Dr. Robert J. Hardy

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University of Texas Health Science Center at Houston
School of Public Health
Coordinating Center for Clinical Trials
Biostatistics
ProfessorAppointed: 1978
University of Texas Health Science Center at Houston
School of Public Health
Coordinating Center for Clinical Trials (Public Health)
Biostatistics
Allan King ProfessorAppointed: 2002

Mailing Address

University of Texas Health Science Center at Houston
School of Public Health
1200 Herman Pressler, RAS E-833
Houston, Texas 77030
United States

Contact Information

Phone: (713) 500-9524
Fax: (713) 500-9530
Robert.J.Hardy@uth.tmc.edu

Qualifications

Ph.D., University of California, Berkeley, Biostatistics, 1969.
M.S., Tulane University, Biostatistics, 1964.
B.S., Southeastern Louisiana University, Mathematics, 1962.

Expertise and Research Interests

Research of this investigator deals with the design and conduct of large clinical studies and in developing statistical methods appropriate to analysis of data collected. This involves analysis of survival time data, life table methods, mathematical modeling of biological processes, the analysis of paired (or matched) data, and statistical methods particularly suited to epidemiological research. Work at the UTHSC has been on seven large multi-center randomized clinical trials. Five studies were designed to evaluate treatment of cardiovascular diseases: Hypertension Detection and Follow-up Program; Aspirin in Transcient Attacks Trial; Beta-Blocker Heart Attack Trial; Aspirin-Persantine Trial; and Systolic Hypertension in the Elderly Program. In the last 20 years he has been the Director of the Coordinating Center activities for three studies that deal with the treatment of retinopathy of prematurity (ROP): Multicenter Study of Cryotherapy for ROP (CRYO-ROP); Multicenter Study of Light Reduction in ROP (LIGHT-ROP) and the Early Treatment for ROP (ETROP) study. Treatments of ROP identified in these studies are currently used in many hospital neonatal intensive care nurseries in the United States as well as several foreign countries. Further research includes the development of an approach to outcome-based management of ROP.

Other Expertise

Academic Experience:
- State of New York--Committee for the Review of Doctoral Programs in Epidemiology and Biostatistics--Columbia University (1987)
- University of Oklahoma--Committee to Review Doctoral Program in Epidemiology and Biostatistics (1988)
- University of Michigan--Committee to Review Biostatistics Program (1990)

Business Experience:
- Amblyopia in Astigmatic Children: Development and Treatment, Part II (AADCAT) - Chair, Data Monitoring and Oversight Committee - Arizona University (2006 - Present)
- Infant Aphakia Treatment Study (IATS) - Chair, Data and Safety Monitoring Committee - Emory University School of Public Health (2004-Present)
- Maternal Oral Therapy to Reduce Obstetric Risk (MOTOR) - Chair, Data and Safety Monitoring Committee, National Institute of Dental and Craniofacial Research (2003- Present)
- Obstetrics and Periodontal Therapy Study(OPT) - Chair, Data and Safety Monitoring Committee - University of Minnesota School of Dentistry (2002-Present)
- The Multicenter Trial of Early Treatment for Retinopathy of Prematurity, Executive Committee and Principal Investigator for the Coordinating Center (1999-Present)
- Correction of Myopia Evaluation Trial (COMET)--Chair, Data and Safety Monitoring Committee (1996-2003)
- PURSUIT Study--Member, Data and Safety Monitoring Committee (1995-1998)
- Dietary Intervention Study in children--Member, Data and Safety Monitoring Committee (1988-1994)
- Collaborative Normal Fusion Glaucoma Study--Member, Data and Safety Monitoring Committee (1993-1995)
- Prospective Evaluation of Radial Keratotomy, National Eye Institute--Chair, Data and Safety Monitoring Board (Follow-up of PERK participants) (1993-1995)

Keywords

COS Keywords:

Biostatistics, Cardiovascular Diseases, Clinical Trial, Epidemiology, Eye Diseases, Heart Diseases, Mathematical Modeling (Medical), Outcomes Research (Medical), Statistics.

