including the areas of Cardiology, Rheumatology,
Psychiatry, Endocrinology, and Heptatology.
Roughly half of these were safety only DSMBs, while the other half
reviewed safety and efficacy. Most of
those reviewing safety and efficacy (or effectiveness – devices) used death as
the primary endpoint. I have served as
the Co-Chair for one of these DSMBs and as a US statistical representative on an
International DSMBS for 7 of these committees.
As of January 2001, 3 of these
DSMBs are ongoing, and an additional 3 DSMBs are in planning stages.
1994-1996 BRI International, Inc., Chapel Hill, NC
Director of
Biometrics and Director of Chapel Hill
Operations
Responsible for
the entire Chapel Hill North Carolina
operations. Directs the office, and is
responsible for all the day to day and long term planning of this office and of
the entire Biometrics staff across all the North American operations
office. This includes budgeting,
resource planning and allocation, facilities management, computer and network
support (Novell Network).
Assists Senior
Director, Project Operations Division, in oversight of administrative functions
associated with the scientific and technical staff. Supervises the staff of biostatisticians, scientists, research
programmers, and medical writers.
Provides technical expertise and administrative direction to specific
projects involving clinical research.
Supervises and delegates tasks for biostatisticians, scientists,
programmers, and medical writers in
POD. Maintains client
communications.
Develops study
design with other project team members.
Develops literature review strategy with Medical Writer. Designs database with System Analyst and
provides database management advice to CRAs.
Oversees technical quality assurance of data, analyses, and
documents. Develops analysis plans,
oversees analyses, provides interpretation of results, and oversees generation
of reports. Oversees tables generation
and preparation and submission of major FDA regulatory documents.
1988 - 1994 Burroughs Wellcome Co., Research Triangle Park, NC
Senior
Statistician I and II
Was responsible
for protocol design, protocol writing (statistical section), and review;
analysis plans; data monitoring (statistical); statistical computing (data
listings and analyses); statistical report writing; final study report writing
and review; management of statisticians assigned to project; cross-study
summaries of safety and efficacy (NDA); manuscript preparation; Data and Safety
Monitoring Board analyses (when required); and investigator's meeting
preparation.
Responsible for
statistical manuscripts and presentation; continuous improvement process team;
and statistical designs for optimal drug development. Six years of
experience as project statistician plus 1 year of experience in
administrative management.
1986 - 1988 UNC School
of Pharmacy, Chapel Hill, NC
Visiting
Assistant Professor
1983 - 1986 UNC Department of Biostatistics, Lipids
Research Clinics Program, Chapel Hill,
NC
Research
Assistant (Statistician)
1981 - 1982 UNC Department of Biostatistics, Lipids
Research Clinics Program, Chapel Hill,
NC
Graduate
Assistant
1980 - 1981 North Carolina Memorial Hospital, Chapel Hill, NC
Staff Pharmacist
1978 - 1980 UNC School
of Pharmacy, Chapel Hill, NC
Pharmacy
Practice Resident
1977 - 1978 Middlesex General Hospital, New Brunswick, NJ
Pharmacy
Technician
1972 - 1974 Hunt's Pharmacy, Paterson, NJ
Clerk
PROFESSIONAL AFFILIATIONS:
The Biometrics
Society
American
Statistical Association
PUBLICATIONS:
Tennison M.D., Greenwood R., Lewis
D., and Thorn M.D. Discontinuing
Antiepileptic Drugs in Children with Epilepsy:
Comparison of a Six-Week and Nine-Month Taper Period. New England
Journal of Medicine. 1994; x():
Thorn
M.D. Automated Classification of Fatal
Cardiovascular End Points in Large Scale Multi-Center Clinical Trials. Dr.P.H. dissertation, Department of
Biostatistics, UNC School of Public Health.
Beza J.B., Stritter F.T.,
Caiola S.M., McDermott J.H., and Thorn M.D.
The effects of a preceptor development program. American Journal of Pharmaceutical
Education. 1992; 56(1): 44-47.
Miles M.V.,
Snead O.C.,
and Thorn M.D. Predictability of Unbound
Antiepileptic Drug Concentrations in Children Treated with Valproic Acid and
Phenytoin. Clinical Pharmacy. 1988; 7:688-693.
Abernathy J.R., Thorn M.D., Ekelund L..G,
Holme I.,
Stinnett S.S., Shestov D.B., and Deev A.D.
Correlates of Systolic and Diastolic Blood Pressure in Men Aged 40-59
Years Sampled From the United States of America
and Union of Soviet
Socialist Republics Lipid Research Clinics
Populatios. American Journal of Cardiology. 1988; 61:1071-1075.
