FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2807780552> ?p ?o ?g. }

• W2807780552 endingPage "e180283" @default.
• W2807780552 startingPage "e180283" @default.
• W2807780552 abstract "<h3>Importance</h3> The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws. <h3>Objective</h3> To determine the timing and duration of expanded access programs for investigational medicines initiated prior to FDA approval. <h3>Design and Setting</h3> This cross-sectional study examined expanded access and compassionate use programs registered through August 1, 2017, identified from ClinicalTrials.gov and publicly available FDA documents. <h3>Main Outcomes and Measures</h3> Start date of each program and 3 key regulatory dates (investigational new drug application activation, initial new drug application submission, and FDA approval), and timing and duration of expanded access availability in relation to new drug application submission and FDA approval. <h3>Results</h3> Through ClinicalTrials.gov, 92 FDA-approved drugs and biologics with associated expanded access programs initiated prior to FDA approval were identified. These programs were initiated between September 1996 and June 2017 for medicines that were most commonly used to treat cancer (n = 46 [50.0%]); metabolic, endocrine, and genetic diseases (n = 16 [17.4%]); and infectious diseases (n = 14 [15.2%]). The median (interquartile range) premarket expanded access availability was 10.0 (6.0-19.5) months, constituting a median (interquartile range) of 14% (7%-25%) of the premarket clinical development period (investigational new drug application activation to FDA approval). Of 92 expanded access programs, 64 (69.6%) were initiated just before or after new drug application submission: 24 (26.1%) were initiated during the 6-month period before, and 40 (43.5%) in the 6 months after. <h3>Conclusions and Relevance</h3> Over the past 2 decades, expanded access programs have provided access to investigational medicines for which evidence of safety and effectiveness was established. For medicines that ultimately receive FDA approval, these findings suggest that the FDA and pharmaceutical industry have established a balance between investigational new drug access and protection of patients from therapies without established safety. This balance may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act." @default.
• W2807780552 created "2018-06-21" @default.
• W2807780552 creator A5031832642 @default.
• W2807780552 creator A5040621892 @default.
• W2807780552 creator A5041605241 @default.
• W2807780552 creator A5063151563 @default.
• W2807780552 date "2018-06-15" @default.
• W2807780552 modified "2023-09-25" @default.
• W2807780552 title "Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs" @default.
• W2807780552 cites W2520965749 @default.
• W2807780552 cites W2739632067 @default.
• W2807780552 cites W2756390229 @default.
• W2807780552 cites W2790495681 @default.
• W2807780552 cites W3022987889 @default.
• W2807780552 doi "https://doi.org/10.1001/jamanetworkopen.2018.0283" @default.
• W2807780552 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6324420" @default.
• W2807780552 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/30646072" @default.
• W2807780552 hasPublicationYear "2018" @default.
• W2807780552 type Work @default.
• W2807780552 sameAs 2807780552 @default.
• W2807780552 citedByCount "23" @default.
• W2807780552 countsByYear W28077805522019 @default.
• W2807780552 countsByYear W28077805522020 @default.
• W2807780552 countsByYear W28077805522021 @default.
• W2807780552 countsByYear W28077805522022 @default.
• W2807780552 countsByYear W28077805522023 @default.
• W2807780552 crossrefType "journal-article" @default.
• W2807780552 hasAuthorship W2807780552A5031832642 @default.
• W2807780552 hasAuthorship W2807780552A5040621892 @default.
• W2807780552 hasAuthorship W2807780552A5041605241 @default.
• W2807780552 hasAuthorship W2807780552A5063151563 @default.
• W2807780552 hasBestOaLocation W28077805521 @default.
• W2807780552 hasConcept C119060515 @default.
• W2807780552 hasConcept C126322002 @default.
• W2807780552 hasConcept C143998085 @default.
• W2807780552 hasConcept C2775832928 @default.
• W2807780552 hasConcept C2780035454 @default.
• W2807780552 hasConcept C2908902254 @default.
• W2807780552 hasConcept C2910824759 @default.
• W2807780552 hasConcept C2992293740 @default.
• W2807780552 hasConcept C3018890749 @default.
• W2807780552 hasConcept C502991105 @default.
• W2807780552 hasConcept C512399662 @default.
• W2807780552 hasConcept C535046627 @default.
• W2807780552 hasConcept C71924100 @default.
• W2807780552 hasConcept C98274493 @default.
• W2807780552 hasConceptScore W2807780552C119060515 @default.
• W2807780552 hasConceptScore W2807780552C126322002 @default.
• W2807780552 hasConceptScore W2807780552C143998085 @default.
• W2807780552 hasConceptScore W2807780552C2775832928 @default.
• W2807780552 hasConceptScore W2807780552C2780035454 @default.
• W2807780552 hasConceptScore W2807780552C2908902254 @default.
• W2807780552 hasConceptScore W2807780552C2910824759 @default.
• W2807780552 hasConceptScore W2807780552C2992293740 @default.
• W2807780552 hasConceptScore W2807780552C3018890749 @default.
• W2807780552 hasConceptScore W2807780552C502991105 @default.
• W2807780552 hasConceptScore W2807780552C512399662 @default.
• W2807780552 hasConceptScore W2807780552C535046627 @default.
• W2807780552 hasConceptScore W2807780552C71924100 @default.
• W2807780552 hasConceptScore W2807780552C98274493 @default.
• W2807780552 hasIssue "2" @default.
• W2807780552 hasLocation W28077805521 @default.
• W2807780552 hasLocation W28077805522 @default.
• W2807780552 hasLocation W28077805523 @default.
• W2807780552 hasLocation W28077805524 @default.
• W2807780552 hasOpenAccess W2807780552 @default.
• W2807780552 hasPrimaryLocation W28077805521 @default.
• W2807780552 hasRelatedWork W1565218950 @default.
• W2807780552 hasRelatedWork W2568006000 @default.
• W2807780552 hasRelatedWork W2588162428 @default.
• W2807780552 hasRelatedWork W2801130524 @default.
• W2807780552 hasRelatedWork W2807780552 @default.
• W2807780552 hasRelatedWork W2981880839 @default.
• W2807780552 hasRelatedWork W3183635082 @default.
• W2807780552 hasRelatedWork W3209353468 @default.
• W2807780552 hasRelatedWork W4233248044 @default.
• W2807780552 hasRelatedWork W4301195367 @default.
• W2807780552 hasVolume "1" @default.
• W2807780552 isParatext "false" @default.
• W2807780552 isRetracted "false" @default.
• W2807780552 magId "2807780552" @default.
• W2807780552 workType "article" @default.