ArticleClinical pharmacology and therapeutics2019
Innovation in Regulatory Science Is Meeting Evolution of Clinical Evidence Generation.
Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed, 24 citations in OpenAlex.
- Managing costly new drugs to support equitable access: international collaboration and patient engagement to assess value, and managed entry agreements.BMJ (Clinical research ed.) · 2025Article
- Current landscape of innovative drug development and regulatory support in China.Signal transduction and targeted therapy · 2025Review
- Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry.Pharmaceutics · 2024Review
- Review
- Introduction of managed entry agreements in Korea: Problem, policy, and politics.Frontiers in pharmacology · 2023Article
- Global Regulatory and Public Health Initiatives to Advance Pediatric Drug Development for Rare Diseases.Therapeutic innovation & regulatory science · 2022Review
- Pulmonary lesions: correlative study of dynamic triple-phase enhanced CT perfusion imaging with tumor angiogenesis and vascular endothelial growth factor expression.BMC medical imaging · 2021Article
- Regulatory science: The need for empowering Indian innovation.The Indian journal of medical research · 2021Article
- The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions.Pharmaceutical medicine · 2021Article
- Mitigating Deficiencies in Evidence during Regulatory Assessments of Advanced Therapies: A Comparative Study with Other Biologicals.Molecular therapy. Methods & clinical development · 2020Article
- Real-World Evidence Studies of Oritavancin Use in Gram-Positive Infections Augment Randomized Controlled Trials to Address Clinical and Economic Outcomes.Drugs - real world outcomes · 2020Article
- Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.Digital biomarkers · 2020Review
- Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: Findings and implications.Medicine access @ point of careArticle
- Should Medical Devices Be Regulated as Rigorously as Drugs?The Canadian journal of hospital pharmacyArticle
- Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.Digital biomarkersArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
At the turn of the century, the pharmaceutical industry began a transition toward a focus on oncology, rare diseases, and other areas of high unmet need that required a new, more complex approach to drug development. For many of these disease states and novel approaches to therapy, traditional approaches to clinical trial design fall short, and a number of innovative trial designs have emerged. In light of these changes, regulators across the globe are implementing new programs to provide regular development program support, facilitate accelerated access, use real-world data, and use digital tools to improve patients' lives. Emerging market regulators are also focusing on simplifying their regulatory pathways via regional harmonization schemes with varying levels of ambition. These changes in the external environment imply that biopharma regulatory teams need to adapt and evolve, leveraging digital tools, data, and analytics, and positioning themselves as strategic advisors during development.
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.