- Email: [email protected]
Preliminary program combined annual scientific sessions the society for clinical trials and eighth annual symposium for coordinating clinical trials
Preliminary Program
Combined Annual Scientific Sessions The Society for Clinical Trials and
Eighth Annual Symposium for Coordinating Clinical Trials May 11 13, 1981 Holiday Inn (Van Ness), San Francisco, California
Sunday, May 10 4:00-8:00 PM
Registration
7:00-10:00 PM
Evening Social Hour
Monday, May 11 8:00 AM
Registration
9:00 AM
Welcome
9:30 AM
Conference Address
Harold P Roth, President, Society for Chmcal Trials Wflham Foege, Director, Centers for Disease Control 10:10 AM
Invited Presentation The National Death Index and Its Relationship to Chmcal Trials, Mrs Dorothy Rice, D~rector, National Center for Health StaUstlcs
10:40-11:00 PM
Break
11:00-12:30 PM
Contributed Paper Session 1 (four simultaneous sesssons) Session IA: Sample Size
11:00 AM
Proving the Null Hypothesis m Chmcal Trials WC Blackwelder, National Institute of Allergy and Infectious Diseases (01)
11:20 AM
Momtormg Chntcal Trials to Terminate Accrual LV Rubenstem and MH Gaff, Blometry Branch, Nataonal Cancer lnshtute (02)
11:40 AM
Sample Size Conslderatlons in Chronic Dtsease Chmcal Trials Number of Patients Versus Follow-Up Time M Bauer, C Redmond, B Barton, Umverslty of Plttsburgh (03)
12:00 PM
Comparison of Estimated Patient Accrual and Sample Size From a Pilot Study and Trial Data Involving Acute Disease NC Fox, TD Hartwell, WK Poole, S Mulhn, Research Triangle Institute, North Carolina (04)
11:00 AM
Johnson and Johnson's Live for Life Program T Hartwell, P Stolley, P Plserchla, J Dawes, J Rasswefler, Research Triangle Institute, North Carolina (05)
Session IB: Alternatives to Clinical Trials
Controlled Chmcal Trials 2, 59-65 (1981) (~) 1961 Elsevier North Holland, lnc , 52 Vanderbflt Avenue, New York, NY 10017
59 0197-2456/81/01005900750250
60
Prehmmary Program
11:20 AM
Data Banks and Chmcal Trials From Adversaries to Complementary "Fools SC Kumtz, C Gross, A tteyman, Nahonal lnshtute of Neurological and Commumcatwe Disorders and Stroke (06)
11:40 A M
A Chmcal Data Bank Approach to Orthognathlc Surgery Research C Phdhps, Umverslty of North Carohna (07i
12:00 PM
Insufficiency of Comparing Consecutive Trials to ['rove Treatment Elfioency An Example m Acute Lymphoblastlc Leukemia C Chastang, MF Auclerc, JP Chantalou, M Wed, C Jacqulllat, F (;remy, Untte INSERM, [htie-Salpetnere, Paris, France tO,'¢J Session IC: Measurement Quality Control
11:00 AM
Radiation Therapy Quality Control Methodology and Results GW Grundy, Radiation Therapy Oncology Group, Philadelphia, Pennsylvania ¢09J
11:20 AM
How Valid are the Data Collected in a Complex Mulhcenter Clinical l'rtal ~ SM Mulhn, National Heart, Lung, and Blood Institute (10)
11:40 AM
Analysis of Quality Control Data Using Fleiss' Extension of Cohen's Kappa to Test That Observed Agreement Achieves a Predetermined Standard B Tdley, R Forthofer, R Hamst, University ot Texas System Cancer Center (11~
12:00 PM
Comparison of Local versus Central Tumor Measurements in a Multicenter Cancer Trial WG Henderson, JF Martin, LR Zacharski, Ihnes VA Cooperahve Studies Program Coordinating Center t 12)
11:00 AM
Identifying Pubhshed Reports of Chmcal Trials C Memert and K t h g g m s , Johns t{opkms University f13~
11:20 AM
ttow Blind Was The Patient Blind in AMIS > J Howard and AMIS Research Study Group, National I leart, Lung, and Blood Inshtute t 14;
11:40 A M
Evaluation of Beneht When lntercurrent Mortality is High SF Kelsey, KM Detre, JL Bttsko, Umvers~ty of Pittsburgh 115;
12:00 PM
'Fermmat~on ot a Multicenter Chmcal Trial Start Issues E Damelson, D Kousch-Howard, Harvard University School of Pubhc Health (16~
Session ID: Selected Topics
12:30-2:00 PM
Lunch
2:00-4:00 PM
Plenary Session 1 What Should Clinical Trials Cost and Who Should Pay tor Them ~ Thomas C Chalmers, Mount Smm School of Medicine, Chairperson Panel includes - - A r m a n d Llttman, l h n e s VA --Roger Crossley, Smith, Khne, and French Laboratories --Daniel Present, Mount Sinai School of Medicine --John Singleton, University ot Colorado -Leonard Schaeffer, Director ot Student Loan Marketing Assoclahon -Aziza Berk, Economist, Mount Sinai School of Medicine
4:00-4:15 PM
Break
4:15-5:15 PM
Contributed Paper Session II (tour simultaneous sessions) Session IIA: Survival Analysis
4:15 PM
Estimation of Mortality Prediction Function in Follow-up Studies Lifetime Analysis RC Elandt-Johnson and AR Meibohm, University of North Carohna (17J
