Michael Proschan CV - NIAID - National Institutes of Health

November 2011
Michael Proschan
Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases
6700A Rockledge Drive, Room 5140
Bethesda, Maryland 20892-7609
ProschaM@mail.nih.gov
EDUCATION
Aug., 1989 Ph.D. in Statistics, Florida State University, Tallahassee, Florida.
March, 1982 Master of Science in Statistics, Stanford University, Stanford, California.
June, 1980 Bachelor of Science in Statistics/Mathematics (double major), Florida
State University.
HONORS
2005 Fellow of the American Statistical Association.
1998 NIH Merit Award for excellent teamwork of the Project Office for the
Dietary Approaches to Stop Hypertension (DASH) trial.
1993 NIH Merit Award for exceptional performance of statistical collaborations
in clinical research programs at NHLBI.
1984 Voted top first year theoretical statistics graduate student at Florida State
University.
1980 Graduated Summa Cum Laude from Florida State University.
1978 Invited to join Phi-Beta-Kappa Honor Society as an undergraduate at
Florida State University.
1977-1980 Made the Dean's List every quarter as an undergraduate at Florida State
University.
1

PROFESSIONAL EXPERIENCE
Jan., 2006 Mathematical Statistician
-Present Biostatistics Research Branch
National Institute of Allergy and Infectious Diseases.
Oct., 1989 Mathematical Statistician
-December 2005 Office of Biostatistics Research
National Heart, Lung, and Blood Institute.
Spring, 2008 Lecturer
Summer 2008 School of Arts and Sciences Advanced Academic Programs
Johns Hopkins University, Shady Grove Campus
Fall,1997,1999,
2001,2003,2005,
2007 Instructor
Methodology in Clinical Trials
Foundation for Advanced Education in The Sciences, a graduate school at
the National Institutes of Health. The course focuses on statistical aspects
of clinical trials, but covers non-statistical issues as well.
July, 1983 Statistics Teaching Assistant
-Aug., 1989 Florida State University.
Sep., 1985 Statistics Consultant
-Dec., 1985 Florida State University Statistical Consulting Center.
Dec., 1984 Expert Witness in Statistics for the Defense
The Florida State University vs. Sylvia Huegli.
Sep., 1982 Instructor
-Apr., 1983 Palm Beach Junior College, Palm Beach Gardens, Florida.
May, 1982 Engineering Statistician
-May, 1983 Pratt/Whitney Aircraft, West Palm Beach, Florida.
Sep., 1980 Statistics Teaching and Research Assistant
-Apr., 1982 Stanford University.
June, 1980 Mathematics Laboratory Assistant
-Aug., 1980 Tallahassee Community College, Tallahassee, Florida.
2

PUBLICATIONS (STATISTICAL)
1. Proschan, M. (2011). Randomization. In Randomized Controlled Trials in the
Behavioral Clinical Sciences: Methods and Analyses (P. Kaufmann, K. Davidson, and H.
Kraemer, editors). Springer, New York. Submitted.
2. Proschan, M. (2011). Sample Size/Power. In Randomized Controlled Trials in the
Behavioral Clinical Sciences: Methods and Analyses (P. Kaufmann, K. Davidson, and H.
Kraemer, editors). Springer, New York. Submitted.
3. Posch, M. and Proschan, M. (2011). Unplanned adaptations before breaking the blind.
Submitted.
4. Proschan, M., Brittain, E., and Kammerman, L. (2011). Author’s Reply. Biometrics (in
press).
5. Proschan, M., Brittain, E., and Kammerman, L. (2011). Minimize the use of
minimization with unequal allocation. Biometrics 67, 1135-1141.
6. Proschan, M. and Shaw, P. Asymptotics of Bonferroni for dependent normal test
statistics. Statistics and Probability Letters 81, 739-748.
7. Proschan, M. and Nason, M. (2011). A note on correction of information time in a
survival trial using a spending function. Statistics in the Biosciences 3, 250-259.
8. Proschan, M., Brittain, E., Fay, M. (2010). Does treatment effect depend on control
event rate? Revisiting a meta-analysis of suicidality and antidepressant use in children.
Clinical Trials 7, 109-117.
9. Proschan, M., Brittain, E., Fay, M. (2010). Response to commentary. Clinical Trials
7, 120.
10. Proschan, M. and Nason, M. (2010). Author’s reply. Biometrics 66, 993.
11. Fay, M. and Proschan, M. (2010). Wilcoxon-Mann-Whitney or t-test? On assumptions
for hypothesis tests and multiple interpretations of decision rules. Statistical Surveys 4,
1-39.
12. Proschan, M. and Rosenthal, J. (2010). Beyond the quintessential quincunx. American
Statistician 64, 78-82.
3

