ReviewClinical and translational science2021
Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm.
Review in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
37 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.Nature medicine · 2024Guideline
- An Investigation of Instability in Dried Blood Spot Samples for Pharmacokinetic Sampling in Phase 3 Trials of Verubecestat.The AAPS journal · 2022Trial
- Patient engagement in protocol development for rare disease clinical trials: a framework.Research involvement and engagement · 2026Article
- Review
- A real-world feasibility study: at home longitudinal use of the Cumulus NeuLogiq® platform for electrophysiological and neurocognitive measures in patients with mild Alzheimer's Disease dementia.Frontiers in digital health · 2026Article
- Advancing Early Clinical Trials: The Transformative Potential of Decentralized Designs and Digital Technologies in Phase 1 Clinical Trial.Clinical pharmacology and therapeutics · 2025Article
- Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.Journal of medical Internet research · 2025Article
- Developing digital health technologies for frontotemporal degeneration.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Impact of Platform Design and Usability on Adherence and Retention: Randomized Web- and Mobile-Based Longitudinal Study.Journal of participatory medicine · 2025Article
- Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals.Contemporary clinical trials communications · 2025Article
- Building a Digital Health Research Platform to Enable Recruitment, Enrollment, Data Collection, and Follow-Up for a Highly Diverse Longitudinal US Cohort of 1 Million People in the All of Us Research Program: Design and Implementation Study.Journal of medical Internet research · 2025Article
- Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China.Frontiers in medicine · 2025Article
- At-Home Self-Collection of Pharmacokinetic Data: Design and Results From a Phase 1 Open-Label Feasibility Trial.Clinical pharmacology in drug development · 2025Article
- The Digital Platform and Its Emerging Role in Decentralized Clinical Trials.Journal of medical Internet research · 2024Article
- Digital biomarkers for precision diagnosis and monitoring in Parkinson's disease.NPJ digital medicine · 2024Review
- Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis.JMIR cancer · 2024Article
- N-of-1 health optimization: Digital monitoring of biomarker dynamics to gamify adherence to metabolic switching.PNAS nexus · 2024Article
- The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data.Therapeutic innovation & regulatory science · 2024Review
- Decentralisation in Clinical Trials and Patient Centricity: Benefits and Challenges.Pharmaceutical medicine · 2024Review
- Establishment of Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT): a multi-stakeholder public-private partnership-based organization to accelerate the transformation of clinical trials.Translational and clinical pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The rapidly advancing field of digital health technologies provides a great opportunity to radically transform the way clinical trials are conducted and to shift the clinical trial paradigm from a site-centric to a patient-centric model. Merck's (Kenilworth, NJ) digitally enabled clinical trial initiative is focused on introduction of digital technologies into the clinical trial paradigm to reduce patient burden, improve drug adherence, provide a means of more closely engaging with the patient, and enable higher quality, faster, and more frequent data collection. This paper will describe the following four key areas of focus from Merck's digitally enabled clinical trials initiative, along with corresponding enabling technologies: (i) use of technologies that can monitor and improve drug adherence (smart dosing), (ii) collection of pharmacokinetic (PK), pharmacodynamic (PD), and biomarker samples in an outpatient setting (patient-centric sampling), (iii) use of digital devices to collect and measure physiological and behavioral data (digital biomarkers), and (iv) use of data platforms that integrate digital data streams, visualize data in real-time, and provide a means of greater patient engagement during the trial (digital platform). Furthermore, this paper will discuss the synergistic power in implementation of these approaches jointly within a trial to enable better understanding of adherence, safety, efficacy, PK, PD, and corresponding exposure-response relationships of investigational therapies as well as reduced patient burden for clinical trial participation. Obstacle and challenges to adoption and full realization of the vision of patient-centric, digitally enabled trials will also be discussed.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.