 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
Wittes J, Barrett-Connor E, Braunwald E, Chesney M, Cohen HJ, DeMets D, Dunn L, Dwyer J, Heaney RP, Vogel V, Walters L, Yusuf S. Monitoring the randomized trials of the Women's Health Initiative: the experience of the Data and Safety Monitoring Board. Clinical Trials 2007; 4:218-234. Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs C, Wittes J, Heppner DG. Phase I randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine 2007; 25:176-184. Sadoff J, Wittes J. Editorial: correlates, surrogates, and vaccines. J Infect Dis (to appear, 2007). Borer JS, Pouleur H, Abadie E, Follath F, Wittes J, Pfeffer MA, Pitt B, Zannad F. Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. Eur Heart J, in press. Withers M, McKinney D, Ogutu B, Waitumbi J, Milman J, Apollo
O, Allen O, Tucker K, Soisson L, Diggs C, Leach A, Wittes J, Dubovsky F,
Stewart A, Remich S, Cohen J, Ballou R, Holland C, Lyon J, Angov E, Stoute J,
Martin S, Heppner D. Safety and reactogenicity of an MSP-1 malaria vaccine
candidate: a randomized, phase Ib, dose-escalation trial in Kenyan children. PLoS to appear, 2006. Wittes J, Lachenbruch P. Opening the adaptive toolbox. Biometrical Journal, to appear 2006. Lachenbruch P, Wittes J. Some aspects of the application of internal pilot studies. Biometrical Journal, to appear 2006. Gorse GJ, O’Connor TZ, Young SL, Habib MP, Wittes J, Neuzil KM, Nichol K. Impact of a winter respiratory virus season on patients with COPD and association with influenza vaccination. Solomon SD, Pfeffer MA, McMurray
JJV, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG,
Bertagnolli M, Arber N, Wittes J. Effect of celecoxib on cardiovascular events
and blood pressure in two trials for prevention of colorectal adenoma. Circulation 2006; 114:1028-1035. Arber N, Eagle C, Spicak J, Racz I, Dite
P, Hajer J, Zavoral M, Lechuga M, Gerletti P, Tang J, Rosenstein R, Macdonald
K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B. Celecoxib for
the prevention of colorectal adenomatous polyps. N Engl J Med 2006; 355:885-895. Bertagnolli M, Eagle C, Zauber AG,
Redston M, Solomon SD, Kim K, Tang J, Rosenstein R, Wittes J, Corle D, Hess T,
Woloj M, Boisserie F, Anderson W, Viner J, Bagheri DB, J, Chung D, Dewar T,
Foley R, Hoffman N, Macrae F, Pruitt RE, Saltzman J, Salzberg B, Sylwestrowicz
T, Gordon G, Hawk E. Celecoxib for the prevention of sporadic colorectal
adenomas. N Engl J Med 2006;
355:873-884. Wittes J. A tale of three species –
rabbits, chickens and humans: an interview with clinical trials pioneer
Jeremiah Stamler. Clinical Trials
2006; 3:320-334. Wittes J, Boissel J, Furberg C, Julian D,
Kulbertus H, Pocock S. Stopping the Randomized Aldactone Evaluation Study early
for efficacy. In DeMets D, Furberg C, Friedman L (eds). Data Monitoring in Clinical Trials, A Case Studies Approach.
Springer, 148-157, 2006. Pocock S,
Wilhelmsen L, Dickstein K, Francis G, Wittes J. Data monitoring experience in
the moxonidine congestive heart failure trial. In DeMets D, Furberg C, Friedman
L (eds). Data Monitoring in Clinical
Trials, A Case Studies Approach. Springer, 148-157, 2006. Wittes J, Holmgren E, Christ-Schmidt H, Bajamonde A. Making
independence work: monitoring the bevacizumab colorectal cancer clinical trial.
