Full list of publications and research grants available at (Scholars at Duke)

Perez, Marco V., Kenneth W. Mahaffey, Haley Hedlin, John S. Rumsfeld, Ariadna Garcia, Todd Ferris, Vidhya Balasubramanian, et al. “Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation..” N Engl J Med 381, no. 20 (November 14, 2019): 1909–17. https://doi.org/10.1056/NEJMoa1901183.

Hopley CW, Kavanagh S, Patel MR, Ostrom C, Baumgartner I, Berger JS, Blomster JI, Fowkes FGR, Jones WS, Katona BG, Mahaffey KW, Norgren L, Rockhold FW, Hiatt WR. Chronic kidney disease and risk for cardiovascular and limb outcomes in patients with symptomatic peripheral artery disease: The EUCLID trial. Vasc Med. 2019 Oct;24(5):422-430. doi: 10.1177/1358863X19864172.

Olivier, Christoph B., Hillary Mulder, William R. Hiatt, W Schuyler Jones, F Gerry R. Fowkes, Frank W. Rockhold, Jeffrey S. Berger, et al. “Incidence, Characteristics, and Outcomes of Myocardial Infarction in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial..” Jama Cardiol 4, no. 1 (January 1, 2019): 7–15. https://doi.org/10.1001/jamacardio.2018.4171.

Ward, Rachael, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F Gerry R. Fowkes, et al. “Major bleeding in patients with peripheral artery disease: Insights from the EUCLID trial..” Am Heart J 220 (November 18, 2019): 51–58. https://doi.org/10.1016/j.ahj.2019.11.007.

Rockhold, Frank, Christina Bromley, Erin K. Wagner, and Marc Buyse. “Open science: The open clinical trials data journey..” Clin Trials 16, no. 5 (October 2019): 539–46. https://doi.org/10.1177/1740774519865512.

Kolls, Brad J., Shelly Sapp, Frank W. Rockhold, J Dedrick Jordan, Keith E. Dombrowski, F Gerry R. Fowkes, Kenneth W. Mahaffey, et al. “Stroke in Patients With Peripheral Artery Disease..” Stroke 50, no. 6 (June 2019): 1356–63. https://doi.org/10.1161/STROKEAHA.118.023534.

Kansal, Aman, Zhen Huang, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F Gerry Fowkes, et al. “Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial..” Circ Cardiovasc Interv 12, no. 10 (October 2019). https://doi.org/10.1161/CIRCINTERVENTIONS.119.008069.

Rockhold, Frank W., Anne Lindblad, Jay P. Siegel, and Geert Molenberghs. “University of Pennsylvania 11th annual conference on statistical issues in clinical trials: Estimands, missing data and sensitivity analysis (morning panel session)..” Clin Trials 16, no. 4 (August 2019): 350–62. https://doi.org/10.1177/1740774519853573.

Hess, Connie N., Zhen Huang, Manesh R. Patel, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, F Gerry R. Fowkes, Held, P; Jones, WS; Katona, B; Mahaffey, KW; Norgren, L; Rockhold, FW; Hiatt, WR  “Acute Limb Ischemia in Peripheral Artery Disease: Insights from EUCLID..” Circulation, June 26, 2019. https://doi.org/10.1161

Gutierrez, J Antonio, Hillary Mulder, W Schuyler Jones, Frank W. Rockhold, Iris Baumgartner, Jeffrey S. Berger, Juuso I. Blomster, et al. “Polyvascular Disease and Risk of Major Adverse Cardiovascular Events in Peripheral Artery Disease: A Secondary Analysis of the EUCLID Trial..” Jama Netw Open 1, no. 7 (November 2, 2018). https://doi.org/10.1001/jamanetworkopen.2018.5239.

Li, Rebecca, Jessica Scott, Frank Rockhold, Nina Hill, Julie Wood, and Ida Sim. “Moving Data Sharing Forward: The Launch of the Vivli Platform.” Nam Perspectives 8, no. 11 (November 19, 2018). https://doi.org/10.31478/201811b.

Norgren, L, Patel, MR, Hiatt, WR, Wojdyla, DM, Fowkes, FGR, Baumgartner, I, Mahaffey, KW, Berger, JS, Jones, WS, Katona, BG, Held, P, Blomster, JI, Rockhold, FW, Björck, M, and EUCLID Steering Committee and Investigators,. “Outcomes of Patients with Critical Limb Ischaemia in the EUCLID Trial.” European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery 55, no. 1 (January 2018): 109-117

Berger, Jeffrey S., Beth L. Abramson, Renato D. Lopes, Gretchen Heizer, Frank W. Rockhold, Iris Baumgartner, F Gerry R. Fowkes, et al. “Ticagrelor versus clopidogrel in patients with symptomatic peripheral artery disease and prior coronary artery disease: Insights from the EUCLID trial..” Vasc Med 23, no. 6 (December 2018): 523–30.

Peterson, Eric D., and Frank W. Rockhold.Finding Means to Fulfill the Societal and Academic Imperative for Open Data Access and Sharing..” Jama Cardiol 3, no. 9 (September 1, 2018): 793–94. https://doi.org/10.1001/jamacardio.2018.0129.