Additional Terms:

Biostatistics, Clinical Trials Methodology, Eye Diseases, Heart Disease, Life Table, Mathematical Models, Outcomes Research, Statistical Epidemiology, Statistical Methods, Survival Analysis.

Memberships

American Association for the Advancement of Science
American Public Health Association
American Statistical Association
Association for Research in Vision and Ophthalmology
International Biometric Society
Society for Clinical Trials

Previous Positions

2000-2004, Co-director, University of Texas Health Science Center at Houston, School of Public Health, Coordinating Center for Clinical Trials
1995-1997, Convener, University of Texas Health Science Center at Houston, School of Public Health, Biostatistics Faculty
1988-1994, Associate Dean, University of Texas Health Science Center at Houston, School of Public Health, Academic Affairs
1978-1983, Convener, University of Texas Health Science Center at Houston, School of Public Health, Biostatistics Faculty
1975-1977, Deputy Director, University of Texas Health Science Center at Houston, School of Public Health, Coordinating Center, Hypertension Detection and Follow-up Program
1975-1978, Associate Professor, University of Texas Health Science Center at Houston, School of Public Health, Biostatistics
1974-1975, Associate Professor, Yale University, School of Medicine, Epidemiology and Public Health, Biostatistics
1969-1974, Associate Professor, Yale University, School of Public Health, Epidemiology and Public Health, Biostatistics

Funding Received

  • National Institutes of Health (NIH): Early Treatment of Retinopathy of Prematurity (ETROP), $20,801,864, 3/9/1999 to 9/29/2009.
  • National Institutes of Health (NIH): Study of Antihypertensive Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), $85,710,785, 08/02/93 to 07/31/2002.
  • National Eye Institute: Feasibility Trial of Light Reduction for Retinopathy of Prematurity (LIGHT-ROP) Coordinating Center, $174,122, 04/01/95 to 03/31/2000.
  • National Eye Institute: Core Grant for Vision Research, $2,412,000, 03/01/94 to 2009.
  • National Eye Institute: Cryotherapy Treatment of Retinopathy of Prematurity (CRYO-ROP) Follow-up, $4,014,640, 03/01/85 to 2004.

