The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions
The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration’s expanded access pathway and the pathway created by the more recent...
| Главные авторы: | ; ; ; |
|---|---|
| Формат: | Электронный ресурс Статья |
| Язык: | Английский |
| Проверить наличие: | HBZ Gateway |
| Interlibrary Loan: | Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany) |
| Опубликовано: |
2019
|
| В: |
The Hastings Center report
Год: 2019, Том: 49, Выпуск: 2, Страницы: 36-39 |
| Online-ссылка: |
Presumably Free Access Volltext (lizenzpflichtig) Volltext (lizenzpflichtig) |
MARC
| LEADER | 00000naa a22000002c 4500 | ||
|---|---|---|---|
| 001 | 1937529576 | ||
| 003 | DE-627 | ||
| 005 | 20251002055614.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 251002s2019 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1002/hast.991 |2 doi | |
| 035 | |a (DE-627)1937529576 | ||
| 035 | |a (DE-599)KXP1937529576 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 1 |2 ssgn | ||
| 100 | 1 | |a Spector-Bagdady, Kayte |e VerfasserIn |4 aut | |
| 109 | |a Spector-Bagdady, Kayte |a Bagdady, Kayte Spector- | ||
| 245 | 1 | 4 | |a The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions |
| 264 | 1 | |c 2019 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 520 | |a The U.S. federal government provides two tracks for eligible patients to obtain access outside clinical trials to investigational interventions currently under study for potential clinical benefits: the Food and Drug Administration’s expanded access pathway and the pathway created by the more recent Right to Try Act. In this issue of the Hastings Center Report, with a critical focus on patients, industry, and the research enterprise, Kelly Folkers and colleagues frame the inherent challenges that these pathways are meant to solve and have also inadvertently created. But an additional key focus is how the relevant situations should be managed at the bedside and how the system risks both inefficient and inequitable access to options at the institutional level. Although either pathway could be helpful to patients, the challenges of having the pathways coexist are greater than the sum of their parts. Individual clinicians represent the front line of the regulatory and eligibility challenges of expanded access and right to try, making clinical education a critical component of a comprehensive approach to using them well. But it is medical institutions that must take the lead on supporting access to investigational options in the most equitable and effective manner possible. | ||
| 601 | |a Institution | ||
| 601 | |a Intervention | ||
| 700 | 1 | |a Weatherwax, Kevin J. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gravelin, Misty |e VerfasserIn |4 aut | |
| 700 | 1 | |a Shuman, Andrew G. |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |a Hastings Center |t The Hastings Center report |d Malden, Mass. : Wiley, 1971 |g 49(2019), 2, Seite 36-39 |h Online-Ressource |w (DE-627)341346551 |w (DE-600)2067369-3 |w (DE-576)258761822 |x 1552-146X |7 nnas |
| 773 | 1 | 8 | |g volume:49 |g year:2019 |g number:2 |g pages:36-39 |
| 856 | |u https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/hast.991 |x unpaywall |z Vermutlich kostenfreier Zugang |h publisher [deprecated] | ||
| 856 | 4 | 0 | |u https://doi.org/10.1002/hast.991 |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://onlinelibrary.wiley.com/doi/abs/10.1002/hast.991 |x Verlag |z lizenzpflichtig |3 Volltext |
| 912 | |a NOMM | ||
| 935 | |a mteo | ||
| 951 | |a AR | ||
| ELC | |a 1 | ||
| ITA | |a 1 |t 1 | ||
| LOK | |0 000 xxxxxcx a22 zn 4500 | ||
| LOK | |0 001 4779655757 | ||
| LOK | |0 003 DE-627 | ||
| LOK | |0 004 1937529576 | ||
| LOK | |0 005 20251002055614 | ||
| LOK | |0 008 251002||||||||||||||||ger||||||| | ||
| LOK | |0 035 |a (DE-Tue135)IxTheo#2025-09-26#66FC908048F7E0218EB18E55C941C55FA3EE384C | ||
| LOK | |0 040 |a DE-Tue135 |c DE-627 |d DE-Tue135 | ||
| LOK | |0 092 |o n | ||
| LOK | |0 852 |a DE-Tue135 | ||
| LOK | |0 852 1 |9 00 | ||
| LOK | |0 935 |a ixrk |a ixzs |a zota |a tiep | ||
| OAS | |a 1 | ||
| ORI | |a TA-MARC-ixtheoa001.raw | ||