4:35 PM
A Likelihood Ratio Statistic to Compare Survival Time in a Surgical Trial J Souchek, Hines VA Cooperative Studies Program Coordinating Center t18)
4:55 PM
Direct Adlusted Survival Curves for Comparing Two Treatments MH Gad, DP Byar, SB Green, National Cancer Institute (19;
Prehmmary Program
61
S e s s i o n lIB: Ethics 4:15 PM
Randomization From the First Pahent--Gettmg It Together with the Surgeons A Hdhs and SL Fine, Johns tfopkms University (20)
4:35 PM
Consent Form Suggested Improvement JE Bearman, L Neumann, S Weitzman, Epidemiology and t iealth Services Evaluation Unit, Ben-Gurlon University, Israel (2D
4:55 PM
Should the Role of the Institution Review Board be Expanded to Consider~the Relationship Between the Feasibility o! Study Completion and Patient Rlsk~ KE Stanley, Sidney Farber Cancer lnshtute and Harvard University (22)
4:15 PM
Some Factors Affecting Patient Recruitment m VA Cooperative Studies SF Bmgham, VK) Wflhford, DG Weiss, JF Collins, Perry Point VA Cooperative Studies Program Coordinating Center 12.3~
4:35 PM
Risk, Response, and Efhciency in Explanatory Trials RA Mdner, DL Sackett, McMaster University, Hamilton Ontario, Canada (24)
4:55 PM
Accrual of Patients Into a Multihospltal Cancer Clinical Trial and Its Implications on Planning Future Studies JF Martin, WG Henderson, LR Zacharski, t hnes VA Cooperative Studies Program Coordinating Center (25)
S e s s i o n llC: Patient Recruitment
S e s s i o n liD: Data Reduction 4:15 PM
Impact of Duplicate Measurements on the Design and Analysis of a Mulhcenter Clinical Trial GJ Pnid'homme, MR Fisher, GL Knatterud, Umverslty of Maryland 126)
4:35 PM
Refinement of Endpomt Measurement Based on a Quality Control Substudy The NHLBI Type lI Coronary Intervention Study Group and KM Detre, University of Pittsburgh (27~
4:55 PM
Background Diabetic Retmopathy Angiofluorography Quantitative Measurement DAMAD Study Group, C Baudom, G Quentel, Coordinating Center, INSERM, Vflleluif, France (28)
Tuesday, M a y 12 9:00-10:30 AM
Contributed Paper S e s s i o n Ill (four simultaneous sessions) S e s s i o n IliA: Selected Statistical Topics
9:00 AM
Comparing Treatments in Subsets of Pahents DP Byar, SB Green, Nahonal Cancer Inshtute (29)
9:20 AM
Statistical Approaches for Relating End Results to Amount of Drug Received in Breast Cancer Therapy Trials C Redmond, HS Wleand, B Fisher, Umverslty of Pittsburgh (30;
9:40 AM
Treatment Assignment Bias in Controlled Chmcal Trials P Celano, TC Chalmers, tI Sacks, H Smith, Jr , Mount Sinai School of Medicine (31)
10:10 AM
The Mantel-Haenszel Statistic in Strahhed Randomized Trials with Balanced Blocked Allocation Within Strata N Blrkett and A Donner, University of Western Ontario (32; S e s s i o n IIIB: Data M a n a g e m e n t
9:00 AM
Computer Based Clinical Trial Data Documentat.on J Levme, National Institute of Mental Health (33)
9:20 AM
Assessment of Intelligent Terminals for Data Entry Experience m Three Clinical Trials G Bowden, F LoPresh, S Polhzzi, Maryland Medical Research Institute (34~
9:40 AIM
The Future of Statistical Computer Packages .n Clinical Trial Analysis BA Barton, Maryland Medical Research Institute ~35)
62 10:10 AM
Prehmmary
Program
An Outcomes Momtormg System for Multlcenter Cooperative Chmcal Studies WK Poole, TD }iartwell, AV Rao, BK Hastings, NC Fox, DA Whltehurst, Research Trangle Institute, North Carohna (36~ S e s s i o n lllC: T h e D r o p o u t P r o b l e m
9:00 AM
Chmcal Trial Dropouts Analysis of Demography and Reasons JL Probstfleld, ML Russell, W lnsull, Jr , Baylor-Method,st Lipid Research Chmc, Houston, Texas (37)
9:20 AM
Who Drops Out of Chmcal Tnals--..-The VA Cooperat,ve Study Experience JF Colhns, SF Bmgham, WO Wflhford, DG Wmss, Perry I'omt VA Cooperatp.'e Studies Program Coordinating Center (38~
9:40 AM
Which Patients Will Be Lost to Follow-Up ~ JA Cramer, JF Colhns, RH Mattson, West Haven VA Epilepsy Cooperative Study Group (39~
10:10 AM
The Problem of Attributing Deaths ot Non-Adherers The VA Coronary Bypass Experience KM Detre, PN Peduzzi, West ttaven VA Cooperative Studms Program Coordinating Center (.I0~ S e s s i o n IIID: Poster S e s s m n