13. Follmann, D., Fay, M., and Proschan, M. (2009). Chop-lump tests for vaccine trials.
Biometrics 65, 885-893.
14. Lan, K., Hu, P., and Proschan, M. (2009). A conditional power approach to the
evaluation of predictive power. Statistics in Biopharmaceutical Research 1, 131-136.
15. Proschan, M. (2009). Sample size re-estimation in clinical trials. Biometrical Journal
51, 348-357.
16. Proschan, M. (2008). Multiple comparisons. In Encyclopedia of Clinical Trials (R.
D’Agostino, L. Sullivan, and J. Massaro, editors), Wiley, New York.
17. Proschan, M. and Nason, M. (2008). Conditioning in 2x2 tables. Biometrics 65, 316-
322.
18. Proschan, M. (2008). Self experimentation and web trials. Chance 21, 7-9.
19. Proschan, M. (2008). The normal approximation to the binomial. The American
Statistician 62, 62-63.
20. Follmann, D. and Proschan, M. (2008). Cluster without fluster: The effect of correlated
outcomes on inference in randomized clinical trials. Statistics in Medicine 27, 795-809.
21. Proschan, M., Lan, K., and Wittes, J. (2006). Statistical Monitoring of Clinical Trials: A
Unified Approach. Springer, New York.
22. Proschan, M. and Hunsberger, S. (2006). Combining treatment selection and definitive
testing (discussion). Biometrical Journal 48, 690-692.
23. Proschan, M. (2006). Are flexible designs sound? (discussion). Biometrics 62, 674-676.
24. Proschan, M. and Leifer, E. (2006). Comparison of two or more measurement techniques
to a standard. Contemporary Clinical Trials 27, 472-482.
25. Proschan, M. (2006). Clinical trials reliably test dietary claims. Chance 19, 53-56.
26. Proschan, M. (2005). Encyclopedia of Biostatistics, 2nd edition, (P. Armitage and T.
Colton, editors), Expectation, 1826-1830. Wiley, New York.
27. Proschan, M. (2005). Two-stage sample size re-estimation based on a nuisance
parameter. Journal of Biopharmaceutical Statistics 15, 559-574.
4

28. Proschan, M., Leifer, E., and Liu, Q (2005). Adaptive Regression. Journal of
Biopharmaceutical statistics 15, 593-603.
29. Proschan, M. and Follmann, D. (2004). A permutation approach to the Behrens-Fisher
problem. Journal of the Korean Statistical Society 33, 79-97.
30. Proschan, M. (2004). Book review of Multiple Analyses in Clinical Trials:
Fundamentals for Investigators. Statistics in Medicine 23, 3551-3552.
31. Proschan, M. Advances in Clinical Trial Biostatistics (N. Geller, editor) (2004), Chapter
4: Adaptive Two Stage Designs. Marcel Dekker, Inc., New York.
32. Stylianou, M.,Proschan, M., and Flournoy, N. (2003). Estimating the probability of
toxicity at the target dose following an up-and-down design. Statistics in Medicine 22,
535-543.
33. Follmann, D., Proschan, M., and Leifer, E. (2003). Multiple outputation: Inference for
complex clustered data by averaging analyses from independent data. Biometrics 59, 420-
429.
34. Proschan, M. (2002). The geometry of two-stage tests. Statistica Sinica 13, 163-177.
35. Proschan, M., Liu, Q., and Hunsberger, S. (2002). Practical mid-course sample size
modification in clinical trials. Controlled Clinical Trials 24, 4-15.
36. Liu, Q., Proschan, M., and Pledger, G. (2002). The theory of adaptation. Journal of the
American Statistical Association 97, 1034-1041.
37. Proschan, M. and Waclawiw, M. (2001). Author’s reply. Controlled Clinical Trials 22,
550-552.
38. Proschan, M., McMahon, R., Shih, J., Hunsberger, S., Geller, N., Knatterud, G., and
Wittes, J. (2001). Sensitivity analysis using an imputation method for missing binary
data in clinical trials. Journal of Statistical Planning and Inference 96, 155-165.
39. Proschan, M. and Waclawiw, M. (2000). Practical guidelines for multiplicity adjustment
in clinical trials. Controlled Clinical Trials 21, 527-539.
40. Proschan, M. and Wittes, J. (2000). An improved double sampling method based on the
variance. Biometrics 56, 1183-1187.
41. Proschan, M. (2001). Author’s reply. Statistics in Medicine 20, 320-321.
5

42. Wittes, J., Schabenberger,O., Zucker, D., Brittain, E., and Proschan, M. (1999). Internal
pilot studies I: Type I error rate of the naive t-test. Statistics in Medicine 18, 3481-3491.
43. Follmann, D. and Proschan, M. (1999). A multivariate test for interaction for use in
clinical trials. Biometrics 55, 1151-1155.
44. Proschan, M. (1999). Statistical methods for monitoring clinical trials. Journal of
Biopharmaceutical Statistics 9, 599-615.
45. Follmann, D. and Proschan, M. (1999). A simple permutation-type method for testing
circular uniformity with correlated angular measurements. Biometrics 55, 782-791.
46. Proschan, M. (1999). Properties of spending function boundaries. Biometrika 86, 466-
473.
47. Follmann, D. and Proschan, M. (1999). Valid inference in random effects meta-analysis.
Biometrics 55, 732-737.
48. Proschan, M. (1999). A multiple comparison procedure for three- and four-armed
controlled clinical trials. Statistics in Medicine 18, 787-798.
49. Feldman, H., Proschan, M., Murray, D., Goff, D., Stylianou, M., Dulberg, E.,
McGovern, P., Chan, W., Mann, N., Bittner, V. for the REACT study group (1998).
Statistical design of REACT (Rapid Early Action for Coronary Treatment), a multi-site
community trial with continual data collection. Controlled Clinical Trials 19, 391-403.
50. Proschan, M. and Presnell, B. (1998). Expect the unexpected from conditional
expectation. The American Statistician 52, 248-252.
51. Proschan, M. and Follmann, D. (1997). A restricted test of circadian rhythm. Journal of
the American Statistical Association, 92, 717-724.
52. Proschan, M. (1997). Conditional power with Fisher's least significant difference
procedure. Biometrika, 84, 197-208.
53. Geller, N. and Proschan M. (1996). Meta-analysis of clinical trials: a consumer's guide.
Journal of Biopharmaceutical Statistics 6, 377-394.
54. Proschan, M. (1996). On the distribution of the unpaired t-statistic with paired data.
Statistics in Medicine 15, 1059-1063.
55. Proschan, M. and Hunsberger, S. (1995). Designed extension of studies based on
conditional power. Biometrics 51, 1315-1324.
6

