Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

Authors: Califf, Robert M., Zarin, Deborah A., Kramer, Judith M., Sherman, Rachel F., Aberle, Laura H., Tasneem, Asba

Source: Califf, Robert M. and Zarin, Deborah A. and Kramer, Judith M. and Sherman, Rachel F. and Aberle, Laura H. and Tasneem, Asba (2012) Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010. JAMA: The Journal of the American Medical Association, 307 (17). pp. 1838-1847. ISSN 0098-7484

Relation: http://jama.ama-assn.org/content/307/17/1838.abstract; http://health-equity.pitt.edu/3906/

Remarks by the Commissioner of Food and Drugs

Authors: Califf, Robert M.

Source: Food and Drug Law Journal, 2023 Jan 01. 78(1), 1-6.

Access URL: https://www.jstor.org/stable/27253981

Identifying a stable and generalizable factor structure of major depressive disorder across three large longitudinal cohorts

Authors: Schilsky, Richard L. ^e, Allen, Jennifer ^f, Anderson, MaryAnn ^f, Anstrom, Kevin ^f, Araujo, Lucus ^f, Arges, Kristine ^f, Ardalan, Kaveh ^f, Baldwin, Bridget ^f, Balu, Suresh ^f, Bashir, Mustafa R. ^f, Bhapkar, Manju ^f, Bigelow, Robert ^f, Black, Tanya ^f, Blanco, Rosalia ^f, Bloomfield, Gerald ^f, Borkar, Durga ^f, Bouk, Leah ^f, Boulware, Ebony ^f, Brugnoni, Nikki ^f, Campbell, Erin ^f, Campbell, Paul ^f, Carin, Larry ^f, Cassella, Tammy Jo ^f, Cates, Tina ^f, Montgomery, Ranee Chatterjee ^f, Christian, Victoria ^f, Choong, John ^f, Cohen-Wolkowiez, Michael ^f, Cook, Elizabeth ^f, Cousins, Scott ^f, Crawford, Ashley ^f, Datta, Nisha ^f, Daubert, Melissa ^f, Davis, James ^f, Dirkes, Jillian ^f, Doan, Isabelle ^f, Dockery, Marie ^f, Douglas, Pamela S. ^f, Duckworth, Shelly ^f, Dunham, Ashley ^f, Dunn, Gary ^f, Ebersohl, Ryan ^f, Eckstrand, Julie ^f, Fang, Vivienne ^f, Flora, April ^f, Ford, Emily ^f, Foster, Lucia ^f, Fraulo, Elizabeth ^f, French, John ^f, Ginsburg, Geoffrey S. ^f, Green, Cindy ^f, Greene, Latoya ^f, Guptill, Jeffrey ^f, Hamel, Donna ^f, Hamill, Jennifer ^f, Harrington, Chris ^f, Harrison, Rob ^f, Hedges, Lauren ^f, Heidenfelder, Brooke ^f, Hernandez, Adrian F. ^f, Heydary, Cindy ^f, Hicks, Tim ^f, Hight, Lina ^f, Hopkins, Deborah ^f, Huang, Erich S. ^f, Huh, Grace ^f, Hurst, Jillian ^f, Inman, Kelly ^f, Janas, Gemini ^f, Jaffee, Glenn ^f, Johnson, Janace ^f, Keaton, Tiffanie ^f, Khouri, Michel ^f, King, Daniel ^f, Korzekwinski, Jennifer ^f, Koweek, Lynne H. ^f, Kuo, Anthony ^f, Kwee, Lydia ^f, Landis, Dawn ^f, Lipsky, Rachele ^f, Lopez, Desiree ^f, Lowry, Carolyn ^f, Marcom, Kelly ^f, Marsolo, Keith ^f, McAdams, Paige ^f, McCall, Shannon ^f, McGarrah, Robert ^f, McGugan, John ^f, Mee, Dani ^f, Mervin-Blake, Sabrena ^f, Mettu, Prithu ^f, Meyer, Mathias ^f, Meyers, Justin ^f, Miller, Calire N. ^f, Moen, Rebecca ^f, Muhlbaier, Lawrence H. ^f, Murphy, Michael ^f, Neely, Ben ^f, Newby, L. Kristin ^f, Nicoldson, Jayne ^f, Nguyen, Hoang ^f, Nguyen, Maggie ^f, O'Brien, Lori ^f, Onal, Sumru ^f, O'Quinn, Jeremey ^f, Page, David ^f, Pagidipati, Neha J. ^f, Parikh, Kishan ^f, Palmer, Sarah R. ^f, Patrick-Lake, Bray ^f, Pattison, Brenda ^f, Pencina, Michael ^f, Peterson, Eric D. ^f, Piccini, Jon ^f, Poole, Terry ^f, Povsic, Tom ^f, Provencher, Alicia ^f, Rabineau, Dawn ^f, Rich, Annette ^f, Rimmer, Susan ^f, Schwartz, Fides ^f, Serafin, Angela ^f, Shah, Nishant ^f, Shah, Svati ^f, Shields, Kelly ^f, Shipes, Steven ^f, Shrader, Peter ^f, Stiber, Jon ^f, Sutton, Lynn ^f, Swamy, Geeta ^f, Thomas, Betsy ^f, Torres, Sandra ^f, Tucci, Debara ^f, Twisdale, Anthony ^f, Walker, Brooke ^f, Whitney, Susan A. ^f, Williamson, Robin ^f, Wilverding, Lauren ^f, Wong, Charlene A. ^f, Wruck, Lisa ^f, Young, Ellen ^f, Perlmutter, Jane ^g, Krug, Sarah ^h, Bowman-Zatzkin, S. Whitney ⁱ, Assimes, Themistocles ^k, Bajaj, Vikram ^k, Cheong, Maxwell ^k, Das, Millie ^k, Desai, Manisha ^k, Fan, Alice C. ^k, Fleischmann, Dominik ^k, Gambhir, Sanjiv S. ^k, Gold, Garry ^k, Haddad, Francois ^k, Hong, David ^k, Langlotz, Curtis ^k, Liao, Yaping J. ^k, Lu, Rong ^k, Mahaffey, Kenneth W. ^k, Maron, David ^k, McCue, Rebecca ^k, Munshi, Rajan ^k, Rodriguez, Fatima ^k, Shashidhar, Sumana ^k, Sledge, George ^k, Spielman, Susie ^k, Spitler, Ryan ^k, Swope, Sue ^k, Williams, Donna ^k, Pepine, Carl J ^l, Lantos, John D ^m, Pignone, Michael ⁿ, Heagerty, Patrick ^o, Beskow, Laura ^p, Bernard, Gordon ^p, Abad, Kelley ^q, Angi, Giulia ^q, Califf, Robert M. ^q, Deang, Lawrence ^q, Huynh, Joy ^q, Liu, Manway ^q, Mao, Cherry ^q, Magdaleno, Michael ^q, Marks, William J., Jr. ^q, Mega, Jessica ^q, Miller, David ^q, Ong, Nicole ^q, Patel, Darshita ^q, Ridaura, Vanessa ^q, Shore, Scarlet ^q, Short, Sarah ^q, Tran, Michelle ^q, Vu, Veronica ^q, Wong, Celeste ^q, Green, Robert C. ^r, Hernandez, John ^s, Benge, Jolene ^t, Negrete, Gislia ^t, Sierra, Gelsey ^t, Schaack, Terry ^t, Tseng, Vincent W.S. ^{a, ⁎}, Tharp, Jordan A. ^a, Reiter, Jacob E. ^{a, b}, Ferrer, Weston ^a, Hong, David S. ^b, Doraiswamy, P. Murali ^{c, d}, Nickels, Stefanie ^a

