May 2-5, 1982 Pittsburgh Hilton, Gateway Center, Philadelphia, PA
Sunday, May 2
4:00-8:00 PM
7:00-10:00 PM
Monday, May 3
8:00 AM
9:00 AM
9:30 AM
10:10 AM
10:40--11:00 AM
11:00-12:30 PM
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12:00 PM
11:00 AM
Registration
Evening Social Hour
Registration
Welcome Robert S. Gordon, Jr., President Society for Clinical Trials
Conference Address Industrial Support of Academic Research--Hope or Delusion? Ronald W. Lamont-Havers, M.D., Director for Research Policy, Massachusetts General Hospital, Boston
Invited Presentation The Controlled Trials Requirement in the FD&C Act J. Richard Crout, M.D., Director, Bureau of Drugs, FDA
Break
Contributed Paper Session I
Session IA: Sequential Monitoring of Clinical Trials Chairperson: Larry R. Muenz, National Cancer Institute
Aspects of Early Termination in the Beta-Blocker Heart Attack Trial D. DeMets, National Heart, Lung, and Blood Institute (01P
Confidence Intervals in Sequential Clinical Trials C. Jennison, Cornell University (02)
Curtailed Sampling Procedures for Clinical Trials N. Herrmann, University of Pennsylvania (03)
Multiple Testing in Clinical Trials D.G. Seigel, National Eye Institute (04)
Session IB: Data Base Management Systems Chairperson: Theresa Hu, Mayo Clinic
Computer Support System for the Execution of Clinical Studies M.W. Turner, American College of Radiology (05)
1Numbers in parentheses are those of the abstracts in the following section.
Generalized Data Management Systems: A Report on the State of the Art S.W. Singer, Dedicated Response Data Processinng Consultants (06)
Database Management of Clinical Research Data-Five Years of Experience J.M. Long, University of Minnesota (07)
A Computerized Data Form Control System B.A. Barton, Maryland Medical Research Institute (08)
Session IC: Compliance Chairperson: Helen J. Golenzer, Mayo Clinic
Compliance Patterns in AMIS M.E. Mattson, National Heart, Lung and Blood Institute (09)
Effect of Spouse Support and Health Beliefs on Patient Adherence W.J. Doherty, University of Iowa (10)
Comparison of Good and Poor Adherers J.P. Burke, George Washington University (11)
A Survey of Noncompliance Patterns in a Cooperative Study T.J. Tosch, VA Cooperative Studies Program, Veterans Administration Medical Center, Seattle (12)
Session ID: Specific Trials Chairperson: Joseph Pater, Ontario Cancer Foundation
A New Multicenter Clinical Trial in Diabetes---A View from the Bottom C. Siebert, NIADDK, National Institutes of Health (13)
Propranolol for Migraine: A Multidose Crossover Trial to Explore Intersubject Variability and Tailor Therapy to the Individual I.H. Gomolin, Beth Israel Hospital, Boston (14)
Issues in the Design of Chronotherapeutic Trials: A Time-Shift Experiment in Insulin-Treated Diabetics M.I. Schmidt, University of North Carolina (15)
Evaluation and Documentation of the Occurrence of Infection in the Granulocyte Transfusion Study J.E. Connett, University of Minnesota (16)
Lunch
Plenary Session I Clinical Trials--Efficiency and Effectiveness The increasing use of clinical trials to obtain information on the relative merits of completing medical treatments has been justly praised by those interested in placing therapeutics on a more solid scientific basis. Unfortunately, there are such economic problems in carrying out successful trials that their future use is in doubt. The speakers at this plenary session will explore various strategies that may increase the efficiency and effectiveness of clinical trials without reducing their validity.
Chairperson: Stephen George, St. Jude's Childrens Research Hospital Robert Bechhofer, Cornell University William R. Harlan, Department of Population Health and Nutrition
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3:30--4:00 PM
4:00-5:00 PM
4:00 PM
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4:40 PM
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4:40 PM
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4:40 PM
5:00--6:00 PM
Tuesday, May 4
9:00--10:30 AM
Stuart Pocock, Royal Free Hospital, London Discussant: Jay Herson, M.D. Anderson Hospital and Tumor Institute
Break
Contributed Paper Session II
Session IIA: Statistical Topics Chairperson: Sheryl F. Kelsey, University of Pittsburgh
A Sequential Log Rank Test W.D. Dupont, Vanderbilt University Medical School (17)
A Test for Detecting Mortality Trends, and a Comparison with the Mantel-Haenszel Test R.C. Elandt-Johnson, University of North Carolina (18)
Maximum Likelihood Estimation for the Exponential and Weibull Models H.E. Rockette, University of Pittsburgh (19)
Session IIB: Interactive Computing Chairperson: Barbara S. Hawkins, Johns Hopkins University
The Development of a Clinical Trials Computer System (CTCS) R.H. Friedman, University Hospital, Boston (20)
Interactive, Computerized Data Base Management System in a Multicenter Clinical Trial J.C. Torner, University of Iowa (21)
Distributed Computer Support for Clinical Field Studies L.C. Gatewood, University of Minnesota (22)
Session IIC: Quality Control Chairperson: Paul L. Canner, University of Maryland
Southwest Oncology Group Data Managers Survey D.W. Christie, University of Mississippi Medical Center (23)
Nosological Coding of Cause of Death in a Clinical Trial I.D. Curb, University of Texas School of Public Health (24)
A Procedure for Evaluating Performance of Clinics Participating in Multicenter Controlled Clincial Trials G.R. Wise, University of Utah Medical Center (25)
Session IID: Clinical Trials Problems Chairperson: David M. Nitzberg, G.D. Searle & Co.
