FDA seeks to ease burden on trial review boards
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《英国医生杂志》
The growth in the number and complexity of clinical trials has put great strain on institutional review boards in the United States, say experts in evidence submitted to the US Food and Drug Administration.
The boards were set up to approve and review biomedical research using humans. But the pressures on them, due in part to the large number of sites in trials, are growing to such an extent that a new approach is needed, in particular to recording adverse events, the FDA was told at a public hearing at its headquarters on 21 March.
The meeting was held to find out how the process might be improved to best meet the primary purpose of the review boards: to protect the rights and welfare of participants in clinical trials.
Greg Koski, a doctor affiliated with Massachusetts General Hospital and a former director of the US Office of Human Research Protections, presented the most detailed and far reaching proposal, in testifying on behalf of the Association of Clinical Research Professionals.
"What we need to do now goes beyond tweaking the existing system," he said. "There is an urgent need and a compelling justification to create and implement a comprehensive national adverse event reporting system that takes advantage of currently available information technologies.
"The best outcome will come from mining a comprehensive database of timely, reliable information. It can and must serve many goals and masters, recognising that not all parties need the same things."
Dr Koski said it was important to keep the collection of data simple, to ensure that the data were collated in the same way and that they were made available immediately. The system should be based on the internet and be capable of interacting with all types of data processing technologies, he added.
He said the system also should embrace the FDA's Med-Watch programme of recording adverse events associated with drugs once they go on the market. Patients and their families and carers should be encouraged to add entries, he said: "Sometimes the most sensitive observers are the ones who are taking care of mom."
Acknowledging the costs of creating and operating such a system, Dr Koski proposed "a user based national trust fund model analogous to that which supports the national air traffic safety system."
Owen Reese, executive director of the independent Western Institutional Review Board, told the hearing: "The process is plagued with inefficiency and duplication."
The sentiment was shared by all the 19 people who testified at the meeting. Although most boards were willing to shoulder the burden of examining adverse events that occur at their own site, many complained of being inundated with adverse event reports from other sites in the same trial and sometimes from trials that merely use a similar compound. Boards seldom have either the skills or the resources to evaluate data from external sites.
"Data should not be confused with information. Information is data bestowed with meaning and utility," said Sandra Alfano, vice chairwoman of the independent review board at the Yale University School of Medicine. A strong consensus existed for creating independent data safety monitoring boards for all multicentre trials and for those structures to forward relevant reports in a meaningful context to the relevant independent review boards.
Meanwhile Howard Dickler, speaking for the Association of American Medical Colleges, recommended that the sponsor of the drug or device be made responsible for the preparation of the summary adverse event report.(Bob Roehr)
The boards were set up to approve and review biomedical research using humans. But the pressures on them, due in part to the large number of sites in trials, are growing to such an extent that a new approach is needed, in particular to recording adverse events, the FDA was told at a public hearing at its headquarters on 21 March.
The meeting was held to find out how the process might be improved to best meet the primary purpose of the review boards: to protect the rights and welfare of participants in clinical trials.
Greg Koski, a doctor affiliated with Massachusetts General Hospital and a former director of the US Office of Human Research Protections, presented the most detailed and far reaching proposal, in testifying on behalf of the Association of Clinical Research Professionals.
"What we need to do now goes beyond tweaking the existing system," he said. "There is an urgent need and a compelling justification to create and implement a comprehensive national adverse event reporting system that takes advantage of currently available information technologies.
"The best outcome will come from mining a comprehensive database of timely, reliable information. It can and must serve many goals and masters, recognising that not all parties need the same things."
Dr Koski said it was important to keep the collection of data simple, to ensure that the data were collated in the same way and that they were made available immediately. The system should be based on the internet and be capable of interacting with all types of data processing technologies, he added.
He said the system also should embrace the FDA's Med-Watch programme of recording adverse events associated with drugs once they go on the market. Patients and their families and carers should be encouraged to add entries, he said: "Sometimes the most sensitive observers are the ones who are taking care of mom."
Acknowledging the costs of creating and operating such a system, Dr Koski proposed "a user based national trust fund model analogous to that which supports the national air traffic safety system."
Owen Reese, executive director of the independent Western Institutional Review Board, told the hearing: "The process is plagued with inefficiency and duplication."
The sentiment was shared by all the 19 people who testified at the meeting. Although most boards were willing to shoulder the burden of examining adverse events that occur at their own site, many complained of being inundated with adverse event reports from other sites in the same trial and sometimes from trials that merely use a similar compound. Boards seldom have either the skills or the resources to evaluate data from external sites.
"Data should not be confused with information. Information is data bestowed with meaning and utility," said Sandra Alfano, vice chairwoman of the independent review board at the Yale University School of Medicine. A strong consensus existed for creating independent data safety monitoring boards for all multicentre trials and for those structures to forward relevant reports in a meaningful context to the relevant independent review boards.
Meanwhile Howard Dickler, speaking for the Association of American Medical Colleges, recommended that the sponsor of the drug or device be made responsible for the preparation of the summary adverse event report.(Bob Roehr)