584 related articles for article (PubMed ID: 34003270)
1. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.
Hutchinson N; Carlisle B; Doussau A; Bosan R; Gumnit E; MacPherson A; Fergusson DA; Kimmelman J
JAMA Netw Open; 2021 May; 4(5):e2110456. PubMed ID: 34003270
[TBL] [Abstract][Full Text] [Related]
2. Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017.
Zhang AD; Puthumana J; Downing NS; Shah ND; Krumholz HM; Ross JS
JAMA Netw Open; 2020 Apr; 3(4):e203284. PubMed ID: 32315070
[TBL] [Abstract][Full Text] [Related]
3. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
[TBL] [Abstract][Full Text] [Related]
4. The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs.
Ladanie A; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
Trials; 2018 Sep; 19(1):505. PubMed ID: 30231912
[TBL] [Abstract][Full Text] [Related]
5. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
[TBL] [Abstract][Full Text] [Related]
6. Quantifying Patient Investment in Novel Neurological Drug Development.
MacPherson A; Gumnit E; Ouimet C; Hutchinson N; Kieburtz K; Pearson TS; Kimmelman J
Neurotherapeutics; 2022 Sep; 19(5):1507-1513. PubMed ID: 35764764
[TBL] [Abstract][Full Text] [Related]
7. Participation of women and sex analyses in late-phase clinical trials of new molecular entity drugs and biologics approved by the FDA in 2007-2009.
Poon R; Khanijow K; Umarjee S; Fadiran E; Yu M; Zhang L; Parekh A
J Womens Health (Larchmt); 2013 Jul; 22(7):604-16. PubMed ID: 23768021
[TBL] [Abstract][Full Text] [Related]
8. Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval.
Shaw DL; Dhruva SS; Ross JS
J Manag Care Spec Pharm; 2018 Dec; 24(12):1230-1238. PubMed ID: 30479199
[TBL] [Abstract][Full Text] [Related]
9. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.
Wallach JD; Egilman AC; Dhruva SS; McCarthy ME; Miller JE; Woloshin S; Schwartz LM; Ross JS
BMJ; 2018 May; 361():k2031. PubMed ID: 29794072
[TBL] [Abstract][Full Text] [Related]
10. Comparison of Long-term Survival Benefits in Trials of Immune Checkpoint Inhibitor vs Non-Immune Checkpoint Inhibitor Anticancer Agents Using ASCO Value Framework and ESMO Magnitude of Clinical Benefit Scale.
Everest L; Shah M; Chan KKW
JAMA Netw Open; 2019 Jul; 2(7):e196803. PubMed ID: 31290990
[TBL] [Abstract][Full Text] [Related]
11. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.
Feinberg BA; Gajra A; Zettler ME; Phillips TD; Phillips EG; Kish JK
Value Health; 2020 Oct; 23(10):1358-1365. PubMed ID: 33032780
[TBL] [Abstract][Full Text] [Related]
12. Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.
Vivot A; Jacot J; Zeitoun JD; Ravaud P; Crequit P; Porcher R
Ann Oncol; 2017 May; 28(5):1111-1116. PubMed ID: 28453694
[TBL] [Abstract][Full Text] [Related]
13. Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration.
Tibau A; Ocana A; Anguera G; Seruga B; Templeton AJ; Barnadas A; Amir E
JAMA Oncol; 2016 Jun; 2(6):744-50. PubMed ID: 26940233
[TBL] [Abstract][Full Text] [Related]
14. Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review.
Arciero V; Delos Santos S; Koshy L; Rahmadian A; Saluja R; Everest L; Parmar A; Chan KKW
JAMA Netw Open; 2021 Feb; 4(2):e2033004. PubMed ID: 33570573
[TBL] [Abstract][Full Text] [Related]
15. Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration.
Tibau A; Molto C; Ocana A; Templeton AJ; Del Carpio LP; Del Paggio JC; Barnadas A; Booth CM; Amir E
J Natl Cancer Inst; 2018 May; 110(5):486-492. PubMed ID: 29244173
[TBL] [Abstract][Full Text] [Related]
16. Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations.
Jiang DM; Chan KKW; Jang RW; Booth C; Liu G; Amir E; Mason R; Everest L; Elimova E
Cancer Med; 2019 Apr; 8(4):1584-1593. PubMed ID: 30848108
[TBL] [Abstract][Full Text] [Related]
17. Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.
Wallach JD; Luxkaranayagam AT; Dhruva SS; Miller JE; Ross JS
BMC Med; 2019 Jun; 17(1):117. PubMed ID: 31203816
[TBL] [Abstract][Full Text] [Related]
18. Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products.
Moore TJ; Mouslim MC; Blunt JL; Alexander GC; Shermock KM
JAMA Intern Med; 2021 Jan; 181(1):52-60. PubMed ID: 33031559
[TBL] [Abstract][Full Text] [Related]
19. Enrollment of Black Participants in Pivotal Clinical Trials Supporting US Food and Drug Administration Approval of Chimeric Antigen Receptor-T Cell Therapy for Hematological Malignant Neoplasms.
Al Hadidi S; Schinke C; Thanendrarajan S; Zangari M; van Rhee F
JAMA Netw Open; 2022 Apr; 5(4):e228161. PubMed ID: 35442451
[TBL] [Abstract][Full Text] [Related]
20. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Naci H; Smalley KR; Kesselheim AS
JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]