Other Publications/Presentations
Letters to the Editor
Tarek A Hammad, Azadeh Shoaibi, Mark Levenson, David Graham, Judy A Staffa, Aloka Chakravarty, Solomon Iyasu. Drug risk assessment and data reuse. A letter in response to Toh, S., Avorn, J., D'Agostino, R. B., Gurwitz, J. H., Psaty, B. M., Rothman, K. J., Saag, K. G., Sturkenboom, M. C.J.M., Vandenbroucke, J. P., Winterstein, A. G. and Strom, B. L. (2013), Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs. Pharmacoepidem. Drug Safe.. doi: 10.1002/pds.3478.
Marc B. Stone, Tarek A. Hammad. Fluoxetine and suicidal ideation in minor depression. Journal of Psychiatric Research. DOI information: 10.1016/j.jpsychires.2013.09.012.
Tarek A Hammad, Andrew D Mosholder. Trends in Adolescent Suicide Rates and Antidepressant Drugs Prescription: An Update and a Word of Caution. A rapid response to Stone et al. BMJ 2009;339:b2880 (http://www.bmj.com/content/339/bmj.b2880.long/reply#bmj_el_244907).
Tarek A Hammad, Andrew D Mosholder. Suicide and antidepressants: Beware extrapolation from ecological data. BMJ 2010; 341:c6844 doi: 10.1136/bmj.c6844 (Published 30 November 2010). Cite this as: BMJ 2010; 341:c6844
Evelyn K. Mentari, Marc Stone, Tarek A. Hammad. “Antiepileptic Drugs and Suicide Attempts in Patients With Bipolar Disorder”. ARCH GEN PSYCHIATRY, 2010, 67 (NO. 9).
Tarek A. Hammad, Iyasu, S. “Pharmacoepidemiology Initiatives in CDER/FDA: Practical Implications”. Invited commentary, ISPE NEWSLETTER - volume 11 , number 2, 2007.
Invited commentary on paper by Bridge et al (JAMA 2007;297:1683–96) for the Evidence-Based Mental Health journal, a BMJ online publication, 2007.
Temple R, Tarek A. Hammad, Laughren T, Stone M. Letter to the Editor in response to Kaizar, et al article entitled “Do antidepressants cause suicidality in children? A Bayesian meta-analysis” in the same issue of the journal. Clinical Trials, 2006, 3(2):94-96.
Published Abstracts
Compendium of Methods For Measuring Patient Preferences In Medical Treatment. V Soekhai, C Whichello, B Levitan, J Veldwijk, T Hammad, U Kihlbom, E van Overbeeke, S Russo, A Mohamed, R Hermann, I Huys, V Patadia, J Juhaeri, E de Bekker-Grob. Value in Health, Volume 20, Issue 9, 2017, Pages A684-A685, ISSN 1098-3015. Also, in Volume27, IssueS2, Supplement: Abstracts of the 34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Prague Congress Centre, Prague, Czech Republic, August 22–26, 2018.
Devine S, Hammad TA, Kaplan S, McCune S, Aly H. Identifying cases of persistent pulmonary hypertension in the newborn within the general practice research database using the clinical free-text entries. Pharmacoepidemiol Drug Saf 17: S139-S139, 316 Suppl 1 AUG 2008.
Devine ST, Hammad TA. Last menstrual period estimation techniques compared to physician recorded last menstrual period dates in the general practice research database. Pharmacoepidemiol Drug Saf 17: S228-S228, 519 Suppl 1 AUG 2008.
Devine ST, Hammad TA, Andrews EB. Validation of pregnancy identification algorithm within the general practice research database. Pharmacoepidemiol Drug Saf 17: S126-S126, 286 Suppl 1 AUG 2008.
Hammad TA, McAdams MA, Feight A, Iyasu S, Dal Pan GJ. Determining the predictive value of Read/OXMIS codes to identify incident acute myocardial infarction in the General Practice Research Database. Pharmacoepidemiol Drug Saf 17: S125-S126, 284 Suppl 1 AUG 2008.
Kaplan S, Hammad TA. Drug switching patterns among patients using ezetimibe: Claims data study. Pharmacoepidemiol Drug Saf 17: S74-S74, 167 Suppl 1 AUG 2008.
McAdams MA, Gelperin K, Governale LA, Swartz L, Hammad TA, Dal Pan GJ. Patterns of adverse event reporting for four members of the angiotensin II receptor blockers class of drugs: Revisiting the weber effect. Pharmacoepidemiol Drug Saf 17: S16-S16, 035 Suppl 1 AUG 2008.
Pamer C, Kaplan S, Wu YT, Hammad TA, Mosholder AD, Rochester G. Changes in US antidepressant and antipsychotic prescription patterns in the time period following FDA actions. Pharmacoepidemiol Drug Saf 17: S95-
S96, 217 Suppl 1 AUG 2008.
Tarek A. Hammad, T. Laughren, J. A. Racoosin. “Antidepressant Use and Suicidality in Pediatric Patients: A Meta-Analysis”. Pharmacoepidemiology and Drug Safety, 2005, 14(suppl 2):S54.
Tarek A. Hammad. “Results of the Analysis of Suicidality in Pediatric Trials of Newer Antidepressants”. Advisory committee web site - Food and Drug Administration Web site. Available at: http://www.fda.gov/ohrms/dockets/ac/cder04.html#PsychopharmacologicDrugs. Accessed 10/24/2006.
A.A.E. El-Mohandes, H. Aly, Tarek A. Hammad, M. Mohamed, N. Janosy and P. Urso. “Does Pre-pregnancy Maternal Obesity Influence Length of Gestation and Birth Weight (BW)? A Multivariate Analysis”. Pediatric Research. 2004;55:594A.
Tarek A. Hammad, A. Mosholder, G. Boehm, J. A. Racoosin, T. Laughren. “Incidence of Suicide in Randomized Controlled Trials of Patients with Major Depressive Disorder”. Pharmacoepidemiology and Drug Safety, 2003, 12(suppl 1):S156.