In DeMets D, Furberg C, Friedman L (eds). Data
Monitoring in Clinical Trials, A Case Studies Approach. Springer, 148-157,
2006. Harmatz P, Giugliani R, Schwartz I, Guffon N, Teles EL, Sa
Miranda MC, Wraith JE, Beck M, Arash L, Scarpa M, Yu Z, Wittes J, Berger K,
Newman M, Lowe A, Kakkis E, Swiedler S. Enzyme replacement therapy for
Mucopolysaccharidosis VI: a phase 3, randomized, double-blind,
placebo-controlled, multinational study of recombinant human
n-acetylgalactosamine 4-sulfatase (recombinant human arylsufatase B or rhASB)
and follow-on, open-label extension study. Journal of Pediatrics, 2006;
148:533-539. Lachenbruch P, Wittes J. Sentinel event methods for
monitoring unanticipated adverse events. Statistics
in Medicine, 2006 to appear. Mathew J,
Wittes J, McSherry F, Williford W, Garg R, Probstfield J, Yusuf S, Group DI.
Racial differences in outcome and treatment effect in congestive heart failure.
American Heart Journal 2005;
150:968-976. Wittes J.
Design Considerations in Randomized Controlled Trials With a Focus on Usual
Care Arms: Compared to What? Some Thoughts on the Choice of Controls. 2005;
36-44. Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D,
Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA,
Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs C,
Wittes J, Heppner DG. Phase I randomized double-blind safety and immunogenicity
trial of Plasmodium falciparum
malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in
adults in western Black HR, Elliott WJ, Grandits G, Grambsch P, Lucente T,
Neaton JD, Grimm RH, Hansson L, Lacouciere Y, Muller JE, Sleight P, Weber MA,
White WB, Williams GH, Wittes J, Zanchetti A, and Anders R, for the CONVINCE
Research Group. Results of the Controlled ONset of Verapamil INvestigation of
Cardiovascular Endpoints (CONVINCE) trial by geographical region. Journal of Hypertension 2005;
23:1099-1106. Wittes J. Discussion of a paper by Sampson and Sill. Biometrical Journal, 2005; 47:276-277. Wittes J. Adaptive designs for clinical trials. P Armitage,
T Colton (eds). Encyclopedia of
Biostatistics, Second Edition. Villahermosa L, Fajardo T, Abalos R,
Balagon M, Tan E, Cellona R, Palmer J, Wittes J, Thomas S, Kook K, Walsh G,
Walsh D. A randomized, double-blind, double-dummy, controlled dose comparison
of thalidomide for treatment of erythema nodosum leprosum. Am J Trop Med Hyg, 2005; 75:518-526. Solomon S, McMurray J, Pfeffer M, Wittes
J, Fowler R, Finn P, Anderson W, Zauber A, Hawk E, Bertagnolli M.
Cardiovascular risk associated with celecoxib in a clinical trial for
colorectal adenoma prevention. New Engl J
of Med 2005; 352:1071-1080. DeMets D, Fleming T, Rockhold F, Massie
B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R. Liability
issues for data monitoring committee members. Clinical Trials 2004; 1:525-531. Pocock S, Wilhelmsen L, Dickstein K,
Francis G, Wittes J. The data monitoring experience in the MOXCON trial. European Heart J 2004; 25:1974-1978. Wittes J. Forming your Phase III trial’s Data and Saftey Monitoring
Board: a perspective on safety. J
Investigative Med, 2004; 52: 453-458. Gorse G, O’Connor T, Newman F, Mandava M, Mendelman P, Wittes J,
Peduzzi P. Immunity to influenza in older adults with chronic obstructive
pulmonary disease. J Infect Dis 2004;
190:11-19. Wittes J.
Playing safe and preserving integrity: making the FDA model work. Stat in Med 2004; 23:1523-1525. Black H, Elliott W…Wittes J…Anders R.
Principal results of the controlled onset Verapamil investigation of cardiovascular
end points (CONVINCE) trial. JAMA
2003; 289:2073-2082. Califf R, Morse M, Wittes J…Sugarman J.
