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Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Gyawali B, Hey SP, Kesselheim AS. Gyawali B, et al. JAMA Intern Med. 2019 Jul 1;179(7):906-913. doi: 10.1001/jamainternmed.2019.0462. JAMA Intern Med. 2019. PMID: 31135808 Free PMC article. Review.
IMPORTANCE: The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigational cancer drugs to be approved by demonstrating a beneficial effect on a surrogate measure (eg, progression-free surv …
IMPORTANCE: The US Food and Drug Administration's (FDA's) accelerated approval pathway allows investigati …
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
Cherla A, Naci H, Kesselheim AS, Gyawali B, Mossialos E. Cherla A, et al. JAMA Intern Med. 2021 Apr 1;181(4):490-498. doi: 10.1001/jamainternmed.2020.8441. JAMA Intern Med. 2021. PMID: 33616607 Free PMC article.
IMPORTANCE: Numerous cancer drugs have received accelerated approval from the US Food and Drug Administration (FDA) based on clinical trial outcomes that are otherwise not acceptable for traditional FDA approval; the acce
IMPORTANCE: Numerous cancer drugs have received accelerated approval from the US Food and Drug Adm …
An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
Chen EY, Raghunathan V, Prasad V. Chen EY, et al. JAMA Intern Med. 2019 Jul 1;179(7):915-921. doi: 10.1001/jamainternmed.2019.0583. JAMA Intern Med. 2019. PMID: 31135822 Free PMC article. Review.
MAIN OUTCOMES AND MEASURES: The primary outcome was the RR used as the basis for FDA approval. The secondary outcome was rate of complete response. RESULTS: Eighty-five indications for 59 cancer drugs were identified, 32 (38%) received regular appro
MAIN OUTCOMES AND MEASURES: The primary outcome was the RR used as the basis for FDA approval. The secondary outcome was rate of comp …
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. Ladanie A, et al. JAMA Netw Open. 2020 Nov 2;3(11):e2024406. doi: 10.1001/jamanetworkopen.2020.24406. JAMA Netw Open. 2020. PMID: 33170262 Free PMC article.
IMPORTANCE: Clinical trial evidence used to support drug approval is typically the only information on benefits and harms that patients and clinicians can use for decision-making when novel cancer therapies become available. ...OBJECTIVE: To des …
IMPORTANCE: Clinical trial evidence used to support drug approval is typically the only information on benefits
AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter.
Griffiths GO, FitzGerald R, Jaki T, Corkhill A, Reynolds H, Ewings S, Condie S, Tilt E, Johnson L, Radford M, Simpson C, Saunders G, Yeats S, Mozgunov P, Tansley-Hancock O, Martin K, Downs N, Eberhart I, Martin JWB, Goncalves C, Song A, Fletcher T, Byrne K, Lalloo DG, Owen A, Jacobs M, Walker L, Lyon R, Woods C, Gibney J, Chiong J, Chandiwana N, Jacob S, Lamorde M, Orrell C, Pirmohamed M, Khoo S; AGILE investigators. Griffiths GO, et al. Trials. 2021 Jul 26;22(1):487. doi: 10.1186/s13063-021-05458-4. Trials. 2021. PMID: 34311777 Free PMC article.
BACKGROUND: There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. ...AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accele
BACKGROUND: There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. ...AGI …
FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA. Suzman DL, et al. Oncologist. 2019 Apr;24(4):563-569. doi: 10.1634/theoncologist.2018-0084. Epub 2018 Dec 12. Oncologist. 2019. PMID: 30541754 Free PMC article. Clinical Trial.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible …
The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in Ap …
Anaplastic lymphoma kinase tyrosine kinase inhibitors in non-small cell lung cancer.
Vavalà T, Mariniello A, Novello S. Vavalà T, et al. Transl Cancer Res. 2019 Jan;8(Suppl 1):S48-S54. doi: 10.21037/tcr.2018.10.23. Transl Cancer Res. 2019. PMID: 35117063 Free PMC article. Review.
Lung cancer still represents the leading cause of cancer-related mortality. ...In fact, among ALK TKIs available, crizotinib was the first to receive FDA accelerate approval for ALK rearranged NSCLC patients. ...
Lung cancer still represents the leading cause of cancer-related mortality. ...In fact, among ALK TKIs available, crizotinib w …
Clinical and outcome research in oncology. The need for integration.
Apolone G. Apolone G. Health Qual Life Outcomes. 2003 Apr 3;1:3. doi: 10.1186/1477-7525-1-3. Health Qual Life Outcomes. 2003. PMID: 12713667 Free PMC article.
Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but qu …
Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified e …
Effectiveness of stop smoking interventions among adults: protocol for an overview of systematic reviews and an updated systematic review.
Hersi M, Traversy G, Thombs BD, Beck A, Skidmore B, Groulx S, Lang E, Reynolds DL, Wilson B, Bernstein SL, Selby P, Johnson-Obaseki S, Manuel D, Pakhale S, Presseau J, Courage S, Hutton B, Shea BJ, Welch V, Morrow M, Little J, Stevens A. Hersi M, et al. Syst Rev. 2019 Jan 19;8(1):28. doi: 10.1186/s13643-018-0928-x. Syst Rev. 2019. PMID: 30660199 Free PMC article.
This protocol outlines an evidence review which will evaluate the benefits and harms of stop smoking interventions in adults. METHODS: The evidence review will consist of two stages. First, an overview of systematic reviews evaluating the benefits and harms of vario …
This protocol outlines an evidence review which will evaluate the benefits and harms of stop smoking interventions in adults. METHODS …
ACCELERATE - Five years accelerating cancer drug development for children and adolescents.
Pearson ADJ, Weiner SL, Adamson PC, Karres D, Reaman G, Rousseau R, Blanc P, Norga K, Skolnik J, Kearns P, Scobie N, Barry E, Marshall LV, Knox L, Caron H, Wariabharaj D, Pappo A, DuBois SG, Gore L, Kieran M, Weigel B, Fox E, Nysom K, de Rojas T, Vassal G. Pearson ADJ, et al. Eur J Cancer. 2022 May;166:145-164. doi: 10.1016/j.ejca.2022.01.033. Epub 2022 Mar 12. Eur J Cancer. 2022. PMID: 35290915 Free article. Review.
Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term side-effects for children and adolescents with cancer. The international multi-stakeholder organisation ACCELERATE was created to …
Rapid evaluation and subsequent regulatory approval of new drugs are critical to improving survival and reducing long-term sid …
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