L. Lippiello, J. Woodward, R. Karpman, Tarek A. Hammad. “Beneficial Effect of Cartilage Disease-Modifying Agents Tested in Chondrocyte Cultures and a Rabbit Instability Model of Osteoarthritis”. Arthritis & Rheumatism, 1999, 42(9):S256.
N. Gabr, M. H. Hussein, Tarek A. Hammad, M. Aboel-Einin, A. Orieby, E. Shawky and A. Saad. "Two Years Epidemiological Follow Up Studies on S.Haematobium Infection in El-Minya". American Journal of Tropical Medicine and Hygiene, 1995, 53(2):264.
Tarek A. Hammad, M. F. Abdel-Wahab, N. DeClaris, A. El-Sahly, N. El-Kady and G. T. Strickland. "Applications of Artificial Neural Networks Modeling of the Epidemiology of Schistosomiasis". American Journal of Tropical Medicine and Hygiene, 1994, 51(3):194.
M. Afifi, Tarek A. Hammad, N. Gabr, S. El-Shinawi, R. Khalifa and M. Azab. "Immunodiagnosis of Toxoplasmosis: Comparative Evaluation of Five Methods and Application of Neural Networks Methodology in Acute Infection Prediction". American Journal of Tropical Medicine and Hygiene, 1994, 51(3):184.
Oral Presentations, Symposia, Workshops, and Posters
“A digital therapy for patients with Multiple Sclerosis and Major Depressive Disorder” Philippe Truffinet, Raphael Bejuit, Jeffrey Chavin, Tarek Hammad, Sharon Morgenbesser, Gretchen McTigue. Sanofi 2020 North America Research and Development Science Week.
DIA 2019 two invited talks: “Checkpoint Inhibitor-Associated Myocarditis: Methodological Issues Around Prevention and/or Early Detection?” and “Use of Real-world Evidence in Personalized Benefit Risk Assessment: Closing the Knowledge Gap”. DIA Global Annual Meeting, San Diego, June 23-27, 2019.
Invited presentation “Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement”. DIA Health Canada presentation, 2018 Canadian Pharmacovigilance and Risk Management Strategies Conference, Ottawa, ON, Canada, October 29, 2018.
The 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 2018 Prague, Czech Republic:
“Benefit-Risk Assessment in Drug Development: Update and Special Analytical Considerations”. Invited talk in ISPE Benefit Risk Assessment Educational Session.
"Enhancing presentation skills: Preparing and delivering an effective oral research presentation”. Invited talk in ISPE Newcomers/Early Stage Investigator Workshop.
Abstract # 1970, "Use of Real-World Evidence in Personalized Benefit Risk Assessment: Closing the Knowledge Gap". Cathy Anne Pinto, Tommi Tervonen , Kevin Marsh, Dimitra Lambrelli , Anna Schultze, Andrew Tershakovec1, Johanna Hyacinthe1, Thibaud Prawitz, Tarek Hammad
Abstract # 2589, "Use of Real-World Evidence in Personalized Benefit-Risk Assessment: Detecting Treatment Patterns Using Gaussian Mixture Models". Tommi Tervonen, Cathy Anne Pinto, Kevin Marsh, Dimitra Lambrelli, Anna Schultze, Thibaud Prawitz, Andy Tershakovec, Tarek Hammad
Long-term Clinical Outcomes Following a Myocardial Infarction among the General Population in England. Authors: Anna Schultze, Rikisha Shah, Andrew Tershakovec, Tarek Hammad, Tommi Tervonen, Cathy Anne Pinto, Dimitra Lambrelli
Invited presentation “The Revised ICH M4E Benefit-Risk Assessment Guidance: Update and Analytic Implications” in a symposium on “Benefit-Risk Management in Pharmacovigilance”, Boston, MA 2018
Invited presentation “Myocarditis: Prevention and/or Early Detection?”, in a workshop entitled “Myocarditis: An Immune Related AE of Checkpoint Inhibitors.” December 15,2017, Pfizer Peapack Campus. Hosted by Project Data Sphere, LLC.
“Incorporating psychological constructs into patient preference studies: Which you should consider including in your next study?” Dario Monzani, Selena Russo, Ulrik Kihlbom, Chiara Jongerius, Flavia Faccio, Silvia Pizzoli, Giulia Marton, Laura Vergani, Cathy Anne Pinto, Sarah Harding, Rosanne Janssens, Jürgen Kübler, Gwenda Simmons, Marie Falahee, Richard Hermann, Tarek Hammad, Gabriella Pravettoni. Abstract submitted for ISPOR Europe 2018 conference in Barcelona, November 10-14, 2018.
Soekhai V, Whichello C, Levitan B, Veldwijk J, Hammad T, Kihlbom U, van Overbeeke E, Russo S, Mohamed A, Hermann R, Huys I, Patadia V, Juhaeri J, de Bekker-Grob E. “Compendium of Methods for Measuring Patient Preferences in Medical Treatment”. ISPOR 20th Annual European Congress, Glasgow, Scotland, November 2017.
The 33rd International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 2017 Montreal, Canada:
“Benefit-Risk Assessment in Drug Development: Update and Special Analytical Considerations”. Invited talk in ISPE Benefit Risk Assessment Educational Session.
"Enhancing presentation skills: Preparing and delivering an effective oral research presentation”. Invited talk in ISPE Newcomers/Early Stage Investigator Workshop.
Invited presentation in DIA 2017 annual meeting symposium: “The Revised ICH M4E Benefit-Risk Assessment Guidance: Update and Practical Implications” in the symposium entitled “New Considerations in Benefit-Risk Management” at the 2017 Annual DIA meeting, June 18-22, Chicago Il.
“Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement”. Invited presentation in the DIA Pharmacovigilance and Risk Management Strategies Conference, Jan 23, 2017, Washington D.C.
“Quantitative Benefit-Risk Assessment Methodologies: Old Concepts and New Challenges in Decision Making”. Invited lecture in UMBC-Stanford Workshop on Clinical Trials and Regulatory Science (Statistics for Drug Development in Big Data Era: Challenges in Design, Analysis and Reproducibility), University of Maryland Baltimore County campus, Maryland, September 24, 2016.
