Designing dementia treatment studies: Diagnosis, efficacy criteria,and duration
R. Spiegel
Bok Engelsk 1996
| Utgitt | 1996
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| Omfang | Side 149- 154
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| Opplysninger | Development of treatments for dementia is beset by special problemsin defining the diagnosis, establishing efficacy criteria, andspecifying the necessary duration of study. There is need foragreement among clinicians and scientists on diagnostic subgroups ofdementia. Similarly, there is a need for harmonization of theregulatory guidelines in Europe, Japan, and the United Statesregarding the decision set of variables on which to base efficacyclaims. The duration of trials must be based upon the intended claim:transient symptomatic benefit, maintained symptomatic benefit, or atherapeutic effect on disease progression. Claims other thantransient benefit require long-term trials, suggested to be of atleast six months in duration. Problems with long-term studies includeslow patient accrual, high dropout rates, changing milieu, low returnon investment, and lack of unanimity regarding regulatoryrequirements. Regulatory authorities must come to some accord,consonant with current clinical/scientific wisdom and consensus,regarding diagnosis, efficacy criteria, and feasible study duration,in order to attract continued sponsor investment in the developmentof antidementia treatments.
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| Emner |