56. Proschan, M. and Follmann, D. (1995). Multiple comparisons with control in a single
experiment versus separate experiments; Why do we feel differently? The American
Statistician 49, 144-149.
57. Geller, N., Proschan, M., and Follmann, D. (1995). Group sequential monitoring of
multi-armed clinical trials. Drug Information Journal 29, 705-713.
58. Proschan, M., Follmann, D., and Geller, N. (1994). Monitoring multi-armed trials.
Statistics in Medicine 13, 1441-1452.
59. Proschan, M. (1994). Influence of selection bias on type 1 error rate under random
permuted block designs. Statistica Sinica 4, 219-231.
60. McMahon, R., Proschan, M., Geller, N., Stone, P. and Sopko, G. (1994). Sample size
calculation for clinical trials in which entry criteria and outcomes are counts of events.
Statistics in Medicine 13, 859-870.
61. Follmann, D. and Proschan, M. (1994). The effect of estimation and biasing strategies
on selection bias in clinical trials with permuted blocks. Journal of Statistical Planning
and Inference 39, 1-17.
62. Follmann, D., Proschan, M., and Geller, N. (1994). Monitoring pairwise comparisons in
multi-armed clinical trials. Biometrics 50, 325-336.
63. Proschan, M., Follmann, D., and Waclawiw, M. (1992). Effects of assumption
violations on type 1 error rate in group sequential monitoring. Biometrics 48, 1131-1143.
64. Proschan, M. and Leysieffer, F. (1992). A partial ordering of rank densities. Journal of
Multivariate Analysis 40, 84-93.
65. Proschan, M. (1991). A note on Blackwell and Hodges (1957) and Diaconis and
Graham (1981). Annals of Statistics 19, 1106-1108.
66. Boland, P. and Proschan, M. (1990). The use of statistical evidence in allegations of
exam cheating. Chance 3, 10-14.
67. Proschan, M. (1989). Contributions to the theory of arrangement increasing functions.
Ph.D. dissertation.
OTHERS
7

68. Vassena, L., Miao, H., Malnati, M., Cassina, G., Proschan, M., Hirsch, V., Morre, M.,
Fauci, A., and Lusso, P. (2010). IL-7 treatment prevents the depletion of naïve and
central memory CD4+ T cells during acute SIV infection in rhesus macaques. Submitted.
69. Dlamini, J., Ledwaba, L., Mokwena, N., Mokhathi, T., Orsega, S., Tsoku,M., Kowo, H.,
Proschan, M., Khabo, P., Maja, P., and Hadigan, C. (2010). Lactic acidosis and
symptomatic hyperlactitemia in a randomized trial of first-line therapy in HIV-infected
adults in South Africa. Antiviral Therapy (in press).
70. Catalfamo, M., Wilhelm, C., Lueng, Tcheung, Proschan, M., Friesen, T., Park, J.,
Adelsberger, J., Baseler, M., Maldarelli, F. Davey, R., Roby, G.. Rehm, C., and Lane, C.
(2010). CD4 and CD8 T cell immune activation during chronic HIV infection: Roles of
homeostasis, HIV, type-1 IFN, and IL-7. The Journal of Immunology (in press).
71. Moir, S., Buckner, C., Ho1, J., Wang, W., Chen, J., Waldner, A., Posada, J., Kardava1, L.
O’Shea, M., Kottilil, S., Chun, T., Proschan, M., and Fauci, S. (2010). B cells in early
and chronic HIV infection: evidence for preservation of immune function associated with
early initiation of antiretroviral therapy. Blood 116, 5571-5579..
72. Ciccone, E., Read, S., Mannon, P., Yao, M., Hodge, J., Dewar, R., Chairez, C.,
Proschan, M., Kovacs, J., Sereti, I. (2010) Cycling of gut mucosal CD4+ T cells
decreases after prolonged anti-retroviral therapy and is associated with plasma LPS
levels. Mucosal Immunology 3 172-181.
73. Osinusi, A., Rasimas, J., Bishop, R., Proschan, M., McLaughlin, M., Murphy, A.,
Cortez, K., Polis, M., Masur, H., Rosenstein, D., Kottili, S. (2009). HIV/Hepatitis C
virus-coinfected virologic responders to pegylated interferon and ribavirin therapy more
frequently incur Interferon-related adverse events than non-responders do. JAIDS 53,
357-363.
74. Dinoso, J., Kim, S., Wiegand, A. Palmer, S., Gange, S., Cranmer, L., O’Shea, A.,
Callender, M., Spivak, A., Brennan, T., Kearney, M., Proschan, M., Mican , J., Rehm,
C., Coffin, J., Mellors, J., Siliciano, R., Maldarelli, F. (2009). Treatment intensification
does not reduce residual HIV-1 viremia in patients on highly active antiretroviral therapy.
Proceedings of the National Academy of Science 106, 9403-9408.
75. Sereti, I., Dunham, R., Spritzler, J., Aga, E., Proschan, M., Medvik, K., Battaglia, C.,
Landay, A., Pahwa, S., Fischl, M., Asmuth, D., Tenorio, A., Altman, J., Fox, L., Moir, S.,
Malaspina, A., Morre, M., Buffet, R., Silvestri, G., and Lederman M. (2009). IL-7
administration drives T cell-cycle entry and expansion in HIV-1 infection.
Blood 113, 6304-6314.
8

