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PubMed Journals Articles About "Clinical Trials Have Have Limits When Drug Untreatable" RSS

15:35 EST 25th January 2020 | BioPortfolio

Clinical Trials Have Have Limits When Drug Untreatable PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Clinical Trials Have Have Limits When Drug Untreatable articles that have been published worldwide.

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Showing "Clinical trials have have limits when drug untreatable" PubMed Articles 1–25 of 40,000+

Myasthenia gravis: Historical achievements and the "golden age" of clinical trials.

Since the death of Chief Opechankanough >350 years ago, the myasthenia gravis (MG) community has gained extensive knowledge about MG and how to treat it. This review highlights key milestones in the history of treatment and discusses the current "golden age" of clinical trials. Although originally thought by many clinicians to be a disorder of hysteria and fluctuating weakness without observable cause, MG is one the most understood autoimmune neurologic disorders. However, studying it in clinical trials h...


Prediction of Drug Approval After Phase I Clinical Trials in Oncology: RESOLVED2.

Drug development in oncology currently is facing a conjunction of an increasing number of antineoplastic agents (ANAs) candidate for phase I clinical trials (P1CTs) and an important attrition rate for final approval. We aimed to develop a machine learning algorithm (RESOLVED2) to predict drug development outcome, which could support early go/no-go decisions after P1CTs by better selection of drugs suitable for further development.

Clinical drug development for dementia with Lewy bodies: past and present.

: Dementia with Lewy bodies (DLB) is an under-researched area despite being the second most common type of degenerative dementia after Alzheimer's disease. It is an area of unmet need with no approved symptomatic or disease-modifying therapies. The pharmacological management of DLB is complex and challenging because early trials of drugs for DLB have resulted in no demonstrable efficacy. Randomized controlled trials (RCTs) in the DLB population have only recently been initiated. Understanding results from p...


Beyond "Intent-to-treat" and "Per protocol": Improving assessment of treatment effects in clinical trials through the specification of an estimand.

There is a key problem in randomised clinical trials as outcomes can be distorted due to informative post-randomisation events. This is inadequately addressed by the use of traditional intention-to-treat or per protocol analysis sets and often either ignored or wrongly labelled as missing data. As a consequence, the treatment effects of interest in a clinical trial are not well defined and their estimates might be misinterpreted. The estimand framework should help all those planning, conducting and analysin...

Data Integrity in Global Clinical Trials: Discussions from Joint US FDA and MHRA UK Good Clinical Practice Workshop.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (US-FDA) Center for Drug...

OCTANE: Oncology Clinical Trial Annotation Engine.

Many targeted therapies are currently available only via clinical trials. Therefore, routine precision oncology using biomarker-based assignment to drug depends on matching patients to clinical trials. A comprehensive and up-to-date trial database is necessary for optimal patient-trial matching.

US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.

The size of estimated treatment effects on the basis of which the US Food and Drug Administration (FDA) has approved drugs and devices with data from nonrandomized clinical trials (non-RCTs) remains unknown.

Clinical Trial Portfolios: A Critical Oversight in Human Research Ethics, Drug Regulation, and Policy.

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios-series of trials th...

'Becoming-with' a repeat healthy volunteer: Managing and negotiating trust among repeat healthy volunteers in commercial clinical drug trials.

Recent sociological research has raised important sociological and ethical questions about the role of financial rewards in terms of healthy volunteer involvement in clinical trials. Research suggests that it would be parochial to assume financial rewards alone are sufficient to explain repeat healthy volunteering. This paper explores other factors that might explain repeat healthy volunteering behaviours in phase I clinical drug trials. Drawing on qualitative research with healthy volunteers, the paper arg...

Optimal two-stage designs for exploratory basket trials.

The primary goal of an exploratory oncology clinical trial is to identify an effective drug for further development. To account for tumor indication selection error, multiple tumor indications are often selected for simultaneous testing in a basket trial. In this article, we propose optimal and minimax two-stage basket trial designs for exploratory clinical trials. Inactive tumor indications are pruned in stage 1 and the active tumor indications are pooled at end of stage 2 to assess overall effectiveness o...

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials.

Numerous reasons have been identified for why U.S.-based principal investigators choose to not continue participating in FDA-regulated trials. However, unexplored are reasons why a substantial number of principal investigators, facing the same challenges, remain engaged in clinical research. This study aimed to both describe barriers and identify factors that contribute to active investigators' success in conducting multiple FDA-regulated trials.

A Good Practice-Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study.

With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on ...

Key indicators of phase transition for clinical trials through machine learning.

A significant number of drugs fail during the clinical testing stage. To understand the attrition of drugs through the regulatory process, here we review and advance machine-learning (ML) and natural language-processing algorithms to investigate the importance of factors in clinical trials that are linked with failure in Phases II and III. We find that clinical trial phase transitions can be predicted with an average accuracy of 80%. Identifying these trials provides information to sponsors facing difficult...

Impact of diagnostic methods on efficacy estimation - a proof-of-principle based on historical examples.

Accurate diagnostic methods are essential for evaluating treatment efficacy in clinical trials, including vaccine trials. Although a plethora of studies assessing novel or modified treatment options is available, clinical trials evaluating the sensitivity and specificity of diagnostic methods in compliance with the demands of drug registration trials are scarce. We assessed the accuracy of diagnostic methods in two vaccine trials conducted in 1995 and 2009 to demonstrate the impact of sensitivity and specif...

