carbar
04-18-2006, 08:52 AM
A major NIH meeting led to recommendations for conducting better clinical trials
Barnett S. Kramer*, Joan Wilentz, Duane Alexander, John Burklow, Lawrence M. Friedman, Richard Hodes, Ruth Kirschstein, Amy Patterson, Griffin Rodgers, Stephen E. Straus
FOR FULL REPORT :
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030144
EXTRACT:
NUMBER 8 OF THE 9 RECOMMENDATIONS
Recommendation 8: Establish Two-Way Communications with Communities, Consumers, and Patient Advocacy Groups in Developing, Implementing, and Reporting Clinical Trials
That message is taken very seriously by two other groups of key players in communicating the results of clinical trials: reporters and patient advocacy groups. The best reporters do much more than act as passive conveyors of news releases about scientific findings; they serve as “honest brokers” of the evidence and provide context for new findings.
Patient advocacy groups play a different role from journalists, since they have an interest in promoting research and communicating results. Noteworthy among such groups has been the AIDS activist organization, Act Up. A representative of the group offered a cautionary tale about surrogate end points. To speed up the development of AIDS drugs in the early 1990s, some advocates urged use of an increase in CD4 T cell counts as a surrogate for efficacy in clinical trials—which, in the case of dideoxyinosine, was a mistake. Changes in the CD4 counts did not always accurately predict health outcomes and survival.
Barnett S. Kramer*, Joan Wilentz, Duane Alexander, John Burklow, Lawrence M. Friedman, Richard Hodes, Ruth Kirschstein, Amy Patterson, Griffin Rodgers, Stephen E. Straus
FOR FULL REPORT :
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0030144
EXTRACT:
NUMBER 8 OF THE 9 RECOMMENDATIONS
Recommendation 8: Establish Two-Way Communications with Communities, Consumers, and Patient Advocacy Groups in Developing, Implementing, and Reporting Clinical Trials
That message is taken very seriously by two other groups of key players in communicating the results of clinical trials: reporters and patient advocacy groups. The best reporters do much more than act as passive conveyors of news releases about scientific findings; they serve as “honest brokers” of the evidence and provide context for new findings.
Patient advocacy groups play a different role from journalists, since they have an interest in promoting research and communicating results. Noteworthy among such groups has been the AIDS activist organization, Act Up. A representative of the group offered a cautionary tale about surrogate end points. To speed up the development of AIDS drugs in the early 1990s, some advocates urged use of an increase in CD4 T cell counts as a surrogate for efficacy in clinical trials—which, in the case of dideoxyinosine, was a mistake. Changes in the CD4 counts did not always accurately predict health outcomes and survival.