76. Moir, S., Ho, J., Malaspina, A., Wang, W., Dipoto, A., O’Shea, M., Roby, G., Kottilil, S.,
Arthos, J., Proschan, M., Chun, T., Fauci, A. (2008). Evidence for HIV-associated B
cell exhaustion in a dysfunctional memory B cell compartment in HIV-infected viremic
individuals. Journal of Experimental Medicine 205, 1797-1805.
77. Brantley, P., Appel, L., Hollis, J., Stevens, V., Ard, J., Champagne, C., Elmer, P., Harsha,
D., Myers, V., Proschan, M., Vollmer, W., and Svetkey, L. (2008). Design
considerations and rationale of a multi-center trial to sustain weight loss: the weight loss
maintenance trial. Clinical Trials 5, 546-556.
78. Higgins, J., Metcalf, J., Stevens, R., Baseler, M., Proschan, M., Lane, H., and Sereti, I.
(2008). Effects of delays in peripheral blood processing, including cryopreservation, on
detection of CD31 expression on naïve CD4 T-cells. Clinical and Vaccine Immunology
15, 1141-1143.
79. Moir, S., Malaspina, A., Ho, J., Wang, W., Dipoto, A., O’Shea, M., Roby, G., Mican, J.,
Kottilil, S., Chun, T., Proschan, M., Fauci, A. (2008). Normalization of B cell counts
and subpopulations after antiretroviral therapy in chronic HIV disease. Journal of
Infectious Diseases 197, 572-579.
80. Nussenblatt, V., McLaughlin, M., Rehm, C., Lempicki, R., Brann, T., Yang, J.,
Proschan, M., Highbarger, H., Dewar, R., Imamichi, T., Koratich, C., Neumann, A.,
Masur, H., Polis, M., and Kottilil, S. (2007). Immunodeficiency and intrinsic IFN
resistance are associated with viral breakthrough to HCV therapy in HIV-coinfected
patients. AIDS Research and Human Retroviruses 23, 1354-1359.
81. Vassena, L., Proschan, M., Fauci, A., and Lusso, P. (2007). Interleukin 7 reduces the
levels of spontaneous apoptosis in CD4+ and CD8+ T-cells from HIV-1 infected
individuals. Proceedings of the National Academy of Sciences 104, 2355-2360.
82. Leenen, F., Nwachuku, C., Black, H., Cushman, W., Davis, B., Simpson, L., Alderman,
M., Atlas, S., Basile, J., Cuyjet, A., Dart, R., Felicetta, J., Grimm, R., Haywood, L., Jafri,
S., Proschan, M., Thadani, U., Whelton, P., Wright, J. for the Antihypertensive and
Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) Collaborative Research
Group (2006). Clinical events in high-risk hypertensive patients randomly assigned to
calcium channel blocker versus angiotensin-converting enzyme inhibitor in the
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack trial.
Hypertension 48, 374-384.
83. Jatoi, I. and Proschan, M. (2006). Clinical trial results applied to the management of the
individual cancer patient. World Journal of Surgery 30, 1184-1189.
9

84. Davis, B., Piller, L.B., Cutler, J., Furberg, C., Dunn, K., Franklin, S., Goff, D., Leenen,
F., Mohiuddin, S., Papademetriou, V., Proschan, M., Ellsworth, A., Golden, J., Colon,
P., Crow, R. for the ALLHAT Collaborative Research Group (2006). The role of
diuretics in the prevention of heart failure: The Antihypertensive and Lipid Lowering
Treatment to Prevent Heart Attack Trial. Circulation 113, 2201-2210.
85. Elmer, P. , Obarzanek, E., Vollmer, W., Simons-Morton, D., Stevens, V., Young, D., Lin,
P., Champagne, C., Harsha, D., Svetkey, L., Ard, J., Brantley, P., Proschan, M., Erlinger,
T., Appel, L. (2006) for the Premier Collaborative Research Group. Effects of
comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure
control: 18-month results of a randomized trial. Annals of Internal Medicine 144, 485-
495.
86. Jatoi, I. and Proschan, M. (2005). Randomized trials of breast conserving therapy versus
mastectomy for primary breast cancer: A pooled analysis of updated results. The
American Journal of Clinical Oncology 28, 289-294.
87. Vollmer, W., Appel, L., Svetkey, L., Moore, T., Vogt, T., Conlin, P., Proschan, M., and
Harsha, D. (2005). Comparing office-based and ambulatory blood pressure monitoring in
clinical trials. Journal of Human Hypertension 19, 77-82.
88. Hallstrom, A., Ornato, J., Weisfeldt, M., Travers, A., Christenson, J., McBurnie, M.,
Zalenski, R., Becker, L., Schron, E., and Proschan, M. (2004). Public-access
defibrillation and survival after out-of-hospital cardiac arrest. The New England Journal
of Medicine 351, 637-646.
89. Svetkey, L., Simons-Morton, D., Proschan, M., Sacks, F., Conlin, P., Harsha, D., Moore,
T. (2004). Effect of the Dietary Approaches to Stop Hypertension diet and reduced
sodium intake on bp control. Journal of Clinical Hypertension 6, 373-381.
90. Domanski, M. and Proschan, M. (2004). The metabolic syndrome. Journal of the
American College of Cardiology 43, 1396-1398.
91. Obarzanek, E., Proschan, M., Vollmer, W., Moore, T., Sacks, F., Appel, L., Svetkey, L.,
Most-Windhauser, M., Cutler, J. (2003). Individual blood pressure responses to changes
in salt intake: Results from the DASH-Sodium trial. Hypertension 42, 459-467.
92. Svetkey, L., Harsha, D., Vollmer, W., Stevens, V., Obarzanek, E., Elmer, P., Lin, P.,
Champagne, C., Simons-Morton, D., Aickin, M., Proschan, M., and Appel, L. (2003).
Premier: A clinical trial of comprehensive lifestyle modification for blood pressure
control: Rationale, design, and baseline characteristics. Annals of Epidemiology 13, 462-
471.
10