Do Patient Intake Characteristics Change over Time in Multihospital Clinical Trials? W.O. Williford, Cooperative Studies Program Coordinating Center, VA Medical Center, Perry Point, MD (26)
Canadian Breast Screening Study: Impediments to Progress C.I. Baines, University of Toronto (27)
Randomized Clinical Trials in Neurosurgery S.J. Haines, University of Minnesota (28)
Business Meeting, Society for Clinical Trials
Contributed Paper Session III
Session IliA: Statistical Topics Chairperson: John Matts, University of Minnesota
128 Final Program
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Three Markov-Chain Designs for Dose-Ranging J.A. Bolognese, Merck, Sharp & Dohme Research Labs (29)
Post Hoc Analysis of Subsets of Responders J.C. Reading, University of Utah School of Medicine (30)
Addressing the Hypothesis of a Cure After Disease-Free-Survival (DFS) of Two Years in the Intergroup Rhabdomyosarcoma Study (IRS-I) M.A. Foulkes, University of Texas System Cancer Center (31)
Severity of Illness in Clinical Trials W.A. Knaus, George Washington University Medical Center (32)
Session IIIB: General Issues Chairperson: Sylvan Green, National Cancer Institute
Impact of Clinical Trials on Medical Practice L.M. Friedman, NHLBI (33)
The Uninformed Subject: Moral Dilemmas After the Fact J.M. Howard, National Cancer Institute (34)
Community-Based Trial of Vitamin A Prophylaxis in Indonesia B.S. Hawkins, Johns Hopkins University School of Medicine (35)
Assessing the Effectiveness of Screening Programs L.W. Chambers, McMaster University, Ontario (36)
Session IIIC: Tools for Gathering Data Chairperson: Harold P. Roth, National Institutes of Health
Tools for Community Trials J.R.H. Charlton, St. Thomas's Hospital Medical School, London (37)
A System for the Computerization of Individually Prescribed Medication M.D. Thorn, University of North Carolina (38)
The Role of Computer Assisted Telephone Interviewing in Clinical Research J.A. Crawley, The Upjohn Company (39)
Reliability of Patient-Reported Health Events in an Outpatient Drug Monitoring Study J.S. Gardner, The Upjohn Company (40)
Session IIID: Poster Session
Nursing Practice in a Clinical Trial Setting J.M. Brunell, USPHS Hospital, San Francisco (P-41)
Sample Size Charts for Trials Designed to Show Equivalence W.C. Blackwelder, National Institute of Allergy and Infectious Diseases (P-42)
The Health Behaviors Questionnaire for Predicting Adherence to Prescribed Regimens: Development and Standardization D.L. Goodwin, Baylor College of Medicine-Methodist Hospital (P-43)
Multiple Intervention: A Key to Behavior Change C.P. Sugars, University of California, Davis (P-44)
Error-Free Rate Measurement on Study Forms as Initially Received in the Coordinating Center C.M. White, University of Minnesota (P-45)
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10:30-11:00 AM
11:00-12:30 PM
NCI's Clinical Trials Monitoring Service C.G. Smith, Mathtech, Inc. (P-46)
Drug by Center Interaction: An Investigator's Guide A.F. Johnson, Smith Kline & French Laboratories (P-47)
Evaluation of Large Clinical Datasets Using an Interactive Graphics System (PRIM/H) D.M. Switz, Medical College of Virginia (P48)
Functional Equality of Coordinating Centers in a Multicenter Clinical Trial: Experience of the International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT) Y. Alamercery, Hopital Cardio-Vasculaire et Pneumologique, Lyon, France (P-49)
Annotation of Programming Workload for Multiple Studies P.D. Surbey, University of Minnesota (P-50)
Cost Effective Report Generation W.L. Rasmussen, University of Minnesota (P-51)
Utilizing a Computer Follow-up System in a Clinical Trial to Increase Response Rates K.H. Kirkpatrick, University of California, Davis (P-52)
Tasks and Responsibilities of a Trial Bureau in a Comprehensive Cancer Center J.W. van der Velden, Rotterdams Radiotherapeutic Institute, Netherlands (P-53)
Break
Workshop Session I
Community Intervention Trials---Issues and Future Role [WI-A] Community intervention trials provide an approach to assessing interventions in the prevention of disease in free living populations. The specific methodological issues include comparing outcome by community. Dissemination of information to large numbers of individuals can be more efficiently handled in community programs than in studies with individualized intervention. Furthermore, such trial findings are more meaningful from a public health viewpoint in terms of determining the overall impact of an intervention in a society and in being able to generalize the results. However, several methodological problems of the community trial need to be considered: blinding and strict control may be difficult, the ethical issues are different and implementation of effective intervention presents logistic problems. Cause-and-effect relationships may be difficult to disentangle in these trials. Moreover, there are concerns about the utility and applicability of standard statistical design and analysis methods. These and other issues related to the community intervention trials and its role in the future will be addressed especially as contrasted to the conventional randomized clinical trial. Specific topics include: What questions can be answered? What does recruitment mean? How is intervention achieved? Do conventional design and analysis methods apply? What is the future for community trials?
