ReviewClinical and translational science2018
Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care.
Review in Clinical and translational science, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
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
30 citing papers in PubMed, 60 citations in OpenAlex.
- Integrating Real-World Data and Pharmacometrics to Bridge Evidence Gaps in Special Populations: A State-of-the-Art Review.Pharmaceutics · 2026Review
- Model-informed precision dosing of carboplatin in cancer patients by leveraging myelosuppression data from electronic health records.British journal of clinical pharmacology · 2026Article
- A scoping review on using real-world data to evaluate the effectiveness of mHealth applications.NPJ digital medicine · 2026Article
- Psilocybin in Neuropsychiatric Disorders: Seeking Valuable Evidence in History, Pure Science, Clinical Trials and Real-World Data (RWD).Brain sciences · 2026Review
- Review
- Real world data on digital remote refraction in a healthy population of 14,680 eyes.NPJ digital medicine · 2025Article
- Article
- The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring.Journal of medical Internet research · 2024Article
- Learning across diverse biomedical data modalities and cohorts: Challenges and opportunities for innovation.Patterns (New York, N.Y.) · 2024Review
- How Precise are Nanomedicines in Overcoming the Blood-Brain Barrier? A Comprehensive Review of the Literature.International journal of nanomedicine · 2024Review
- Continuous Improvement of Digital Health Applications Linked to Real-World Performance Monitoring: Safe Moving Targets?Mayo Clinic proceedings. Digital health · 2023Review
- Model-based approach to identify predictors of paclitaxel-induced myelosuppression in "real-world" administration.CPT: pharmacometrics & systems pharmacology · 2023Article
- Article
- The challenges of access to innovative medicines with limited evidence in the European Union.Frontiers in pharmacology · 2023Review
- Real-world data for precision public health of noncommunicable diseases: a scoping review.BMC public health · 2022Article
- Real-world data: a brief review of the methods, applications, challenges and opportunities.BMC medical research methodology · 2022Review
- RWD-Cockpit: Application for Quality Assessment of Real-world Data.JMIR formative research · 2022Article
- How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model.Clinical and translational science · 2022Article
- Integrating real-world data to accelerate and guide drug development: A clinical pharmacology perspective.Clinical and translational science · 2022Review
- The Effect of Digitization on the Safe Management of Anticoagulants.Applied clinical informatics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
Abstract
While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review provides an overview of real-world data (RWD) and related advances in the regulatory framework, and discusses their impact on clinical research and development. A framework for linking drug development decisions with the value proposition of the drug, utilizing pharmacokinetic-pharmacodynamic-pharmacoeconomic models, is introduced. The summary presented here is based on the presentations and discussion at the symposium entitled Innovation at the Intersection of Clinical Trials and Real-World Data to Advance Patient Care at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2017 Annual Meeting.
Indexed as
Identifiers
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.