Alternatives in Chmcal Data Presentatmn SA Salem, Smith Khne and French Labs, Philadelphia, Pennsylvania (P4D Sample Szze Reqmrements for Group Randomization A Donner, N Blrkett, Umverslty of Western Ontario U'42~ The Analysis of Conditional Crossover Designs GM Fava, SG Buhlte, Knoll Pharmaceutical Co . Whtppany, New Jersey (P43~ Momtormg and Accounting of lnvestlgatlonal Drug Supplies m a Multtcenter Chn,cal Trial LM Young, TJ Tosch, Albuquerque VA Cooperat.ve Studies Program Chmcal Research Pharmacy Coordinating Center (P44) A Computer Management System for Drug Shipment, Assignment and Inventory and for Pat,ent Schedul,ng and Forms Inventory m a Muir,hospital Cooperative Study DG Archibald, C Lee. CM Haakenson, West Haven VA Cooperatwe Studies Program Coordinating Center (P45) An Alternative Method ot Evaluation of Chmcal Trials in Arthritis JC Reading, MJ Egger, JR Ward, HJ Williams, MJ Coleman, Umversltv of Utah. College of Medicine ~I~-t6) Design of a Chmcal Trial Evaluating Timing of Surgery-.Cooperative Aneurysm Study J Torner, N Kassell, P Lachenbruch, R Woolson, University of Iowa (P47~ Graphical Nonparametnc Techniques for Exploring Hazard Functions with TimeVarying Covanates HT Thaler, Bmstattstics Laboratory, Memorial Sloan-Kettermg Cancer Center, New York (P48) An lnteractlve Data Quality Assurance Program WD Dupont, RF Wright, Vanderbflt Umversity (P49) M o m t o n n g Late Effects of Therapy in Chmcal Trials J Herson, LC Strong, The Umvers,ty of Texas System Cancer Center, Houston, Texas ¢P50) Adlustmg Treatment to Seventy Use ot l'rognostlc Knowledge m the Design ot Randomized Clinical Trials C Chastang, A Auqmer, B A.sselam, F Gremy, INSERM, Pit~e-Salpetnere, Pans, France (P5D
Prehmmary
Program
63
Use of a Natural History Phase for the Design of Trials for Duchenne Muscular Dystrophy Collaborative investigation of Duchenne Dystrophy Group, Washington Umverslty, St LOUIS(P521 Unreliability of Relapse Frequency as Predictor of Long Term Survival in Adluvant Breast Cancer R Chlebowskl, J Welner, V Ryden, J Bateman, The Western Cancer Study Group, Los Angeles, Cahfornla (P53) Protocol for Protocols HJ Golenzer, Mayo Comprehensive Cancer Center, Rochester, Minnesota (P54; The Coordinating Center m a Clinical Trial JD Curb, CM Hawkins, EO Smith, N Zimbaldl, C Ford, B Carter, C Cooper, University of Texas School of Pubhc Health and Baylor College of Medicine, t fouston, Texas (P55) DAMAD Program A Controlled Chnlcal Trial of Antlaggregant Agents on the Course of Background Diabetic Retlnopathy DAMAD Study Research Group, D Job, C Baudoln, Coordinating Center, INSERM, Vlllelulf, France (P56J Delegation of Specialized Arrhythmla Analysis Tasks in the Multlcenter PostInfarction Program (MPIP) KW Clark, LM Rolnltzky, JP Miller, RE Klelger, S Thanavaro, JT Bigger, Jr , and other MPIP participants, Washington University fPS7) Implementing an Adherence Counselors Skills Training Program Iowa Lipid Research Clinic DC Tucker, HG Schrott, BL Henmngs, HB Engen, The University of Iowa (P58) Cholesterol Lowenng Atherosclerosls Study CLAS Research Group, S Azen, S Nesslm, D Blankenhorn, University of Southern California (P59) Identification of Varied Training Needs of a Clinical Trial Staff by Oblectlve Documentation of Their Interviewing and Counseling Skills ML Russell, W lnsull, Jr , JL Probstfleld, The Baylor-Methodlst Lipid Research Clinic ftouston, Texas (P601 Computerized Data Transmission in Clinical Research JA Bollert, FR Nlchol, SL Anderson, BI Plckerlng, Institute for Biological Research and Development, l n c , Newport Beach, California ¢1)61) 10:30-11:00 AM
Break
11:00 AM
Business Meeting
12:00-1:30 PM
Lunch
1:30-3:00 PM
Plenary Session II Recruitment for Clinical Trials The Coronary l ' n m a r y Prevention Trial and its lmphcatlons for Future Trials Organizer Reagan Bradford, Oklahoma Medical Research Foundation
3:00-3:20 PM
Break
3:20-5:20 PM
Workshop Sessions (five simultaneous sessions) Organizer Katherine Detre, University of Pittsburgh A Utilization of Results from Quality Control Programs for End Point Diagnosis and Measurement Orgamzer Paul Canner, University of Maryland B Adlustment for Covarlates Orqanlc.er Paul Meier, University of Chicago C Impact of Data Base Management Systems on the Organization and Administration ot Clinical Trials Organizer Ted Weiss, Alcohol, Drug Abuse, and Mental Health Administration
64
Prehmmary
Program
D Data Base M a n a g e m e n t S y s t e m s A Technical Introduction a n d COverview Organtzer H e r m a n E Mitchell, U m v e r s t t y ot P i t t s b u r g h E D e s i g n of Data Collection I n s t r u m e n t s Orgamzer Barbara S H a w k i n s , T h e Johns H o p k i n s School ot H y g i e n e a n d P u b h c Health
5:20 PM
