Symptom trajectories in discontinuation trials

Discontinuation of pediatric trials.

It is said that a research study is completed when its results are submitted for consideration to the scientific community, which will ultimately assess, accept, and eventually adopt those results. In order for our peers to determine the validity of a scientific study, they need to get all the information about the study to adequately review its methodological rigor and the significance of its ...

Symptom trajectories in posttreatment cancer survivors.

BACKGROUND Cancer survivorship following cancer treatment is uncertain as physical and psychological sequelae related to the disease or its treatment may persist. However, little is known about the experience of symptoms after treatment. OBJECTIVES The purposes of this study were to (1) examine postchemotherapy (post-CTX) symptom trajectories in cancer survivors and (2) determine whether demo...

Bayesian enrichment strategies for randomized discontinuation trials.

We propose optimal choice of the design parameters for random discontinuation designs (RDD) using a Bayesian decision-theoretic approach. We consider applications of RDDs to oncology phase II studies evaluating activity of cytostatic agents. The design consists of two stages. The preliminary open-label stage treats all patients with the new agent and identifies a possibly sensitive subpopulatio...

Core symptom measures in cancer clinical trials.

Group-based Symptom Trajectories in Indicated Prevention of Adolescent Depression.

BACKGROUND Adolescent depression prevention research has focused on mean intervention outcomes, but has not considered heterogeneity in symptom course. Here, we empirically identify subgroups with distinct trajectories of depressive symptom change among adolescents enrolled in two indicated depression prevention trials and examine how cognitive-behavioral (CB) interventions and baseline predict...