List of Presentations (2000-2008)

Please contact Rho, Inc. for more information or to request of a copy of a presentation.

2008 Presentations

Abolafia, Jeffrey and DiIorio, Frank. “Managing the Change and Growth of a Metadata-Based System.” Invited paper presented at SAS Global Forum 2008, San Antonio, TX, March 16 - 19, 2008.

Helms, Russell W. “What CDSIC Standards Do To and For Statisticians.” 44th DIA Annual Meeting, Session 422: What Statisticians Need to Know about CDISC, Boston, MA, June 26, 2008.

2007 Presentations

DiIorio, Frank and Abolafia, Jeffrey. “The Electronic Project: Effectively Using Metadata Throughout the Project Life Cycle.” Invited paper presented at SAS Global Forum 2007, Orlando, FL, April 16 - 19, 2007.

Hahn, Jamie and Alison Fowlkes “Facing the Challenges of Late Phase Trials: A Case Study.” SCDM 2007 Fall Conference, Chicago, IL, September 16–19, 2007.

Ritch, Kelly “Phase-Specific Measures to Determine CRO Performance: A CRO Perspective.” SCDM 2007 Fall Conference, Chicago, IL, September 16–19, 2007.

Gilbert, S.A. and Chen, L. “Using SAS® Proc NLMIXED for Robust Regression.” SAS Global Forum, Orlando, FL, April 16–19, 2007.

2006 Presentations

DiIorio, Frank and Abolafia, Jeffrey. “The Design and Use of Metadata: Part Fine Art, Part Black Art.” Invited paper presented 31st Annual SAS Users Group International (SUGI31) Conference, San Francisco, CA, March 26 - 29, 2006.

Kesler, K. L. and Helms, Ronald W. “Using Adaptive Designs: A Case Study and Lessons Learned.” DIA Statistics Conference, Washington, D.C., March 13–15, 2006

Monti, Katherine L. “Building a Career in Statistics One Opportunity at a Time.” UNC Department of Biostatistics Seminar, Chapel Hill, NC, March 1, 2006

Monti, K. “So What Do Statisticians Really Do?” Pine Manor College, Chestnut Hill, MA, May 17, 2006

Noga, Stephen M. “So You Want to Be a Manager? — Summarization of the SUGI30 Panel Discussion On Issues to Consider Before Aiming for a Management Career Path.” Invited paper presented at SUGI 31 Conference, San Francisco, CA, March 26 – March 29, 2006.

2005 Presentations

Betensky, R., Laird, N., Monti, K., Williams, P. and Weller, E. “Careers in Biostatistics: A Woman's Perspective.” A Panel Discussion at Harvard School of Public Health, Boston, MA, May 15, 2005

Haworth, Lauren, Noga, Stephen M., Kuligowski, Andrew T. “So You Want to Be a Manager? — A Panel Discussion On Issues to Consider Before Aiming for a Management Career Path.” Invited paper presented at SESUG 05 Conference, Portsmouth, VA, October 23 – October 26, 2005.

Noga, Stephen M., Haworth, Lauren, Kuligowski, Andrew T. “So You Want to Be a Manager? — A Panel Discussion On Issues to Consider Before Aiming for a Management Career Path.” Invited paper presented at SUGI 30 Conference, Philadelphia, PA, April 10 – April 13, 2005.

2004 Presentations

DiIorio, Frank and Abolafia, Jeffrey. “Dictionary Tables and Views: Essential Tools for Serious Applications.” Invited paper presented at the 29th Annual SAS Users Group International (SUGI29) Conference, Montreal, Canada, May 9 - 12, 2004.

Helms, Ronald W. “NonStop Drug Development: A Statistically Noncontroversial Strategy for Accelerating Biopharm Product Development.” Annual DIA Workshop in the Statistical Methodology in the Biopharmaceutical Sciences, Philadelphia, PA, March, 2004.

Helms, Ronald W. and Kesler, K. L. “Tutorial: A Brief Overview of the Analysis of Informatively Censored Clinical Trials Data.” Annual DIA Workshop on Statistical Methodology in the Biopharmaceutical Sciences, Philadelphia, PA, March 1, 2004.

Helms, Russell W. “Adaptive Randomization: Promise with Problems.” Presentation Handouts. Annual DIA Workshop on Statistical Methodology in the Biopharmaceutical Sciences, Philadelphia, PA, March 3, 2004.

Helms, Russell W. “Documenting Scientific Issues in Clinical Trial Analyses.” Presentation Handouts. DIA Fortieth Annual Meeting, Washington, DC, June 16, 2004.

