Objectives and Endpoints
Objective of the Alzheimer’s prevention trial was to determine if hormone replacement therapy delays Alzheimer's disease or memory loss. Achieving objective should be independent of observing a particular outcome of the trial.
The outcomes of the study that can be measured objectively for determining if the intervention being studied is beneficial, are also known as endpoints. They are the quantitative measurements that are required by the objectives and are determined for each individual participant taking part in the study. Clinical trials have primary objective or endpoint. Any additional objective or endpoint is considered to be secondary. Primary endpoint helps in calculating the sample size.
Primary Endpoint: …show more content…
If one single therapy has similar effects on various different endpoints with creation of a composite can be led to achievement of adequate powerful trial with less number of patients. In addition to this there may be situations where a therapy might have decreased outcome by deaths of patients before they reach the expected outcome. In this situation a composite may act as the way of evaluating safety.
Composites can lead into trouble when considered for combined events of very different importance to patients.
Surrogate Endpoint: It is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. Surrogate endpoint is biology related or clinically meaningful endpoint which usually tracks the progress or extent of the disease. It is also known as surrogate marker and are used when primary endpoint is not desired one or when number of events is small, due to which conduction of clinical trial for gathering statistically significant number of endpoints is not practical. Choice of surrogate endpoint is taken into account when investigators are unable to access the definitive endpoint due to cost, time or difficulty …show more content…
It is also hypothesized that women randomized to oral estrogen would perform better on memory tasks over the period of time than women on placebo. The specific aims of this study were to: 1. Differentiate between five year cumulative incidence rate of clinically or placebo; 2.Compare the rate of memory change in five successive years among the women randomized to either estrogens or placebo. 3. Compare five year cumulative incidence rates of adverse effects and mortality rate from all causes among the women randomized to either estrogens or placebo while examining
Objective of the Alzheimer’s prevention trial was to determine if hormone replacement therapy delays Alzheimer's disease or memory loss. Achieving objective should be independent of observing a particular outcome of the trial.
The outcomes of the study that can be measured objectively for determining if the intervention being studied is beneficial, are also known as endpoints. They are the quantitative measurements that are required by the objectives and are determined for each individual participant taking part in the study. Clinical trials have primary objective or endpoint. Any additional objective or endpoint is considered to be secondary. Primary endpoint helps in calculating the sample size.
Primary Endpoint: …show more content…
If one single therapy has similar effects on various different endpoints with creation of a composite can be led to achievement of adequate powerful trial with less number of patients. In addition to this there may be situations where a therapy might have decreased outcome by deaths of patients before they reach the expected outcome. In this situation a composite may act as the way of evaluating safety.
Composites can lead into trouble when considered for combined events of very different importance to patients.
Surrogate Endpoint: It is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship. Surrogate endpoint is biology related or clinically meaningful endpoint which usually tracks the progress or extent of the disease. It is also known as surrogate marker and are used when primary endpoint is not desired one or when number of events is small, due to which conduction of clinical trial for gathering statistically significant number of endpoints is not practical. Choice of surrogate endpoint is taken into account when investigators are unable to access the definitive endpoint due to cost, time or difficulty …show more content…
It is also hypothesized that women randomized to oral estrogen would perform better on memory tasks over the period of time than women on placebo. The specific aims of this study were to: 1. Differentiate between five year cumulative incidence rate of clinically or placebo; 2.Compare the rate of memory change in five successive years among the women randomized to either estrogens or placebo. 3. Compare five year cumulative incidence rates of adverse effects and mortality rate from all causes among the women randomized to either estrogens or placebo while examining