Evidence map›Paper›PMID 28507222›Full record

ArticleJournal of medical ethics2017

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies.

Michelle Hume, Linda L Lewis, Robert M Nelson

Open access · greenAbstract read
In one paragraph

Article in Journal of medical ethics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 7% of its field
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Modeling the Impact of PrEP Programs for Adolescent Sexual Minority Males Based on Empirical Estimates for the PrEP Continuum of Care.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2021
    Article
  4. Article
  5. Article
  6. Article
  7. HIV Prevention Interventions for Adolescents.Current HIV/AIDS reports · 2019
    Review
  8. Advancing HIV Biomedical Prevention Research for At-Risk Adolescents.Journal of acquired immune deficiency syndromes (1999) · 2018
    Article
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 at 3 institutions in 2 countries.

Michelle HumeDepartment of Psychiatry, University of Wisconsin, Madison, Wisconsin, USA.
Linda L LewisClinton Health Access Initiative, Boston, Massachusetts, USA.
Robert M NelsonOffice of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland, USA.
Clinton Health Access Initiative · USFood and Drug Administration · THUniversity of Wisconsin–Madison · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission.

Indexed as

Informed Consent By MinorsParental ConsentAdolescentAdultAnti-HIV AgentsBiomedical ResearchEthics, ResearchGoalsGovernment RegulationHIV InfectionsHumansInformed ConsentLicensureUnited StatesAnti-HIV AgentsChildrenClinical trialsHIV Infection and AIDSMinors/Parental ConsentResearch Ethics

Identifiers

PMID28507222
PMCPMC5685924
OpenAlexW2616194793

What OpenQuestion holds

Textmetadata
LicenceTDM
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.