Enrolling Adolescents in Disease/Target-Appropriate Adult Oncology Clinical Trials of Investigational Agents.

The enrollment of adolescents with cancer in clinical trials is much lower than that of younger pediatric patients. For adolescents with "adult-type" cancers, lack of access to relevant trials is cited as one of the reasons for this discrepancy. Adolescents are generally not eligible for enrollment in adult oncology trials, and initial pediatric trials for many drugs are conducted years later, often after the drug is approved.

Ethical Considerations in Conducting Pediatric and Neonatal Research in Clinical Pharmacology.

The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children. We review a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics.

Parental permission and child assent in research on children.

Grounded on the ethical principle of respect for persons, parental permission and child assent function together to protect the child and to foster the development of the child's self-determination. Although both parental permission and child assent involve the same components of information sharing, comprehension, and voluntariness, how these three components are understood and operationalized should differ depending on the developmental level of the child. For example, the amount of information that a child must comprehend to provide meaningful and developmentally appropriate child assent (or dissent) should be allowed to vary with the age and maturity of the child.

Ethical considerations in conducting pediatric research.

The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children in clinical research. We propose a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics.

Predictive value of myocardial perfusion single-photon emission computed tomography and the impact of renal function on cardiac death.

Background: Patients with chronic kidney disease (CKD) have worse cardiovascular outcomes than those without CKD. The prognostic utility of myocardial perfusion single-photon emission CT (MPS) in patients with varying degrees of renal dysfunction and the impact of CKD on cardiac death prediction in patients undergoing MPS have not been investigated.

Methods And Results: We followed up 1652 consecutive patients who underwent stress MPS (32% exercise, 95% gated) for cardiac death for a mean of 2.

Rare atypical squamous cells of undetermined significance (ASCUS): a clinically significant diagnosis?

To determine the clinical significance of rare atypical squamous cells of undetermined significance (ASCUS) in cervical screening, we studied 748 ASCUS cases prospectively noted to have rare abnormal cells. Comparing the rare ASCUS (RASC) group (defined as five or fewer abnormal cells) statistically to cases diagnosed as within normal limits (WNL), ASCUS unqualified as to number of cells low-grade squamous intraepithelial lesion (LGSIL), and high-grade SIL (HGSIL), we found that the probability of the RASC patients having an abnormal cytology (ASCUS/SIL) or biopsy (dysplasia) result within 1 yr was greater than that of the WNL group, but less than that for ASCUS unqualified, LGSIL, or HGSIL. When only ThinPrep specimens or cases with subsequent definitive SIL/dysplasia were considered, the RASC group was not significantly different from the WNL group.