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Costs and benefits of electronic mail of clinical trial communication
Abstracts
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are 20.6% (observed) and 23.8% (expected u n d e r equal C). There were 187 placebo events (9.8%) and 155 in the T group (8.1%). Equal C yields an expected 145 T group events, an increase of 31% in the observed between group difference. These event rates produce sample size requirements that would be 43% lower if C in the T group were as high as in the placebo. We believe that C differences are common in clinical trials involving treatments with important side effects. We conclude that between-group differences in C can dramatically increase sample size requirements and lead to underestimates of the efficacy of treatments with attributes that reduce C.
Costs and Benefits of Electronic Mail for Clinical Trial Communication Bruce A. B a r t o n
Maryland Medical Research Institute, Baltimore, Maryland (P09) It is clear that timely communication in the management of clinical trials, especially during the planning phase, is important, if not critical, to the success of the study. Frequently, the investigators at the clinical centers are difficult to reach and a n u m b e r of return telephone calls are necessary to establish contact. Electronic mail has been proposed as an answer to this problem. During the planning phase and the feasibility phase of the Dietary Intervention Study in Children (DISC), two different electronic mall systems were utilized to facilitate communication. The first was based on a central mainframe-class computer with the electronic mail system accessed through remote terminals or microcomputers. The second system had a central post office implemented on a microcomputer at the Coordinating Center accessed by microcomputers at each clinical center using the same software as the central post office. A comparison of the features of each system, such as ease of use, speed of transmission, cost of use, and cost of the hardware and software, is presented. In addition, a comparison with normal telephone communication and FAX communication is made. Training costs and startup time are also considered.
The Importance of a Central Institutional Review Board in Multicenter Clinical Trials R i c h a r d D. N e w m a n a n d D a v i d C. G i l s o n G.D. Searle & Co., Skokie, Illinois (P10) A major consideration in the timely management of any clinical trial is the review and approval of the study by an Institutional Review Board (IRB). When managing a multicenter trial, the challenge of obtaining IRB approval is strongly related to the n u m b e r of participating study sites. Many physicians in private practice or associated with small local practices may not even have familiarity with the IRB requirements. In such cases, the use of a central IRB may afford several benefits: (1) safety oversight for all patients and investigators; (2) uniform and carefully reviewed informed consents; (3) timely review of both protocol and study sites; and (4) procedures and structure of the central IRB that conform to FDA requirements. In a phase III multicenter study conducted in 1987, more than 400 study sites needed and received central IRB approval within a 3-month period. Where necessary, as dictated by local practice or hospital policy, a local IRB also reviewed and approved the study. However, during the period of study enrollment only 25% of the sites requiring a local IRB received a timely review and approval.
Expert System for Problem Diagnosis of Distributed Data Processing Systems Ellis C l a r k e
Maryland Medical Research Institute, Baltimore, Maryland ( P l l ) An expert system was developed for use on a microcomputer to diagnose problems arising from data entry, security system conflicts, database integrity, and electronic communications in a distributed data processing system. This expert system interactively diagnoses a problem and either proposes a solution or refers the problem to a programmer at the coordinating center. The rules used by this diagnostic expert system were developed from actual problems arising from a clinical trial using microcomputer-based distributed processing. If the problem set eventually contains many problems that could be resolved at a clinic, the system would be installed at each clinic in the trial to advise on problems without first consulting a programmer at the coordinating center. The diagnostic system's use is expected to reduce the time and the costs necessary for maintenance of the distributed data processing system.
265
are 20.6% (observed) and 23.8% (expected u n d e r equal C). There were 187 placebo events (9.8%) and 155 in the T group (8.1%). Equal C yields an expected 145 T group events, an increase of 31% in the observed between group difference. These event rates produce sample size requirements that would be 43% lower if C in the T group were as high as in the placebo. We believe that C differences are common in clinical trials involving treatments with important side effects. We conclude that between-group differences in C can dramatically increase sample size requirements and lead to underestimates of the efficacy of treatments with attributes that reduce C.
Costs and Benefits of Electronic Mail for Clinical Trial Communication Bruce A. B a r t o n
Maryland Medical Research Institute, Baltimore, Maryland (P09) It is clear that timely communication in the management of clinical trials, especially during the planning phase, is important, if not critical, to the success of the study. Frequently, the investigators at the clinical centers are difficult to reach and a n u m b e r of return telephone calls are necessary to establish contact. Electronic mail has been proposed as an answer to this problem. During the planning phase and the feasibility phase of the Dietary Intervention Study in Children (DISC), two different electronic mall systems were utilized to facilitate communication. The first was based on a central mainframe-class computer with the electronic mail system accessed through remote terminals or microcomputers. The second system had a central post office implemented on a microcomputer at the Coordinating Center accessed by microcomputers at each clinical center using the same software as the central post office. A comparison of the features of each system, such as ease of use, speed of transmission, cost of use, and cost of the hardware and software, is presented. In addition, a comparison with normal telephone communication and FAX communication is made. Training costs and startup time are also considered.
The Importance of a Central Institutional Review Board in Multicenter Clinical Trials R i c h a r d D. N e w m a n a n d D a v i d C. G i l s o n G.D. Searle & Co., Skokie, Illinois (P10) A major consideration in the timely management of any clinical trial is the review and approval of the study by an Institutional Review Board (IRB). When managing a multicenter trial, the challenge of obtaining IRB approval is strongly related to the n u m b e r of participating study sites. Many physicians in private practice or associated with small local practices may not even have familiarity with the IRB requirements. In such cases, the use of a central IRB may afford several benefits: (1) safety oversight for all patients and investigators; (2) uniform and carefully reviewed informed consents; (3) timely review of both protocol and study sites; and (4) procedures and structure of the central IRB that conform to FDA requirements. In a phase III multicenter study conducted in 1987, more than 400 study sites needed and received central IRB approval within a 3-month period. Where necessary, as dictated by local practice or hospital policy, a local IRB also reviewed and approved the study. However, during the period of study enrollment only 25% of the sites requiring a local IRB received a timely review and approval.
Expert System for Problem Diagnosis of Distributed Data Processing Systems Ellis C l a r k e
Maryland Medical Research Institute, Baltimore, Maryland ( P l l ) An expert system was developed for use on a microcomputer to diagnose problems arising from data entry, security system conflicts, database integrity, and electronic communications in a distributed data processing system. This expert system interactively diagnoses a problem and either proposes a solution or refers the problem to a programmer at the coordinating center. The rules used by this diagnostic expert system were developed from actual problems arising from a clinical trial using microcomputer-based distributed processing. If the problem set eventually contains many problems that could be resolved at a clinic, the system would be installed at each clinic in the trial to advise on problems without first consulting a programmer at the coordinating center. The diagnostic system's use is expected to reduce the time and the costs necessary for maintenance of the distributed data processing system.