Towards protecting the safety of participants in clinical trials. Controlled Clinical Trials 2003;
24:256-271. Gorse G, O’Connor T…Wittes J…Peduzzi P.
Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines
in older adults with chronic obstructive pulmonary disease: a VA cooperative
study. Vaccine 2002; 21:2133-2144. Wittes J. On changing a long-term
clinical trial midstream. Stat in Med
2002; 21:2789-2795. Wittes J. Sample size calculations for
randomized controlled trials. Am J
Epidemiol 2002; 24:39-53. Althuis MD,
Jordan NE, Ludington EA, Wittes JT. Glucose and insulin responses to dietary
chromium supplements: a meta-analysis. Am
J Clin Nutr 2002; 76:148-155. Nyman JA, Martinson MS, Nelson D, Nugent
S, Collins D, Wittes J, Wilt TJ, Robins SJ, Rubins HB. Cost-effectiveness of
Gemfibrozil for coronary heart disease patients with low levels of high-density
lipoprotein cholesterol. Arch Int Med 2002;
162:177-182. Packer M, Wittes J, Stump D. Terms of
reference for Data and Safety Monitoring Committees. Am Heart J 2001; 141:542-547. De Gruttola V, Clax P, DeMets D, Downing
G, Ellenberg S, Friedman L, Gail M, Prentice R, Wittes J, Zeger S.
Considerations in the evaluation of surrogate endpoints in clinical trials:
summary of a National Institutes of Health Workshop. Controlled Clinical Trials 2001; 22:485-502. Robins SJ,
Collins D, Wittes JT, Papademetriou V, Deedwania P, Schaefer EJ, McNamara JR,
Kashyap ML, Hershman JM, Wexler LF, Rubins HB. Relation of gemfibrozil treatment
and lipid levels with major coronary events: VA-HIT: A randomized controlled
trial. JAMA 2001; 285:1585-1591. Proschan MA,
McMahon RP, Shih JH, Hunsberger SA, Geller NL, Knatterud G, Wittes J.
Sensitivity analysis using an imputation method for missing binary data in
clinical trials. J Stat Planning and
Inference 2001; 96:155-165. Wittes J.
Clinical trials of the effectiveness of devices: An analogy with drugs. Surgery 2001; 129:517-523. Wittes J. Active-control trials: a
linguistic problem. International Chinese
Statistical Association Bulletin 2001; 39-40. Kester K, McKinney D, Tornieporth N,
Ockenhouse C, Heppner D, Hall T, Krzych U, Delchambre M, Voss G, Dowler M,
Palensky J, Wittes J, Cohen J, Ballou W. Efficacy of recombinant
circumsporozoite protein vaccine regimens against experimental Plasmodium
falciparum malaria. J Infec Dis 2001;
183:640-647. Black Wittes J. Discussion of a paper by Sampson and Sill. Biometrical Journal, 2005; 47:276-277. Wittes J. Adaptive designs for clinical trials. P Armitage, T Colton (eds). Encyclopedia of Biostatistics, Second Edition. New York: John Wiley, 1:51-55, 2005. Villahermosa L, Fajardo T, Abalos R, Balagon M, Tan E, Cellona R, Palmer J, Wittes J, Thomas S, Kook K, Walsh G, Walsh D. A randomized, double-blind, double-dummy, controlled dose comparison of thalidomide for treatment of erythema nodosum leprosum. Am J Trop Med Hyg, 2005; 75:518-526. Solomon S, McMurray J, Pfeffer M, Wittes J, Fowler R, Finn P, Anderson W, Zauber A, Hawk E, Bertagnolli M. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. New Engl J of Med 2005; 352:1071-1080. DeMets D, Fleming T, Rockhold F, Massie B, Merchant T, Meisel A, Mishkin B, Wittes J, Stump D, Califf R. Liability issues for data monitoring committee members. Clinical Trials 2004; 1:525-531. Pocock S, Wilhelmsen L, Dickstein K, Francis G, Wittes J. The data monitoring experience in the MOXCON trial. European Heart J 2004; 25:1974-1978. Wittes
J. Forming your Phase III trial’s
Data and Saftey Monitoring Board: a perspective on safety. J Investigative Med, 2004; 52: 453-458. Gorse
G, O’Connor T, Newman F, Mandava M, Mendelman P, Wittes J, Peduzzi P.