93. Lin, P, Proschan, M., Bray, G., Fernandez, C., Hoben, K., Windhauser, M., Karanja, N.,
Obarzanek, E. (2003). Estimation of energy requirements in a controlled feeding trial.
American Journal of Clinical Nutrition 77, 639-645.
94. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group
(2002). Major outcomes in high-risk hypertensive patients randomized to angiotensinconverting
enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive
and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 288,
2981-2997.
95. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group
(2002). Major Outcomes in moderately hypercholesterolemic, hypertensive patients
randomized to pravastatin vs usual care: The Antihypertensive and Lipid Lowering
Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA 288, 2998-3007.
96. Waters, D., Alderman, E., Hsia, J., Howard, B., Cobb, F., Rogers, W., Ouyang, P.,
Thompson, P., Tardif, J., Higginson, L., Bittner, V., Steffes, M., Gordon, D., Proschan,
M., Younes, N., Verter, J. Effects of hormone replacement therapy and antioxidant
vitamin supplements on coronary atherosclerosis in postmenopausal women: A
randomized controlled trial. JAMA 288, 2432-2440.
97. Hsia, J., Alderman, E., Verter, J., Rogers, W., Thompson, P., Howard, B., Cobb, F.,
Ouyang, P., Tardif, J., Higginson, L.,Bittner, V., Barofsky, I., Steffes, M., Gordon, D.,
Proschan, M., Younes, N., Waters, D. (2002). Women’s Angiographic Vitamin and
Estrogen Trial: Design and Methods. Controlled Clinical Trials 23, 708-727.
98. Sacks, F., Svetkey, L., Vollmer, W., Appel, L., Bray, G., Harsha, D., Obarzanek, E.,
Conlin, P., Miller, E., Simons-Morton, D., Karanja, N., Lin, P., Other authors: Aickin,
M., Most-Windhauser, M., Moore, T., Proschan, M., Cutler, J. Windhauser, M., Moore,
T., and Cutler, J. (2001). Effects on blood pressure of reduced dietary sodium and the
Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative
Research Group. The New England Journal of Medicine 344, 3-10.
99. Grimm, R., Margolis, K., Papademetriou, V., Cushman, W., Ford, C., Bettencourt, J.,
Alderman, M., Basile, J., Black, H., DeQuattro, V., Eckfeldt, J., Hawkins, C., Perry, H.,
Proschan, M. (2000). Baseline characteristics of the 42,448 high risk hypertensive
patients enrolled in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart
Attack Trial (ALLHAT). Hypertension 37, 19-27.
100. Obarzanek, E., Sacks, F., Vollmer, W., Bray, G., Miller, E., Lin, P., Karanja, N.,
Windhauser, M., Moore, T., Swain, J., Bales, C., and Proschan, M. on behalf of the
DASH Research Group (2000). Effects on blood lipids of a blood pressure-lowering diet:
11

