Abstract
The increasing rate of failed trails found in mood and anxiety disorders is now being seen in Alzheimer’s studies. Factors related to the administration of clinician rating scales, such as poor inter-rater reliability, poor interview quality and rater bias may be a contributing factor. Studies have found inter-rater reliability to be problematic in Alzheimer’s studies, even with less subjective outcome measures. Lack of standardization of administration and scoring procedures has been identified as a major contributing factor. Remediation through better training procedures has been found to be successful, although ongoing calibration is needed to prevent rater drift. Expectancy bias and baseline score inflation is more difficult to remediate. Inflation of baseline scores increases placebo response, since lower severity has been found to be associated with higher placebo response. The use of centralized raters that are independent from study sites may help ameliorate these issues. Increased methodological research examining new approaches to these problems is warranted. The increased costs associated with this research should offset the time and expense of continuing with ‘business as usual’.
Keywords: Clinical trials, outcome assessment, reliability, research design, training, telemedicine.
Current Alzheimer Research
Title: Inaccuracy in Clinical Trials: Effects and Methods to Control Inaccuracy
Volume: 7 Issue: 7
Author(s): K. A. Kobak
Affiliation:
Keywords: Clinical trials, outcome assessment, reliability, research design, training, telemedicine.
Abstract: The increasing rate of failed trails found in mood and anxiety disorders is now being seen in Alzheimer’s studies. Factors related to the administration of clinician rating scales, such as poor inter-rater reliability, poor interview quality and rater bias may be a contributing factor. Studies have found inter-rater reliability to be problematic in Alzheimer’s studies, even with less subjective outcome measures. Lack of standardization of administration and scoring procedures has been identified as a major contributing factor. Remediation through better training procedures has been found to be successful, although ongoing calibration is needed to prevent rater drift. Expectancy bias and baseline score inflation is more difficult to remediate. Inflation of baseline scores increases placebo response, since lower severity has been found to be associated with higher placebo response. The use of centralized raters that are independent from study sites may help ameliorate these issues. Increased methodological research examining new approaches to these problems is warranted. The increased costs associated with this research should offset the time and expense of continuing with ‘business as usual’.
Export Options
About this article
Cite this article as:
A. Kobak K., Inaccuracy in Clinical Trials: Effects and Methods to Control Inaccuracy, Current Alzheimer Research 2010; 7 (7) . https://dx.doi.org/10.2174/156720510793499057
DOI https://dx.doi.org/10.2174/156720510793499057 |
Print ISSN 1567-2050 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5828 |
Call for Papers in Thematic Issues
New Advances in the Prevention, Diagnosis, Treatment, and Rehabilitation of Alzheimer's Disease
Aims and Scope: Introduction: Alzheimer's disease (AD) poses a significant global health challenge, with an increasing prevalence that demands concerted efforts to advance our understanding and strategies for prevention, diagnosis, treatment, and rehabilitation. This thematic issue aims to bring together cutting-edge research and innovative approaches from multidisciplinary perspectives to address ...read more
Current updates on the Role of Neuroinflammation in Neurodegenerative Disorders
Neuroinflammation is an invariable hallmark of chronic and acute neurodegenerative disorders and has long been considered a potential drug target for Alzheimer?s disease (AD) and dementia. Significant evidence of inflammatory processes as a feature of AD is provided by the presence of inflammatory markers in plasma, CSF and postmortem brain ...read more
Deep Learning for Advancing Alzheimer's Disease Research
Alzheimer's disease (AD) poses a significant global health challenge, with an increasing number of individuals affected yearly. Deep learning, a subfield of artificial intelligence, has shown immense potential in various domains, including healthcare. This thematic issue of Current Alzheimer Research explores the application of deep learning techniques in advancing our ...read more
Diagnostic and therapeutic biomarkers of dementia
Dementia affects 18 million people worldwide. Dementia is a syndrome of symptoms caused by brain disease, usually chronic or progressive, clinically characterized by multiple impairments of higher cortical functions such as memory, thinking, orientation, and learning. In addition, in the course of dementia, cognitive deficits are observed, which often hinder ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
- Announcements
Related Articles
-
Neurotoxicity of β-Amyloid Protein: Oligomerization, Channel Formation and Calcium Dyshomeostasis
Current Pharmaceutical Design Views on Amyloid Hypothesis and Secretase Inhibitors for Treating Alzheimers Disease: Progress and Problems
Current Pharmaceutical Design Advancement in Obesity Management: Leptin and Adiponectin Patents
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery Modulating the Amyloidogenesis of α-Synuclein
Current Neuropharmacology Potential Biomarkers for Depression Associated with Coronary Artery Disease: A Critical Review
Current Molecular Medicine Neuroprotective Effects of Lithium in Patients with Bipolar Disorder
Current Psychopharmacology Elucidating the Risk Factors for Progression from Amyloid-Negative Amnestic Mild Cognitive Impairment to Dementia
Current Alzheimer Research Differences Between Parkinson’s and Huntington’s Diseases and Their Role for Prioritization of Stem Cell-Based Treatments
Current Molecular Medicine Alzheimer’s Disease: New Concepts on the Role of Autoimmunity and NLRP3 Inflammasome in the Pathogenesis of the Disease
Current Neuropharmacology Development of Small-Molecule Inhibitors of Raf
Recent Patents on Anti-Infective Drug Discovery Hybrid PET Imaging in Neurologic Disease: PET/MRI Rather than PET/CT
Current Medical Imaging Pharmacological Tools to Activate Microglia and their Possible use to Study Neural Network Patho-physiology
Current Neuropharmacology The Effects of Gender and CYP46 and Apo E Polymorphism on 24S-Hydroxycholesterol Levels in Alzheimers Patients Treated with Statins
Current Alzheimer Research Conformationally Controlled Mechanistic Aspects of BACE 1 Inhibitors
Central Nervous System Agents in Medicinal Chemistry Protein Kinase C – Possible Therapeutic Target to Treat Cardiovascular Diseases
Cardiovascular & Hematological Disorders-Drug Targets Cyclooxygenases in the Central Nervous System: Implications for Treatment of Neurological Disorders
Current Pharmaceutical Design Central Nervous System Manifestations in Systemic Lupus Erythematosus
Current Rheumatology Reviews Treating Hypertension in the Elderly: Common Problems and Solutions
Current Hypertension Reviews Anandamide Dysfunction in Prodromal and Established Psychosis
Current Pharmaceutical Design Polyphenols Beyond Barriers: A Glimpse into the Brain
Current Neuropharmacology