AI Article Synopsis
- The Clinical Trials Act was enacted in April 2018 to address research misconduct and build trust in clinical trials in Japan.
- "Specified clinical trials" involve tests using unapproved pharmaceuticals or medical devices, often funded by manufacturers with approved products.
- Key requirements for these trials include adherence to standards, approval from a certified review board, submission of plans to health authorities, and agreements with funding manufacturers.
Article Abstract
Two years have passed since the Clinical Trials Act came into effect in April 2018. There were a series of research misconducts behind the legislation, and the Clinical Trials Act was enacted to ensure confidence in clinical trials conducted in Japan. The term "specified clinical trials" refers to clinical trials conducted using pharmaceuticals or medical devices, approval for which has not been obtained, or clinical trials conducted receiving research funds or other benefits provided by a manufacturer with marketing approval for pharmaceuticals or medical devices. The key elements in conducting specified clinical trials are as follows: (1) compliance with clinical trial standards, (2) approval by the certified review board, (3) submission of the trial plan to the Minister of Health, Labour, and Welfare, and (4) entering into an agreement with a manufacturer providing research funds. This manuscript overviews the Clinical Trials Act and the conduct of specified clinical trials by reviewing the key issues behind the legislation.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.11406/rinketsu.61.1007 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Drug Development.
Alzheimers Dement
December 2024
GSK R&D, Stevenage, Hertfordshire, United Kingdom.
Background: Genetic variants in GRN, the gene encoding progranulin, are causal for or are associated with the risk of multiple neurodegenerative diseases. Modulating progranulin has been considered as a therapeutic strategy for neurodegenerative diseases including Frontotemporal Dementia (FTD) and Alzheimer's Disease (AD). Here, we integrated genetics with proteomic data to determine the causal human evidence for the therapeutic benefit of modulating progranulin in AD.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
University of Kentucky Sanders-Brown Center on Aging, Lexington, KY, USA.
Background: The presence of multiple comorbid pathologic features in late-onset dementia has been well documented across cohort studies that incorporate autopsy evaluation. It is likely that such mixed pathology potentially confounds the results of interventional trials that are designed to target a solitary pathophysiologic mechanism in Alzheimer's disease and related dementias (ADRD).
Method: The UK ADRC autopsy database was screened for participants who had previously engaged in therapeutic interventional trials for Alzheimer's disease, vascular cognitive impairment, dementia, and/or ADRD prevention trials from 2005 to the present.
Drug Development.
Alzheimers Dement
December 2024
Alzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Amsterdam, North Holland, Netherlands.
The lack of an in-vivo pathology marker for synuclein pathology has been a long standing challenge for dementia for Lewy bodies (DLB) research. This issue is critically important for phase II trials, which are often small, requiring the precise measurement of the biological effects, whether disease modifying or symptomatic. Recent advances have enabled the determination of alpha-synuclein pathology status with CSF measurements, using aggregation assays [RT-QUIC].
View Article and Find Full Text PDFBackground: Alzheimer's disease (AD) is a progressive neurodegenerative disease characterized by the formation of amyloid-beta (Aβ) plaques and neurofibrillary tangles (NFTs) composed of tau aggregates. Research in animal models has generated hypotheses on the underlying mechanisms of the interaction between Aβ and tau pathology. In support of this interaction, results from clinical trials have shown that treatment with anti-Aβ monoclonal antibodies (mAbs) affects tau pathology.
View Article and Find Full Text PDFBackground: Clinical outcome assessments (COAs) are an important part of clinical trials to measure what is meaningful to patients and caregivers. This study aimed to examine trends in Alzheimer's Disease (AD) COAs used in clinical trials, given the FDA's recent emphasis on patient-focused drug development and early AD.
Method: ClinicalTrials.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!