End of Tuesday's Session
7:00 PM
Social Hour
8:00 PM
Banquet l'hfllp Lee, Speaker, Professor ot S o o a l M e d , o n e Director, t tealth Pohc3' Program U m v e r s l t y ot C a h f o r m a Medical School, San Francisco Former A s s i s t a n t Secretary for Health, DHEW
Wednesday, May 13 8:30-10:00 A M
Contributed Paper Session IV (tour s i m u l t a n e o u s s e s s i o n s ) Session IVA: Allocation and Randomization
8:30 A M
T r e a t m e n t Allocation by M i n i m u m L , k e h h o o d M A l c k m , D e p a r t m e n t of M a t h e m a t i c s , Arizona State U n i v e r s i t y ¢621
8:50 A M
O p t i m a l Allocation for the C o m p a r i s o n of P r o p o r t i o n s JJ S c h l e s s e l m a n , E B n t t a m , Blometry Branch, National Institute of Child Health a n d H u m a n D e v e l o p m e n t ¢03J
9:10 A M
Evaluation of A d a p t i v e R a n d o m i z a t i o n for a Small Scale Clinical Trial DM Black, AM B a g m e w s k a , SB Hulley, K M o M g , BW Brown, Jt , Systolic I t y p e r t e n s i o n in the Elderly Program, San Francisco, California ~64)
9:30 A M
Data D e p e n d e n t T r e a t m e n t Allocation in Clinical Trials U s i n g a Sequential Version ot t h e l.ogrank Test MI. Lesser. Memorial S l o a n - K e t t e r m g Cancer Center, New York 165)
Session IVB: "Framing and Certaficat~on 8:30 AM
D e s i g n of a National C o u n s e l i n g Skills P r o g r a m tor Clinical Trial Staff J D u n b a r , F Peterson, H Schrott, B Schucker, T S m i t h , M Russell, E Wade, R Wetzel, Stantord U m v e r s t t v School ot M e d i c i n e ¢66)
8:50 A M
A d h e r e n c e Specialist Cernficatlon B Schucker. J D u n b a r , F Peterson, M Russell, H Schrott, T Smith. E Wade, R Wetzel, Lipid Research Clinics Program, National t teart, L u n g , a n d Blood Institute (b7~
9:10 A M
T r a i n i n g a n d Certlhcatlon ot Visual Function T e c h n , c l a n s in the Early T r e a t m e n t Diabetic R e m o p a t h y S t u d v A Kassott, G Bresmck. I C a v e n d e l , J Buehler, R t l a r n s o n , A Reggtardo. A l b a n y Medical College If, d~
9:30 A M
T r a i n i n g a n d Certltlcation ot Blood P r e s s u r e O b s e r v e r s in a Clinical "Frtal JD C u r b , D l.abarthe, G Cutter, S Polzner, CM t l a w k m s , U n i v e r s i t y ot Texas School ot P u b h c Health a n d Baylor College ot M e d i c i n e , i l o u s t o n , Texas f69;
Session IVC: Coordinating Centers 8:30 AM
Mayo Cancer C e n t e r Q u a l i t y A s s u r a n c e S y s t e m Personnel O r g a n i z a t i o n a n d S t u d v D e s i g n Aspects JR O'Fallon, DI. A h m a n n , J Bill, HJ Golenzer, TC Hu, CG Moertel, JR Offord, WF Taylor, Mayo C h m c , Rochester, M i n n e s o t a (701
8:50 A M
C o m p u t e r - A i d e d Data M a n a g e m e n t a n d Data Q u a h t y Control in Multicenter Clinical C a n c e r Trials M Van Glabbeke, M Buyse, J Renard, M D e P a u w , EORTC Data Center, Instltut Bordet, Brussels, Belgium tTD
9:10 A M
M a n a g e m e n t ot a C o o r d i n a t i n g Center for Multlcenter Clinical Tnals Y C h a n , D Collins, West ~taven VA Cooperatp.'e S t u d i e s l ' r o g r a m C o o r d i n a t i n g ( ' e n t e r r721
Prehmmary Program
9:30 AM
65
Statistical Center Data Management m Multlcenter Clinical Trials EL Orlow, E McFadden, Sidney Farber Cancer Institute, Boston, Massachusetts (73)
Session IVD: Selected Statistical Topics 8:30 AM
Use ot Jackknife Techmques in Determ,nmg a "Best" Subset of Covarlates for the Cox Proport,onal-Hazards Modcl R Fagerstrom, tt Smith, H Sacks, B Cohen, Mount Smal School of Medicine, New York (74;
8:50 AM
Cumulative Sum Statistics Apphcat,ons in Chmcal Trials DL Hawkins, JD Knoke, Umverslty of North Carohna (75~
9:10 AM
Development and Vahdatlon of a VA Risk Function to Pred,ct Mortality P Peduzzl, KM Detre, Y Chan, A Oberman, G Cutter, West Haven VA Cooperative Studies Program Coordinating Center and Umverslty of Alabama (76:
9:30 AM
Analysis of Cancer Patient Survival with the Welbull Model SB Green, DP Byar, National Cancer Institute (77)
10:00-10:30 AM
Break
10:30-12:00 PM
Plenary Paper Session 111 To Count or Not to Count Are Exclusions Post-Randomlzatton Permissible, and Can the Degree of Bias Be Measured ~ Chmrperson Christian R Khmt, Maryland Medical Research Institute Speakers --Robert Elashoff, University of Cahtorma --Paul Canner, Umverslty of Maryland - - D a w d DeMets, National Heart, Lung, and Blood Institute --Michael Gent, McMaster Umverslty Dzscussants --Gennell Knatterud, Unwers~ty of Maryland --Byron W Brown, Jr , Stanford Medxcal Center
