A Road Map for Peer Review of Real-World Evidence Studies on Safety and Effectiveness of Treatments.

"Funding and Duality of Interest. A.G.W. has received research funding from the NIH, Agency for Healthcare Research and Quality, Patient-Centered Outcomes Research Institute, Centers for Disease Control and Prevention, FDA, the State of Florida, the Bill and Melinda Gates Foundation, and Merck Sharpe & Dohme. She has received consulting honoraria from Arbor Pharmaceuticals, Bayer, Ipsen, and Genentech, Inc. V.E. is a salaried employee of Aarhus University, which receives institutional research funding from public and private entities, including regulators, pharmaceutical companies, and contract research organizations. J.S.B. was an employee of the Harvard Pilgrim Health Care Institute (HPHCI) during the project. He is now Chief Scientific Officer at TriNetX, LLC. He has received research funding via HPHCI from the NIH, Patient-Centered Outcomes Research Institute, FDA, the Biologics and Biosimilars Collective Intelligence Consortium, the Reagan-Udall Foundation, GSK, Janssen, and Pfizer. He has received consulting fees from Forian, Inc., Intercept Pharmaceuticals, Jazz Pharmaceuticals, Mathematica Policy Research, and IBM. He is on an external advisory board of PicnicHealth. T.S. receives investigator-initiated research funding and support as a principal investigator (R01 AG056479) from the National Institute on Aging and as a coinvestigator (R01 HL118255 and R01MD011680) from the NIH. He also receives salary support as director of comparative effectiveness research (CER), NC TraCS Institute, from a UNC clinical and translational science award (UL1TR002489), from the Center for Pharmacoepidemiology (current members GSK, UCB BioSciences, Takeda, AbbVie, and Boehringer Ingelheim), from a pharmaceutical company (Novo Nordisk), and by a generous contribution from Dr. Nancy A. Dreyer to the Department of Epidemiology, University of North Carolina at Chapel Hill. T.S. does not accept personal compensation of any kind from any pharmaceutical company. He owns stock in Novartis, Roche, and Novo Nordisk. M.Y.S. is a full-time employee of Evidera, Inc., PPD, a part of Thermo Fisher Scientific. When this article was prepared, she was a full-time employee of AstraZeneca, PLC, and she is a shareholder in the company."

"Funding and Duality of Interest. A.G.W. has received research funding from the NIH, Agency for Healthcare Research and Quality, Patient-Centered Outcomes Research Institute, Centers for Disease Control and Prevention, FDA, the State of Florida, the Bill and Melinda Gates Foundation, and Merck Sharpe & Dohme. She has received consulting honoraria from Arbor Pharmaceuticals, Bayer, Ipsen, and Genentech, Inc. V.E. is a salaried employee of Aarhus University, which receives institutional research funding from public and private entities, including regulators, pharmaceutical companies, and contract research organizations. J.S.B. was an employee of the Harvard Pilgrim Health Care Institute (HPHCI) during the project. He is now Chief Scientific Officer at TriNetX, LLC. He has received research funding via HPHCI from the NIH, Patient-Centered Outcomes Research Institute, FDA, the Biologics and Biosimilars Collective Intelligence Consortium, the Reagan-Udall Foundation, GSK, Janssen, and Pfizer. He has received consulting fees from Forian, Inc., Intercept Pharmaceuticals, Jazz Pharmaceuticals, Mathematica Policy Research, and IBM. He is on an external advisory board of PicnicHealth. T.S. receives investigator-initiated research funding and support as a principal investigator (R01 AG056479) from the National Institute on Aging and as a coinvestigator (R01 HL118255 and R01MD011680) from the NIH. He also receives salary support as director of comparative effectiveness research (CER), NC TraCS Institute, from a UNC clinical and translational science award (UL1TR002489), from the Center for Pharmacoepidemiology (current members GSK, UCB BioSciences, Takeda, AbbVie, and Boehringer Ingelheim), from a pharmaceutical company (Novo Nordisk), and by a generous contribution from Dr. Nancy A. Dreyer to the Department of Epidemiology, University of North Carolina at Chapel Hill. T.S. does not accept personal compensation of any kind from any pharmaceutical company. He owns stock in Novartis, Roche, and Novo Nordisk. M.Y.S. is a full-time employee of Evidera, Inc., PPD, a part of Thermo Fisher Scientific. When this article was prepared, she was a full-time employee of AstraZeneca, PLC, and she is a shareholder in the company."