Ritch, Kelly “Evolving Roles and Skills in Clinical Data Management.” DIA Fortieth Annual Meeting, Washington, DC, June 14, 2004.

Robinson, T., Zimmer, L., Rosanbalm, S., and Wallace, D. “Design Issues of an International Study in the Treatment of Acquired Immune Deficiency Syndrome Associated Cryptococcal Meningitis.” Presentation Handouts. Society for Clinical Trials Annual Meeting , New Orleans, LA, May 24, 2004.

Wilson, Stephen E., and Helms, Russell W. “Tutorial on Analysis Databases: Defining and Constructing Analysis Databases.” Annual DIA Workshop on Statistical Methodology in the Biopharmaceutical Sciences, Philadelphia, PA, March 3, 2004. FDA reviewers use a sponsor's clinical trials analysis database in assessing the efficacy and safety of a new drug or biologic product. Industry statisticians are heavily involved in designing and creating this “important product” of clinical research and in communicating with FDA statisticians during the review of an NDA. This tutorial will describe evolving standards for the creation, description, and submission of these analysis files. In addition to the general audience of the conference, this tutorial is of potential interest to regulatory and clinical data management professionals. For a copy of this tutorial, contact us.

Monti, K. L. “Stratified Randomization in Clinical Trials.” Massachusetts Biotech Conference, Boston, MA. Jan. 30, 2004.

2003 Presentations

DiLorio, Frank and Abolafia, Jeffrey. “Dictionary Tables and Views: Essential Tools for Serious Applications.” Presentation Handouts. Eleventh Annual Southeast SAS Users Group Conference, St. Pete Beach, FL, September 2003.

Helms, Russell W. “An Introduction to Analysis Databases.” DIA Eighteenth Annual Workshop for Clinical Data Management , Philadelphia, PA.

Helms, Russell W. “One–PROC–Away: The Essence of an Analysis Database.” ASA/JSM, San Francisco, CA, August 2003.

Helms, Russell W. "The SCIENCE in Analysis Databases.” FDA/Biopharmaceutical Industry Workshop, Bethesda, MD, September, 2003.

Kesler, K. L. and Helms, Ronald W. “Statistical and Practical Aspects of a Non-Stop Drug Development Strategy.” International Biometric Society 2003 ENAR Spring Meeting, Tampa, FL.

Kesler, K. L. and Helms, Ronald W. “Designing Cost Efficient Phase II Trials with the Goal of Getting to Phase III: Alpha? Power? Irrelevant!" DIA Annual Meeting, San Antonio, TX.

Marcucci, G. and Monti, K. L. “When is Stratification Detrimental to Design? Part I.” International Biometric Society 2003 ENAR Spring Meeting, Tampa, FL.

Monti, K. L. and Marcucci, G. "When is Stratification Detrimental to a Design? Part II.” International Biometric Society 2003 ENAR Spring Meeting, Tampa, FL.

Monti, K. L. “The Cost-Efficiencies of Quality Data Management: A Statistician's Perspective.” Massachusetts Biotech Conference, Boston, MA.

Monti, K. L. “What Do Statisticians Do?” Career Night. Boston Chapter of the ASA, Boston University, Boston, MA.

Monti, K. L. and Yovetich, N. A. “Data Management Systems — What a Project Manager Needs to Know.” ACRP's Twenty-Seventh Annual North American Conference and Exposition, Philadelphia, PA, April 5–9, 2003.

Pan, W. “Semiparametric Estimation in Transition Measurement Error Models.” International Biometric Society 2003 ENAR Spring Meeting, Tampa, FL.

Rosanbalm, S. and Wallace, D. D. “An Interim Monitoring Strategy for a Small Sample Incidence Density Problem.” International Biometric Society 2003 ENAR Spring Meeting, Tampa, FL.

2002 Presentations

Allen, J. and Keyes-Elstein, L. L. “Estimation of power for a repeated measures design when the outcome has a Poisson expected value and variance over-dispersion.” Poster at the spring meeting of the International Biometric Society, Eastern North American Region (ENAR).

Allen, K. “Boston Area Statisticians Reach Out to High School Statistics Teachers.” Poster at Project Start-Up, Joint Statistical Meetings, New York, NY.

Carter-Edwards, L., Jackson, S. A., Perry, A., McCullough, K., Godette, D., Spencer, E. A., Reddy, S. C., Runaldue, M., and Svetkey, L. P. “Feasibility and Effectiveness of a Blood Pressure Lowering Program among African American Couples: The CHASE Pilot Study.” Second National Cardiovascular Conference, Washington, DC.