“Notable Aspects of The New ICH-M4E(R2) Guidance For Benefit-Risk Assessment And Related Methodological Challenges”. Invited lecture in the annual UNC Center for Pharmacoepidemiology Methodology Workshop, 2016.
The 2016 International Population Data Linkage Conference held in Swansea, Wales: “Cancer recording in patients with type 2 diabetes in primary care and hospital admission data.” Rachael Williams, Arlene M Gallagher, Tjeerd van Staa, Tarek Hammad, Bert Leufkens, and Frank de Vries
The 32nd International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 2016 Dublin, Ireland:
“Benefit-Risk Assessment in Drug Development: Update and Special Analytical Considerations”. Invited talk in ISPE Benefit Risk Assessment Educational Session.
"Enhancing presentation skills: Preparing and delivering an effective oral research presentation”. Invited talk in ISPE Newcomers/Early Stage Investigator Workshop.
“Evidence Synthesis and Meta-Analysis for Drug Safety: Report of CIOMS Working Group X”. A presentation in a symposium entitled "The Role of Evidence Synthesis in Drug Safety Evaluation and Regulation".
“Key Methodological Challenges in Conducting Benefit-risk Assessment in Drug Development”. A presentation in a symposium entitled "The Agony and the Ecstasy: The Creation of the Revised ICH M4E Benefit-Risk Assessment Guideline and Practical Implications for Patients, Industry and Regulators".
Invited speaker in ISPE webinar series on Benefit-Risk, Jan 21, 2016: “Benefit Risk Assessment And The Future of Drug Development Process”.
“Analysis and Interpretation of Clinical Research Data” and “Introduction to Systematic Review and Meta-Analysis Methods”. Invited lectures in the Annual Summer Institute of Clinical Health Research, University of Windsor, June 2014 and 2015.
“Overview of Medical Product Development and Benefit-Risk Assessment: Context for Patient Engagement”. Invited presentation in the DIA Benefit Risk meeting entitled “Patient Engagement and Communication in Benefit-Risk Assessment Through the Life Cycle of Medical Products”. September 17-18, 2015. North Bethesda, MD
“How “Sensitive" Should Scientists Be: The Dilemma of Clinical Endpoints and Drug Exposure Definitions”. Invited lecture in the annual UNC Center for Pharmacoepidemiology Methodology Workshop, 2015.
Invited speaker of three presentations in “Benefit-Risk Assessment of Medicinal Products Symposium: Current Status and Update”, June 4 - 5, 2015, Grand Hilton Seoul, Seoul, Republic of Korea.
International Society of Pharmacoepidemiology Webinar, March 18, 2015, “Building And Sustaining A Successful Scientific Team: Top Ten Tips”
“Preparing an effective oral research presentation”. Invited presentation in the Early Stage Pharmacoepidemiology Workshop, 2015. 31st International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), Boston, MA.
Abstract: #85 – “Changes in US Oral Anticoagulant Drug Prescription Patterns During Period of FDA Actions”. The ISPE’s 31st International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), August 22-26, 2015, Boston.
Keynote speaker, Abbvie PV Forum “Benefit-Risk Assessment As The Next Big Thing: What Is Lost in Translation?” September 29, 2014, Chicago.
Invited presentation, “Sources of Bias in Meta-analysis of RCTs”. The BBS Seminar entitled “Meta-Analysis of Clinical Safety Data”. Basel Biometric Section of the Austro-Swiss Region of the International Biometric Society, Oct 2, 2014, Basel, Switzerland.
Invited talk in Merck’s Global Medical Affairs Webinar “Challenges and limitations of meta-analysis of randomized clinical trials”, October 2013.
“Introduction to Systematic Review and Meta-Analysis Methods”. Invited Workshop in the Summer Institute of Clinical Health Research, University of Windsor, Faculty of Nursing in collaboration with the Schulich School of Medicine & Dentistry - Windsor Program, and the de Souza Institute, June 2013.
Esther H. Zhou, Kate Gelperin, David J. Graham, Yulan Ding, Mark Levenson, Martin Rose, Shannin F. Davillier, and Tarek A. Hammad., "Validation of Stroke in the Clinical Practice Research Datalink (CPRD)". Poster abstract: # 85, Publication #476. The 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Montreal, Canada, August 23-28, 2013.
Invited lecture “Role of Meta-analysis in Drug Safety: Basic Concepts”. Student Council in the 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Montreal, Canada, August 23-28, 2013.
Jeremy A. Rassen, Darren Toh, Mary K. Kowal, Karin Johnson, Azadeh Shoabi, Tarek A. Hammad, Marsha A. Raebel, John H. Holmes, Kevin Haynes, Jessica Myers, Sebastian Schneeweiss, and the Members of the Mini-Sentinel Strategies for Data Sharing and Analysis Workgroup. “EVALUATING STRATEGIES FOR DATA SHARING AND ANALYSES IN DISTRIBUTED DATA SETTINGS”. Abstract in Academy Health Electronic Data Methods (EDM) Forum 2013.
“Introduction to Systematic Review and Meta-Analysis Methods”. Invited Workshop in the Summer Institute of Clinical Health Research, University of Windsor, Faculty of Nursing in collaboration with the Schulich School of Medicine & Dentistry - Windsor Program, and the de Souza Institute, June 2013
Invited talk, "Role of Observational Data in Regulatory Decision Making: The Drug Safety Paradigm" in the DIA Pharmacovigilance and Risk Management Strategies, January 14-16, 2013, Washington DC.
Invited talk, “The Drug Safety Paradigm: Role of Observational Data” in the International Society for Pharmacoepidemiology Webinar for students (SISPE) , March 6, 2013
invited online talk, "The Drug Safety Paradigm: Role of Observational Data" in the "Introduction to Epidemiology" course, The Saint Louis University, Center for Outcomes Research, April 2013.
Invited talk in the Brookings Institute, Washington, DC, September 2012. “A Perspective on the Context of Drug Safety Evaluation and Data Reuse” in the Expert Workshop: "Overcoming Statistical Challenges to the Re-Use of Data within the Mini-Sentinel Distributed Database."
