PAH in CTD – Clinical Trials Criteria and Performance

2009 ◽  
pp. 275-288
Author(s):  
James R. Seibold
Keyword(s):  
Clinical Trials ◽  
And Performance

scholarly journals FDAAA TrialsTracker: A live informatics tool to monitor compliance with FDA requirements to report clinical trial results

2018 ◽  
Author(s):  
Nicholas J. DeVito ◽  
Seb Bacon ◽  
Ben Goldacre
Keyword(s):  
Clinical Trials ◽  
Relevant Information ◽  
Reporting Requirements ◽  
Practical Support ◽  
The Us ◽  
Us Government ◽  
Results Reporting ◽  
And Performance ◽  
Legal Frameworks ◽  
Clinical Trial Results

AbstractIntroductionNon-publication of clinical trials results is an ongoing issue. In 2016 the US government updated the results reporting requirements to ClinicalTrials.gov for trials covered under the FDA Amendments Act 2007. We set out to develop and deliver an online tool which publicly monitors compliance with these reporting requirements, facilitates open public audit, and promotes accountability.MethodsWe conducted a review of the relevant legislation to extract the requirements on reporting results. Specific areas of the statutes were operationalized in code based on the results of our policy review, publicly available data from ClinicalTrials.gov, and communications with ClinicalTrials.gov staff. We developed methods to identify trials required to report results, using publicly available registry data; to incorporate additional relevant information such as key dates and trial sponsors; and to determine when each trial became due. This data was then used to construct a live tracking website.ResultsThere were a number of administrative and technical hurdles to successful operationalization of our tracker. Decisions and assumptions related to overcoming these issues are detailed along with clarifications directly from ClinicalTrials.gov. The FDAAA TrialsTracker was successfully launched in February 2018 and provides users with an overview of results reporting compliance.DiscussionClinical trials continue to go unreported despite numerous guidelines, commitments, and legal frameworks intended to address this issue. In the absence of formal sanctions from the FDA and others, we argue tools such as ours - providing live data on trial reporting - can improve accountability and performance. In addition, our service helps sponsors identify their own individual trials that have not yet reported results: we therefore offer positive practical support for sponsors who wish to ensure that all their completed trials have reported.

scholarly journals Missing Data in Randomized Clinical Trials for Weight Loss: Scope of the Problem, State of the Field, and Performance of Statistical Methods

PLoS ONE ◽  
2009 ◽  
Vol 4 (8) ◽  
pp. e6624 ◽  
Author(s):  
Mai A. Elobeid ◽  
Miguel A. Padilla ◽  
Theresa McVie ◽  
Olivia Thomas ◽  
David W. Brock ◽  
...  
Keyword(s):  
Weight Loss ◽  
Clinical Trials ◽  
Missing Data ◽  
Statistical Methods ◽  
Randomized Clinical Trials ◽  
And Performance ◽  
State Of The Field

Personalizing Oncology: Perspectives and Prospects

2013 ◽  
Vol 31 (15) ◽  
pp. 1904-1911 ◽  
Author(s):  
John Mendelsohn
Keyword(s):  
Clinical Trials ◽  
Molecular Targets ◽  
Targeted Drugs ◽  
Genetic Aberrations ◽  
Patients With Cancer ◽  
Reasonable Cost ◽  
Before And After ◽  
Cancer Medicine ◽  
And Performance ◽  
Selection Of

This article provides an overview of the research, beginning a century ago, that has led to the current use of genomically informed methods for selection of targeted therapies to treat individual patients with cancer—so-called precision cancer medicine. Until 1980, most research on cancer therapy was not targeted in the sense we use the word today. Since then, there has been an acceleration in research identifying genetic and molecular targets and in clinical trials using biomarkers that identify the presence of genetic or molecular markers in a patient's cancer to select appropriate targeted therapy. This approach has been made possible by increased knowledge of the genetic pathogenesis of cancer and by increased capacity to sequence genes and genomes in clinically useful timeframes and at a reasonable cost. However, many challenges and pitfalls remain in selecting optimal targets, interpreting data on genetic aberrations, designing effective targeted drugs and antibodies, dealing with resistance to treatments, identifying appropriate combinations of therapies, and performing the complex clinical trials that are required. Future clinical research with experimental targeted agents is likely to be more informative because of appropriate preselection of patients enrolled onto trials and performance of genetic and molecular studies on specimens of a patient's cancer before and after treatment.

scholarly journals Characteristics and Performance of a Modified Version of the ADCS-CGIC CIBIC+ for Mild Cognitive Impairment Clinical Trials

2009 ◽  
Vol 23 (3) ◽  
pp. 260-267 ◽  
Author(s):  
Lon S. Schneider ◽  
Rema Raman ◽  
Frederick A. Schmitt ◽  
Rachelle S. Doody ◽  
Philip Insel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
And Performance

scholarly journals Feasibility of Direct Sputum Molecular Testing for Drug Resistance as Part of Tuberculosis Clinical Trials Eligibility Screening

Diagnostics ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. 56
Author(s):  
Narges Alipanah ◽  
Priya B. Shete ◽  
Hanh Nguyen ◽  
Nhung Viet Nguyen ◽  
Lien Luu ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Clinical Trials ◽  
Test Performance ◽  
High Sensitivity ◽  
Drug Susceptibility ◽  
Drug Susceptibility Testing ◽  
Prior History ◽  
Molecular Testing ◽  
Screening Procedures ◽  
And Performance

A rapid diagnosis of drug-resistant tuberculosis (TB) is critical for early initiation of effective therapy. Molecular testing with line probe assays (MTBDRplus and MTBDRsl) on culture isolates has been available for some time and significantly reduces the time to diagnosis of drug resistance. However, routine use of this test directly on sputum is less common. As part of enrollment screening procedures for tuberculosis clinical trials conducted in Hanoi, Vietnam, we evaluated the feasibility and performance of line probe assay (LPA) testing directly on sputum samples from 315 participants with no prior history of TB treatment. Test performance characteristics for the detection of rifampin (RIF) and isoniazid (INH) drug resistance as compared to culture-based drug susceptibility testing (DST) reference standard were calculated. LPA demonstrated high sensitivity and specificity for the diagnosis of drug resistance. Scaling up molecular testing on sputum as part of time-sensitive clinical trial screening procedures in high TB burden settings is feasible and will reduce both time to initiation of appropriate therapy and the risk of late exclusions due to microbiologic ineligibility.

scholarly journals Relationships Between Authorship Contributions and Authors' Industry Financial Ties Among Oncology Clinical Trials

2010 ◽  
Vol 28 (8) ◽  
pp. 1316-1321 ◽  
Author(s):  
Susannah L. Rose ◽  
Monika K. Krzyzanowska ◽  
Steven Joffe
Keyword(s):  
Clinical Trials ◽  
Mixed Models ◽  
Design Analysis ◽  
Age Group ◽  
Industry Funding ◽  
Level Data ◽  
Oncology Clinical Trials ◽  
And Performance ◽  
Single Versus ◽  
Number Of Authors

Purpose To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. Methods Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. Conclusion Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry.

Guidelines for the use and performance of quantitative outcome measures in ALS clinical trials

1997 ◽  
Vol 147 (1) ◽  
pp. 97-111 ◽  
Author(s):  
James R. Brinkmann ◽  
Patricia Andres ◽  
Michelle Mendoza ◽  
Mohammed Sanjak
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
And Performance
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