Abernathy
J.R., Thorn M.D., Trobaugh G., Ekelund L., Maciolowski M., Loupovetsky B.,
Shelnova S., Zhukovsky G.S., Shestov D.B., and Deev A.D. Prevalence of Ischemic Resting and Stress ECG
Abnormalities and Rose
Questionnaire Angina in Men Aged
40-59 in the US and USSR Lipid
Research Clinics Program Populations.
Circulation. 1988; 77:270-278.
Thorn
M.D., Ingram D.D.,
Abernathy J.R.,
and Maciolowski
M.
The Lipid Research Clinics Population Studies Data Book. Volume III The USSR First Prevalence Study. U.S. Department of Health and Human
Services, NIH Publication, November 1986;
No. 87-2727.
Ingram D.D., Thorn M.D., Stinnett S.S., and Deev A.D.
US and USSR
Nutrient Intake, Plasma Lipids and Lipoproteins in Men Ages 40-59 Sampled From
Lipid Research Clinics (LRC) Populations.
Prevention Medicine. 1985;
14:264-271.
Thorn
M.D., Pulliam C.C., Symons
M.J., and Eckel F.M. Statistical and Research Quality of the
Medical and Pharmacy Literatures.
American Journal of Hospital Pharmacy.
1985; 42:1077-1082.
Thorn
M.D. A Method of Computerization of
Individually Prescribed Non-Trial Medication.
M.S. paper, Department of Biostatistics, UNC School of Public Health.
Thorn
M.D. A Comparative Review of the
Research and Statistical Methods of the Medical and Pharmacy Literatures. M.S. paper, Division of Pharmacy Practice,
UNC School of Pharmacy.
Bernstein C., Thorn M.D, Monees
K., Spell R., and O’Connor
J.B. A Prospective Study of Factors that
Determine Cecal Intubation Time at Colonoscopy. Gastrointestinal Endoscopy
2005; 61:72-75.
SYMPOSIA PUBLICATIONS:
Abernathy
J.R., Furberg B., Thorn M.D., Ekelund L.G., Deev A.D., Shestov D.B., Zhukovsky
G.S., and Tyroler H.A. Correlates of
Systolic and Diastolic Blood Pressure in Men Aged 20-39 Years From US and USSR
Lipid Research Clinic Populations.
Atherosclerosis Reviews. 1988;
17:111-124.
Furberg
B., Abernathy J.R., Thomas R.P., Ekelund L.G., Thorn M.D., Shestov D.B., Deev
A.D., Levy R.I., and Perova N.V.
Correlates of Lipids and Lipoproteins in Men Aged 20-39 Years From US
and USSR
Lipid Research Clinic Populations. Atherosclerosis Reviews. 1988; 17:125-138.
Thorn
M.D., Furberg B., Abernathy J.R., Ekelund L.G., Deev A.D., Shestov D.B, Rifkind
B.M., and Oganov R.G. Correlates of
Systolic and Diastolic Blood Pressure in Women-Aged 20-69 Years From US and USSR
Lipid Research Clinics Populations. Atherosclerosis Reviews. 1988; 17:157-186.
Furberg B.,
Abernathy J.R.,
Thorn M.D., Ekelund L.G., Irving S.H.,
Deev A.D., Shestov D.B., Williams O.D., and Oganov R.G.
Correlates of Systolic and diastolic Blood Pressure in Women-Aged 20-69
Years From US and USSR Lipid Research Clinics Populations. Atherosclerosis Reviews. 1988; 17:185-200.
Johansson S.,
Thorn M.D., Furberg
B., Chang I.Y.,
Ekelund L.G., Oganov R.G., and Sheffield
L.T. Electrocardiographic Abnormalities
and Rose Questionnaire Angina in Women Aged 30-69
Years. A Cross-Sectional Study of Selected US and USSR Populations. Atherosclerosis Reviews. 1988; 17:243-256.
Shestov
D.B., Deev A.D, Zhukovsky G.S., Thorn M.D., Davis C.E., and Klimov A.N. Coronary Heart Disease Risk
Factors and Mortality in the USSR
Lipid Research Clinics Follow-up Study.
Atherosclerosis Reviews. 1988;
17:261-276.
Tyroler
H.A., Levy R.I.,
Thorn M.D., Davis C.E.,
Deev A.D., and Shestov D.B. High Density Lipoprotein Cholesterol and
coronary Heart Disease Mortality: Experience of White Men Aged 40-59 Years From
the US Lipid Research Clinics Mortality Follow-up Study. Atherosclerosis Reviews. 1988; 17:277-286.
PRESENTATIONS:
Thorn
M.D., and Hurley F.L.