Publications

  • Writing Committee, Visual acuity at 10 years in the CRYO-ROP Study Eyes: Effect of retinal residua of ROP, Archives of Ophthalomology, 124, 199-202, 2006
  • Repka MX, Tung B, Good WV, Shapiro M, Capone A, Baker JD, Barr CC, Phelps DL, van Heuven WAJ, Outcome of eyes developing retinal detachment during early treatment for retinopathy of prematurity study (ETROP), Archives of Ophthalmology, 124, 24-30, 2006
  • VanderVeen DK, Coats DK, Dobson V, Frederick D, Gordon RA, Hardy RJ, Neely DE, Palmer EA, Steidl SM, Tung B, Good WV on behalf of the Early Treatment for Retinopathy of Prematurity Cooperative Group, The prevalence and course of strabismus in the first year of life for infants with prethreshold ROP: Findings from the early treatment for retinopathy of prematurity study, Archives of Ophthalmology, 124, 766-773, 2006
  • Jones J, MacKinnon B on behalf of the Early Treatment for Retinopathy of Prematurity Cooperative Group, The early treatment for ROP (ETROP) randomized trial: study results and nursing care adaptations, Insight (The Journal of the American Society of Ophthalmic Registered Nurses, Inc.), 30(2), 7-13, April-June 2005
  • Editorial Committee for the Cryotherapy for Retinopathy of Prematurity Cooperative Group, Fifteen-year Outcomes Following Threshold Retinopathy of Prematurity: Final Results from the Multicenter Trial of Cryotherapy, Archives of Ophthalmology, 123, 311-318, 2005
  • Good WV, Hardy RJ, The dilemma of exercising clinical judgment in the treatment of retinopathy of prematurity-reply, Archives of Ophthalmology, 123, 409-410, 2005
  • The Early Treatment for Retinopathy of Prematurity Cooperative Group, The incidence and course of retinopathy of prematurity: Findings from the early treatment for retinopathy of prematurity study, Pediatrics, 116(1), 15-23, 2005
  • Davitt BV, Dobson V, Good WV, Hardy RJ, Quinn GE, Siatkowski RM, Summers CG, Tung B for the Early Treatment of Retinopathy of Prematurity Cooperative Group, Prevalence of myopia at 9 months in Infants with high-risk prethreshold retinopathy of prematurity, Ophthalmology, 112, 1564-1568, 2005
  • Msall ME, Phelps DL, Hardy RJ, Dobson V, Quinn GE, Summers CG, Tremont MR, Cryotherapy for Retinopathy of Prematurity Cooperative Group, Educational and social competencies at 8 years in children with threshold retinopathy of prematurity in the CRYO-ROP multicenter study, Pediatrics, 113(4), 790-9, April 2004 Abstract
  • Early Treatment for Retinopathy of Prematurity Cooperative Group (Writing Committee, Chair), Multicenter Trial of Early Treatment for Retinopathy of Prematurity: Study Design, Controlled Clinical Trials, 25, 311-325, 2004
  • Quinn GE, Dobson V, Saigal S, Phelps DL, Hardy FJ, Tung B, Summers GS, Palmer EA on behalf of the CRYO-ROP Cooperative Group, Health related quality of life at age 10 years in very-low-birth-weight with and without severe retinopathy of prematurity, Archives of Ophthalmology, 2004
  • Phelps DL on behalf of the Early Treatment for Retinopathy Cooperative Group, The early treatment for retinopathy of prematurity study: Better outcomes, changing strategy, Pediatrics, 114, 490-491, 2004
  • Good WV on behalf of the Early Treatment for Retinopathy of Prematurity Cooperative Group, Final results of the early treatment for retinopathy of prematurity (ETROP) randomized trial, Trans Am Ophthalmol Soc, 102, 233-250, 2004
  • Hardy RJ, Palmer EA, Dobson V, Summers CG, Phelps DL, Quinn GE, Good WV, Tung B, Cryotherapy for Retinopathy of Prematurity Cooperative Group, Risk analysis of prethreshold retinopathy of prematurity, Archives of Ophthalmology, 121(12), 1697-701, December 2003 Abstract
  • Early Treatment for Retinopathy of Prematurity Cooperative Group (Writing Committee, Member), Revised indications for treatment of retinopathy of prematurity (ROP): Results of the early treatment for ROP (ETROP) randomized trial, Archives of Ophthalmology, 121, 1684-1696, 2003
  • Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) (Writing Committee, Member), Manual of Procedures, Vol. IV, Phase IV Follow-up Study. Springfield, VA: National Technical Information Service, US Department of Commerce publication, PB2003-3106503, 2003
  • Lai D, Hardy RJ, Measuring the Impact of Hepatitis A Virus in Chinese Cities: A life table approach, Asia-Pacific Journal of Public Health, 15(2), 2003
  • Reynolds JD, Dobson V, Quinn GE, Fielder AR, Palmer EA, Saunders RA, Hardy RJ, Phelps DL, Baker JD, Trese MT, Schaffer D, Tung B, CRYO-ROP and LIGHT-ROP Cooperative Study Groups, Evidence-based screening criteria for retinopathy of prematurity: natural history data from the CRYO-ROP and LIGHT-ROP studies, Archives of Ophthalmology, 120(11), 1470-6, November 2002 Abstract
  • Cryotherapy for Retinopathy of Prematurity Cooperative Group (Writing Committee, Member). Multicenter Trial of Cryotherapy for Retinopaty of Prematurity, Natural History ROP: Ocular Outcome at 5½ Years in Premature Infants with Birth Weights Less than 1251 g, Archives of Ophthalmology, 120, 595-599, 2002
  • Kennedy KA, Fielder AR, Hardy RJ, Tung B, Gordon DC, Reynolds JD, LIGHT-ROP Cooperative Group, Reduced lighting does not improve medical outcomes in very low birth weight infants, The Journal of Pediatrics, 139(4), 527-31, October 2001 Abstract
  • Good WV, Hardy RJ, The multicenter study of Early Treatment for Retinopathy of Prematurity (ETROP), Ophthalmology, 108(6), 1013-4, June 2001 Abstract
  • Quinn GE, Dobson V, Siatkowski R, Hardy RJ, Kivlin J, Palmer EA, Phelps DL, Repka MX, Summers CG, Tung B, Chan W, Cryotherapy for Retinopathy of Prematurity Cooperative Group, Does cryotherapy affect refractive error? Results from treated versus control eyes in the cryotherapy for retinopathy of prematurity trial, Ophthalmology, 108(2), 343-7, February 2001 Abstract
  • Cryotherapy for Retinopathy of Prematurity Cooperative Group (Writing Committee, Member), Contrast sensitivity in eyes with threshold ROP from the CRYO-ROP trial, Archives of Ophthalmology, 119(8), 1129-1133, 2001
  • Cryotherapy for Retinopathy of Prematurity Cooperative Group (Writing Committee, Member), Effect of ablative cryotherapy for threshold retinopathy of Prematurity: Results of Goldmann perimetry at age 10 years, Archives of Ophthalmology, 119(8), 1120-1125, 2001
  • Cryotherapy for Retinopathy of Prematurity Cooperative Group (Writing Committee, Member), Ophthalmological outcomes at 10 years, Archives of Ophthalmology, 119(8), 1110-1118, 2001
  • Suarez L, Hendricks KA, Cooper SP, Sweeney AM, Hardy RJ, Larsen RD, Neural tube defects among Mexican Americans living on the US-Mexico border: effects of folic acid and dietary folate, American Journal of Epidemiology, 152(11), 1017-23, December 2000 Abstract
  • Msall ME, Phelps DL, DiGaudio KM, Dobson V, Tung B, McClead RE, Quinn GE, Reynolds JD, Hardy RJ, Palmer EA, Severity of neonatal retinopathy of prematurity is predictive of neurodevelopmental functional outcome at age 5.5 years. Behalf of the Cryotherapy for Retinopathy of Prematurity Cooperativ, Pediatrics, 106(5), 998-1005, November 2000 Abstract
  • Lai D, Guo F, Hardy RJ, Standardized mortality ratio and life expectancy: a comparative study of Chinese mortality, International Journal of Epidemiology, 29(5), 852-5, October 2000 Abstract
  • Lai D, Davis BR, Hardy RJ, Fractional Brownian Motion and Clinical Trials, Journal of Applied Statistics, 27, 103-108, 2000
  • Lai D, Hardy RJ, Potential gains in life expectancy or years of potential life lost: impact of competing risks of death, International Journal of Epidemiology, 28(5), 894-8, October 1999
  • Harvey EM, Dobson V, Tung B, Quinn GE, Hardy RJ, Interobserver agreement for grating acuity and letter acuity assessment in 1- to 5.5-year-olds with severe retinopathy of prematurity, Investigative Ophthalmology and Visual Science, 40(7), 1565-76, June 1999