12:00 PM
Adjournment
Combined Annual Scientific Sessions The Society for Clinical Trials and
Eighth Annual Symposium for Coordinating Clinical Trials May 11 13, 1981 Holiday Inn (Van Ness), San Francisco, California
Sunday, May 10 4:00-8:00 PM
Registration
7:00-10:00 PM
Evening Social Hour
Monday, May 11 8:00 AM
Registration
9:00 AM
Welcome
9:30 AM
Conference Address
Harold P Roth, President, Society for Chmcal Trials Wflham Foege, Director, Centers for Disease Control 10:10 AM
Invited Presentation The National Death Index and Its Relationship to Chmcal Trials, Mrs Dorothy Rice, D~rector, National Center for Health StaUstlcs
10:40-11:00 PM
Break
11:00-12:30 PM
Contributed Paper Session 1 (four simultaneous sesssons) Session IA: Sample Size
11:00 AM
Proving the Null Hypothesis m Chmcal Trials WC Blackwelder, National Institute of Allergy and Infectious Diseases (01)
11:20 AM
Momtormg Chntcal Trials to Terminate Accrual LV Rubenstem and MH Gaff, Blometry Branch, Nataonal Cancer lnshtute (02)
11:40 AM
Sample Size Conslderatlons in Chronic Dtsease Chmcal Trials Number of Patients Versus Follow-Up Time M Bauer, C Redmond, B Barton, Umverslty of Plttsburgh (03)
12:00 PM
Comparison of Estimated Patient Accrual and Sample Size From a Pilot Study and Trial Data Involving Acute Disease NC Fox, TD Hartwell, WK Poole, S Mulhn, Research Triangle Institute, North Carolina (04)
11:00 AM
Johnson and Johnson's Live for Life Program T Hartwell, P Stolley, P Plserchla, J Dawes, J Rasswefler, Research Triangle Institute, North Carolina (05)
Session IB: Alternatives to Clinical Trials
Controlled Chmcal Trials 2, 59-65 (1981) (~) 1961 Elsevier North Holland, lnc , 52 Vanderbflt Avenue, New York, NY 10017
59 0197-2456/81/01005900750250
60
Prehmmary Program
11:20 AM
Data Banks and Chmcal Trials From Adversaries to Complementary "Fools SC Kumtz, C Gross, A tteyman, Nahonal lnshtute of Neurological and Commumcatwe Disorders and Stroke (06)
11:40 A M
A Chmcal Data Bank Approach to Orthognathlc Surgery Research C Phdhps, Umverslty of North Carohna (07i
12:00 PM
Insufficiency of Comparing Consecutive Trials to ['rove Treatment Elfioency An Example m Acute Lymphoblastlc Leukemia C Chastang, MF Auclerc, JP Chantalou, M Wed, C Jacqulllat, F (;remy, Untte INSERM, [htie-Salpetnere, Paris, France tO,'¢J Session IC: Measurement Quality Control
11:00 AM
Radiation Therapy Quality Control Methodology and Results GW Grundy, Radiation Therapy Oncology Group, Philadelphia, Pennsylvania ¢09J
11:20 AM
How Valid are the Data Collected in a Complex Mulhcenter Clinical l'rtal ~ SM Mulhn, National Heart, Lung, and Blood Institute (10)
11:40 AM
Analysis of Quality Control Data Using Fleiss' Extension of Cohen's Kappa to Test That Observed Agreement Achieves a Predetermined Standard B Tdley, R Forthofer, R Hamst, University ot Texas System Cancer Center (11~
12:00 PM
Comparison of Local versus Central Tumor Measurements in a Multicenter Cancer Trial WG Henderson, JF Martin, LR Zacharski, Ihnes VA Cooperahve Studies Program Coordinating Center t 12)
11:00 AM
Identifying Pubhshed Reports of Chmcal Trials C Memert and K t h g g m s , Johns t{opkms University f13~
11:20 AM
ttow Blind Was The Patient Blind in AMIS > J Howard and AMIS Research Study Group, National I leart, Lung, and Blood Inshtute t 14;
11:40 A M
Evaluation of Beneht When lntercurrent Mortality is High SF Kelsey, KM Detre, JL Bttsko, Umvers~ty of Pittsburgh 115;
12:00 PM
'Fermmat~on ot a Multicenter Chmcal Trial Start Issues E Damelson, D Kousch-Howard, Harvard University School of Pubhc Health (16~
Session ID: Selected Topics
12:30-2:00 PM
Lunch
2:00-4:00 PM
Plenary Session 1 What Should Clinical Trials Cost and Who Should Pay tor Them ~ Thomas C Chalmers, Mount Smm School of Medicine, Chairperson Panel includes - - A r m a n d Llttman, l h n e s VA --Roger Crossley, Smith, Khne, and French Laboratories --Daniel Present, Mount Sinai School of Medicine --John Singleton, University ot Colorado -Leonard Schaeffer, Director ot Student Loan Marketing Assoclahon -Aziza Berk, Economist, Mount Sinai School of Medicine
4:00-4:15 PM
Break
4:15-5:15 PM
Contributed Paper Session II (tour simultaneous sessions) Session IIA: Survival Analysis
4:15 PM
Estimation of Mortality Prediction Function in Follow-up Studies Lifetime Analysis RC Elandt-Johnson and AR Meibohm, University of North Carohna (17J
4:35 PM