Invited lecture “Top Ten Tips to Get Published”. Student Council in the 28th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Barcelona, Spain, August 22-26, 2012.
Posters and oral presentations at the 28th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Barcelona, Spain, August 22-26, 2012:
· [65] Validating a Gestational Length Algorithm Based on Administrative Health Plan Data
. [345] Cardiovascular Risk of Olmesartan (Olm) Compared with Other Angiotensin-II Receptor Blockers (ARBs)
· [543] Risk of Acute Myocardial Infarction (AMI), Stroke, or Death in GPRD Patients Treated with Olmesartan (Olm) or Other Angiotensin Receptor Blockers (ARBs)
· [692] Methods for Linking Mothers and Infants within Health Plans for Studies of Medication Safety in Pregnancy
· [723] Validation of Congenital Cardiac Malformations in the General Practice Research Database
· [802] Antiepileptic Drug Use among Pregnant Women in the U.S., 2001-2007: A MEPREP Study
· [808] Prevalence and Trends in the Use of Antipsychotics during Pregnancy in the U.S., 2001-2007
· [849] Validation of Cataract Diagnosis in the UK General Practice Research Database
· [850] Validation of Glaucoma Diagnosis in the UK General Practice Research Database
· [800] Patterns of Antidepressant and Antipsychotic Use during Pregnancy "Risk of Acute Myocardial Infarction (AMI), Stroke, or Death in GPRD Patients Treated with Olmesartan (Olm) or Other Angiotensin Receptor Blockers (ARBs)"
“Utilization of Meta-analysis of Observational Data in the Paradigm of Drug Safety in the FDA” Invited presentation in the International Society for Pharmacoepidemiology 2012 Mid-Year Meeting, Miami Beach, FL.
“Epidemiologic Drug Safety Data: The Need for Quality Assessment”. 48th DIA Annual Meeting “Collaborate to Innovate”, Pennsylvania Convention Center, June 24-28, 2012, Philadelphia, PA.
“Overview of relevant methodological limitations of meta-analysis of RCT data in drug safety”. 48th DIA Annual Meeting “Collaborate to Innovate”, Pennsylvania Convention Center, June 24-28, 2012, Philadelphia, PA.
”Challenges With The Secondary Use of RCTs in Drug Safety”, Invited presentation in the FDA/QSPI Biostatistics, Statistical Programming, and Data Management Summit, FDA White Oak Campus, Silver Spring, MD, March 8, 2012
"How FDA uses Epidemiology Data in Drug Safety”. Invited presentation in the Pharmacovigilance and Risk Management Strategies, January 23-25, 2012 Sheraton National Hotel, Arlington, VA.
Posters and oral presentations at the 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, August 14 - 17, 2011, Chicago, Illinois
"Duration of Benzodiazepine Use and Concomitancy with Antidepressants in a National Database” #378· “Use Patterns and Concomitant Use of Isotretinoin and Contraceptive Agents before and after iPLEDGE Implementation” #322
“AERscope: A Streamlined Method To Describe FDA Adverse Event Reporting System (AERS) Data Using a Novel SAS/IntrNet Application”
“Antidepressant and Antipsychotic Dispensing among Montelukast Initiators” #243
“Association between Minocycline and Thyroid Cancer in the GPRD: Preliminary Findings” #595
“SSRIs Use during Pregnancy and the Risk of Cardiac Congenital Malformations using the General Practice Research Database” #576
“Association between Antidepressant Drugs and Cancer in the UK-Based General Practice Research Database: A Cohort Study” #571
“Association between Antidepressant Drugs and Cataracts in the UK-Based General Practice Research Database: A Cohort Study” #809
Tarek A. Hammad, George A. Neyarapally, Simone P. Pinheiro, Solomon Iyasu. Title of symposium: “Application of Quality of Evidence Assessment Tools to the Evaluation of Pharmacoepidemiologic Safety Studies.” The 27th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, August 14 - 17, 2011, Chicago, Illinois.
Ted Guo, S. Christopher Jones, Enxu Zhao, Kate Gelperin, Tarek A. Hammad. "AERscope: A Streamlined Method to Describe FDA Adverse Event Reporting System (AERS) Data Using a Novel SASIntrNet Application", poster in the DIA/FDA CDER/CBER Computational Science Annual Meeting, March 14-15, 2011, Sheraton National Hotel | Arlington, VA, USA
Tarek A. Hammad, Simone P Pinheiro, David Irvine, Steven Kesten. “Role of Meta-Analysis in Drug Safety: Methodological Considerations and Regulatory Implications”. Presented in the 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Brighton, England, UK, August 19-22, 2010.
“Pharmacoepidemiology at the FDA NSAIDs and Acute Myocardial Infarction: A Case Study”. Invited presentation in the Saint Louis University Center for Outcomes Research, October 20, 2009.
“Conducting Drug Safety Research at the FDA NSAIDs and Acute Myocardial Infarction: A Case Study”. Invited presentation in the University of Windsor, Canada, September 24, 2009.
Hui Zhang, Hammad A Tarek, David C Christiani, Edward Giovannuci. “Hypoglycemic Agents and the Risk of Cancer”. Presented in the 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Brighton, England, UK, August 19-22, 2010.
Hui Zhang, Hammad A Tarek, , Edward Giovannuci, Elizabeth Kang, David C Christiani. “Validation of Cancer Diagnoses Recorded in the General Practice Research Database”. Presented in the 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Brighton, England, UK, August 19-22, 2010.
“Data Efficiencies and Analytic Approaches for Post-market Safety: An Introduction”. Invited presentation in the DIA/FDA CDER/CBER Computational Science Annual Meeting, Bethesda North Marriott, Bethesda, MD, USA, March 22-23, 2010.
“The Role of Meta-analysis of Clinical Trials in Drug Safety: A Regulatory Perspective” Invited presentation in the Center For Pharmacoepidemiology At Johns Hopkins University, Thursdays Seminar Series, Bloomberg School of Public Health, February 18, 2010.