Immunity to influenza in older adults with chronic obstructive pulmonary
disease. J Infect Dis 2004;
190:11-19. Wittes J. Playing safe and preserving integrity: making the FDA model work. Stat in Med 2004; 23:1523-1525. Black H, Elliott W…Wittes J…Anders R. Principal results of the controlled onset Verapamil investigation of cardiovascular end points (CONVINCE) trial. JAMA 2003; 289:2073-2082. Califf R, Morse M, Wittes J…Sugarman J. Towards protecting the safety of participants in clinical trials. Controlled Clinical Trials 2003; 24:256-271. Gorse G, O’Connor T…Wittes J…Peduzzi P. Efficacy trial of live, cold-adapted and inactivated influenza virus vaccines in older adults with chronic obstructive pulmonary disease: a VA cooperative study. Vaccine 2002; 21:2133-2144. Wittes J. On changing a long-term clinical trial midstream. Stat in Med 2002; 21:2789-2795. Wittes J. Sample size calculations for randomized controlled trials. Am J Epidemiol 2002; 24:39-53. Althuis MD, Jordan NE, Ludington EA, Wittes JT. Glucose and insulin responses to dietary chromium supplements: a meta-analysis. Am J Clin Nutr 2002; 76:148-155. Nyman JA, Martinson MS, Nelson D, Nugent S, Collins D, Wittes J, Wilt TJ, Robins SJ, Rubins HB. Cost-effectiveness of Gemfibrozil for coronary heart disease patients with low levels of high-density lipoprotein cholesterol. Arch Int Med 2002; 162:177-182. Packer M, Wittes J, Stump D. Terms of reference for Data and Safety Monitoring Committees. Am Heart J 2001; 141:542-547. De Gruttola V, Clax P, DeMets D, Downing G, Ellenberg S, Friedman L, Gail M, Prentice R, Wittes J, Zeger S. Considerations in the evaluation of surrogate endpoints in clinical trials: summary of a National Institutes of Health Workshop. Controlled Clinical Trials 2001; 22:485-502. Robins SJ, Collins D, Wittes JT, Papademetriou V, Deedwania P, Schaefer EJ, McNamara JR, Kashyap ML, Hershman JM, Wexler LF, Rubins HB. Relation of gemfibrozil treatment and lipid levels with major coronary events: VA-HIT: A randomized controlled trial. JAMA 2001; 285:1585-1591. Proschan MA, McMahon RP, Shih JH, Hunsberger SA, Geller NL, Knatterud G, Wittes J. Sensitivity analysis using an imputation method for missing binary data in clinical trials. J Stat Planning and Inference 2001; 96:155-165. Wittes J. Clinical trials of the effectiveness of devices: An analogy with drugs. Surgery 2001; 129:517-523. Wittes J. Active-control trials: a linguistic problem. International Chinese Statistical Association Bulletin 2001; 39-40. Kester K, McKinney D, Tornieporth N, Ockenhouse C, Heppner D, Hall T, Krzych U, Delchambre M, Voss G, Dowler M, Palensky J, Wittes J, Cohen J, Ballou W. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infec Dis 2001; 183:640-647. Black HR, Elliott WJ, Neaton JD, Grandits G, Grambsch P, Grimm RH, Hannson L, Lacoucière Y, Muller J, Sleight P, Weber MA, White WB, Williams G, Wittes J, Sanchetti A, Fakouhi TD, Anders RJ. Baseline characteristics and early blood pressure control in the CONVINCE trial. Hypertension 2001; 37:12-18. Wittes J, Palensky J, Asner D, Julian D, Boissel J, Furberg C, Kulbertus H, Pocock S, Roniker B. Experience collecting interim data on mortality: an example from the RALES study. Current Controlled Trials in Cardiovascular Medicine 2001; 2:59-62. Wittes J. Data safety monitoring boards: a brief introduction. Biopharmaceutical Report 2000; 8:1-7, 10-11. Wittes