Statistical Issues in Medical Devices: An Industry Perspective. American Statistical Assocation 1996
Statistical Meetings (Special Contributed Session. August 7, 1996. (INVITED)
Thorn
M.D. Using Sequential Trial Methodology for Interim Analyses - Practical
Applications and Issues. Joint Annual
Meeting Statistical Society of Canada
and Institute of Mathemeatical Statistics. Montreal Canada
July 10-13, 1995. (INVITED)
Thorn
M.D., Small R., Huffman C.,
McSorley P.,
and Souza K.
Applications of Total Quality Management in Clinical Research in the
Pharmaceutical Industry. American
Statistical Association 1994 Winter Conference. Atlanta GA
January 6-9, 1994. (INVITED)
Hinderliter
A.L., Willis
P.W., Thorn M.D., Long W., and the
North American Primary Pulmonary Hypertension Study Group. Echocardiographic Effects of Prostacyclin in
Primary Pulmonary Hypertension. 66th
Scientific Session American Heart Association Meeting. Atlanta, GA. November 8-11, 1993.
Thorn
M.D. Using Sequential Trial Methodology
for Interim Analyses - A Congestive Heart Failure Survival Study
Experience. 15th Annual Midwest Biopharmaceutical Statistics Workshop. Muncie,
IN May, 1992.
Miles M.V.,
Bass J., Tennison M.B., Holcomb B.J., and Thorn M.D.
Effects of Liquid Enteral Feeding on Carbamazepine (CBZ) Suspension
Absorption. American Society for Clinical Pharmacology and Therapeutics, 1989
meeting.
SYMPOSIA PRESENTATIONS:
Sznajd
J., Pajak A., Misiowiec P., Magdon M., Rywik S., Przestalska-Malkin H., Kupsc
W., Williams O.D., Thomas R.T., Irving S.H., Abernathy J.R., and Thorn
M.D. Poland and US Collaborative Study
on Cardiovascular Epidemiology: Introductory Baseline. Presented at the 3rd US-Poland Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Pajak
A., Celinski A., Morawski R., Furberg B., Abernathy J.R., Thomas R.P., Irving
S.H., Williams O.D., and Thorn M.D. Poland and US Collaborative Study on
Cardiovascular Epidemiology: Correlates of Systolic and Diastolic Blood
Pressure in Men Aged 35-64 Years From Selected Poland and US Samples. Presented at the 3rd US-Poland Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Czarnecka H.,
Pajak A., Konopka M., Furberg B.,
Irving
S.H., Thomas
R.P., Abernathy
J.R., Williams
O.D., and Thorn M.D. Poland
and US Collaborative Study on Cardiovascular Epidemiology: Correlates of Systolic and Diastolic Blood
Pressure in Men Aged 35-64 Years From Selected Poland and US Samples. Presented at the 3rd US-Poland Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Czarnecka H.,
Pajak A., Konopka M., Furberg B.,
Irving
S.H., Thomas
R.P., Abernathy
J.R., Williams
O.D., and Thorn M.D. Poland and US Collaborative Study
in Cardiovascular Epidemiology: Correlates of Lipids and Lipoproteins in Men
Aged 35-64 Years From Selected Polish and US Samples. Presented at the 3rd US-Poland Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Misiowiec
P., Pajak A., Mizera R., Furberg B., Abernathy J.R., Thomas R.P., Irving S.H.,
Thorn M.D., and Williams O.D. Poland and US
Collaborative Study on Cardiovascular Epidemiology: Correlates of Systolic and Diastolic Blood
Pressure in Women Age 35-64 From Selected Polish and US Samples. Presented at the 3rd US-Poland Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Baczynaska
E., Pajak A., Morawska I., Sznajd J., Furberg B., Thomas R.P., Irving S.H.,
Abernathy J.R., Williams O.D., and Thorn M.D.
