Real-world evidence and regulatory drug approval

Michael J Raphael^{1

2

3}, Bishal Gyawali^{1

2

3

4}, Christopher M Booth^{5

6

7}

Affiliations

¹ Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Canada.
² Department of Oncology, Queen's University, Kingston, Canada.
³ Department of Public Health Sciences, Queen's University, Kingston, Canada.
⁴ Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
⁵ Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Canada. booth@queensu.ca.
⁶ Department of Oncology, Queen's University, Kingston, Canada. booth@queensu.ca.
⁷ Department of Public Health Sciences, Queen's University, Kingston, Canada. booth@queensu.ca.

Michael J Raphael et al. Nat Rev Clin Oncol. 2020 May.

. 2020 May;17(5):271-272.

doi: 10.1038/s41571-020-0345-7.

Michael J Raphael^{1

2

3}, Bishal Gyawali^{1

2

3

4}, Christopher M Booth^{5

6

7}

¹ Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Canada.
² Department of Oncology, Queen's University, Kingston, Canada.
³ Department of Public Health Sciences, Queen's University, Kingston, Canada.
⁴ Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
⁵ Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston, Canada. booth@queensu.ca.
⁶ Department of Oncology, Queen's University, Kingston, Canada. booth@queensu.ca.
⁷ Department of Public Health Sciences, Queen's University, Kingston, Canada. booth@queensu.ca.

No abstract available

References

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1. Przepiorka, D. et al. FDA approval: blinatumomab. Clin. Cancer Res. 21, 4035–4039 (2015). - DOI
1. Gokbuget, N. et al. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica 101, 1524–1533 (2016). - DOI
1. Kantarjian, H. et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N. Engl. J. Med. 376, 836–847 (2017). - DOI
1. Pease, A. M. et al. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ 357, j1680 (2017). - DOI