Source: In Psychiatry Research March 2024 333

Remarks by the Commissioner of Food and Drugs

Authors: Califf, Robert M.

Source: Food and Drug Law Journal, 2022 Jan 01. 77(1), 1-5.

Access URL: https://www.jstor.org/stable/27161553

General Anxiety Disorder-7 Questionnaire as a marker of low socioeconomic status and inequity

Authors: Nunes, Julio C., Carroll, Megan K., Mahaffey, Kenneth W., Califf, Robert M., Doraiswamy, P. Murali, Short, Sarah, Shah, Svati H., Swope, Susan, Williams, Donna, Hernandez, Adrian F., Hong, David S.

Source: In Journal of Affective Disorders 15 November 2022 317:287-297

The Beginning of a "Regulatory Renaissance": Positioning Regulatory Coverage at the Interface of Human Expertise and Digital Support.

Authors: Jones, James, Califf, Robert M.

Source: Therapeutic Innovation & Regulatory Science; May2025, Vol. 59 Issue 3, p403-408, 6p

Is regulatory science ready for artificial intelligence?

Authors: Hartung, Thomas, Whelan, Maurice, Tong, Weida, Califf, Robert M.

Source: NPJ Digital Medicine; 4/11/2025, Vol. 8 Issue 1, p1-5, 5p

The Ecosystem to Support People With Heart Failure

Authors: Califf, Robert M.

Source: In Journal of Cardiac Failure April 2022 28(4):650-658

Plasma Volume Status and Its Association With In-Hospital and Postdischarge Outcomes in Decompensated Heart Failure

Authors: Fudim, Marat, Lerman, Joseph B., Page, Courtney, Alhanti, Brooke, Califf, Robert M., Ezekowitz, Justin A., Girerd, Nicolas, Grodin, Justin L., Miller, Wayne L., Pandey, Ambarish, Rossignol, Patrick, Starling, Randall C., Tang, W.H. Wilson, Zannad, Faiez, Hernandez, Adrian F., O'connor, Christopher M., Mentz, Robert J.