Zhang H, Hammad A T, Christiani D, Giovannuci E. The Risk of Cancer Associated with Anti-diabetic Agents. Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Tarek A Hammad, Carol Pamer, Susan McCune, Sigal Kaplan, Hany Aly, and Solomon Iyasu. Validation of Persistent Pulmonary Hypertension in the Newborn (PPHN) Within The UK-based General Practice Research Database (GPRD): Comparing two approaches. Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Tarek A Hammad, Carol Pamer, Susan McCune, Sigal Kaplan, Hany Aly, John Yap, and Solomon Iyasu. Association between maternal exposure to antidepressant drugs and persistent pulmonary hypertension of the newborn (PPHN) in the mother-baby linked records in the UK-based General Practice Research Database (GPRD): Preliminary results. Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Thamir M Alshammari, Syed Rizwanuddin Ahmad, Lynette Swartz, Tarek A Hammad. Comparison of Adverse Drug Reactions (ADRs) Reports Submitted to the FDA by Consumers and Healthcare Professionals (HCPs). Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Gerald J Dal Pan, Tarek A Hammad, Solomon Iyasu, Judy A. Staffa. The Past, Present and Future of Pharmacoepidemiology at CDER, FDA. Symposium presentation in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Joshua J. Gagne, Tarek A. Hammad, Solomon Iyasu. Individual-level time series analysis of antidepressant and antipsychotic drug use around varenicline initiation. Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Joshua J. Gagne, Tarek A. Hammad, Solomon Iyasu. Incident Anticoagulant Use Among Users Of Extended-Cycle Versus Conventional Oral Contraceptives. Presented in the 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
Invited presentation "Strengths and Limitations of RCTs: Role of Pharmacoepidemiology in Post-Marketing Evaluation of Adverse Events". International Suicidality Capstone Meeting: Academia, Government, and Industry Forum, Research Design and Analytic Methods to Address Suicidality Issues session. January 26-27, 2009. University of Columbia, New York.
Invited lecture “Role of Randomized Clinical Trials in Drug Safety: Suicidality in Pediatric Patients Treated With Antidepressant Drugs”, Seminars on Drug Safety -Case-based Approach to Methodological and Practical Issues-, EPI 297, SPRING I 2009, Harvard School of Public Health, March 2, 2009.
Invited lecture “Conducting Drug Safety Research at the FDA: Antidepressant Drugs and Persistent Pulmonary Hypertension in the Newborn”, Harvard School of Public Health, March 3, 2009.
Tarek A Hammad, Mara A McAdams, Andrea Feight, Solomon Iyasu, Gerald J Dal Pan. Determining the Predictive Value of Read Codes to Identify Incident Acute Myocardial Infarction in the General Practice Research Database. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Scott T Devine, Tarek A Hammad, Elizabeth B Andrews. Validation of Pregnancy Identification Algorithm within the General Practice Research Database. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Scott Devine, Tarek A Hammad, Sigal Kaplan, Susan McCune, Hany Aly. Identifying Cases of Persistent Pulmonary Hypertension in the Newborn within the General Practice Research Database Using the Clinical Free-Text Entries. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Scott T Devine, Tarek A Hammad. Last Menstrual Period Estimation Techniques Compared to Physician Recorded Last Menstrual Period Dates in the General Practice Research Database. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Mara A McAdams, Kate Gelperin, Laura A Governale, Lynette Swartz, Tarek A Hammad, Gerald J Dal Pan.Patterns of Adverse Event Reporting for Four Members of the Angiotensin II Receptor Blockers Class of Drugs: Revisiting the Weber Effect. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Sigal Kaplan, Tarek A Hammad. Drug Switching Patterns among Patients Using Ezetimibe: Claims Data Study. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Carol Pamer, Sigal Kaplan, Yu-Te Wu, Tarek A Hammad, Andrew D Mosholder, George Rochester. Changes in US Antidepressant and Antipsychotic Prescription Patterns in the Time Period Following FDA Actions. Presented in the 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
Invited lecture “Conducting Drug Safety Research at the FDA. NSAIDs and Acute Myocardial Infarction: A Case Study”, Harvard School of Public Health, March 4, 2008; College of Pharmacy, University of Rhode Island, April 30, 2008; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, May 16, 2008
Massaro AN, Hammad TA, Olaode A, Jazzo B, and Aly H. “Massage and kinesthetic stimulation (exercise) improve weight gain in very low birth weight (VLBW) preterm infants -results from a randomized controlled trial.” Presented at the 2008 Pediatric Academic Societies' Annual Meeting in Honolulu, Hawaii, May 3-6.
Janakiraman V, Tarek A Hammad, El-Mohandes A, Obican S, Aly H. “Do Prepregnancy Risk Factors for Preterm Birth Among African American Women Differ By Gestational Age?”. Society of Maternal-Fetal Medicine, 28th Annual Scientific Meeting. Dallas, TX, January 2008.
Janakiraman V, Tarek A Hammad, Aly H, Obican S, El-Mohandes A. “Prepregnancy Risk Factors Associated with Extremely Preterm Birth: Are There Racial Differences?”. Society of Maternal-Fetal Medicine, 28th Annual Scientific Meeting. Dallas, TX January 2008.
Kruzick TL, Tarek A Hammad, Mohamed M, Aly H. “Does the initiation of enteral feeds affect lymphocyte count in premature infants?” E-PAS. 2007:61:5905.5
Nesterenko TH, Molan B, Tarek A Hammad, Aly H. “Is there any relation between the use of oxygen and head growth in premature infants with bronchopulmonary dysplasia (BPD)?” E-PAS. 2007:61:466.
Andrew D. Mosholder, Carol Pamer, Sigal Kaplan, Tarek A. Hammad, Mary Willy, and Laura A. Governale “Trends in U.S. Prescriptions for Antidepressants in Children, Adolescents and Young Adults”. Presented as poster in the 23rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Quebec City, Canada, August 19-22, 2007.