Garro, J. “Assessing the Effect Of Episode Duration Variation on Treatment Efficacy for Recurrent Events.” Annual Conference of the Society for Clinical Trials (SCT), Arlington, VA.

Hart, S., Walter, M., Xanthos, G., Cline, J., and Powell, H. “Why Families Enroll And Continue Participating In Pediatric Research Studies.” Poster at the annual meeting of the Society for Clinical Trials, Arlington, VA.

Helms, Russell W. “Cleft Lip and Palate: A Patient’s Perspective.” Not Just Lip Service: Caring for the Child with Cleft Lip and Palate, University of North Carolina Dental School Continuing Education Symposium, Chapel Hill, NC.

Helms, Russell W. “Homeostatic Control of Normal Organ Size in Mathematical Models of Carcinogenesis IV: Parameter Estimation in the Homeostatic Control Model. “ Annual Meeting of the Eastern North American Region of the International Biometric Society.

Helms, Ronald W., Kesler, K. L., Monti, K. L., and Wallace, D. D. “Design Strategies for Phase II through Phase III: The Traditional Approach Compared to New Strategies Using Fewer, Larger Studies with Multiple Intermediate Analysis or ‘NonStop Drug Development.’ ” FDA/Industry Workshop, Bethesda, MD.

Kesler, K. L. and Helms, Ronald W. “Non–stop Drug Development: Statistical Methods for More Time Efficient Trials.” The International Biometric Society, Eastern North American Region, Crystal City, MD.

Keyes–Elstein, L. L. and Shah, B. “Comparison of approximate tests for fixed effects in incomplete block designs.” Spring meeting of the International Biometric Society, Eastern North American Region.

Lail, A., Dampier, C., Eggleston, B., Kesler, K., and Donfield, S. “Methods for Analyzing Pain Data in Patients with Sickle Cell Disease.” 2002 Meeting of the Society for Clinical Trials.

Little, C. “Taking Advantage of Good Clinical Data Management Practices: Progress and Activities on the GCDMP Over the Last Year.” 2001 SCDM Annual Spring Conference, Seattle, WA.

Little, C., Hopkins, D. G., and Helms, Ronald W. “Data Quality In Clinical Data Management: Proven Strategies For Achieving High-Quality Data—A Brief Tutorial.” Instructors, DIA Data Quality and Metrics and Best Practices in Clinical Data Management, Philadelphia, PA.

Marquis, C. M. and Wallace, D. D. “Sample Size Estimation For A Cluster-Based Randomized Trial With Incidence Density Outcome Measures.” Annual Meeting of the Society for Clinical Trials (SCT).

Mitchell, H. E. “Clinical Trials in Special Populations: Issues in Design and Implementation.” Society for Clinical Trials Meeting, Arlington, VA.

Mitchell, H. E. “Results of the Inner City Air Pollution Study.” Presidential Symposium, American Academy of Allergy Asthma & Immunology, New York, NY.

Mitchell, H. E. “The National Cooperative Inner-City Asthma Studies.” Invited presentation, University of Connecticut, Storrs, CT.

Mitchell, H. E. “The NIAID/NIEHS Inner-City Asthma Study and Inner City Air Pollution Study.” NIEHS Symposium, National Institute of Environmental Health Sciences, RTP, NC.

Monti, K. L. and Helms, Ronald W. “Clinical Trials Data Management System: What it is. What it does. How it does it. How it interacts with clinical personnel.” Association of Clinical Research Professionals, Toronto, Canada.

Pan, W. “Transition Measurement Error Models for Longitudinal Data.” Eastern North American Region (ENAR) of the International Biometrics Society, Washington, DC.

Pinto, C., Walter, M., Mitchell, H. E. “Validity of Reported Environmental Tobacco Smoke Exposure In The Homes Of Inner-City Children With Asthma.” Society for Clinical Trials Meeting, Arlington, VA.

Runaldue, M., Carter-Edwards, L., and Keyes-Elstein, L. “A New Index for Diet and Blood Pressure Awareness: A Comparative Analysis of the KDBP Score.” Eastern North American Region of the International Biometrics Society, Arlington, VA.

Setty, B.N.Y., Dampier, C., Eggleston, B., O’Neal, P., Gilday, M., Ely, E., Moss, S., Kularni, S., Brodecki, D., Keyes-Elstein, L., and Stuart, M. “Vasocclusion in Infants and Toddlers with Sickle Cell Disease (SCD): Relationship to Adhesion Markers.” Pediatric Academic Societies’ Annual Meeting.

