Dataset Information

Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance.

ABSTRACT:

Introduction

Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field.

Methods

A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials in dementia prevention. A working group of researchers and clinicians with expertise in dementia trials further refined the recommendations.

Results

Overall, the recommendations support the delivery of decentralized trials in dementia prevention provided adequate safety checks and balances are included. A total of 40 recommendations are presented, spanning aspects of decentralized clinical trials, including safety, dispensing, outcome assessment, and data collection.

Discussion

These recommendations provide an accessible, pragmatic guide for the design and conduct of remote medication trials for dementia prevention.

Highlights

Clinical trials of medication have begun adopting decentralized approaches. Researchers in the field lack guidance on what would be appropriate circumstances and frameworks for what would be appropriate circumstances and frameworks for the use of decentralized trial methods in dementia prevention. The present report provides consensus-based expert recommendations for decentralized clinical trials for dementia prevention.

SUBMITTER: Howard L

PROVIDER: S-EPMC11247660 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature

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Publications

Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance.

Howard Leanne L Abdelnour Carla C Abner Erin L EL Allegri Ricardo F RF Dodge Hiroko H HH Gauthier Serge S Hoyos Camilla M CM Jicha Gregory A GA Kehoe Patrick G PG Mummery Catherine J CJ Ogunniyi Adesola A Scarmeas Nikolaos N Chen Xiaoying X Titiner Jodie R JR Weber Christopher R CR Peters Ruth R

Alzheimer's & dementia : the journal of the Alzheimer's Association 20240602 7

<h4>Introduction</h4>Recent growth in the functionality and use of technology has prompted an increased interest in the potential for remote or decentralized clinical trials in dementia. There are many potential benefits associated with decentralized medication trials, but we currently lack specific recommendations for their delivery in the dementia field.<h4>Methods</h4>A modified Delphi method engaged an expert panel to develop recommendations for the conduct of decentralized medication trials ...[more]

PMID: 38824659

Similar Datasets

Project description:ImportanceLess than 5% of patients with cancer enroll in a clinical trial, partly due to financial and logistic burdens, especially among underserved populations. The COVID-19 pandemic marked a substantial shift in the adoption of decentralized trial operations by pharmaceutical companies.ObjectiveTo assess the current global state of adoption of decentralized trial technologies, understand factors that may be driving or preventing adoption, and highlight aspirations and direction for industry to enable more patient-centric trials.Design, setting, and participantsThe Bloomberg New Economy International Cancer Coalition, composed of patient advocacy, industry, government regulator, and academic medical center representatives, developed a survey directed to global biopharmaceutical companies of the coalition from October 1 through December 31, 2022, with a focus on registrational clinical trials. The data for this survey study were analyzed between January 1 and 31, 2023.ExposureAdoption of decentralized clinical trial technologies.Main outcomes and measuresThe survey measured (1) outcomes of different remote monitoring and data collection technologies on patient centricity, (2) adoption of these technologies in oncology and all therapeutic areas, and (3) barriers and facilitators to adoption using descriptive statistics.ResultsAll 8 invited coalition companies completed the survey, representing 33% of the oncology market by revenues in 2021. Across nearly all technologies, adoption in oncology trials lags that of all trials. In the current state, electronic diaries and electronic clinical outcome assessments are the most used technology, with a mean (SD) of 56% (19%) and 51% (29%) adoption for all trials and oncology trials, respectively, whereas visits within local physician networks is the least adopted at a mean (SD) of 12% (18%) and 7% (9%), respectively. Looking forward, the difference between the current and aspired adoption rate in 5 years for oncology is large, with respondents expecting a 40% or greater absolute adoption increase in 8 of the 11 technologies surveyed. Furthermore, digitally enabled recruitment, local imaging capabilities, and local physician networks were identified as technologies that could be most effective for improving patient centricity in the long term.Conclusions and relevanceThese findings may help to galvanize momentum toward greater adoption of enabling technologies to support a new paradigm of trials that are more accessible, less burdensome, and more inclusive.

Dataset Information

Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance.

Introduction

Methods

Results

Discussion

Highlights

Publications

Decentralized clinical trials for medications to reduce the risk of dementia: Consensus report and guidance.

Similar Datasets

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