  • Dobson V, Quinn GE, Siatkowski RM, Baker JD, Hardy RJ, Reynolds JD, Trese MT, Tung B, Agreement between grating acuity at age 1 year and Snellen acuity at age 5.5 years in the preterm child. Cryotherapy for Retinopathy of Prematurity Cooperative Group, Investigative Ophthalmology and Visual Science, 40(2), 496-503, February 1999
  • Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP). Manual of Procedures, Phase III Follow-up Study. Springfield, VA: National Technical Information Service, U.S. Department of Commerce publication, III, PB99-123010, 1999
  • Harvey EM, Dobson V, Tung B, Quinn GE, Hardy RJ, Inerobserver agreement for grating acuity and letter acuity assessment in 1- to 5 1/2- year-olds with severe retinopathy of prematurity, Investigative Ophthalmology and Visual Science, 40, 1565-1576, 1999
  • Demchuk AM, Morgenstern LB, Krieger DW, Linda Chi T, Hu W, Wein TH, Hardy RJ, Grotta JC, Buchan AM, Serum glucose level and diabetes predict tissue plasminogen activator-related intracerebral hemorrhage in acute ischemic stroke, Stroke, 30(1), 34-9, Jan 1999
  • Multicenter Trial of Cryotheapy for REtinopathy of Prematurity (CRYO-ROP). Manual of Procedures, Phse III Follow-up Study, U.S. Department of Commerce publication, III(National Technical), PB99-123010, 1999
  • Lai D, Hardy RJ., Potential Gains in Life Expectancy or Years of Potential Life Lost: Impact of Competing Risks of Death, International Journal of Epidemiology, 28, 894-898, 1999
  • Harvey EM, LIGHT-ROP Cooperative Group: The Design of the Multicenter Study of Light Reduction Retinopathy of Prematurity (LIGHT-ROP), Journal of Pediatric Ophthalmology and Strabismus, 36, 257-263, 1999
  • Emery R, Delclos G, Cooper SP, Hardy R, Evaluating the relative status of health and safety programs for minority academic and research institutions, American Industrial Hygiene Association Journal, 59(12), 882-8, December 1998
  • Quinn G E, Dobson V, Kivlin J, Kaufman L M, Repka M X, Reynolds J D, Gordon R A, Hardy R J, Tung B, Stone R A, Prevalence of myopia between 3 months and 5 1/2 years in preterm infants with and without retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group, Ophthalmology, 105(7), 1292-300, July 1998
  • Reynolds J D, Hardy R J, Kennedy K A, Spencer R, van Heuven W A, Fielder A R, Lack of efficacy of light reduction in preventing retinopathy of prematurity. Light Reduction in Retinopathy of Prematurity (LIGHT-ROP) Cooperative Group [see comments], New England Journal of Medicine, 338(22), 1572-6, 28 May 1998 Abstract
  • Bremer D L, Palmer E A, Fellows R R, Baker J D, Hardy R J, Tung B, Rogers G L, Strabismus in premature infants in the first year of life. Cryotherapy for Retinopathy of Prematurity Cooperative Group, Archives of Ophthalmology, 116(3), 329-33, March 1998
  • Chiang CL, Hardy RJ, Wun CC, Chiang R, Estimation of Duration of Separation, Widowhood, and Family Life Cycle, Theoretical Population Biology, 54, 202-212, 1998
  • Emery R, Delclos G, Cooper SP, Hardy RJ, Evaluating the relative status of health and safety programs for minority academic and research institutions, American Industrial Hygiene Association Journal, 12(59), 882-888, 1998
  • Saunders R A, Donahue M L, Christmann L M, Pakalnis A V, Tung B, Hardy R J, Phelps D L, Racial variation in retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group, Archives of Ophthalmology, 115(5), 604-8, May 1997
  • Lai D, Tsai S P, Hardy R J, Impact of HIV/AIDS on life expectancy in the United States, Aids, 11(2), 203-7, February 1997
  • Hardy, RJ, Palmer EA, Schaffer DB, Phelps DL, Davis BR, Cooper CJ for the CRYO-ROP Cooperative Group, Outcome-based management of retinopaty of prematurity, Journal of Pediatric Ophthalmology and Strabismus, Vol 1, 46-54, 1997