the Dietary Approaches to Stop Hypertension (DASH) trial. The American Journal of
Clinical Nutrition 74, 80-89.
101. Luepker, R., Raczynski, J., Osganian, S., Goldberg, R., Finnegan, J., Hedges, J., Goff, D.,
Eisenberg, M., Zapka, J., Feldman, H., Labarthe, D., McGovern, P., Cornell, C.,
Proschan, M., Simons-Morton, D., (2000). Effect of a community intervention on
patient delay and emergency medical service use in acute coronary heart disease: The
Rapid Early Action for Coronary Treatment (REACT) Trial. Journal of the American
Medical Association 284, 60-67.
102. Svetkey, L., Sacks, F., Obarzanek, E., Vollmer, W., Appel, L., Lin, P., Karanja, N,
Harsha, D., Bray, G., Aickin, M., Proschan, M., Windhauser, M., Swain, J., McCarron,
P., Rhodes, D., Laws, R. (1999). The DASH diet, sodium intake and blood pressure
trial(DASH-sodium): Rationale and design. Journal of the American Dietetic Association
(Supplement) 99, s96-s104.
103. Friedman, L. and Proschan, M. (1998). P-value interpretation and alpha allocation in
clinical trials (Editorial). Annals of Epidemiology 8, 349-350.
104. Simons-Morton, D., Goff, D., Osganian, S., Goldberg, R., Raczynski, J., Finnegan, J.,
Zapka, J., Eisenberg, M., Proschan, M., Feldman, H., Hedges, J., and Luepker, R.(1998).
Rapid Early Action for Coronary Treatment (REACT): Rationale, design, and baseline
characteristics. Academic Emergency Medicine 5, 726-738.
105. Sharaf, B., Bourassa, M., McMahon, R., Pepine, C., Chaitman, B., Williams, D., Miele,
N., Davies, R., Proschan, M., Conti, C. for the ACIP investigators (1998). Clinical and
detailed angiographic findings in patients with ambulatory electrocardiographic ischemia
without critical coronary narrowing: Results from the Asymptomatic Cardiac Ischemia
Pilot (ACIP) study. Clinical Cardiology 21, 86-92.
106. Carney, R., Becker, L., Ketterer, M., Knatterud, G., Krantz, D., Freedland, K., Lindholm,
L., McMahon, R., Proschan, M., Raczynski, J., Sheps, D. (1998). Reproducibility of
mental stress-induced myocardial ischemia in the Psychophysiological Investigations of
Myocardial Ischemia (PIMI). Psychosomatic Medicine 60, 64-70.
107. Proschan, M., Davis, B., Cutler, J., Ford, C., Furberg, C., Grimm, R., Oparil, S. (1997).
ALLHAT and calcium channel blockers. American Journal of Hypertension 10, 142-
143.
108. Stone, P., Chaitman, B., McMahon, R., Andrews, T., MacCallum, G., Sharaf, B.,
Frishman, W., Deanfield, J., Sopko, G., Pratt, C., Goldberg, A., Rogers, W., Hill, J.,
Proschan, M., Pepine, C., Bourassa, M., Conti, C. (1996). Asymptomatic Cardiac
12

Ischemia Pilot (ACIP) Study: Relationship between exercise-induced and ambulatory
ischemia in patients with stable coronary disease. Circulation, 94, 1537-1544.
109. Mulcahy, D., Dakak, N., Zalos, G., Andrews, N., Proschan, M., Waclawiw, M.,
Schenke, B., and Quyyumi, A. (1996). Patterns and behavior of transient myocardial
ischemia in stable coronary disease are the same in both sexes: a comparative study.
Journal of the American College of Cardiology 27(7), 1629-1636.
110. Davis, B., Cutler, J., Gordon, D., Furberg, C., Wright, J., Cushman, W., Grimm, R.,
LaRosa, J., Whelton, P., Perry, H., Alderman, M., Ford, C., Oparil, S., Francis, C.,
Proschan, M., Pressel, S., Black, H., Hawkins, C. (1996). Rationale and design for the
Antihypertensive and Lipid Lowering treatment to prevent Heart Attack Trial (ALLHAT).
American Journal of Hypertension 9, 342-360.
111. Sacks, F., Obarzanek, E., Windhauser, M., Svetkey, L., Vollmer, W., McCullough, M.,
Karanja, N., Lin, P., Steele, P., Proschan, M., Evans, M., Appel, L., Bray, G., Vogt, T.,
Moore, T. (1995). Rationale and design of the Dietary Approaches to Stop Hypertension
Trial (DASH): A multicenter controlled feeding study of dietary patterns to lower blood
pressure. Annals of Epidemiology 5, 108-118.
112. Spirito, P., Pelliccia, A., Proschan, M., Granata, M., Spataro, A., Bellone, P., Caselli, G.,
Biffi, A., Vecchio, C., Maron, B. (1994). Morphology of the athlete's heart assessed by
echocardiography in 947 elite athletes representing 27 sports. The American Journal of
Cardiology 74, 802-806.
113. Pepine, C., Geller, N., Knatterud, G., Bourassa, M., Chaitman, B., Davies, R., Day, P.,
Deanfield, J., Goldberg, A., McMahon, R., Miller, H., Ouyang, P., Pratt, C., Proschan,
M., Rogers, W., Selwyn, A., Sharaf, B., Sopko, G., Stone, P., Conti, R (1994). The
Asymptomatic Cardiac Ischemia Pilot (ACIP) study: Design of a randomized clinical
trial, baseline data and implications for a long term outcome trial. Journal of the
American College of Cardiology 24, 1-10.
114. Mautner, S., Mautner, G., Froehlich, J., Feuerstein, I., Proschan, M., Roberts, W.,
Doppman, J. (1994). Coronary artery disease: Prediction with in vitro electron beam CT.
Radiology 192, 625-630.
115. Mautner, G., Mautner, S., Froehlich, J., Feuerstein, I., Proschan, M., Roberts, W.,
Doppman, J. (1994). Coronary artery calcification: Assessment with electron beam CT
and histomorphometric correlation. Radiology 192, 619-623.
13

