Evidence map›Paper›PMID 39913029›Full record

ReviewTherapeutic innovation & regulatory science2025

The Ethics of the "Right-to-Try" Movement in an Era of Regulatory Flux.

Neil Jain, David Ralston, Cheryl Erwin

Abstract readReview
PubMed Publisher
In one paragraph

Review in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Neil JainCenter of Excellence for Ethics, Humanities and Spirituality, Texas Tech University Health Sciences Center, Lubbock, TX, USA. njain5466@gmail.com.ORCID http://orcid.org/0000-0002-3452-2988
David RalstonCenter of Excellence for Ethics, Humanities and Spirituality, Texas Tech University Health Sciences Center, Lubbock, TX, USA.
Cheryl ErwinCenter of Excellence for Ethics, Humanities and Spirituality, Texas Tech University Health Sciences Center, Lubbock, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 signed on May 30, 2018 under President Trump has been championed by patient advocacy groups as a victory for individuals with life threatening illnesses willing to undergo experimental treatment. The act is not a novel idea, but rather a nuanced result of the previous attempts to challenge the US Food and Drug Administration's (FDA) authority on drug approval and distribution. Currently, right-to-try programs coexist with an already existing expanded access program run by the FDA. The difference is that right-to-try requests eliminate FDA guidance and authorization. The objectives of this study are to review prior historical challenges to the FDA and how they eventually influenced right-to-try movements, examine the law itself and its arguments written by advocates and critics, discuss how its implications fit into the current climate of regulatory flux, and propose the impacts it has on influencing patient care and the scientific process.

Indexed as

Compassionate Use TrialsDrug ApprovalHumansUnited StatesUnited States Food and Drug AdministrationAbigail allianceExpanded accessFDAGoldwater instituteRegulationRight-to-Try

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.