J. Editorial: Subgroups: time to change the question? J Evidence Based Cardiovascular Med 2000; 4:79-81. Proschan M., Wittes J. An improved double sampling procedure based on the variance. Biometrics 2000; 56:18-22. Walker RE, Bechtel CM, Natarajan V, Baseler M, Hege KM, Metcalf JA, Stevens R, Hazen A, Blaese RM, Chen CC, Leitman SF, Palensky J, Wittes J, Davey RT Jr, Falloon J, Polis MA, Kovacs JA, Broad DF, Levine BL, Roberts MR, Masur H, Lane HC. Long term in vivo survival of receptor-modified syngeneic T cells in patients with HIV infection. Blood 2000; 96:467-474. Treanor JJ, Kotloff K, Betts RF, Belshe R, Newman F, Iacuzio D, Wittes J, Bryant M. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine 2000; 18:899-906. Belshe RB, Gruber WC, Mendelman PM, Cho I, Reisinger K, Block SL, Wittes J, Iacuzio D, Piedra P, Treanor J, King J, Kotloff K, Bernstein DI, Hayden FG, Zangwill K, Yan L, Wolff M. Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine. J Pediatr 2000; 136:168-175. Zucker DM, Wittes JT, Schabenberger O, Brittain E. Internal pilot studies II: comparison of various procedures. Stat Med 1999; 18:3493-3509. Wittes J. Mantel Unhyphenated. Stat Med 1999; 18:3381-3388. Colton T, Wittes J. In honour of Nathan Mantel's 80th birthday. Stat Med 1999; 18:3379. Wittes J, Schabenberger O, Zucker D, Brittain E, Proschan M. Internal pilot studies I: type I error rate of the naive t-test. Stat Med 1999; 18:3481-3491. Wittes J. Ten most commonly asked questions about statistical analysis of clinical trials. Card in Rev 1999; 7:5-8. Wittes J, Lakatos E, Black D, Geraci B, Davis B, Moye L, Probstfield J. Selecting screening criteria for clinical trials: an example from the Systolic Hypertension in the Elderly Program. Control Clin Trials 1999; 20:121-132. Wittes J, Friedman HP. Editorial: Searching for evidence of altered gene expression: a comment on statistical analysis of microarray data. JNCI 1999; 91:400-401. Sonis ST, Eilers JP, Epstein JB, LeVeque FG, Liggett WH Jr, Mulagha MT, Peterson DE, Rose AH, Schubert MM, Spijkervet FK, Wittes J. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer 1999; 85:2103-2113. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J. Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. N Engl J Med 1999; 341:410-418. Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999; 341:709-717. Nichol KL, Mendelman PM, Mallon KP, Jackson LA, Gorse GJ, Belshe RB, Glezen WP, Wittes J. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA 1999; 282:137-144. Iwane MK, Wittes J, Collins DE, Rubins HB. Simultaneous screening for three correlated lipids in the VA HDL Intervention Trial. J Clin Epidemiol 1999; 52:685‑693. Derkx B, Wittes J, McCloskey R. Randomized placebo-controlled trial of HA-1A, a human monoclonal anti-endotoxin antibody, in children with meningococcal septic shock. Clin Infect Dis 1999; 28:770-777. Wittes J. Disentangling competing risks in clinical trials. Actes du Seminaire. Vannes: 3, 5-22, 1998-1999. Wittes J. Randomized treatment assignment. P Armitage, T Colton (eds). Encyclopedia of Biostatistics. John Wiley, 1998. The Alpha-1-Antitrypsin Deficiency Registry Study Group. Survival and FEV1 decline in individuals with severe deficiency of alpha1-antitrypsin. Am J Respir Crit Care Med 1998; 158:49-59. Judd JT, Baer DJ, Clevidence BA, Muesing RA, Chen SC, Weststrate JA, Meijer GW, Wittes J, Lichtenstein AH, Vilella-Bach M, Schaefer EJ. Effects of margarine compared with those of butter on blood lipid profiles related to cardiovascular disease risk factors in normolipemic adults fed controlled diets. Am J Clin Nutr 1998; 68:768-777. Black Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M, Reisinger K, Block S, Wittes J, Rabinovich R. