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References
1.21st Century Cures Act . www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
2.FDA Medical Review – blinatumomab . www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005MedRedt.pdf
3.American Cancer Society's report on the status of cancer disparities in the United States, 2021 .
Islami
et al. CA Cancer J Clin. , 2022 Mar ; 72 (2 ):112 –143 . acjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21703
4.Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry . www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations
5.Geographic relationship between lung cancer clinical trial sites and patient prevalence and demographics in the Medicare Fee-for-service program .
Roy
et al. Cancer Epidemiol Biomarkers Prev , 2020 ; 29 (6 Suppl_2 ): Abstract D081. aacrjournals.org/cebp/article/29/6_Supplement_2/D081/237842/Abstract-D081-Geographic-relationship-between-lung
6.The GRACE Checklist: A Validated Assessment Tool for High Quality Observational Studies of Comparative Effectiveness . pubmed.ncbi.nlm.nih.gov/27668559/
7.Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable .
Dreyer
N.
Ther Innov Regul Sci. , 2018 May ; 52 (3 ):362 –368 . pubmed.ncbi.nlm.nih.gov/29714575/
8.FDA, NCI study will serve as prototype for streamlined pragmatic trials . friendsofcancerresearch.org/news/biocentury-fda-nci-study-will-serve-as-prototype-for-streamlined-pragmatic-trials/
9.RECOVERY trial website . www.recoverytrial.net/
10.Real-World Evidence—Where Are We Now?
Concato
J.
and
Corrigan-Curay
J.
N Engl J Med
, 2022 ; 386 :1680 –1682 . www.nejm.org/doi/full/10.1056/NEJMp2200089