Tarek A Hammad, Kaplan S, Graham DJ, Staffa JA, Kornegay CJ, McCune S, Aly H. “Association between Antidepressant Drugs and Persistent Pulmonary Hypertension in Newborns in the UK-Based General Practice Research Database: A Cohort Study of Mother-Baby Linked Pairs”. Presented as poster in the 23rd International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Quebec City, Canada, August 19-22, 2007.
Tarek A Hammad. “FDA’s Experience Analyzing the GPRD Electronic Medical Record for Drug Safety Issues” Invited lecture in the weekly Research Seminar of the Center for Outcomes and Evidence, Agency for Healthcare Research and Quality (AHRQ), Rockville, MD, January 11, 2007.
Tarek A Hammad, Graham DJ, Staffa JA, Kornegay CJ, Dal Pan G. Association between Cyclooxygenase-2 selective Non-Steroidal Anti-Inflammatory Drugs and Acute Myocardial Infarction in the General Practice Research Database: Preliminary Findings. Presented in the 22nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management. “Pharmacoepidemiology for Public Health”. Lisboa Convention Centre, Lisbon, Portugal, August 24-27, 2006.
J Essers, AO Kandil, Tarek A Hammad, AN Massaro, A Olaode, M Mohamed, H Aly, JT Wung. “Is oxygen (O2) harmful to the gastrointestinal tract (GIT) of premature infants supported with nasal continuous positive airway pressure (NCPAP)?” Presented in the Pediatric Academic Societies’ Annual Meeting, 2006 (PAS. 2006:59:413).
Tarek A. Hammad. “Practical Aspects of Retrieving Data from GPRD”. Invited presentation to the GPRD User Group Meeting, adjunct to the 21st International Conference on Pharmacoepidemiology and Therapeutic Risk Nashville, TN, USA, August 20, 2005.
Tarek A. Hammad, T. Laughren, J. A. Racoosin. “Antidepressant Use and Suicidality in Pediatric Patients: A Meta-Analysis”. Presented in the 21st International Conference on Pharmacoepidemiology and Therapeutic Risk Management, Nashville, TN, USA, August 21-24, 2005.
C Gaitatzes, H Aly, Y Mohamed, Tarek A Hammad, S Bathgate. “Does ABO phenotype correlate with the incidence of low birth weight, preeclampsia and arrest of labor in preterm deliveries? An epidemiological study”. Presented in the Pediatric Academic Societies Annual Meeting, Washington DC, USA, May 14-17, 2005 (PAS, 2005:57:1289)
E Kim, Y Mohamed, Tarek A Hammad, C Macri, H Aly. “Examining ABO phenotypes as a risk factor for chorioamnionitis and urinary tract infection in pregnant women”. Presented in the Pediatric Academic Societies Annual Meeting, Washington DC, USA, May 14-17, 2005 (PAS, 2005:57:166).
A Tanveer, S Bathgate, Y Mohamed, Tarek A Hammad, H Aly. “Does advanced maternal age significantly increase risk for prematurity and low birth weight? An epidemiologic study”. Presented in the Pediatric Academic Societies Annual Meeting, Washington DC, USA, May 14-17, 2005 (PAS, 2005:57:616).
AE El-Mohandes, H Aly, Tarek A Hammad, P Urso, S Bathgate. “Does Anemia persist as a potent predictor of low birth weight in a US population?” Presented in the Pediatric Academic Societies Annual Meeting, Washington DC, USA, May 14-17, 2005 (PAS, 2005:57:295).
SL Bathgate, A Tanveer, Tarek A Hammad, CJ Macri, Y Mohamed, H Aly. “Does Advanced Maternal Age increase the Risk of Intrapartum Fetal Heart Rate Abnormalities or Operative Delivery?” Presented in the Pediatric Academic Societies Annual Meeting, Washington DC, USA, May 14-17, 2005 (PAS, 2005:57:618).
H Aly, J Tioseco, Tarek A. Hammad, BL Short. “Does ABO phenotype impact the response to inhaled nitric oxide (iNO) in infants with persistent pulmonary hypertension of the newborn (PPHN)?” (PAS. 2005:57:2989).
AE El-Mohandes, H Aly, Tarek A. Hammad, P Urso, C Macri. Race affects the influence of maternal age on low birth weight and preterm birth (PAS. 2005:57:3082).
Tarek A. Hammad. “Suicidal Behavior in Randomized Controlled Trials of Antidepressants in Pediatric Psychiatry Populations: Findings and Problems of Interpretation”. Presented in the 51st Annual American Academy of Child and Adolescent Psychiatry Meeting. Research Forum “Issues in the Conduct and Interpretation of Studies of Adolescent Depression”, Washington, DC, USA, October 19–20, 2004.
A.A.E. El-Mohandes, H. Aly, Tarek A. Hammad, M. Mohamed, N. Janosy and P. Urso. “Does Pre-pregnancy Maternal Obesity Influence Length of Gestation and Birth Weight (BW)? A Multivariate Analysis”. Presented in the Pediatric Academic Societies Annual Meeting, San Francisco, CA, USA, May, 2004.
Tarek A. Hammad. “Drug Safety Assessment in the New Millennium: Where Do We Stand?” Presented in the Bi-Annual Conference of the Association of Egyptian-American Scholars, Washington, DC, USA, May 22-23, 2004.
Tarek A. Hammad, A. Mosholder, G. Boehm, J. A. Racoosin, T. Laughren. “Incidence of Suicide in Randomized Controlled Trials of Patients with Major Depressive Disorder”. Presented in the 19th International Conference on Pharmacoepidemiology & 1st International Conference on Therapeutic Risk Management, Philadelphia, PA, USA, August 24, 2003.
Tarek A. Hammad. “An Association between Atypical Antipsychotic Drug Use and Cerebrovascular Adverse Events in Patients with Dementia”. Invited presentation in the 43rd Annual NCDEU (New Clinical Drug Evaluation Unit) Meeting sponsored by the National Institute of Mental Health, Baco Raton, Fl, USA, May 2003.
Tarek A. Hammad. “Methodological Considerations in the Review of NDA Safety Data”. Invited presentation in the 38th Drug Information Association Annual Meeting, Chicago, IL, USA, June 16, 2002.
