ArticleClinical pharmacology and therapeutics2015
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Article in Clinical pharmacology and therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers.
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Who cites it
70 citing papers in PubMed.
- Ensuring safety and accountability in China's biomedical translation system.Nature biotechnology · 2026Article
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
- Real-world effectiveness of pembrolizumab for first-line treatment of metastatic non-small-cell lung cancer: a decade of evidence and experience.Future oncology (London, England) · 2026Review
- Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority.NPJ digital medicine · 2026Review
- A Multidimensional Definition of Pre-Osteoarthritis: Toward 21st-Century Subclinical Detection and Targeted Intervention.International journal of molecular sciences · 2025Review
- Artificial Intelligence in Small-Molecule Drug Discovery: A Critical Review of Methods, Applications, and Real-World Outcomes.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Enhancing translational research impact through collaborative process innovation.Journal of clinical and translational science · 2025Article
- Early access disparities in innovative therapies across the US, EU, China, and Japan.Frontiers in medicine · 2025Article
- Advice to the FDA to Improve Its Proposed Guidelines to Rationalize Clinical Trials by Restricting Placebo Control, Preventing Low-Powered Studies, and Disallowing Studies Where Bioavailability Is Not Proven.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Evolving assessment pathways for precision oncology medicines to improve patient access: a tumor-agnostic lens.The oncologist · 2024Article
- Escalating costs of innovative medicines: perspective and proposals.Frontiers in public health · 2024Article
- Design differences and variation in results between randomised trials and non-randomised emulations: meta-analysis of RCT-DUPLICATE data.BMJ medicine · 2024Article
- DESIGN DIFFERENCES EXPLAIN VARIATION IN RESULTS BETWEEN RANDOMIZED TRIALS AND THEIR NON-RANDOMIZED EMULATIONS.medRxiv : the preprint server for health sciences · 2023Article
- RAPID framework for improved access to precision oncology for lethal disease: Results from a modified multi-round delphi study.Frontiers in health services · 2023Article
- [Evidence-based health care with pharmaceuticals for rare diseases: the role of digitalisation].Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2022Review
- Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.Nature communications · 2022Article
- Cost-effectiveness Analysis of Pertuzumab With Trastuzumab in Patients With Metastatic Breast Cancer.JAMA oncology · 2022Article
- The value of anticancer drugs - a regulatory view.Nature reviews. Clinical oncology · 2022Review
- Challenges and Opportunities With Routinely Collected Data on the Utilization of Cancer Medicines. Perspectives From Health Authority Personnel Across 18 European Countries.Frontiers in pharmacology · 2022Article
- A Framework for Visualizing Study Designs and Data Observability in Electronic Health Record Data.Clinical epidemiology · 2022Article
10 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
41 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.
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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.