Poland
and US Collaborative Study on Cardiovascular Epidemiology: Correlates of Lipids and Lipoproteins in
Women Aged 35-64 Years From Selected Polish and US Samples. Presented at the
3rd US-Poland Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Furberg B.,
Abernathy J.R.,
Thorn M.D., Ekelund L.G., Irving S.H.,
Deev A.D., and Shestov D.B. Correlates of Systolic and Diastolic Blood
Pressure in Men Aged 20-39 Years From US and USSR Lipid Research Clinic
Populations. Presented at the 3rd
US-USSR Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Furberg B., Abernathy
J.R., Thorn M.D., Ekelund L.G., Irving
S.H., Shestov D.B.,
and Deev A.D. Correlates of Lipids and
Lipoproteins in Men Aged 20-39 Years From US and USSR Lipid Research Clinic
Populations. Presented at the 3rd
US-USSR Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Dennis B., Thomas
R.P., Irving S.H.,
Thorn M.D., Abernathy J.R.,
and Furberg B. Nutrient Intake in Men Aged 20-39 From US and USSR Lipid Research Clinic
Populations. Presented at the 3rd
US-USSR Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Thorn
M.D., Furberg B.,
Abernathy J.R.,
Ekelund L.G., Irving
S.H., Deev A.D.,
and Shestov D.B. Correlates of Systolic
and Diastolic Blood Pressures and Lipids and Lipoproteins in Men Aged 20-69
From US and USSR
Lipid Research Clinics Populations. Presented at the 3rd US-USSR Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Furberg B.,
Abernathy J.R.,
Thorn M.D., Ekelund L.G., Irving S.H.,
Deev A.D., and Shestov D.B. Correlates of Systolic and Diastolic Blood
Pressure in Women Aged 20-69 Years From US and USSR Lipid Research Clinics
Populations. Presented at the 3rd
US-USSR Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Furberg B., Abernathy
J.R., Thorn M.D., Ekelund L.G., Irving
S.H., Shestov D.B.,
and Deev A.D. Correlates of Lipids and
Lipoproteins in Women Aged 20-39 Years From US and USSR Lipid Research Clinics
Populations. Presented at the 3rd
US-USSR Symposium, NHLBI, NIH, Bethesda,
MD, September 22-23, 1986.
Dennis B., Thomas
R.P., Irving S.H., Thorn M.D., Abernathy
J.R., and Furberg B. Nutrient Intake in Women Aged 20-69 Years
From US and USSR
Lipid Research Clinics Populations.
Presented at the 3rd US-USSR Symposium, NHLBI, NIH, Bethesda, MD,
September 22-23, 1986.
Johansson S., Thorn M.D., Furberg B.,
Chang I.Y., Irving
S.H., Ekelund L.G.,
and Abernathy J.R.
Electrocardiographic Abnormalities and Rose Questionnaire
Angina in Women Aged 30-69 Years. A
Cross-Sectional Study of Selected US and USSR Populations. Presented at the 3rd US-USSR Symposium,
NHLBI, NIH, Bethesda, MD, September 22-23, 1986.
Shestov
D.B., Thorn M.D., Deev A.D.,
and Davis
C.E. Correlates of Mortality in Men Aged
40-59 Years From USSR
Lipid Research Clinics Populations.
Presented at the 3rd US-USSR Symposium, NHLBI, NIH, Bethesda, MD,
September 22-23, 1986.
Tyroler
H.A., Thorn M.D., Bangdiwala S.I., Deev
A.D., and Shestov
D.B. Correlates of Mortality in Men Aged
40-59 Years From the US
Lipid Research Clinics Populations.
Presented at the 3rd US-USSR Symposium, NHLBI, NIH, Bethesda, MD,
September 22-23, 1986.
POSTER PRESENTATIONS:
Long
W., Rubin L., Barst R., Rich S., Badesch D., Groves B., Tapson V., Bourge R.,
Brundage B., Keller C., Koerner S., Langleben D., Murali S., Uretsky B., Clayton
L., Jobsis M., Thorn M.D., and McGoon M.
Randomized Trial of Conventional Therapy Alone Vs. Conventional Therapy
+ Continuous Infusion of Prostacyclin in Primary Pulmonary Hypertension: A 12 Week Study. San
Francisco, CA American Thoracic Society/American Lung
Association International Conference.
May 18, 1993.
Rubin L.J., Thorn M.D., Mendoza
J., Hood M., Barst R.,
McGoon M., Crow J., and Long W. The influence of continuous therapy with
intravenous prostacyclin on survival in primary pulmonary hypertension. 7th International Conference on
Prostaglandins and Related Compounds, 323, May 28 - June 1, 1990.
Thorn
M.D., Caiola S.M., and Smith R.L. A Computerized Experiential Site Selection
Program: Administrative Uses. AACP meeting, Charleston, SC
July 1987.
Thorn
M.D., Caiola S.M., Smith R.L., and Sawyer W.T.
Student Use of a Computerized, Experiential Site Selection Program. AACP Meeting, Charleston, SC
July 1987.
AWARDS AND HONORS:
Rho Chi Pharmacy Honor Society
Rho Chi Certificate of Achievement
INTERNATIONAL CONSULTANT
ACTIVITIES:
Visiting Scientist, US Component of Joint US-Peoples
Republic of China Cooperation on Cardiovascular
Disease (National Heart, Lung, and Blood Institute). Visit of Beijing
and Guangzhou,
PRC April 7 through June 1, 1985 to set up Data Entry System for data
collection on an IBM
PC/XT and statistical analysis.