Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences.

ingentiumby ingentium

In Clinical Trials Literature.

Decentralized Clinical Trials in the Era of Real-World Evidence: A Critical Assessment of Recent Experiences.

Publication date: Sep 01, 2025

Since the first decentralized clinical trial (DCT) was conducted in 2011, there has been an increased usage of DCT due to its benefits of patient-centricity and generalizability of findings. This trend was further expedited by the global COVID-19 pandemic. We identified 23 case studies across various therapeutic areas and grouped them into different categories according to their purposes-by necessity, for operational benefits, to address unique research questions, to validate innovative digital endpoints, or to validate decentralization as a clinical research platform. We leveraged the estimand framework from ICH E9(R1) including its five attributes (population, treatment, variable, intercurrent event, and summary measure) to critically assess their design and conduct. Common trends, opportunities, and challenges were reported along with recommendations for future DCT. Of note, intercurrent events and associated handling strategies are largely not present when reporting DCT. This is an area that can impact study conclusions and require more dedicated efforts when designing new DCTs.

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Concepts Keywords
Decentralization case study
Global COVID-19
Pandemic decentralized clinical trial
Trial digital healthcare technology
estimand
Humans
Pandemics
Research Design
SARS-CoV-2

Semantics

Type Source Name
disease MESH COVID-19 pandemic
drug DRUGBANK Silver
disease IDO site
drug DRUGBANK Etoperidone
drug DRUGBANK Acetylsalicylic acid
disease IDO intervention
disease MESH atrial fibrillation
drug DRUGBANK Trestolone
disease MESH emergency
disease MESH infection
drug DRUGBANK Hydroxychloroquine
disease MESH irritable bowel syndrome
disease MESH cystic fibrosis
disease MESH sleep quality
disease MESH rare diseases
drug DRUGBANK Pembrolizumab
drug DRUGBANK Alectinib
disease MESH tumors
disease IDO facility
drug DRUGBANK Celiprolol
disease MESH Vascular Ehlers Danlos Syndrome
drug DRUGBANK Omega-3 fatty acids
disease MESH autism spectrum disorder
drug DRUGBANK Coenzyme M
disease MESH acne vulgaris
drug DRUGBANK Atezolizumab
drug DRUGBANK Zoledronic acid
disease MESH parkinsonism
disease MESH osteoporosis
disease MESH contraindications
drug DRUGBANK Trihexyphenidyl
drug DRUGBANK Profenamine
disease MESH influenza
disease MESH stroke
disease MESH bleeding
drug DRUGBANK Ademetionine
disease MESH death
disease MESH dementia
drug DRUGBANK Atorvastatin
drug DRUGBANK Indoleacetic acid
disease MESH major depressive disorder
disease MESH depression
disease MESH movement disorders
drug DRUGBANK Tolterodine
disease MESH Overactive Bladder
drug DRUGBANK Stanolone
disease IDO blood
drug DRUGBANK Crisaborole
disease MESH dermatitis
drug DRUGBANK Spinosad
drug DRUGBANK Aspartame
disease IDO quality
disease MESH abnormalities
disease MESH myocardial infarction
drug DRUGBANK L-Valine
disease MESH treatment failure
drug DRUGBANK Ranitidine
disease IDO process
disease MESH chronic conditions
disease MESH privacy
disease MESH Acute Myeloid Leukemia
pathway KEGG Acute myeloid leukemia
disease MESH Leukemia
disease MESH Lymphoma
disease MESH ramp
drug DRUGBANK Gold
drug DRUGBANK D-Alanine
drug DRUGBANK Ramucirumab
disease MESH Autism

Original Article

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