A Likelihood Ratio Statistic to Compare Survival Time in a Surgical Trial J Souchek, Hines VA Cooperative Studies Program Coordinating Center t18)
4:55 PM
Direct Adlusted Survival Curves for Comparing Two Treatments MH Gad, DP Byar, SB Green, National Cancer Institute (19;
Prehmmary Program
61
S e s s i o n lIB: Ethics 4:15 PM
Randomization From the First Pahent--Gettmg It Together with the Surgeons A Hdhs and SL Fine, Johns tfopkms University (20)
4:35 PM
Consent Form Suggested Improvement JE Bearman, L Neumann, S Weitzman, Epidemiology and t iealth Services Evaluation Unit, Ben-Gurlon University, Israel (2D
4:55 PM
Should the Role of the Institution Review Board be Expanded to Consider~the Relationship Between the Feasibility o! Study Completion and Patient Rlsk~ KE Stanley, Sidney Farber Cancer lnshtute and Harvard University (22)
4:15 PM
Some Factors Affecting Patient Recruitment m VA Cooperative Studies SF Bmgham, VK) Wflhford, DG Weiss, JF Collins, Perry Point VA Cooperative Studies Program Coordinating Center 12.3~
4:35 PM
Risk, Response, and Efhciency in Explanatory Trials RA Mdner, DL Sackett, McMaster University, Hamilton Ontario, Canada (24)
4:55 PM
Accrual of Patients Into a Multihospltal Cancer Clinical Trial and Its Implications on Planning Future Studies JF Martin, WG Henderson, LR Zacharski, t hnes VA Cooperative Studies Program Coordinating Center (25)
S e s s i o n llC: Patient Recruitment
S e s s i o n liD: Data Reduction 4:15 PM
Impact of Duplicate Measurements on the Design and Analysis of a Mulhcenter Clinical Trial GJ Pnid'homme, MR Fisher, GL Knatterud, Umverslty of Maryland 126)
4:35 PM
Refinement of Endpomt Measurement Based on a Quality Control Substudy The NHLBI Type lI Coronary Intervention Study Group and KM Detre, University of Pittsburgh (27~
4:55 PM
Background Diabetic Retmopathy Angiofluorography Quantitative Measurement DAMAD Study Group, C Baudom, G Quentel, Coordinating Center, INSERM, Vflleluif, France (28)
Tuesday, M a y 12 9:00-10:30 AM
Contributed Paper S e s s i o n Ill (four simultaneous sessions) S e s s i o n IliA: Selected Statistical Topics
9:00 AM
Comparing Treatments in Subsets of Pahents DP Byar, SB Green, Nahonal Cancer Inshtute (29)
9:20 AM
Statistical Approaches for Relating End Results to Amount of Drug Received in Breast Cancer Therapy Trials C Redmond, HS Wleand, B Fisher, Umverslty of Pittsburgh (30;
9:40 AM
Treatment Assignment Bias in Controlled Chmcal Trials P Celano, TC Chalmers, tI Sacks, H Smith, Jr , Mount Sinai School of Medicine (31)
10:10 AM
The Mantel-Haenszel Statistic in Strahhed Randomized Trials with Balanced Blocked Allocation Within Strata N Blrkett and A Donner, University of Western Ontario (32; S e s s i o n IIIB: Data M a n a g e m e n t
9:00 AM
Computer Based Clinical Trial Data Documentat.on J Levme, National Institute of Mental Health (33)
9:20 AM
Assessment of Intelligent Terminals for Data Entry Experience m Three Clinical Trials G Bowden, F LoPresh, S Polhzzi, Maryland Medical Research Institute (34~
9:40 AIM
The Future of Statistical Computer Packages .n Clinical Trial Analysis BA Barton, Maryland Medical Research Institute ~35)
62 10:10 AM
Prehmmary
Program
An Outcomes Momtormg System for Multlcenter Cooperative Chmcal Studies WK Poole, TD }iartwell, AV Rao, BK Hastings, NC Fox, DA Whltehurst, Research Trangle Institute, North Carohna (36~ S e s s i o n lllC: T h e D r o p o u t P r o b l e m
9:00 AM
Chmcal Trial Dropouts Analysis of Demography and Reasons JL Probstfleld, ML Russell, W lnsull, Jr , Baylor-Method,st Lipid Research Chmc, Houston, Texas (37)
9:20 AM
Who Drops Out of Chmcal Tnals--..-The VA Cooperat,ve Study Experience JF Colhns, SF Bmgham, WO Wflhford, DG Wmss, Perry I'omt VA Cooperatp.'e Studies Program Coordinating Center (38~
9:40 AM
Which Patients Will Be Lost to Follow-Up ~ JA Cramer, JF Colhns, RH Mattson, West Haven VA Epilepsy Cooperative Study Group (39~
10:10 AM
The Problem of Attributing Deaths ot Non-Adherers The VA Coronary Bypass Experience KM Detre, PN Peduzzi, West ttaven VA Cooperative Studms Program Coordinating Center (.I0~ S e s s i o n IIID: Poster S e s s m n