Developing Effective Alzheimer's Disease Therapies: Clinical Experience and Future Directions.

Alzheimer's disease (AD) clinical trials, focused on disease modifying drugs and conducted in patients with mild to moderate AD, as well as prodromal (early) AD, have failed to reach efficacy endpoints in improving cognitive function in most cases to date or have been terminated due to adverse events. Drugs that have reached clinical stage were reviewed using web resources (such as clinicaltrials.gov, alzforum.org, company press releases, and peer reviewed literature) to identify late stage (Phase II and Ph...

Addressing Heterogeneity in Als Clinical Trials.

Amyotrophic lateral sclerosis (ALS) is a debilitating neurodegenerative disorder, with complex biology and significant clinical heterogeneity. Many preclinical and early phase ALS clinical trials have yielded promising results that could not be replicated in larger Phase 3 confirmatory trials. One reason for the lack of reproducibility may be ALS biological and clinical heterogeneity. Therefore, in this review, we explored sources of ALS heterogeneity that may reduce statistical power to evaluate efficacy i...

Dose Finding in the Clinical Development of 60 US Food and Drug Administration-Approved Drugs Compared With Learning vs. Confirming Recommendations.

This review characterizes clinical development that supported the label dose in 60 drug indications recently approved by the US Food and Drug Administration. With Lewis B. Sheiner's Learning vs. Confirming clinical drug development paradigm as a reference point, the clinical development paths, the design of dose-ranging trials, and the dose-exposure-response characterization were examined using US Food and Drug Administration approval packages. It was found that 89% of clinical development programs included...

Pivotal Considerations for Optimal Deployment of Healthy Volunteers in Oncology Drug Development.

Oncology drug development is among the most challenging of any therapeutic area, with first-in-human trials expected to deliver information on both safety and activity. Until recently, therapeutic approaches in oncology focused on cytotoxic chemotherapy agents, ruling out even the possibility of enrolling normal healthy volunteers (NHVs) in clinical trials due to safety considerations. The emergence of noncytotoxic modalities, including molecularly targeted agents with more favorable safety profiles, howeve...

Horses for courses: an approach to the qualification of clinical trial sites and investigators in ATMPs.

The advanced therapy medicinal products (ATMPs) landscape is entirely different from classical drug development. Academia has been the major source of ATMP development, and academic hospitals act as trial sites for the clinical testing of ATMPs, including early academic-led trials as well as industry-sponsored trials that pursue the full developmental pathway to market authorization. The recent breakthrough developments in some ATMPs, such as genetically engineered immune cells, have confronted academic hos...

Rheumatology Common Toxicity Criteria (RCTC): An Update Reflecting Real-World Use.

The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatology Common Toxicity Criteria (RCTC) version 2.0 was published in 2007 by the OMERACT Drug Safety Working Group, building on limited experience with RCTC version 1.0, to facilitate standardization of assessment (grading) and reporting of adverse events (AEs) commonly seen in rheumatic disease clinical trials (Woodworth et al. in J Rheumatol 34:1401-1414, 2007).

Impact of Precision Medicine on Efficiencies of Novel Drug Development in Cancer.

Precision medicine offers opportunities for reducing the costs, burdens, and time associated with drug development. We examined time, number of trials, indications tested and patient burden needed to achieve first FDA license for all 5 novel anti-cancer precision-medicine drugs and all 10 novel non-precision medicine drugs receiving FDA approval 2010-2014. The 15 drug portfolios encompassed 242 trials: 87 for precision medicine drugs and 155 for non-precision medicine drugs. Embase and MEDLINE databases wer...

Is curcumin bioavailability a problem in humans: lessons from clinical trials.

: Since ancient times, turmeric has been used in several folklore remedies against various ailments. The principle component of turmeric is curcumin and its efficacy has been advocated in and clinical studies for different chronic diseases. However, some studies suggest that curcumin bioavailability is a major problem. : This article discusses over 200 clinical studies with curcumin that have demonstrated pronounced protective role of this compound against cardiovascular diseases, inflammatory diseases, me...

Next Generation DILI Biomarkers: Prioritization of Biomarkers for Qualification and Best Practices for Biospecimen Collection in Drug Development.

The diagnosis and management of drug-induced liver injury (DILI) remains a challenge in clinical trials in drug development. The qualification of emerging biomarkers capable of predicting DILI soon after the initiation of treatment, differentiating DILI from underlying liver disease, identifying the causal entity, and assigning appropriate treatment options after DILI is diagnosed are needed. Qualification efforts have been hindered by lack of properly stored and consented biospecimens that are linked to cl...

Factors Influencing Placebo Responses in Rheumatoid Arthritis Clinical Trials: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Studies.

A better understanding of placebo responses and the specific factors influencing these outcomes is important for clinical trial design. We investigated the magnitude of placebo responses at 3 months and the potential factors influencing these outcomes in rheumatoid arthritis (RA) clinical trials.

Automatic trial eligibility surveillance based on unstructured clinical data.

Insufficient patient enrollment in clinical trials remains a serious and costly problem and is often considered the most critical issue to solve for the clinical trials community. In this project, we assessed the feasibility of automatically detecting a patient's eligibility for a sample of breast cancer clinical trials by mapping coded clinical trial eligibility criteria to the corresponding clinical information automatically extracted from text in the EHR.


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