ArticleTherapeutic innovation & regulatory science2017
Overview of FDA's Expanded Access Program for Investigational Drugs.
Article in Therapeutic innovation & regulatory science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 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
36 citing papers in PubMed, 81 citations in OpenAlex.
- Multicenter Expanded Access Protocol for Research Through Access to Trehalose in People With Amyotrophic Lateral Sclerosis.Muscle & nerve · 2025Trial
- Equity and capacity to benefit from early access to medicines schemes.International journal for equity in health · 2025Review
- The Ethics of the "Right-to-Try" Movement in an Era of Regulatory Flux.Therapeutic innovation & regulatory science · 2025Review
- Neighborhood characteristics of expanded access patients at an academic referral center.Journal of clinical and translational science · 2025Article
- Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production.Frontiers in bioengineering and biotechnology · 2025Review
- Advancing Phage Therapy: A Comprehensive Review of the Safety, Efficacy, and Future Prospects for the Targeted Treatment of Bacterial Infections.Infectious disease reports · 2024Review
- Combating antibiotic resistance in a one health context: a plethora of frontiers.One health outlook · 2024Review
- Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.The European journal of health economics : HEPAC : health economics in prevention and care · 2024Review
- Multicenter expanded access program for access to investigational products for amyotrophic lateral sclerosis.Muscle & nerve · 2024Article
- A Qualitative Interview Study on Expanded Access Clinical Trials for Compassionate Use in Japan.Patient preference and adherence · 2024Article
- A nationwide prospective cohort study on safety of the 17D-204 yellow fever vaccine during a vaccine shortage in Japan.Journal of travel medicine · 2023Article
- Vaccine Innovation Meta-Model for Pandemic Contexts.Journal of pharmaceutical innovation · 2023Article
- Taking AIM at serious illness: implementing an access to investigational medicines expanded access program.Frontiers in medicine · 2023Article
- Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
- Characteristics of the Compassionate Use Program in Japan: An Analysis of Expanded Access Clinical Trials from 2016 to 2021.Clinical pharmacology and therapeutics · 2022Article
- Article
- Potential cannabidiol (CBD) repurposing as antibacterial and promising therapy of CBD plus polymyxin B (PB) against PB-resistant gram-negative bacilli.Scientific reports · 2022Article
- International Country-Level Trends, Factors, and Disparities in Compassionate Use Access to Unlicensed Products for Patients With Serious Medical Conditions.JAMA health forum · 2022Article
- Tracking the phage trends: A comprehensive review of applications in therapy and food production.Frontiers in microbiology · 2022Review
- The continuation of clinical trials in times of war: A need to develop ethics and situationally adaptive clinical research guidelines.Frontiers in medicine · 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
4 authors at 2 institutions in 1 country.
Funding
Abstract
Expanded access, also called "compassionate use," provides a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials. The US Food and Drug Administration (FDA) facilitates the expanded access process; however, access to investigational treatments requires not only FDA's review and authorization but also the active involvement and cooperation of other parties, including drug companies and health care providers, in order to be successful.
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.