Chairpersons: Albert Oberman, University of Alabama at Birmingham, and Curt Furberg, NHLBI
Henry Blackburn, University of Minnesota Allan Donner, University of Western Ontario
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12:30-2:00 PM
2:00--3:30 PM
3:30--4:00 PM
4:00--5:30 PM
John Farquhar, Stanford University Lewis Kuller, University of Pittsburgh
Clinical Trial Data Management Systems: Buy or Write [WI-B] This workshop will attempt to define the scope of data management in clinical trial settings and describe the most effective approach to data processing systems. The advantages and disadvantages of buying data base management software as compared to writing these programs "in house" will be addressed. Speakers from a variety of clinical trial research areas will relate their experiences on each side of this issue. An effort will be made to identify those areas of software development most amenable to custom programming. Similarly, the capabilities, availability, and cost effectiveness of commercial data management software will be discussed.
Chairperson: Herman Mitchell, University of Pittsburgh
Ronald L. Code, Cooperative Studies Program Coordinating Center, VA Medical Center, Palo Alto Fran Glover, M.D., Anderson Hospital, Houston James D. Hosking, University of North Carolina Martha Turner, American College of Radiology
Lunch
Plenary Session II
Clinical Trials of Pharmacological and Psychological Treatments of Mental Disorders
Controlled clinical trials assessing treatments for mental disorders have been widely used for the past 20 years. The introduction of psychopharmacologic agents in the early 1960s has resulted in substantial federal research support by the National Institue of Mental Health and the Veterans Administration. The speakers at this plenary session will provide an overview of controlled clinical trials for treatments of depressive disorders, a comparison of the methodologies employed in studies of medical and mental disorders and methodologic approaches used to assess psychotherapy (a procedure rather than a drug or device) in a clinical trial framework. The session will demonstrate that, although developed rather independently, the methodologies of and progress made in assessing the treatment of mental disorders do not differ substantially from those in assessing medical disorders.
Chairperson: Jerome Levine, National Institute of Mental Health
Gerald L. Klerman, Harvard Medical School C. James Klett, Cooperative Studies Program Coordinating Center, VA Medical Center, Perry Point, MD Morris B. Parloff, National Institute of Mental Health
Break
Workshop Session II
Crossover Designs for Clinical Trials: When and How Should They Be Used? [WII-A] The panelists in this workshop are all well acquainted with the need for valid, efficient clinical trials for the comparative evaluation of drugs. Each one has been concerned with the role of the crossover design in helping to supply this need. R. O'Neill has
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7:00 PM
8:00 PM
Wednesday, May 5
8:30-10:00 AM
long experience in evaluating studies submitted by sponsors to FDA in support of new drug applications and has been instrumental in focusing the attention of biostatisticians on the question chosen as title for this workshop. He will serve as moderator for the session. J. Johnson has been involved with applications of the crossover at Syntex Research, where he served as head of the Department of Biostatistics. He has been concerned with ambiguities arising in the analysis of crossover data and design measures that can be taken to obviate such dilemmas. E. Laska, of the Rockland Research Institute, and H. Patel, of Ciba-Geigy, in papers submitted or in press, have grappled with the problem of carryover effects in the crossover situation. They have examined designs and analyses that allow for carryover effects and will discuss some of their conclusions and recommendations. The panelists hope to encourage members of the audience to contribute their own experiences and recommendations on the central workshop question.
