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Distributed randomization in multicenter clinical trials using microcomputer control
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Abstracts The advanced tocnologics, as information and telematic, are essential to solve the problems of physical separation of personnel in a multicenter trial aiming to resolve differences in treatment and data collection philosophics and to share experience. This structure provides an essential framework for discussion and decision making and for ensuring adherence to established procedures in the trials. Also the clinicians in each institution have the possibility to evaluate closely the data they collect and enabling them to consider all the factors relevant to the patients. The system is now operating successfully and provides the clinicians with a valid aid to research management.
The Optimal Use of a Microcomputer System for D i s t r i b u t e d D a t a Entry Pamela Hartigan, D o r o t h e a Collins, Victor Latvis, Joan Derrico, K a t h y N e w v i n e , Sally Bottino VA Cooperative Studies Program Coordinating Center, West Haven, Connecticut (P-14) The VA Study of Angioplasty Compared to Medical Therapy (ACME) is experimenting with distributed data entry (DDE) in parallel with entry onto paper forms at three of the eight participating centers. The study has a low volume of data (7500 records out of 25,000 projected) and the data base is managed entirely on microcomputers. The data forms for the study were not designed with DDE in mind. The study requires considerable baseline data and minimum repeated measures over time. In spite of successful screening and randomization, study personnel have not had the opportunity for frequent utilization of the system and error rates have remained high. We conclude that the optimal use of microcomputers for data entry is in a large study with less complex data forms that allows for continuous repetitive use. In general, the incorporation of DDE into a trial requires a focused effort to integrate the data entry with all other aspects of the study. Additional lead time should be allowed for thorough training and testing. We also suggest double-entry verification to ensure the quality of the data base. Although DDE requires more planning and resources, the benefits outweigh the disadvantages involved in the extra effort.
Distributed Randomization in Multicenter Clinical Trials Using Microcomputer Control M a r s t o n E. Y o u n g b l o o d , James D. H o s k i n g for the S O L V D Investigators University of North Carolina, Chapel Hill, North Carolina (P-15) One of the most critical procedures in design and conduct of a clinical trial is randomization of participants to treatment assignments. In multicenter studies with dispersed research sites, it is difficult to implement a procedure which is carefully controlled and also convenient for both the clinical centers and coordinating center. This paper describes our 31 months of experience using microcomputer randomization procedures in Studies of Left Ventricular Dysfunction (SOLVD). Software operating on a PC in each of 23 SOLVD clinical centers combines convenience with control. To date, the system has randomized over 5,000 participants in two clinical trials conducted from centers in Brussels, Canada, and U.S. The PC system performed 99% of the randomization for the SOLVE) trials. A backup telephone procedure was used for 72 assignments. Hardware and/or software failure, or electrical power interruption led to 50% of the manual randomizations. User error comprised another 28% of the cases, while 13% of the backup procedures were done for user convenience.
Distributed Data Entry in the AIDS Clinical Trials Group Charles v a n d e r Horst, R. P a d d o c k , L. Myers, J. S i m p s o n , S. Schaeffer, V. P a t h a n a s e t h p o n g Research Triangle Institute, Research Triangle Park, North Carolina (P-16) Since December 1986, 5359 patients have been enrolled in drug studies of the NIH sponsored AIDS Clinical Trials Group. As the Coordinating Center we implemented a distributed data entry system in two months at the 34 group members and satellite clinic networks at four of the members in 16 states in the U.S. Patient data is entered into case report forms which are keyed on site onto IBM ATs. Our VAX computer using error correcting BLAST communications software and Multitech modems polls each site five times per week at night. Over 250,000 bytes of data
Abstracts The advanced tocnologics, as information and telematic, are essential to solve the problems of physical separation of personnel in a multicenter trial aiming to resolve differences in treatment and data collection philosophics and to share experience. This structure provides an essential framework for discussion and decision making and for ensuring adherence to established procedures in the trials. Also the clinicians in each institution have the possibility to evaluate closely the data they collect and enabling them to consider all the factors relevant to the patients. The system is now operating successfully and provides the clinicians with a valid aid to research management.
The Optimal Use of a Microcomputer System for D i s t r i b u t e d D a t a Entry Pamela Hartigan, D o r o t h e a Collins, Victor Latvis, Joan Derrico, K a t h y N e w v i n e , Sally Bottino VA Cooperative Studies Program Coordinating Center, West Haven, Connecticut (P-14) The VA Study of Angioplasty Compared to Medical Therapy (ACME) is experimenting with distributed data entry (DDE) in parallel with entry onto paper forms at three of the eight participating centers. The study has a low volume of data (7500 records out of 25,000 projected) and the data base is managed entirely on microcomputers. The data forms for the study were not designed with DDE in mind. The study requires considerable baseline data and minimum repeated measures over time. In spite of successful screening and randomization, study personnel have not had the opportunity for frequent utilization of the system and error rates have remained high. We conclude that the optimal use of microcomputers for data entry is in a large study with less complex data forms that allows for continuous repetitive use. In general, the incorporation of DDE into a trial requires a focused effort to integrate the data entry with all other aspects of the study. Additional lead time should be allowed for thorough training and testing. We also suggest double-entry verification to ensure the quality of the data base. Although DDE requires more planning and resources, the benefits outweigh the disadvantages involved in the extra effort.
Distributed Randomization in Multicenter Clinical Trials Using Microcomputer Control M a r s t o n E. Y o u n g b l o o d , James D. H o s k i n g for the S O L V D Investigators University of North Carolina, Chapel Hill, North Carolina (P-15) One of the most critical procedures in design and conduct of a clinical trial is randomization of participants to treatment assignments. In multicenter studies with dispersed research sites, it is difficult to implement a procedure which is carefully controlled and also convenient for both the clinical centers and coordinating center. This paper describes our 31 months of experience using microcomputer randomization procedures in Studies of Left Ventricular Dysfunction (SOLVD). Software operating on a PC in each of 23 SOLVD clinical centers combines convenience with control. To date, the system has randomized over 5,000 participants in two clinical trials conducted from centers in Brussels, Canada, and U.S. The PC system performed 99% of the randomization for the SOLVE) trials. A backup telephone procedure was used for 72 assignments. Hardware and/or software failure, or electrical power interruption led to 50% of the manual randomizations. User error comprised another 28% of the cases, while 13% of the backup procedures were done for user convenience.
Distributed Data Entry in the AIDS Clinical Trials Group Charles v a n d e r Horst, R. P a d d o c k , L. Myers, J. S i m p s o n , S. Schaeffer, V. P a t h a n a s e t h p o n g Research Triangle Institute, Research Triangle Park, North Carolina (P-16) Since December 1986, 5359 patients have been enrolled in drug studies of the NIH sponsored AIDS Clinical Trials Group. As the Coordinating Center we implemented a distributed data entry system in two months at the 34 group members and satellite clinic networks at four of the members in 16 states in the U.S. Patient data is entered into case report forms which are keyed on site onto IBM ATs. Our VAX computer using error correcting BLAST communications software and Multitech modems polls each site five times per week at night. Over 250,000 bytes of data