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Early patient accrual for a multicenter clinical trial
Abstracts
717
Angioplasty (PTCA) Registry. To formalize the data management structure and to focus a working group on data management issues, the Data Management Task Group (DMTG) of over 20 data managers was formed in October 1989. The DMTG structures and defines the concept of data management and the crucial role data management plays in successful research. The DMTG meets regularly to bring together the collective experience of data managers to benefit the whole. Meetings include seminars, hands-on workshops, and problem-solving. A training protocol was developed that consists of an orientation package and training program. A Data Management Concepts manual contains information on data management objectives, form design, data flow, report writing, editing and other pertinent topics. The training program consists of assigning mentors, distributing project and software documentation, and orienting and training new personnel. Mentors were identified as a key element of a strong training program. Future goals of the DMTG include standardization of data collection methods and documentation of procedures as we continue to define this dynamic process. P 128 EARLY PATIENT ACCRUAL FOR A MULTICENTER CLINICAL TRIAL Karen Cauch
The Toronto Hospital Toronto, Ontario, Canada Patient recruitment for the 11-center Primary Biliary Cirrhosis (PBC) Ursodeoxycholic Acid (UDCA) Trial was accomplished 10 months earlier than anticipated. Of the 284 eligible patients identified, 79% were successfully enrolled. A number of factors facilitated early recruitment. Prior to each center set-up, contacts were made to identify all possible eligible patients in the geographical catchment area. Center physicians were encouraged to utilize their collegial network for patient referrals, and the research nurses and coordinator worked together to follow-up all patients. An intensive set-up site visit was made to each center by the research coordinator and meetings were held with key personnel to review the protocol, inclusion cdteria and clinic procedures. An early rapport was established between the research coordinator and research nurses. Frequent telephone contact reinforced this team effort and made further site visits, with their associated costs, unnecessary. Each nurse was encouraged to pursue new patients and discuss their eligibility on a weekly basis with the research coordinator. Updates on individual recruiting and the progress of the overall trial were sent out regularly to all participating centers. Early recruitment for this trial was accomplished through successful networking, a sense of competition, and the close contact of individual clinical centers with the coordinating center. P 129 A COMPUTER GENERATED PATIENT TRACKING AND ACCRUAL MECHANISM FOR CLINICAL TRIALS
Ryan M. Stark, David Moher, and lan G. Stlell
Ottawa Civic Hospital Ottawa, Ontario, Canada Clinical trials of any magnitude require accurate patient tracking and accrual records for data integrity and ensured success. The purpose of this project was to develop a standardized, computer generated recording mechanism for use in all single-center and multicenter clinical trials coordinated through the hospital. Research coordinators and research assistants were surveyed as to their desired mechanism format and content variables. A Statistical Analysis System (SAS) macro code was written using the datetime function and embedded Generalized Markup Language (GML) code. This allowed the mechanism to be produced for any given time duration associated with a given trial or specific arms within larger trials. A day planner was also included in the duplex design of the recording mechanism so as to better serve the user in priodtizing his/ her daily activities. To date the mechanism or Standardized Management and Research Tool (SMART) has proven to be both effective and efficacious: (1) patient tracking and accrual records are more easily updated, (2) lost patient records have been minimized or eliminated, (3) SMART has also served to reduce training and education time for research assistants in that it is identical for all trials except for duration, (4) SMART has facilitated data collection in ongoing trials and will continue to be used in future trials. In conclusion, SMART is a useful logistical consideration for clinical tdal management.
717
Angioplasty (PTCA) Registry. To formalize the data management structure and to focus a working group on data management issues, the Data Management Task Group (DMTG) of over 20 data managers was formed in October 1989. The DMTG structures and defines the concept of data management and the crucial role data management plays in successful research. The DMTG meets regularly to bring together the collective experience of data managers to benefit the whole. Meetings include seminars, hands-on workshops, and problem-solving. A training protocol was developed that consists of an orientation package and training program. A Data Management Concepts manual contains information on data management objectives, form design, data flow, report writing, editing and other pertinent topics. The training program consists of assigning mentors, distributing project and software documentation, and orienting and training new personnel. Mentors were identified as a key element of a strong training program. Future goals of the DMTG include standardization of data collection methods and documentation of procedures as we continue to define this dynamic process. P 128 EARLY PATIENT ACCRUAL FOR A MULTICENTER CLINICAL TRIAL Karen Cauch
The Toronto Hospital Toronto, Ontario, Canada Patient recruitment for the 11-center Primary Biliary Cirrhosis (PBC) Ursodeoxycholic Acid (UDCA) Trial was accomplished 10 months earlier than anticipated. Of the 284 eligible patients identified, 79% were successfully enrolled. A number of factors facilitated early recruitment. Prior to each center set-up, contacts were made to identify all possible eligible patients in the geographical catchment area. Center physicians were encouraged to utilize their collegial network for patient referrals, and the research nurses and coordinator worked together to follow-up all patients. An intensive set-up site visit was made to each center by the research coordinator and meetings were held with key personnel to review the protocol, inclusion cdteria and clinic procedures. An early rapport was established between the research coordinator and research nurses. Frequent telephone contact reinforced this team effort and made further site visits, with their associated costs, unnecessary. Each nurse was encouraged to pursue new patients and discuss their eligibility on a weekly basis with the research coordinator. Updates on individual recruiting and the progress of the overall trial were sent out regularly to all participating centers. Early recruitment for this trial was accomplished through successful networking, a sense of competition, and the close contact of individual clinical centers with the coordinating center. P 129 A COMPUTER GENERATED PATIENT TRACKING AND ACCRUAL MECHANISM FOR CLINICAL TRIALS
Ryan M. Stark, David Moher, and lan G. Stlell
Ottawa Civic Hospital Ottawa, Ontario, Canada Clinical trials of any magnitude require accurate patient tracking and accrual records for data integrity and ensured success. The purpose of this project was to develop a standardized, computer generated recording mechanism for use in all single-center and multicenter clinical trials coordinated through the hospital. Research coordinators and research assistants were surveyed as to their desired mechanism format and content variables. A Statistical Analysis System (SAS) macro code was written using the datetime function and embedded Generalized Markup Language (GML) code. This allowed the mechanism to be produced for any given time duration associated with a given trial or specific arms within larger trials. A day planner was also included in the duplex design of the recording mechanism so as to better serve the user in priodtizing his/ her daily activities. To date the mechanism or Standardized Management and Research Tool (SMART) has proven to be both effective and efficacious: (1) patient tracking and accrual records are more easily updated, (2) lost patient records have been minimized or eliminated, (3) SMART has also served to reduce training and education time for research assistants in that it is identical for all trials except for duration, (4) SMART has facilitated data collection in ongoing trials and will continue to be used in future trials. In conclusion, SMART is a useful logistical consideration for clinical tdal management.