Wade, K. D. “The Self-Documenting Database.” 2002 Proceedings of the American Statistical Association, New York, NY.

Walter, M., Xanthos, G., and Estrada, R. “Factors Affecting Compliance with Home Pulmonary Function Monitoring.” Poster at the annual meeting of the Society for Clinical Trials, Arlington, VA.

Wright, R.J., Mitchell, H. E., Visness, C. M., Cohen, S., Gold, D.R. for the ICAS Study Group. “Stress experience in the inner-city: relationship to asthma symptoms, healthcare utilization, and behavior.” American Thoracic Society Meeting, Atlanta, GA

2001 Presentations

Eggleston, B. and Dampier, C. “Recurrent Time to Event Analysis of Binary Daily Diary Data.” Spring Sickle Cell Meetings.

Eggleston, B. and Kesler, K. L. “Survival Analysis of Recurrent Exponential Events.” Spring Meeting of the Eastern North American Region of the International Biometric Society, Charlotte, N.C.

Greene, W. F. and Cai, J. “Measurement error in covariates in the marginal hazards model for multivariate failure time data.” Spring Meeting of the Eastern North American Region of the International Biometric Society, Charlotte, N.C.

Hart, S., Tolbert, W., Walter, M., and Mitchell, H. E. “The Inner-City Asthma Study Group, An Automated expert system for providing physician feedback regarding patient status.” Society for Clinical Trials Meeting, Denver, CO.

Hart, S., Walter, M., Tolbert, W., and Mitchell H. E. “An automated Expert System for Providing Physician Feedback Regarding Patient Status.” Annual Meeting of the Society for Clinical Trials, Denver, CO.

Helms, L. E. and Davis, C.E. “A Comparison of Multiple Imputation and Traditional Missing Data Methods in a Longitudinal Clinical Trial.” Annual Meeting of the Eastern North American Region of the International Biometric Society.

Helms, Russell W. “Homeostatic Control of Normal Organ Size in Mathematical Models of Carcinogenesis III: The Two-Stage Homeostatic Control Model.” Annual Meeting of the Eastern North American Region of the International Biometric Society.

Kalsbeek, W., Morris, C., and Vaughn, B. J. “Effects of Nonresponse on the Mean Squared Error of Estimates from a Longitudinal Study.” 2001 Joint Statistical Meetings.

Kesler, K. L. and Sen, P.K. “The Matrix-Valued Counting Process Model with Proportional Hazards for Sequential Survival Data. Student Competition Winner.” Eastern North American Region of the International Biometric Society, Charlotte, NC.

Lail, A. and Henry, L. “What determines asthma severity among children?” Spring Meeting of the Eastern North American Region of the International Biometric Society, Charlotte, NC.

Little, C. “SCDM Good Clinical Data Management Practices: What Other Topics Need To Be Included in the Document?” Session facilitator at the 2001 SCDM Annual Spring Conference, Galveston Island, TX.

Marquis, C. M. and Wade, K. D. “Coping with Missing and Left-Censored Pharmacokinetic Data.” Annual Meeting of the Society for Clinical Trials (SCT).

Mitchell, H. E. “Environmental Exposure, Skin test sensitivity and Asthma Morbidity.” American Academy of Allergy Asthma & Immunology, New Orleans, LA.

Mitchell, H. E. “Evaluating Effective Data Acquisition Systems: Pre-Conference Workshop Training Session.” Society for Clinical Trials Meeting, Denver,CO.

Mitchell, H. E. (2001) “Matching Technology to Clinical Trial Needs.” Society for Clinical Trials Meeting, Denver,CO.

Monti, K. L. “The Cost of Dirty Data: Pay Now or Pay More Later.” Drug Information Association, Sixteenth Annual Symposium and Exhibition on Clinical Trial Data Management, Atlantic City, NJ.

Reading, Pamela L. “Using SAS to Write SAS—Automate Your Programming Tasks.” Twenty-Sixth Annual Meeting of the International SAS Users Group, Coder’s Corner Section, Long Beach, CA, April, 2001.

Vaidean, G. D., Deev, A., Abolafia, J. M., Shestov, D., Davis, C. E., and Tyroler, H. A. “Heart Rate Recovery after Submaximal Exercise Test and 20 Year All-Cause Mortality Test in Asymptomatic Russian and American Men.” The Lipids Research Clinics Study. The Forty-First Conference on Cardiovascular Disease Epidemiology and Prevention.

Wallace, D. D., McMurray, M., and Helms, Ronald W. “Tracking Clinical Outcomes in a Pediatric Sickle Cell Cohort: An Analysis from the Hug- Kids Study.” Presented at the Twenty-Fifth Annual Meeting of the National Sickle Cell Disease Program, New York, NY.