L. Lippiello, Tarek A. Hammad. “Dose Response and Synergistic Effect of Glucosamine HCl and Chondroitin Sulfate on in Vitro Proteoglycan Synthesis by Bovine and Human Chondrocytes”. Presented in the American Academy of Orthopedic Surgeon, Orlando, FL, USA, 2000.
Tarek A. Hammad. “Clinical Research Challenges in Alternative Medicine: a Closer Look at Nutraceuticals”. Invited seminar lecture, Johns Hopkins School of Public Health, Department of Epidemiology, USA, June 8, 2000.
Tarek A. Hammad. “Experimental and Clinical Research in Nutraceuticals: Update and Current Trends”. Invited presentation in “Nutraceuticals and Medicine”, the 2nd meeting of the American Nutraceutical Association, San Diego, CA, USA, 2000.
Tarek A. Hammad “Glucosamine/Chondroitin combination: Past, Present and Future”. Invited Grand Round presentation, University of Maryland Medical School, Dept of Rheumatology, USA, 1999.
L. Lippiello, J. Woodward, R. Karpman, Tarek A. Hammad. “Beneficial Effect of Cartilage Disease-Modifying Agents Tested in Chondrocyte Cultures and a Rabbit Instability Model of Osteoarthritis”. Presented in the American College of Rheumatology 63rd annual scientific meeting, USA, 1999.
Tarek A. Hammad “Glucosamine and Chondroitin as Chondroprotective Nutraceuticals: Fact or Fiction?” Invited Grand Round presentation, University of Texas-Houston Medical School, Dept of Orthopedic Surgery, USA, 1998.
R. R. Hanson, W. R. Brawner, M. A. Blaik, Tarek A. Hammad, S. A. Kincaid, D. G. Pugh. “Oral Treatment With Cosequin in A Double-Blinded Placebo-Controlled Randomized Clinical Trial as a Selective Symptom Modifying Nutraceutical for Navicular Syndrome”. Presented in the Annual American College of Veterinary Surgeons Scientific Meeting, USA, October 1997.
Tarek A. Hammad. "Studying A Study: How 'Not' to Study Nutraceuticals". Invited presentation in the 1st meeting of the North America Nutraceuticals Council. San Antonio, Texas, USA, May 22, 1996.
R. R. Hanson, L. R. Smalley, G. K. Huff, S. White, Tarek A. Hammad. “Treatment with an oral glucosamine-chondroitin sulfate compound for degenerative joint disease in horses: 25 cases”. Presented in the 35th British Equine Veterinary Association Congress, Warwick, UK, pp 74, 1996.
N. Gabr, M. H. Hussein, Tarek A. Hammad, M. Aboel-Einin, A. Orieby, E. Shawky and A. Saad. "Two Years Epidemiological Follow Up Studies on S.Haematobium Infection in El-Minya." Presented in the 44th Annual Meeting of the American Society of Tropical Medicine and Hygiene, Texas, USA, Nov. 17-21, 1995.
M. Afifi, Tarek A. Hammad, N. Gabr, S. El-Shinawi, R. Khalifa and M. Azab. "Immunodiagnosis of Toxoplasmosis: Comparative Evaluation of Five Methods and Application of Neural Networks Methodology in Acute Infection Prediction". Presented in the 43rd Annual Meeting of the American Society of Tropical Medicine and Hygiene, Ohio, USA, Nov. 13-17, 1994.
Tarek A. Hammad, M. F. Abdel-Wahab, N. DeClaris, A. El-Sahly, N. El-Kady and G. T. Strickland. "Applications of Artificial Neural Networks Modeling of the Epidemiology of Schistosomiasis". Presented in the 43rd Annual Meeting of the American Society of Tropical Medicine and Hygiene, Ohio, USA, Nov. 13-17, 1994.
N. DeClaris, Tarek A. Hammad, M. F. Abdel-Wahab, A. El-Sahly, N. El-Kady and G. T. Strickland. "Neural Network Models for Studying and for Managing in Real-time Schistosomiasis Control Programs". Invited paper presented in the 16th Annual International Conference of the IEEE Engineering in Medical Biology Society, New Opportunities for Biomedical Engineers, Baltimore, Maryland, USA, Nov. 3-6, 1994 (In proceedings volume 1, pp 1362-1363).
Tarek A. Hammad, M. Sexton and P. Langenberg. "Relationship between Blood Lead and Dietary Iron Intake in Preschool Children: a Cross-sectional Study". Presented in the Society of Toxicology Annual Conference, Dallas, Texas, USA, March 13-17, 1994.
Tarek A. Hammad, S. Baily, S. Locus, M. Sexton and P. Langenberg. "Relationship between Nutrients and Trace Elements with Blood Lead in Preschool Children". Presented in the American College of Preventive Medicine and Association of Teachers of Preventive Medicine joint conference, Atlanta, Georgia, USA, March 19-22, 1994.
Tarek A. Hammad. "Pediatric Nutrient and Trace Element Intake Associated with Blood Lead Levels". Visiting Lecture Series, Department of Epidemiology and Preventive Medicine, School of Medicine University of Maryland at Baltimore, USA, September 16, 1993.
FDA Presentations/Lectures
Invited presentation in FDA Public Workshop II: “Benefit-Risk Assessments in Drug Regulatory Decision-Making”. FDA White Oak, Maryland, September 18, 2017.
Invited discussant in a Duke-FDA Workshop entitled “Advancing Structured Benefit-Risk Assessment in FDA Review”. A high-level closed meeting organized by Duke-Margolis Center for Health Policy, Washington DC, October 4, 2017.
Invited discussant in an Institute of Medicine workshop on benefit-risk, FDA White Oak, Maryland, May 12, 2014.
Invited presentation in FDA Public Workshop I: “Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: An Institute of Medicine Workshop”. Talk entitled “Key Sources of Uncertainty in the Assessment of Benefits and Risks of Pharmaceuticals and Associated Challenges”. Food and Drug Administration (FDA) Campus White Oak, Maryland, February 12-13, 2014.