Alternatives in Chmcal Data Presentatmn SA Salem, Smith Khne and French Labs, Philadelphia, Pennsylvania (P4D Sample Szze Reqmrements for Group Randomization A Donner, N Blrkett, Umverslty of Western Ontario U'42~ The Analysis of Conditional Crossover Designs GM Fava, SG Buhlte, Knoll Pharmaceutical Co . Whtppany, New Jersey (P43~ Momtormg and Accounting of lnvestlgatlonal Drug Supplies m a Multtcenter Chn,cal Trial LM Young, TJ Tosch, Albuquerque VA Cooperat.ve Studies Program Chmcal Research Pharmacy Coordinating Center (P44) A Computer Management System for Drug Shipment, Assignment and Inventory and for Pat,ent Schedul,ng and Forms Inventory m a Muir,hospital Cooperative Study DG Archibald, C Lee. CM Haakenson, West Haven VA Cooperatwe Studies Program Coordinating Center (P45) An Alternative Method ot Evaluation of Chmcal Trials in Arthritis JC Reading, MJ Egger, JR Ward, HJ Williams, MJ Coleman, Umversltv of Utah. College of Medicine ~I~-t6) Design of a Chmcal Trial Evaluating Timing of Surgery-.Cooperative Aneurysm Study J Torner, N Kassell, P Lachenbruch, R Woolson, University of Iowa (P47~ Graphical Nonparametnc Techniques for Exploring Hazard Functions with TimeVarying Covanates HT Thaler, Bmstattstics Laboratory, Memorial Sloan-Kettermg Cancer Center, New York (P48) An lnteractlve Data Quality Assurance Program WD Dupont, RF Wright, Vanderbflt Umversity (P49) M o m t o n n g Late Effects of Therapy in Chmcal Trials J Herson, LC Strong, The Umvers,ty of Texas System Cancer Center, Houston, Texas ¢P50) Adlustmg Treatment to Seventy Use ot l'rognostlc Knowledge m the Design ot Randomized Clinical Trials C Chastang, A Auqmer, B A.sselam, F Gremy, INSERM, Pit~e-Salpetnere, Pans, France (P5D
Prehmmary
Program
63
Use of a Natural History Phase for the Design of Trials for Duchenne Muscular Dystrophy Collaborative investigation of Duchenne Dystrophy Group, Washington Umverslty, St LOUIS(P521 Unreliability of Relapse Frequency as Predictor of Long Term Survival in Adluvant Breast Cancer R Chlebowskl, J Welner, V Ryden, J Bateman, The Western Cancer Study Group, Los Angeles, Cahfornla (P53) Protocol for Protocols HJ Golenzer, Mayo Comprehensive Cancer Center, Rochester, Minnesota (P54; The Coordinating Center m a Clinical Trial JD Curb, CM Hawkins, EO Smith, N Zimbaldl, C Ford, B Carter, C Cooper, University of Texas School of Pubhc Health and Baylor College of Medicine, t fouston, Texas (P55) DAMAD Program A Controlled Chnlcal Trial of Antlaggregant Agents on the Course of Background Diabetic Retlnopathy DAMAD Study Research Group, D Job, C Baudoln, Coordinating Center, INSERM, Vlllelulf, France (P56J Delegation of Specialized Arrhythmla Analysis Tasks in the Multlcenter PostInfarction Program (MPIP) KW Clark, LM Rolnltzky, JP Miller, RE Klelger, S Thanavaro, JT Bigger, Jr , and other MPIP participants, Washington University fPS7) Implementing an Adherence Counselors Skills Training Program Iowa Lipid Research Clinic DC Tucker, HG Schrott, BL Henmngs, HB Engen, The University of Iowa (P58) Cholesterol Lowenng Atherosclerosls Study CLAS Research Group, S Azen, S Nesslm, D Blankenhorn, University of Southern California (P59) Identification of Varied Training Needs of a Clinical Trial Staff by Oblectlve Documentation of Their Interviewing and Counseling Skills ML Russell, W lnsull, Jr , JL Probstfleld, The Baylor-Methodlst Lipid Research Clinic ftouston, Texas (P601 Computerized Data Transmission in Clinical Research JA Bollert, FR Nlchol, SL Anderson, BI Plckerlng, Institute for Biological Research and Development, l n c , Newport Beach, California ¢1)61) 10:30-11:00 AM
Break
11:00 AM
Business Meeting
12:00-1:30 PM
Lunch
1:30-3:00 PM
Plenary Session II Recruitment for Clinical Trials The Coronary l ' n m a r y Prevention Trial and its lmphcatlons for Future Trials Organizer Reagan Bradford, Oklahoma Medical Research Foundation
3:00-3:20 PM
Break
3:20-5:20 PM
Workshop Sessions (five simultaneous sessions) Organizer Katherine Detre, University of Pittsburgh A Utilization of Results from Quality Control Programs for End Point Diagnosis and Measurement Orgamzer Paul Canner, University of Maryland B Adlustment for Covarlates Orqanlc.er Paul Meier, University of Chicago C Impact of Data Base Management Systems on the Organization and Administration ot Clinical Trials Organizer Ted Weiss, Alcohol, Drug Abuse, and Mental Health Administration
64
Prehmmary
Program
D Data Base M a n a g e m e n t S y s t e m s A Technical Introduction a n d COverview Organtzer H e r m a n E Mitchell, U m v e r s t t y ot P i t t s b u r g h E D e s i g n of Data Collection I n s t r u m e n t s Orgamzer Barbara S H a w k i n s , T h e Johns H o p k i n s School ot H y g i e n e a n d P u b h c Health
5:20 PM
End of Tuesday's Session
7:00 PM
Social Hour
8:00 PM