Walter, M. and Hart, S. “Methods Employed to Retain and Urban Population: Experience of the Inner-City Asthma Study.” Annual Meeting of the Society for Clinical Trials, Denver, CO.

2000 Presentations

Abolafia, J. M. and Pugh, D.E. “A WYSISYG Application to Summarize Categorical Variables Using the SAS System.” Twenty-Fifth Annual SAS Users Group International Conference.

Abolafia, J. M. and She, L. “The International Studies Project: SAS Version 7/8 Web Tools to the Rescue.” Twenty-Fifth Annual SAS Users Group International Conference.

Greene, W. F. and Cai, J. “Measurement error models for failure time data.” International Biometric Society Conference, Berkeley, CA.

Helms, L. E. and Davis, C.E. “A Comparison of Multiple Imputation and Traditional Missing Data Methods in Clinical Trials.” Annual Meeting of the Eastern North American Region of the International Biometric Society.

Helms, Russell W. “Homeostatic Control of Normal Organ Size in Mathematical Models of Carcinogenesis II: Clonal Expansion in the Two-Stage Model.” Semi-Annual Meeting of the International Biometric Society.

Kesler, K. L. and Sen, P.K. “Variable cluster size and weighted sampling issues in multivariate sequential survival analysis.” Eastern North American Region of the International Biometric Society, Chicago, IL.

Lai, S. M., Duncan, P. W., Johnson, D., and Wallace, D. D. “Sensitivity to Change of Post-Stroke Health Status Assessments?” Twenty-Fifth International Stroke Conference, New Orleans, LA.

Little, C. “SCDM Good Clinical Data Management Practices Document: Overview and Panel Discussion with the Authors.” 2000 SCDM Annual Fall Conference, Arlington, VA.

Mitchell, H. E. “The NIAID/NIEHS Inner-City Asthma Study: Baseline Characteristics.” American Academy of Allergy Asthma & Immunology, San Diego,CA.

Monti, K. L. “Careers in Statistics: Life in the Real World.” Department of Biostatistics, University of North Carolina, Chapel Hill, NC.

Monti, K. L. “How to Review Scientific Papers: Statistical and Methodological Issues.” Grand Rounds, Lowell General Hospital, Lowell, MA.

Monti, K. L. Session Organizer and Presenter. Career Night. Boston Chapter of the ASA, Boston University, Boston, MA.

Pan, W. “False Positive Rates of Pulse Detection Algorithms.” Poster session atJoint Statistical Meeting, Indianapolis, IN.

Pan, W., Carlson, N., Dimaraki, E., Barkan, A., and Brown, M. “False Positive Rates of Pulse Detection Algorithms.” ASA Conference Proceedings.

Radel, J. D., Homan, J.A., Wallace, D. D., Wetzel, D. L., and LeVine, S. M. “Chemical Changes in Photoreceptor Outer Segments Due to Iron-Induced Oxidative Stress: Analysis by Fourier Transform, Infrared (FT-IR) Microspectroscopy.” Annual Meeting of The Association for Research in Vision and Ophthalmology, Fort Lauderdale, FL.

Reading, Pamela L. “Using SAS to Write SAS—Automate Your Programming Tasks.” Annual Meeting of the Southeastern SAS Users Group, Coder’s Corner Section, Charlotte, NC, October 2000.

Rubens, C. A. “Toxicity Studies with the Thrombopoietin Receptor (TpoR) Agonist GW395058 in Rats and Cynomolgus Monkeys.” Poster Presentation.

Sullivan, S. D., Weiss, K. B., Evans, R., Islam, S., Gergen, P. J., Mitchell, H. E., and Crain, E. “The National Cooperative Inner City Asthma Study, An Economic Evaluation of the NCICAS Asthma Counselor Intervention.” American Academy of Allergy Asthma & Immunology, San Diego, CA.

Vojta, P. J., Randels, S. P., Stout, J., Muilenberg, M., Burge, H. A., Lynn, H. S., Mitchell, H. E., O'Connor, G. T., and Zeldin, D. C. “Effects of Physical Interventions on Group I Dust Mite Allergen Levels in Carpet, and Bedding Dust in Inner City Homes.” American Thoracic Society Meeting, Toronto, Canada.

Wallace, D. D., Duncan, P. W., and Lai, S. M. “Are the FIM Motor Scale and Barthel Index Responsive to Change?” Twenty-Fifth International Stroke Conference, New Orleans, LA.