“The Future of Population-Based Postmarket Drug Risk Assessment: A Regulator’s Perspective”. Invited lecture in FDA, CDER, August 2013.
"Do current studies support an association between SSRI use during pregnancy with an increase in persistent pulmonary hypertension of the newborn (PPHN)?". CDER Regulatory Briefing, June 3, 2011.
Invited presentation to the Division of Reproductive Products All Hands meeting “Utilization of Meta-analysis of Observational Data in the Paradigm of Drug Safety in the FDA”, May 2012.
Invited panelist discussant for CDER Scientific Rounds "Does Spiriva HandiHaler Increase the Risk of Cardiovascular Events?: An Example of How the Agency Addressed Evidence from a Meta-analysis" FDA, CDER, April 28, 2010.
Invited presentation: “Methodological Challenges in Premarket Risk Assessment”. Course: Premarketing Clinical Drug Safety and Risk Assessment, The Pharmaceutical Education and Research Institute (PERI), 2009 and 2010.
“Pharmacoepidemiology in CDER”. CDER Forum for International Drug Regulatory Authorities. October 29, 2010.
“Role of Pharmacoepidemiology in Post-Marketing Evaluation of Adverse Events”. Talk for "Basic Epidemiology for Non-epidemiologists" Course – offered once or twice per year starting 2009. The course is accredited for continuing education by the Accreditation Council.
“Interpretation of Study Findings”. Talk for "Basic Epidemiology for Non-epidemiologists" Course – offered once or twice per year starting 2009. The course is accredited for continuing education by the Accreditation Council.
“Role of Meta-analysis of RCTs in Drug Safety”. Talk for "Basic Epidemiology for Non-epidemiologists" Course – offered once or twice per year starting 2009. The course is accredited for continuing education by the Accreditation Council.
“Pharmacoepidemiology in CDER”. CDER Forum for International Drug Regulatory Authorities. April 23, 2010.
Invited presentation: “The Role of Meta-analysis In CDER Decision Making Process”. Drug Safety Oversight Board meeting, May 21, 2009.
“Association between Antidepressant Drugs and Persistent Pulmonary Hypertension in Newborns: A Cohort Study of Mother-Baby Linked Pairs in the UK-Based General Practice Research Database”, Office of Surveillance and Epidemiology Drug Safety Seminar, October 30 & November 6, 2008.
"Determining the predictive value of Read/OXMIS codes to identify incident AMI in the General Practice Research Database”. Office of Surveillance and Epidemiology Drug Safety Seminar, August, 2008.
“Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets”, FDA Public Workshop, May 7, 2008.
"Should epidemiologists strive for immortality? How the road to bias is paved with good intentions." Office of Surveillance and Epidemiology Epi Forum, June 7, 2006.
“Interpreting Drug Safety Data: What You Need to Know as a Reviewer”. Invited lecture in the Clinical Safety Review Series: Learn the "Safety Dance". A Practical Approach to Premarket Safety Review. CDER wide activity, started February 15, 2007 and given twice a year. The series is accredited by the Accreditation Council for Continuing Medical Education (ACCME) for a maximum 15 AMA PRA Category I Credits.
“The Process of Conducting Research Using GPRD. NSAIDs and Acute Myocardial Infarction: A Case Study". Office of Surveillance and Epidemiology Epi Forum, November 30, 2006.
“Examining the Association Between Non-Steroidal Anti-Inflammatory Drugs and Acute Myocardial Infarction”. CDER Regulatory Briefing, August 9, 2006.
“FDA’s Role in Protecting the Public Health: Examining FDA’s Review of Safety and Efficacy Concerns in Anti-Depressant Use by Children”. A participant in the Congressional hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, one hundred eighth Congress (Serial number 108-125, September 23, 2004).
“Full Feature-General Practice Research Database (FF-GPRD)”. Office of Drug Safety Epi Forum, December, 2004.
“Results of the Analysis of Suicidality in Pediatric Trials of Newer Antidepressants”. Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee, Rockville, MD, September 13-14, 2004.
“Plans for Analysis of Patient Level Data for Pediatric Studies”. Psychopharmacologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee, Rockville, MD, February 2, 2004.
“SSRI and suicide in pediatric population”. CDER Regulatory Briefing, September 16, 2003.
“The Evaluation of Monitoring Frequency of Clozapine and Agranulocytosis Rates”. Psychopharmacologic Drugs Advisory Committee, Rockville, MD, June 16, 2003.
“Patient-Reported Outcome (PRO) Working Group: An Update”. Clinical Reviewer’s Meeting, Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, September 16, 2002.
“Risperidone and Cerebrovascular Adverse Events: A Practical Example of Confounding and Interaction”. Clinical Reviewer’s Meeting, Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, March 4, 2002.
“Patient-Reported Outcome (PRO) / Health Related Quality of Life (HRQL)”. Clinical Reviewer’s Meeting, Division of Neuropharmacological Drug Products, Center for Drug Evaluation and Research, 2001.
Acknowledgments
Pinto CA, Chua GN, Bridges JFP, Brookes E, Hyacinthe J, Tervonen T. Comparing Patient Preferences for Antithrombotic Treatment During the Acute and Chronic Phases of Myocardial Infarction: A Discrete-Choice Experiment. Patient. 2022 Mar;15(2):255-266. doi: 10.1007/s40271-021-00548-6. Epub 2021 Sep 27. PMID: 34569030; PMCID: PMC8866301.
Tommi Tervonen, Thibaud Prawitz, Gin Nie Chua, Johanna Hyacinthe, Cathy Anne Pinto, Net clinical benefit of antiplatelet therapy was affected by patient preferences: A personalized benefit-risk assessment, Journal of Clinical Epidemiology, 2022;144:84-92.
Posner et al. Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants. Am J Psychiatry 2007; 164:1035–1043.
Bridge et al. Clinical Response and Risk for Reported Suicidal Ideation and Suicide Attempts in Pediatric Antidepressant Treatment: A Meta-analysis of Randomized Controlled Trials. JAMA, 2007; 297: 1683-1696.