ArticleJournal of pharmaceutical policy and practice2017
The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications.
Article in Journal of pharmaceutical policy and practice, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed.
- Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda.Frontiers in medicine · 2024Article
- The 'false hope' argument in discussions on expanded access to investigational drugs: a critical assessment.Medicine, health care, and philosophy · 2022Article
- Perspectives of Academic Oncologists About Offering Expanded Access to Investigational Drugs.JAMA network open · 2022Article
- Social pharmaceutical innovation and alternative forms of research, development and deployment for drugs for rare diseases.Orphanet journal of rare diseases · 2022Article
- Real-world data from expanded access programmes in health technology assessments: a review of NICE technology appraisals.BMJ open · 2022Review
- Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.British journal of clinical pharmacology · 2020Article
- Early Access Provision for Innovative Medicinal Products in Oncology: Challenges and Opportunities.Frontiers in oncology · 2020Article
- What do patients with unmet medical needs want? A qualitative study of patients' views and experiences with expanded access to unapproved, investigational treatments in the Netherlands.BMC medical ethics · 2019Article
- Patient advocacy organizations' information for patients on pre-approval access to investigational treatments.BMC research notes · 2019Article
- Current State of Compassionate Phage Therapy.Viruses · 2019Review
- Providing Patients with Critical or Life-Threatening Illnesses Access to Experimental Drug Therapy: A Guide to Clinical Trials and the US FDA Expanded Access Program.Pharmaceutical medicine · 2019Review
- Characterizing expanded access and compassionate use programs for experimental drugs.BMC research notes · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes. When expanded access becomes available to larger groups of patients, ethical issues gain prominence, including informed consent, funding issues, disparities in access, and potential adverse effects on clinical drug development. Physicians, patients and policy-makers should not shift the responsibility to address these issues to pharmaceutical companies, but work together to resolve them.
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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.