial in the future (OR 5.22, 95% CI 3.71, 7.34), as was receiving additional training in clinical trials after fellowship (discussion with patients: OR 2.48, 95% CI 1.80, 3.42; recommend in future: OR 1.92, 95% CI 1.37, 2.69). Implementing clinical decision support was not associated with discussing trials with ≥25% of patients (OR 1.12, 95% CI 0.76, 1.67), but was associated with being likely to recommend a trial in the future (OR 1.73, 95% CI 1.11, 2.71). Conclusions: In a national survey of oncologists, we observed differences in physician practices and intention related to clinical trial accrual. Whereas the vast majority (80%) reported being likely or very likely to recommend trials in the future, far fewer (20%) reported discussing trials with their patients within the past 5 years. Implementation of clinical decision support – electronic tools intended to optimize patient care and identification of patient eligibility – was not associated with frequency of past discussion of clinical trials but was associated with recommending a trial in the future. Given the stronger association between experience as a site Principal Investigator and recommending a trial, future research should explore how improving opportunities to lead a clinical trial impact trial accrual.

Topical Review: Enhancing Understanding of the Clinical Meaningfulness of Outcomes to Assess Treatment Benefit from Psychological Therapies for Children with Chronic Pain

2019 ◽  
Author(s):  
Tonya M Palermo ◽  
Susmita Kashikar-Zuck ◽  
Anne Lynch-Jordan
Keyword(s):  
Chronic Pain ◽  
Clinical Trials ◽  
Clinical Significance ◽  
Clinical Decision Making ◽  
Psychological Treatment ◽  
Clinical Decision ◽  
Health Impact ◽  
Treatment Benefit ◽  
Topical Review ◽  
Pediatric Chronic Pain

Abstract Objective Despite the availability of measures for assessing physical, psychological, and health impact in children with chronic pain, there are not established guidelines for interpretation of children’s pain outcomes following psychological treatment. The purpose of this topical review is to discuss clinical significance as a neglected area of consideration in pediatric chronic pain assessment and to make recommendations on how the field can move toward benchmarking on core outcome domains. Method We review definitions of clinical significance and examples of several methodologies that have been used in other populations or are emerging in pediatric chronic pain including anchor-based methods, distribution-based methods, or multimethod approaches. Results Few measures across pediatric chronic pain outcome domains have established clinical significance of scores to interpret meaningful change following treatment limiting the interpretability of findings from clinical trials. In the context of clinical practice, several efforts to examine clinical significance to improve the translation of evidence-based measurement into standard clinical decision-making exist. Conclusions Recommendations are provided to encourage additional validation efforts of outcome measures in pediatric chronic pain and to encourage authors to report clinical significance in clinical trials of psychological interventions for pediatric chronic pain.

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