116. Maron, B., Kogan, J., Proschan, M., Hecht, G., and Roberts, W. (1994). Circadian
variability in the occurrence of sudden cardiac death in patients with hypertrophic
cardiomyopathy. Journal of the American College of Cardiology 23, 1405-1409.
117. Arabia, F., Stewart, S., Nast, E., Talbot, T., Proschan, M., Clark, R. (1994). Errors in
pressure-gradient measurement in prosthetic aortic valves due to pressure recovery-type,
size, and flow rate effects in vitro. Echocardiography 11, 425-436.
118. Peters, R., Zoble, R., Liebson, P., Pawitan, Y., Brooks, M., and Proschan, M. (1993).
Identification of a secondary peak in myocardial infarction onset 11-12 hours after
awakening: The Cardiac Arrhythmia Suppression Trial (CAST) experience. Journal of
the American College of Cardiology 22, 998-1003.
119. Mautner, S., Klues, H., Mautner, G., Proschan, M., Roberts, W., and Maron, B. (1993).
Comparison of mitral valve dimensions in adults with valvular aortic stenosis, pure aortic
regurgitation, and hypertrophic cardiomyopathy. The American Journal of Cardiology
71, 949-953.
120. Klues, H., Dollar, A., Proschan, M., Spirito, P., Roberts, W., and Maron, B. (1993).
Echocardiographic assessment of mitral valve size in obstructive hypertrophic
cardiomyopathy: Anatomic validation from valve specimen. Circulation 88, 548-555.
121. Friedman, L., Bristow, J., Hallstrom, A., Schron, E., Proschan, M., Verter, J., DeMets,
D., Fisch, C., Nies, A., Ruskin, J., Strauss, H., Walters, L. (1993). Data monitoring in the
Cardiac Arrhythmia Suppression Trial. The Online Journal of Current Clinical Trials,
1993.
122. Stewart, S., Nast, E., Arabia, F., Talbot, T. Proschan, M., Clark, R. (1991). Errors in
pressure gradient measurement by continuous wave Doppler: type, size, and age effects in
bioprosthetic aortic valves. Journal of the American College of Cardiology 18, 769-779.
123. Pelliccia, A., Maron, B., Spataro, A., Proschan, M., Spirito, P. (1991). The upper limit
of physiologic cardiac hypertrophy in highly trained elite athletes. New England Journal
of Medicine 5, 295-301.
RECENT INVITED PRESENTATIONS
September 2011. Overview of Potentially Helpful Adaptive Designs for TB. TB Vaccine
Scientific Symposium, Bethesda, Maryland.
14

August 2011. Adaptive Methods before Breaking the Blind. International Society for Clinical
Biostatistics. Ottawa, Canada
May 2011. Lectures on Elementary Statistics, Sample Size/Power, and Survival Analysis.
Intensive Clinical Research Methods Workshop. Cape Town, South Africa.
March 2011. Adaptations Made before Unblinding. Second International Symposium on
Biopharmaceutical Statistics. Berlin, Germany.
November 2010. “The Conservatism of Bonferroni for a Large Number of Nearly Independent
Comparisons.” Johns Hopkins University.
August 2010 “Adaptations That Should Not Raise Objections, but Probably Will.” Joint
Statistical Meeting of the ASA, Vancouver, British Columbia, Canada.
May 2010 “Alternative Designs for Pediatric Trials.” Pediatric Clinical Trial Conference,
Arlington, Virginia.
May 2010 “Minimize the Use of Minimization with Unequal Allocation.” Society of Clinical
Trials Annual Meeting, Baltimore, MD.
November 2009. “Adaptive Trial Experiences I Know of at NIH.” Scientific Advances in
Adaptive Clinical Trial Design, Bethesda, MD.
June 2009. “Adaptive Sample Size Calculations in Clinical Trials.” Statistical Society of
Canada. Vancouver, British Columbia, Canada.
March 2009. “Are Things as Un-Rosi as They Appear?” Meeting of the Eastern North
American Region of the Biometric Society. San Antonio, Texas
July 2009. “Comment on Harm in Safety Studies.” Joint Statistical Meeting of the ASA.
Washington, D.C.
July 2009 Summer Institute on Randomized Controlled Trials with Behavioral Interventions.
November 2008. “Conditioning: Don’t Be Pavlov’s Dog.” George Mason University, Fairfax,
Virginia.
October 2008, Course on clinical research presented by the NIAID Office of Scientific Resource
Development. Topic: small clinical trials.
July 2008. Summer Institute on Randomized Controlled Trials with Behavioral Interventions.
15

March 2008. Statistical Monitoring of Clinical Trials: A Unified Approach (jointly with Janet
Wittes). Eastern North American Region of the Biometric Society.
March 2008. Flexible Designs in Clinical Trials. Joint Meeting of the German, Swiss, and
Austrian Biometric Society Regions.
December 2007. Discussion of “Who’s Minding the Data? Data Monitoring Committees in
Cancer Clinical Trials,” by Peter Keating.
November 2007. Case Studies in Monitoring of Clinical Trials. National Institute of Mental
Health Workshop for Data and Safety Monitoring Board Members.
August 2007. 8-hour short course: Statistical Monitoring of Clinical Trials: A Unified Approach.
Joint Statistical Meetings of the ASA. Salt Lake City, Utah.
November 2006. Conditioning in 2x2 Tables. National Cancer Institute, Bethesda, Maryland.
August 2006. Discussion of Are Flexible Designs Sound? Joint Statistical Meetings of the
ASA. Seattle, Washington.
March 2005. 9-hour short course: Monitoring Clinical Trials, Meeting of the Eastern North
American Region of the Biometric Society, Austin, Texas.
July/August 2001-2006. Summer Training Institute on Randomized Clinical Trials for
Behavioral Interventions, Warrenton, Virginia.
November 2004. Brown vs. The Board of Data Monitoring. FDA, Gaithersburg, Maryland.
March 2004. Adaptive Regression. Workshop on the Design and Analysis of Clinical Trials
Incorporating Treatment Selection, Reading, England.
December 2003. 12 hour short course: Monitoring Clinical Trials. Biopharmaceutical Applied
Statistics Symposium, Savannah, Georgia.
September 2002. A Conservative, Adaptive Sample Size Method for Clinical Trials.
International Society for Clinical Biostatistics, Dijon, France.
October 2002. Clinical Trials: An Introduction for Investigators in Child Neurology: Basic Study
Design. 31 st Annual Meeting of the Child Neurology Society, Washington, D.C.
August 2002. Practical Mid-Course Sample Size Modification in Clinical Trials. American
Statistical Association Meeting, New York.
16

