The Conduct of a Cooperative Clinical Trial

The purpose of this monograph is to address the basic mecha nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi institutional cooperative trials. Multi-institutional cooperative studies require greater atten tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.

Klappentext

The purpose of this monograph is to address the basic mecha­ nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi­ institutional cooperative trials. Multi-institutional cooperative studies require greater atten­ tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi­ cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre­ sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.

Inhalt
1 General Organization.- 1.1 Introduction and Objectives.- 1.2 General Organization.- 1.3 The Coordinating Center.- 1.4 The Statistical Center.- 2 Overview of Group Activities.- 2.1 Introduction.- 2.2 Protocol Generation.- 2.3 Forms Generation.- 2.4 Patient Entry.- 2.5 Data Flow.- 2.6 Form Submission.- 2.7 Completed Forms Review.- 2.8 Computerized Requests and Status Lists.- 2.9 Records Review.- 2.10 Biostatistical Reports.- 3 Institution Specific Activities.- 3.1 Institutional Data Management.- 3.2 Patient Entry.- 3.3 Forms Submission.- 3.4 Clarification Requests.- 3.5 Computerized Requests and Status Lists.- 4 Coordinating Center Specific Activities.- 4.1 The Administrative Office.- 4.2 Patient Entry.- 4.3 Blank Forms Distribution.- 4.4 Patient Files.- 4.5 Reception and Distribution of Forms.- 4.6 Mail Procedure to the Statistical Center.- 4.7 Clarification Requests.- 4.8 Computerized Requests and Study Status Lists.- 4.9 Records Review.- 4.10 Biostatistical Reports.- 4.11 Annual Meetings.- 5 Statistical Center Specific Activities.- 5.1 Mail Logging and Filing.- 5.2 General Forms Review.- 5.3 Coding Conventions.- 5.4 Review of Specific Forms.- 5.5 File Organization.- 5.6 File Maintenance.- 5.6.3 Update Program.- 5.7 Data Retrieval.- 5.8 Computer Listings.- 5.9 Manuals.- 5.10 Workshops.- Appendix 1. Protocol.- Appendix 2. Forms.- Appendix 3. Example of Data Request.- Appendix 4. Example of Patient Listing.- Appendix 5. Participant Forms Submission Log.- Appendix 6. Operations Office Patient Log.- Appendix 7. Sample Page of Randomization List.- Appendix 8. Sample Data File.- Appendix 9. Statistical Center Forms Log.- Appendix 10. Example of an Interim Statistical Analysis.- Appendix 11. Terminology.