Source: In Journal of Cardiac Failure March 2021 27(3):297-308

FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.

Authors: Warraich, Haider J.¹, haider.warraich@fda.hhs.gov, Tazbaz, Troy¹, Califf, Robert M.¹

Source: JAMA: Journal of the American Medical Association; 1/21/2025, Vol. 333 Issue 3, p241-247, 7p

When Diversity Goals Meet Multiregional Trials.

Authors: Mehta, Gautam U.¹, Pazdur, Richard¹, Bumpus, Namandjé N.², Califf, Robert M.²

Source: New England Journal of Medicine; 1/2/2025, Vol. 392 Issue 1, p4-7, 4p

Opportunities for Innovation in Smoking Cessation Therapies: A Perspective From the National Institutes of Health and U.S. Food and Drug Administration.

Authors: Warraich, Haider J., King, Brian A., Compton, Wilson M., Herrmann, Evan S., Hai, Mary Thanh, Califf, Robert M., Bertagnolli, Monica M.

Source: Annals of Internal Medicine; Jan2025, Vol. 178 Issue 1, p122-125, 4p

Subject Terms: SMOKING cessation products, SMOKING cessation, PUBLIC health

Levels of evidence supporting drug, device, and other recommendations in the American Heart Association/American College of Cardiology guidelines

Authors: Fanaroff, Alexander C., Fudim, Marat, Califf, Robert M., Windecker, Stephan, Smith, Sidney C., Jr, Lopes, Renato D.

Source: In American Heart Journal August 2020 226:4-12

Improving Medical Device Safety Surveillance: Bridging Capability and Commitment.

Authors: Curtis, Lesley H.^1,2 (AUTHOR) lesley.curtis@duke.edu, Califf, Robert M.² (AUTHOR)

Source: Journal of the American College of Cardiology (JACC). May2025, Vol. 85 Issue 17, p1713-1715. 3p.

Challenges in the Ethics and Implementation of Learning Health Care Systems.

Authors: Califf, Robert M.¹, Faden, Ruth¹, Kass, Nancy¹, Morain, Stephanie¹, Crane, Matthew¹

Source: American Journal of Bioethics. Aug2023, Vol. 23 Issue 8, p1-4. 4p.

Subject Terms: *ETHICS, *SERIAL publications, *MEDICAL care, *HUMAN services programs, *RESEARCH ethics, *MEDICAL research

Impact of baseline covariate imbalance on bias in treatment effect estimation in cluster randomized trials: Race as an example

Authors: Yang, Siyun, Starks, Monique Anderson, Hernandez, Adrian F., Turner, Elizabeth L., Califf, Robert M., O'Connor, Christopher M., Mentz, Robert J., Roy Choudhury, Kingshuk

Source: In Contemporary Clinical Trials January 2020 88

Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials

Authors: Brennan, J. Matthew, Wruck, Lisa, Pencina, Michael J., Clare, Robert M., Lopes, Renato D., Alexander, John H., O'Brien, Sean, Krucoff, Mitchell, Rao, Sunil V., Wang, Tracy Y., Curtis, Lesley H., Newby, L. Kristin, Granger, Christopher B., Patel, Manesh, Mahaffey, Kenneth, Ross, Joseph S., Normand, Sharon-Lise, Eloff, Benjamin C., Caños, Daniel A., Lokhnygina, Yuliya V., Roe, Matthew T., Califf, Robert M., Marinac-Dabic, Danica, Peterson, Eric D.

Source: In American Heart Journal December 2019 218:110-122

Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF

Authors: Greene, Stephen J., DeVore, Adam D., Sheng, Shubin, Fonarow, Gregg C., Butler, Javed, Califf, Robert M., Hernandez, Adrian F., Matsouaka, Roland A., Samman Tahhan, Ayman, Thomas, Kevin L., Vaduganathan, Muthiah, Yancy, Clyde W., Peterson, Eric D., O’Connor, Christopher M., Mentz, Robert J.

Source: In JACC: Heart Failure November 2019 7(11):980-992

Digital Health Technologies for Cardiometabolic Disease and Diabetes: A Perspective From the U.S. Food and Drug Administration

Authors: Warraich, Haider J. ^∗, Patrick-Lake, Bray, Saha, Anindita, Rashid, Leeda, Pai, Vinay, Abbasi, Ali, Diamond, Matthew C., Tazbaz, Troy, Califf, Robert M.

Source: In Journal of the American College of Cardiology 11 February 2025 85(5):528-535

Natural History of Patients Postacute Coronary Syndrome Based on Heart Failure Status

Authors: Ambrosy, Andrew P., Cerbin, Lukasz P., Fudim, Marat, Clare, Robert M., Lokhnygina, Yuliya, Braunwald, Eugene, Califf, Robert M., Cannon, Christopher P., Tershakovec, Andrew M., Roe, Matthew T., Blazing, Michael A.

Source: In The American Journal of Cardiology 1 November 2018 122(9):1451-1458