Banquet l'hfllp Lee, Speaker, Professor ot S o o a l M e d , o n e Director, t tealth Pohc3' Program U m v e r s l t y ot C a h f o r m a Medical School, San Francisco Former A s s i s t a n t Secretary for Health, DHEW
Wednesday, May 13 8:30-10:00 A M
Contributed Paper Session IV (tour s i m u l t a n e o u s s e s s i o n s ) Session IVA: Allocation and Randomization
8:30 A M
T r e a t m e n t Allocation by M i n i m u m L , k e h h o o d M A l c k m , D e p a r t m e n t of M a t h e m a t i c s , Arizona State U n i v e r s i t y ¢621
8:50 A M
O p t i m a l Allocation for the C o m p a r i s o n of P r o p o r t i o n s JJ S c h l e s s e l m a n , E B n t t a m , Blometry Branch, National Institute of Child Health a n d H u m a n D e v e l o p m e n t ¢03J
9:10 A M
Evaluation of A d a p t i v e R a n d o m i z a t i o n for a Small Scale Clinical Trial DM Black, AM B a g m e w s k a , SB Hulley, K M o M g , BW Brown, Jt , Systolic I t y p e r t e n s i o n in the Elderly Program, San Francisco, California ~64)
9:30 A M
Data D e p e n d e n t T r e a t m e n t Allocation in Clinical Trials U s i n g a Sequential Version ot t h e l.ogrank Test MI. Lesser. Memorial S l o a n - K e t t e r m g Cancer Center, New York 165)
Session IVB: "Framing and Certaficat~on 8:30 AM
D e s i g n of a National C o u n s e l i n g Skills P r o g r a m tor Clinical Trial Staff J D u n b a r , F Peterson, H Schrott, B Schucker, T S m i t h , M Russell, E Wade, R Wetzel, Stantord U m v e r s t t v School ot M e d i c i n e ¢66)
8:50 A M
A d h e r e n c e Specialist Cernficatlon B Schucker. J D u n b a r , F Peterson, M Russell, H Schrott, T Smith. E Wade, R Wetzel, Lipid Research Clinics Program, National t teart, L u n g , a n d Blood Institute (b7~
9:10 A M
T r a i n i n g a n d Certlhcatlon ot Visual Function T e c h n , c l a n s in the Early T r e a t m e n t Diabetic R e m o p a t h y S t u d v A Kassott, G Bresmck. I C a v e n d e l , J Buehler, R t l a r n s o n , A Reggtardo. A l b a n y Medical College If, d~
9:30 A M
T r a i n i n g a n d Certltlcation ot Blood P r e s s u r e O b s e r v e r s in a Clinical "Frtal JD C u r b , D l.abarthe, G Cutter, S Polzner, CM t l a w k m s , U n i v e r s i t y ot Texas School ot P u b h c Health a n d Baylor College ot M e d i c i n e , i l o u s t o n , Texas f69;
Session IVC: Coordinating Centers 8:30 AM
Mayo Cancer C e n t e r Q u a l i t y A s s u r a n c e S y s t e m Personnel O r g a n i z a t i o n a n d S t u d v D e s i g n Aspects JR O'Fallon, DI. A h m a n n , J Bill, HJ Golenzer, TC Hu, CG Moertel, JR Offord, WF Taylor, Mayo C h m c , Rochester, M i n n e s o t a (701
8:50 A M
C o m p u t e r - A i d e d Data M a n a g e m e n t a n d Data Q u a h t y Control in Multicenter Clinical C a n c e r Trials M Van Glabbeke, M Buyse, J Renard, M D e P a u w , EORTC Data Center, Instltut Bordet, Brussels, Belgium tTD
9:10 A M
M a n a g e m e n t ot a C o o r d i n a t i n g Center for Multlcenter Clinical Tnals Y C h a n , D Collins, West ~taven VA Cooperatp.'e S t u d i e s l ' r o g r a m C o o r d i n a t i n g ( ' e n t e r r721
Prehmmary Program
9:30 AM
65
Statistical Center Data Management m Multlcenter Clinical Trials EL Orlow, E McFadden, Sidney Farber Cancer Institute, Boston, Massachusetts (73)
Session IVD: Selected Statistical Topics 8:30 AM
Use ot Jackknife Techmques in Determ,nmg a "Best" Subset of Covarlates for the Cox Proport,onal-Hazards Modcl R Fagerstrom, tt Smith, H Sacks, B Cohen, Mount Smal School of Medicine, New York (74;
8:50 AM
Cumulative Sum Statistics Apphcat,ons in Chmcal Trials DL Hawkins, JD Knoke, Umverslty of North Carohna (75~
9:10 AM
Development and Vahdatlon of a VA Risk Function to Pred,ct Mortality P Peduzzl, KM Detre, Y Chan, A Oberman, G Cutter, West Haven VA Cooperative Studies Program Coordinating Center and Umverslty of Alabama (76:
9:30 AM
Analysis of Cancer Patient Survival with the Welbull Model SB Green, DP Byar, National Cancer Institute (77)
10:00-10:30 AM
Break
10:30-12:00 PM
Plenary Paper Session 111 To Count or Not to Count Are Exclusions Post-Randomlzatton Permissible, and Can the Degree of Bias Be Measured ~ Chmrperson Christian R Khmt, Maryland Medical Research Institute Speakers --Robert Elashoff, University of Cahtorma --Paul Canner, Umverslty of Maryland - - D a w d DeMets, National Heart, Lung, and Blood Institute --Michael Gent, McMaster Umverslty Dzscussants --Gennell Knatterud, Unwers~ty of Maryland --Byron W Brown, Jr , Stanford Medxcal Center
12:00 PM
Adjournment