April 2001. Mid-Course Sample Size Modification Based on Treatment Effect in Clinical Trials.
Harvard University, Boston, Massachusetts.
September 2000. Statistical Methods for Monitoring Clinical Trials. FDA Workshop on Current
Advances In Interim Analysis And Design Modifications, Rockville, Maryland.
February 2000. Two-Stage Procedures To Adaptively Modify Sample Size in Clinical Trials.
Conference On Medical Statistics, Oberwolfach Institute, Oberwolfach, Germany.
January 2000. Adaptive Designs In Clinical Trials, The University of Florida, Gainesville,
Florida.
17

COMMITTEES/OTHER AFFILIATIONS
2008-1010. Associate Editor, Biometrics.
7/10/2006-6/30/2010 Member, FDA Endocrinologic and Metabolic Drugs Advisory Committee.
April 29, 2010. Consultant for the FDA’s Anti-Infective Drug Advisory Committee Meeting on
artesunate to stabilize patients with malaria until they can reach a hospital in resource-limited
settings.
March 1, 2010. Consultant for the FDA’s Cardiorenal Advisory Committee Meeting considering
belatacept to prevent rejection with kidney transplants.
January 23, 2008. Consultant for the FDA’s Gastrointestinal Drugs Advisory Committee
considering the approval of Entereg (Alvimopan) to accelerate time to gastrointestinal recovery
following bowel resection surgery.
October 16, 2007. Consultant for the FDA’s Cardiovascular and Renal Drug Advisory
Committee considering the use of phosphate binders in patients prior to reaching end-stage renal
disease.
December 14, 2006. Consultant for the FDA’s Anti-Infective Drugs Advisory Committee
considering the use of Ketek for community acquired pneumonia, acute bacterial exacerbations
of chronic bronchitis, and acute bacterial sinusitis.
November 29, 2006. Consultant for the FDA’s Arthritis Advisory Committee considering
Celecoxib in children with rheumatoid arthritis.
November 16, 2005. Consultant for the FDA’s Cardiovascular and Renal Drugs Advisory
Committee considering a new drug application (NDA).
June 15, 2005. Consultant for the FDA’s Cardiovascular and Renal Drugs Advisory Committee
concerning class labeling of antihypertensive drugs.
June 6, 2005. Consultant for the FDA’s Pulmonary and Allergy Drugs Advisory Committee
considering a new drug application (NDA).
March 4, 2005. Consultant for the FDA’s Oncologic Drugs Advisory Committee Meeting.
March 6,2003, Consultant for the FDA’s Gastrointestinal Drugs Advisory Committee
considering a new drug application (NDA).
18

March 4,2003, Consultant for the FDA’s Anti-infective Drugs Advisory Committee considering
a new drug application (NDA).
2002 Scientific Committee for the 2002 International Society for Clinical Biostatistics
Conference in Dijon, France.
2000-2006, Consultant for the Association for the Advancement of Medical Instrumentation. My
role is to help develop criteria for determining the accuracy of automatic blood pressure
machines in measuring systolic blood pressure.
1999-2001, Consultant for the Adult Treatment Panel III of the National Cholesterol Education
Program. My role was to conduct meta-analyses of the effects of cholesterol lowering on overall
and specific types of mortality and other endpoints in clinical trials.
1997-2000 Member, Dissertation Committee for Mario Stylianou in pursuit of his Ph.D. in
Statistics, American University.
2003-2004 Member, Dissertation Committee for Chuke Nwachuku in pursuit of his Doctor of
Public Health, George Washington University.
CLINICAL TRIAL EXPERIENCE AT NHLBI
Action to Control Cardiovascular Risk in Diabetes (ACCORD).
Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).
Asymptomatic Cardiac Ischemia Pilot study (ACIP).
Cardiac Arrhythmia Suppression Trial II (CAST II).
Dietary Approaches to Stop Hypertension (DASH).
Dietary Approaches to Stop Hypertension-Sodium (DASH-Sodium).
Dietary Effects of Lipoproteins and Thrombogenic Activity (DELTA).
Estrogen and Graft Atherosclerosis Research Trial (EAGAR).
Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization
Effectiveness (ESCAPE)
Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT).
19

Home AED Trial (HAT)
Multicenter Unsustained Tachycardia Trial (MUSTT).
Open Artery Trial (OAT).
Premier: A trial comparing the blood pressure lowering effects of two multi-component lifestyle
intervention arms, one of which includes the DASH diet, to an advice only arm.
Psychophysiological Investigation of Myocardial Ischemia (PIMI).
Public Access Defibrillation (PAD) Trial.
Rapid Early Action for Coronary Treatment (REACT).
Weight Loss Maintenance Trial (WLM)
Women’s Angiographic Vitamin and Estrogen (WAVE) Trial.
ACTIVITIES IN STATISTICAL SOCIETIES
Former member of the Biometric Society's Regional Advisory Board for the Eastern North
American Region.
Member of the American Statistical Association.
Member of the International Society for Clinical Biostatistics.
OTHER
National Master, United States Chess Federation.
20