Chairperson: Byron W. Brown, Jr., Stanford University Medical Center
Jerry D. Johnson, Syntex Laboratories Eugene M. Laska, Rockland Research Institute Robert O'Neill, FDA Harji I. Patel, Ciba-Geigy
The Clinical Trials as a Guide to Practice [WII-B]
This workshop will explore methods and problems of using the results of a well conducted clinical trial to guide therapeutic decisions for individual patients. The panel will discuss how trial design and reporting influence the applicability of trial results to patient management and consider how trials might be designed to facilitate application to patient care. The panel will address generalizing from the study population to the patient at hand and whether the physician should pay attention to results in a particularly relevant subgroup of study subjects. Panel members will also address generalizing from the precise therapy and clinical setting of the trial to the therapy and setting to be used in practice. Results from the Hypertension Detection and Follow-up Program and other trials will be used to develop and illustrate the discussion.
Chairperson: Joseph A. Ingelfinger, Boston University School of Medicine
Thomas O. Louis, Harvard School of Public Health Thaddeus E. Prout, Greater Baltimore Medical Center and Johns Hopkins University School of Medicine James O. Taylor, East Boston Neighborhood Health Center
Social Hour
Banquet Speaker: Dr. Bernard Fisher, Professor of Surgery, University of Pittsburgh
Contributed Paper Session IV
Session IVA: Statistical Topics Chairperson: Robert W. Makuch, National Cancer Institute
132 Final Program
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Data Analysis Proposed for Use in a Study of Coronary Artery Bypass Grafts J. Souchek, VA Cooperative Studies Program, VA Hospital, Hines (54)
Evaluation of Clinical Laboratory Data J.J. Tiede, Bristol Laboratories (55)
Randomization with Stratification and Institution Balance for Multi-Institution Clinical Trials M.A.P. Bauer, University of Pittsburgh (56)
Bounds on Correlation Coefficients Between Dichotomous Variables and Their Influence on Variable Selection P.N. Peduzzi, Cooperative Studies Program Coordinating Center, VA Medical Center, West Haven (57)
Session IVB: Data Base Management Techniques Chairperson: John M. Long, University of Minnesota
Masterfile Closeout and Data Archival Procedures in the Multiple Risk Factor Intervention Trial S.K. Broste, University of Minnesota (58)
A Data Dictionary Design for Clinical Trials D.H. Hultgren, University of Minnesota (59)
A Table-Driven Edit System with Custom Test Conditions and Messages M.M. Newhouse, Johns Hopkins School of Medicine (60)
The Design and Development of a Statistical Data Base B.A. Barton, Maryland Medical Research Institute (61)
Session IVC: Planning Clinical Trials Chairperson: Satya D. Dubey, Food and Drug Administration
Clinical Trials in Rare Tumors H. Tate, Medical Research Council Centre, Cambridge, England (62)
Stopping Rules in Randomized Control Trials S.S. Chan, Mr. Sinai School of Medicine (63)
Relative Efficiency in the Analysis of Survival Data A.R. Willan, National Cancer Institute of Canada (64)
Cost and Sample Size Determinations J.P. Matts, University of Minnesota (65)
Session IVD: Techniques For Clinical Trials Chairperson: Robert J. Keehn, Medical Follow-up Agency, NAS-NRC
Evaluation of Summary Indices of Response in Controlled Clinical Trials M.J. Egger, University of Utah School of Medicine (66)
Evaluation of Arthritis Clinical Trials Using Survival Analysis J.C. Reading, University of Utah School of Medicine (67)
Developing Simulated Patients for Training and Evaluating Trial Staff in Adherence Counseling M.L. Russell, Baylor College of Medicine-Methodist Hospital (68)
Compliance Measures in the Cholesterol Lowering Atherosclerosis Study (CLAS) S. Nessim, USC School of Medicine (69)
What shapes clinical opinion and practice? What is, and what should be, the role of government in evaluating present practice, finding and testing new approaches, and promoting change? What are, and what should be, the prerogatives and responsibilities of the private sector when it has a stake in (variously) change or the status quo? Speakers will discuss such matters as assessing current practice, changing incentives to adopt research results, the evaluation of health care techniques, the NIH program of consensus development, and the interests of government as the major purchaser and supplier of health services. Emphasis will be on controlled clinical trials.
Chairperson: John Bailar III, Harvard University School of Public Health
Theodore Cooper, Upjohn Company Anthony Komaroff, Harvard Medical School Seymour Perry, Association of American Medical Colleges Discussant: Thomas C. Chalmers, Mt. Sinai Medical Center