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med 1998; 338:1405-1412. The PREVENT Study Group. Reduction of respiratory syncytial virus hospitalization among premature infants and infants with bronchopulmonary dysplasia using respiratory syncytial virus immune globulin prophylaxis. Pediatrics 1997; 99:93-99. The Post Coronary Artery Bypass Graft Trial Investigators. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. N Engl J Med 1997; 336:153-162. Clevidence BA, Judd JT, Schaefer EJ, Jenner JL, Lichtenstein AH, Muesing RA, Wittes J, Sunkin ME. Plasma lipoprotein (a) levels in men and women consuming diets enriched in saturated, cis-, or trans-monounsaturated fatty acids. Arterioscler Thromb Vasc Biol 1997; 17:1657-1661. Brittain E, Palensky J, Blood J, Wittes J. Blinded subjective rankings as a method of assessing treatment effect: a large sample example from the Systolic Hypertension in the Elderly Program (SHEP). Stat Med 1997; 16:681-693. Wittes JT, Kelly A, Plante KM. Meta-analysis of CMVIG studies for the prevention and treatment of CMV infection in transplant patients. Transplant Proc 1996; 28:17-24. Wittes J. A statistical perspective on adverse event reporting in clinical trials. Biopharm Rep 1996; 4:5-10. The ALS CNTF treatment study (ACTS) phase I-II Study Group. The Amyotrophic Lateral Sclerosis Functional Rating Scale. Assessment of activities of daily living in patients with amyotrophic lateral sclerosis. Arch Neurol 1996; 53:141-147. Sherwood JA, Copeland RS, Taylor KA, Abok K, Oloo AJ, Were JB, Strickland GT, Gordon DM, Ballou WR, Bales JD Jr, Wirtz RA, Wittes J, Gross M, Que JU, Cryz SJ, Oster CN, Roberts CR, Sadoff JC. Plasmodium falciparum circumsporozoite vaccine immunogenicity and efficacy trial with natural challenge quantitation in an area of endemic human malaria of Kenya. Vaccine 1996; 14:817-827. Nosten F, Luxemburger C, Kyle DE, Ballou WR, Wittes J, Wah E, Chongsuphajaisiddhi T, Gordon DM, White NJ, Sadoff JC, Heppner DG. Randomised double-blind placebo-controlled trial of SPf66 malaria vaccine in children in northwestern Thailand. Shoklo SPf66 Malaria Vaccine Trial Group. Lancet 1996; 348:701-707. Freedman L, Anderson G, Kipnis V, Prentice R, Wang CY, Rossouw J, Wittes J, DeMets D. Approaches to monitoring the results of long-term disease prevention trials: examples from the Women’s Health Initiative. Control Clin Trials 1996; 17:509-525. Wittes J, Wu M. Natural history of alpha-1AT deficiency. Chapter 18 of Crystal (ed). Alpha-1 Antitrypsin Deficiency: Biology - Pathogenesis - Clinical Manifestations - Therapy. New York: Marcel Dekker, 281-291, 1995. Wittes J. Editorial. Control Clin Trials 1995; 1:1-2. Wittes J. Cross-national The ALS CNTF Treatment Study (ACTS) Phase I-II Study Group. A phase I study of recombinant human ciliary neurotrophic factor (rHCNTF) in patients with amyotrophic lateral sclerosis. Clin Neuropharmacol 1995; 18:515-532. NIH Consensus Development Panel Members. Infectious
disease testing for blood transfusions. NIH
