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TitleStatistics in Medical Research: Developments in Clinical Trials
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LanguageEnglish
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Page 1

Statistics in Medical
Research

Developments in
Clinical Trials

Page 2

Statistics in Medical
Research

Developments in
Clinical Trials

Edmund A. Gehan, Ph.D., and
Noreen A. Lemak, M.D.

The University of Texas
MD. Anderson Cancer Center

Houston, Texas

Springer Science+Business Media7 LLC

Page 108

THE AWAKENING OF STATISTICS IN THE UNITED STATES 103

Gertrude M. Cox. (From Stinnett, S., and Collaborators, 1990, Women in statistics:
Sesquicentennial activities. Am Stat 44:75. Courtesy of the American Statistical Asso-
ciation.)

Page 109

104 CHAPTER 4

As is often the case with those who accomplish much in a lifetime,
Cox seemed to set goals for herself at each stage of her career; she then
worked tirelessly with unusual tenacity and independence to achieve
each target. She would probably attribute her success to luck or to being
in the right place at the right time, but the facts reveal that she prepared
herself well so that she could fulfill each opportunity that came along.

As a young woman, she believed that her life's work should be as a
deaconess in the Methodist Episcopal church, and she prepared for it,
including spending some time caring for children in an orphanage in
Montana (R. L. Anderson et al., 1979). Cox changed her mind, however,
and entered Iowa State College, earning a B.S. degree at the age of 29.
As mentioned before, the first degree in statistics at Iowa State, an M.S.,
was awarded to Cox in 1931.

After she spent 2 years at the University of California at Berkeley,
Snedecor hired Cox as a member of the small group that would be
responsible for the newly created Statistical Laboratory at Iowa State.
She worked there from 1933 to 1940. Cox always enjoyed telling about
Snedecor's dedication of his book, Statistical Methods. "The dedication
simply read, 'to Gertrude,' but Professor Snedecor never did specify to
which Gertrude he referred-his wife Gertrude or his professional
colleague Gertrude" (R. L. Anderson et aI., 1979).

William Cochran worked with Cox from 1938 to 1940 and wrote
that, at that time, in addition to determining the appropriate statistical
analyses for research projects, she was assembling material on experi-
mental designs (Cochran, 1979). A book by that name was completed by
Cochran and Cox and published in 1950.

Since Gertrude disliked the job of writing even more than I
did, she took responsibility for the experimental plans, and I took
primary responsibility for the descriptive text and any hidden
theory. Misprints and errors in the Cochran text have kept me busy
at times for quite a number of years. In over 25 years, one misprint
in one treatment in one plan has been brought to my attention. This
performance was typical of Gertrude's work. The letter pointing out
this misprint cheered me up no end. [Cochran, 1979]

Around 1940, North Carolina State College was preparing to inau-
gurate its new Department of Experimental Statistics in the School of
Agriculture. Snedecor was asked to suggest names of qualified candi-
dates for the unfilled position of head of the department. He showed his
proposed list of men to Cox, who immediately asked, "Why didn't you

Page 215

Subject Index

Acute leukemia, 147, 166-168, 170-174,
182

Adenocarcinoma of vagina, 158-159
AIDS issues, 146, 150
American Statistical Association (ASA),

95-97, 99, 102, 106, 125, 127
Annals of Mathematical Statistics, 99, 109
Annals of Probability, 100
Annals of Statistics, 100
Anthrax vaccine, 46-47
Antihistamines, 89-90
Antisepsis, 47-49

Bayes's theorem, 21-23, 25, 71, 73, 116
Berkson-Gage procedure, 178-179
Biometrics, 106
Biometrika, 51, 57-59, 62, 113
Bladder tumors, 162-164
Bloodletting: see Phlebotomy
Breast carcinoma, 148, 156, 184-185, 188

Cancer Chemotherapy National Service
Center (CCNSC), 129-130

Canon, 2
Case-control design, 90, 155-162, 164-165
Chemotherapy

combination, 149, 166-168
for acute leukemia, 147, 149, 166-68,

170-174
for breast carcinoma, 148, 184-185
for prostate carcinoma, 148
MOPp, 144

Chemotherapy (cont.)
to prolong remission, 149, 170-174

Chi square statistic, 56, 74, 92, 127, 175
Cholera, 38-41, 81
Cohort studies, 162-166
Comparability of patient groups, 136-139
Computers in medical statistics, 22, 43,

131, 139, 142
Correlation, 17, 29, 51, 53, 56, 62, 71, 73,

77, 87, 98, 100, 113
Cox model, 179-181, 183-185

Data Monitoring Committee, 146
De Medicina, 2
Declaration of Helsinki, 143
Digitalis, 8
Double-blind technique, 82, 90, 92, 125,

171-174
Early years of teaching in U.S., 97-98
Eugenics, 59, 60, 65, 69, 71, 77, 80

Foxglove: see Digitalis
Funding clinical trials, 129, 133

Gambling, 20, 23-25
Gehan test, 177
Gunshot wounds, 2-4

Hazard function, 179
Hypothesis testing, 114, 116-117

Informed consent, 136, 143, 150, 151

213

Page 216

214 SUBJECT INDEX

Institute of Mathematical Statistics (IMS),
98-99, 109, 111, 120, 127

International Statistical Institute (lSI), 29,
50, 106, 114, 120, 127

Kaplan-Meier estimate, 178-179

Life table, 14, 16-20, 41-43, 60, 87, 177-
179

Logistic regression model, 179-182

Mann-Whitney test, 177
Mantel-Haenszel procedure, 160-162
Medical Research Council, 85-91
Metanalysis, 185-188
Multivariate analysis, 106-108, 179-181

Natural Inheritance, 53, 54, 77
Numerical method, 31-36
Nuremberg Code, 143

On the Dominance Ratio, 77-78

Petersburg Paradox, 23-24
Phlebotomy, 29-31, 33-36
Placebo effect, 8, 82, 83, 89-90, 171-174
Poliomyelitis, 88, 125-126
Principles of Medical Statistics, 37, 86-87
Probability density function, 179
Proportional hazards model, 179, 183-185
Punch-card machines, 100-102, 108

Randomization, 1, 82, 90-92, 117, 125-
126, 129-153, 166-168

Randomized versus historical control
studies, 132-153

Ranked observations, 175-177
Relative risk, 9, 159-162, 184-185

Rothamsted, 63, 73, 74-77, 79,106,123-124
Royal Society of London, 12
Royal Statistical Society, 27-29, 49-50,

53, 58, 64, 74, 81, 86, 121, 123, 124
Rubella, 88

Sampling, 117, 118, 124, 125, 126
sequential, 168-169
comparison of samples, 174-177

Scurvy, 5-7
Sequential designs and analysis, 108, 145,

168-174
Sexual Behavior in the Human Male, 124-

125
Smallpox, 8-11
Small sample distributions, 62-65
Smoking and cancer, 90, 126, 156-158,

159-160, 164-165
Statistical Methods for Research Workers,

76-77
Statistical Research Group, 108
Statistical Science, 100
Stratification, 137-139
Streptomycin trial, 90-91
Survivorship function, 179

t-statistic, 63, 106, 174
The Design of Experiments, 79-80
The Genetical Theory of Natural Selection,

77-79

University Group Diabetes Project, 142

Women's Health Trial, 165-166

Yellow fever, 29-31

Zelen's randomized consent design, 136

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