Low Wang, CC, Blomster, JI, Heizer, G, Berger, JS, Baumgartner, I, Fowkes, GR, Held, P, Katona, BG, Norgren, L, Jones, WS, Lopes, RD, Olin, JW, Rockhold, FW, Mahaffey, KW, Patel, MR, and Hiatt, WR. “Cardiovascular and Limb Outcomes in Patients with Diabetes and Peripheral Artery Disease.” Journal of the American College of Cardiology 72, no. 25 (December 2018): 3274-3284

Rubin, J.C., Silverstein, J.C., Friedman, C.P.  Kush, R.D., Anderson, W.H., Lichter, A.S., Humphreys, D.J., Brown, J., Crawford, L., Walker, J.M., Tannen, R.L., Berry, K., Lopez, M.H., Kolodner, R.M., Marchibroda, J.M., and Rockhold, F.W.,  Transforming the future of health together: The Learning Health  Systems Consensus Action Plan, Learning Health Systems, April 2018

Baumgartner, I, Norgren, L, Fowkes, FGR, Mulder, H, Patel, MR, Berger, JS, Jones, WS, Rockhold, FW, Katona, BG, Mahaffey, K, Hiatt, WR, and Executive Committee and Investigators of the EUCLID Trial, . “Cardiovascular Outcomes After Lower Extremity Endovascular or Surgical Revascularization: The EUCLID Trial.” Journal of the American College of Cardiology 72, no. 14 (October 2018): 1563-1572.

Pencina, Michael J., Frank W. Rockhold, and Ralph B. D’Agostino. “Deriving Real-World Insights From Real-World Data: Biostatistics to the Rescue..” Ann Intern Med 169, no. 6 (September 18, 2018): 401–2. https://doi.org/10.7326/M18-1093.

Rockhold, Frank. “Comments on ‘Estimands in clinical trials – broadening the perspective’..” Stat Med 36, no. 1 (January 15, 2017): 24–26. https://doi.org/10.1002/sim.7164.

Ohman, E Magnus, Matthew T. Roe, P Gabriel Steg, Stefan K. James, Thomas J. Povsic, Jennifer White, Frank Rockhold, et al. “Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial..” Lancet 389, no. 10081 (May 6, 2017): 1799–1808.

Chan, A. W., J. M. Tetzlaff, D. G. Altman, A. Laupacis, P. C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, et al. “SPIRIT 2013 statement: Defining standard protocol items for clinical trials.” Japanese Pharmacology and Therapeutics 45, no. 12 (January 1, 2017): 1895–1904.

Rockhold, F. W. “Statistical controversies in clinical research: data access and sharing-can we be more transparent about clinical research? Let’s do what’s right for patients..” Ann Oncol 28, no. 8 (August 1,2017): 1734–37. https://doi.org/10.1093/annonc/mdx123.

Rockhold, Frank, Perry Nisen, and Andrew Freeman. “Data Sharing at a Crossroads..” N Engl J Med 375, no. 12 (September 22, 2016): 1115–17. https://doi.org/10.1056/NEJMp1608086.

Chan, An-Wen, Jennifer M. Tetzlaff, Douglas G. Altman, Andreas Laupacis, Peter C. Gøtzsche, Karmela Krle A-Jerić, Asbjørn Hrobjartsson, et al. “SPIRIT 2013 Statement: defining standard protocol items for clinical trials..” Rev Panam Salud Publica 38, no. 6 (December 2015): 506–14.

Berlin, Jesse A., Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher. “Bumps and bridges on the road to responsible sharing of clinical trial data..” Clin Trials 11, no. 1 (February 2014): 7–12. https://doi.org/10.1177/1740774513514497.

Chan, A-W., Tetzlaff, J.M., Altman, D.G., Laupacis, A., Gøtzsche, P.C., Krlezˇa-Jeric´, K., Bjartsson, A.H., Mann, H. Dickersin, K., Berlin, J.A., Dore, C.J., Parulekar, W.R., Summerskill, W.S.M., Groves, T., Schulz, K.F., Sox, H.C., Rockhold, F.W., Rennie, D. and Moher, D.  SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.  Ann Intern Med., 158:200-207, 2013

Chan, A. W., J. M. Tetzlaff, D. G. Altman, A. Laupacis, P. C. Gøtzsche, K. Krleža-Jerić, A. Hróbjartsson, et al. “Spirit 2013 statement: Defining standard protocol items for clinical trials.” Chinese Journal of Evidence Based Medicine 13, no. 12 (January 1, 2013): 1501–7. https://doi.org/10.7507/1672-2531.20130256.

Nisen, Perry, and Frank Rockhold. “Access to patient-level data from GlaxoSmithKline clinical trials..” N Engl J Med 369, no. 5 (August 1, 2013): 475–78. https://doi.org/10.1056/NEJMsr1302541.

Rockhold, Frank W., and Gregory G. Enas. “10 Years with ICH E10: Choice of Control Groups..” Pharm Stat 10, no. 5 (September 2011): 407–9. https://doi.org/10.1002/pst.500.

Strahlman, Ellen, Frank Rockhold, and Andrew Freeman. “Public disclosure of clinical research..” Lancet 373, no. 9672 (April 18, 2009): 1319–20

Rockhold, F. W., A. J. Freeman, and C. A. Metz. “Public disclosure of clinical trial results: A necessary step on the path to transparency and trust.” Pharmaceutical Medicine 23, no. 3 (January 1, 2009): 131–37.

Rockhold, Frank W., and Stephen J. Ruberg. “ICH-E9 reflections and considerations..” Pharm Stat 7, no. 4 (October 2008): 233–35.