Consensus Statement. Bethesda: NIH, Vol. 13, 1-27, 1995. Ballou WR, Blood J, Chongsuphajaissidhi T, Gordon DM, Heppner DG, Kyle DE, Luxemburger C, Nosten F, Sadoff JC, Singhasivanon P, White NJ, Webster KH, Wittes J, Wongsrichanalai C. Field trials of an asexual blood stage malaria vaccine: studies of the synthetic peptide polymer SPf66 in Thailand and the analytic plan for a phase IIb efficacy study. Parasitology 1995; 110 Suppl:S25-S36. Wittes J, Singh BN. Role of controlled clinical trials in drug evaluation. Chapter 3 in BN Singh et al. (eds). Cardiovascular Pharmacology and Therapeutics. New York: Churchhill Livingstone, 31-50, 1994. Wittes J. Thoughts of an accidental entrepreneur. Can a Statistician Earn a Living on her Own? ASA Committee on Women in Statistics, 1994. Lan KKG, Wittes J. Data monitoring in complex clinical trials: which treatment is “better”? J Stat Planning and Inference 1994; 42:241-255. Judd JT, Clevidence BA, Muesing RA, Wittes J, Sunkin ME, Podczasy JJ. Dietary trans fatty acids: effects on plasma lipids and lipoproteins of healthy men and women. Am J Clin Nutr 1994; 59:861-868. Cowan CD, Wittes J. Intercept studies, clinical trials, and cluster experiments: to whom can we extrapolate? Control Clin Trials 1994; 15:24-29. Brown AE, Singharaj P, Webster HK, Pipithkul J, Gordon DM, Boslego JW, Krinchai K, Su-archawaratana P, Wongsrichanalai C, Ballou WR, Permpanich B, Kain KC, Hollingdale MR, Wittes J, Que JU, Gross M, Cryz SJ, Sadoff JC. Safety, immunogenicity and limited efficacy study of a recombinant Plasmodium falciparum circumsporozoite vaccine in Thai soldiers. Vaccine 1994; 12:102-108. Brittain E, Wittes J. Power trips: the factorial design for binary outcomes. Proceedings of the Biopharmaceutical Section of the American Statistical Association. Toronto Canada, 1994. Applegate WB, Pressel S, Wittes J, Luhr J, Shekelle RB, Camel GH, Greenlick MR, Hadley E, Moye L, Perry HM Jr, Schron E, Wegener V. Impact of the treatment of isolated systolic hypertension on behavioral variables. Results from the Systolic Hypertension in the Elderly Program. Arch Intern Med 1994; 154:2154-2160. Wittes J. Subgroup representation in randomized clinical trials. Clinical Trials and Statistics: Proceedings of a Symposium. Board on Mathematical Sciences, National Research Council, National Academy Press, 15-22, 1993. Wittes J. Behind closed doors: the data monitoring board in randomized clinical trials. Stat Med 1993; 12:419-424. Wittes B, Wittes J. Group therapy. New Republic 1993; April 5:15-16. Wallenstein S, Wittes J. The power of the Mantel-Haenszel test for grouped failure time data. Biometrics 1993; 49:1077. Rubins HB, Robins SJ, Iwane MK, Boden WE, Elam MB, Fye CL, Gordon DJ, Schaefer EJ, Schectman G, Wittes JT. Rationale and design of the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial (HIT) for secondary prevention of coronary artery disease in men with low high-density lipoprotein cholesterol and desirable low-density lipoprotein cholesterol. Am J Cardiol 1993; 71:45-52. Piantadosi S, Wittes J. Letter: Politically correct clinical trials. Control Clin Trials 1993; 14:562-567. Peduzzi P, Wittes J, Detre K, Holford T. Analysis as-randomized and the problem of non-adherence: an example from the Veterans Affairs Randomized Trial of Coronary Artery Bypass Surgery. Stat Med 1993; 12:1185-1195. Herson J, Wittes J. The use of interim analysis for sample size adjustment. Drug Information J 1993; 27:753-760. Davis BR, Wittes J, Pressel S, Berge KG, Hawkins CM, Lakatos E, Moye LA, Probstfield JL. Statistical considerations in monitoring the Systolic Hypertension in the Elderly Program (SHEP). Control Clin Trials 1993; 14:350-361. Zucker D, Wittes J. Testing the effect of treatment in experiments with correlated binary outcomes. Biometrics 1992; 48:695-709. Wittes J. Discussion of Chuang-Stein paper “Safety analysis: Too much? Not enough? and How?”