  • Dobson V, Quinn G E, Abramov I, Hardy R J, Tung B, Siatkowski R M, Phelps D L, Color vision measured with pseudoisochromatic plates at five-and-a-half years in eyes of children from the CRYO-ROP study, Investigative Ophthalmology and Visual Science, 37(12), 2467-74, November 1996
  • Quinn G E, Dobson V, Hardy R J, Tung B, Phelps D L, Palmer E A, Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooper, Ophthalmology, 103(9), 1432-7, September 1996
  • Gilbert W S, Quinn G E, Dobson V, Reynolds J, Hardy R J, Palmer E A, Partial retinal detachment at 3 months after threshold retinopathy of prematurity. Long-term structural and functional outcome. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity Cooperat, Archives of Ophthalmology, 114(9), 1085-91, September 1996
  • Quinn GE, Dobson V, Hardy, RJ, Tung B, Phelps DL, Palmer EA, for the CRYO-ROP Cooperative Group, Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity (ROP) from the CRYO-ROP trial, Ophthalmology, 103(9), 1432-7, 1996
  • Dobson V, Quinn GE, Abramov I, Hardy RJ, Tung B, Siatkowski RM, Phelps DL for the Cryotherapy for Retinopathy of Prematurity Group, Color vision measured with standard pseudoisochromatic plates at 5 1/2 years in eye of children from the CRYO-ROP study, Inv Ophthalmol & Vis Sci, 37, 2467-74, 1996
  • Gilbert WS, Quinn GE, Dobson V, Reynolds J, Hardy RJ, Palmer EA, for the CRYO-ROP Cooperative Group, Partial retinal detachment at 3 months after threshold retinopathy of prematurity: Long term structural and functional outcome, Arch Ophthalmol, 114(9), 1085-91, 1996
  • Quinn G E, Dobson V, Biglan A, Evans J, Plotsky D, Hardy R J, Correlation of retinopathy of prematurity in fellow eyes in the cryotherapy for retinopathy of prematurity study. The Cryotherapy for Retinopathy of Prematurity Cooperative Group, Archives of Ophthalmology, 113(4), 469-73, April 1995
  • Davis B R, Hardy R J, Data monitoring in clinical trials: the case for stochastic curtailment, Journal of Clinical Epidemiology, 47(9), 1033-42, September 1994
  • Palmer E A, Hardy R J, Zone I retinopathy of prematurity [letter], Archives of Ophthalmology, 112(2), 156, February 1994
  • Repka M X, Hardy R J, Phelps D L, Summers C G, Surfactant prophylaxis and retinopathy of prematurity, Archives of Ophthalmology, 111(5), 618-20, May 1993
  • Schaffer D B, Palmer E A, Plotsky D F, Metz H S, Flynn J T, Tung B, Hardy R J, Prognostic factors in the natural course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group, Ophthalmology, 100(2), 230-7, February 1993
  • Tsai S P, Hardy R J, Wen C P, The standardized mortality ratio and life expectancy, American Journal of Epidemiology, 135(7), 824-31, 1 Apr 1992
  • Palmer E A, Flynn J T, Hardy R J, Phelps D L, Phillips C L, Schaffer D B, Tung B, Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group, Ophthalmology, 98(11), 1628-40, November 1991
  • Hardy R J, Davis B R, Palmer E A, Tung B, Statistical considerations in terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group, Controlled Clinical Trials, 12(2), 293-303, April 1991
  • Palmer E A, Hardy R J, Davis B R, Stein J A, Mowery R L, Tung B, Phelps D L, Schaffer D B, Flynn J T, Phillips C L, Operational aspects of terminating randomization in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group, Controlled Clinical Trials, 12(2), 277-92, April 1991
  • Cooper S P, Ford C E, Hardy R J, Davis B R, Hawkins C M, Labarthe D R, Results of trials reporting a J-shaped relation between achieved blood pressure and incidence of coronary heart disease [letter], American Journal of Hypertension, 3(9), 733-4, September 1990
  • Hardy R J, Schroder G D, Cooper S P, Buffler P A, Prichard H M, Crane M, A surveillance system for assessing health effects from hazardous exposures, American Journal of Epidemiology, 132(1 Suppl), 532-42, July 1990

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