. Biopharm Rep 1992; 1:10-11. Teo KK, Yusuf S, Wittes J, Theodoropoulos S, Dhalla N, Aikenhead J, Yacoub M. Preserved left ventricular function during supine exercise in patients after orthotopic cardiac transplantation. Eur Heart J 1992; 13:321-329. Hilner JE, McDonald A, Van Horn L, Bragg C, Caan B, Slattery ML, Birch R, Smoak CG, Wittes J. Quality control of dietary data collection in the CARDIA study. Control Clin Trials 1992; 13:156-169. Follmann D, Wittes J, Cutler JA. The use of subjective rankings in clinical trials with an application to cardiovascular disease. Stat Med 1992; 22:427-437. Chalmers TC, Fisher LD, Terrin ML, Wittes J.
Clinical trials: a reader’s guide. Patient
Care 1992; 26:85-102. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266:93-98. Wittes J, Yusuf S, Probstfield J. Letter: Subgroup analysis of clinical trials. Am J Cardiol 1991; 67:330-331. Wittes J, Davis B, Berge K, Cohen J, Grimm R, Hawkins M, Kuller L. Systolic Hypertension in the Elderly Program (SHEP). Baseline characteristics of the randomized SHEP participants. Part 10: Analysis. Hypertension 1991; 17:II 162-167. The SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA 1991; 265:3255-3264. Schucker B, Wittes JT, Santanello NC, Weber SJ, McGoldrick D, Donato K, Levy A, Rifkind BM. Change in cholesterol awareness and action. Results from national physician and public surveys. Arch Intern Med 1991; 151:666-673. Peduzzi P, Detre K, Wittes J, Holford T. Intent-to-treat analysis and the problem of crossovers. An example from the Veterans Administration coronary bypass surgery study. J Thorac Cardiovasc Surg 1991; 101:481-487. Brantly ML, Wittes JT, Vogelmeier CF, Hubbard RC, Fells GA, Crystal RG. Use of a highly purified alpha 1-antitrypsin standard to establish ranges for the common normal and deficient alpha 1-antitrypsin phenotypes. Chest 1991; 100:703-708. Yusuf S, Wittes J, Probstfield J. Editorial:
Evaluating effects of treatment in subgroups of patients within a clinical
trial: the case of non-Q-wave myocardial infarction and beta blockers. Am J Cardiol 1990; 66:220-222. Wittes J, Duggan J, Yusuf S, Held P (eds). Proceedings of the Workshop on Cost and Efficiency in Clinical Trials. Stat Med 1990; 9:1-198. Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med 1990; 9:65-72. Wittes J. Discussion of papers by Wermuth & Lauritzen and Edwards. J Royal Stat Soc 1990; 52:64. Lan K-KG, Wittes J. Linear rank tests for survival data: equivalence of two formulations. Am Stat 1990; 44:23-26. Kragel AH, Reddy SG, Wittes JT, Roberts WC. Morphometric analysis of the composition of coronary arterial plaques in isolated unstable angina pectoris with pain at rest. Am J Cardiol 1990; 66:562-567. Brittain E, Wittes J. The run-in period in clinical trials. The effect of misclassification on efficiency. Control Clin Trials 1990; 11:327-338. |
1625 Massachusetts Avenue NW
Suite 600
Washington DC 20036
phone 202.247.9700
fax 202.247.9701
office@statcollab.com
