Frequency, type, and monetary value of financial conflicts of interest in cancer clinical research.

Purpose: Using data from American Society of Clinical Oncology (ASCO) Annual Meetings, we determined the frequency, type, and monetary value of researchers' financial interests.

Methods: Financial disclosures for the 2004 (3,529 abstracts and 25,416 authors) and 2005 (3,556 abstracts and 26,181 authors) ASCO Annual Meetings were categorized into four groups: no author with a financial interest, research funding only, employment and leadership positions only, or at least one author with a personal financial interest. Interests were stratified by monetary value and other factors.

Endovascular stent grafting versus open surgical repair of descending thoracic aortic aneurysms in low-risk patients: a multicenter comparative trial.

Objective: Results are presented from the first completed multicenter trial directed at gaining approval from the US Food and Drug Administration of endovascular versus open surgical repair of descending thoracic aortic aneurysms.

Methods: Between September 1999 and May 2001, 140 patients with descending thoracic aneurysms were enrolled at 17 sites and evaluated for a Gore TAG Thoracic Endograft. An open surgical control cohort of 94 patients was identified by enrolling historical and concurrent subjects.

Patients' views on financial conflicts of interest in cancer research trials.

Background: Financial ties between researchers or medical centers and companies whose drugs are being tested have come under increasing scrutiny.

Methods: We conducted in-person interviews with 253 patients in cancer-research trials (a 93% response rate) at five U.S.

Acute neonatal effects of cocaine exposure during pregnancy.

Objective: To identify associations between cocaine exposure during pregnancy and medical conditions in newborn infants from birth through hospital discharge.

Design: Multisite, prospective, randomized study.

Setting: Brown University, University of Miami, University of Tennessee (Memphis), and Wayne State University.

Women's angiographic vitamin and estrogen trial: design and methods.

The Women's Angiographic Vitamin and Estrogen trial was a randomized, double-blind, placebo-controlled study designed to test the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease. Postmenopausal women with one or more angiographically documented coronary stenoses of 15-75% at baseline were assigned in a 2 x 2 factorial randomization to active hormone replacement therapy (conjugated estrogens for women who had had a hysterectomy or conjugated estrogens with medroxyprogesterone for women with intact uteri) or placebo and to active vitamins E and C or their placebos. Seven clinical centers, five in the United States and two in Canada, randomized 423 women between July 1997 and July 1999.

Effects of hormone replacement therapy and antioxidant vitamin supplements on coronary atherosclerosis in postmenopausal women: a randomized controlled trial.

Context: Hormone replacement therapy (HRT) and antioxidant vitamins are widely used for secondary prevention in postmenopausal women with coronary disease, but no clinical trials have demonstrated benefit to support their use.

Objective: To determine whether HRT or antioxidant vitamin supplements, alone or in combination, influence the progression of coronary artery disease in postmenopausal women, as measured by serial quantitative coronary angiography.

Design, Setting, And Patients: The Women's Angiographic Vitamin and Estrogen (WAVE) Trial, a randomized, double-blind trial of 423 postmenopausal women with at least one 15% to 75% coronary stenosis at baseline coronary angiography.

Gestational cocaine exposure and intrauterine growth: maternal lifestyle study.

Objective: To estimate the effects of cocaine exposure on intrauterine growth and to investigate at what point in gestation growth deviation would be manifested.

Methods: This is a secondary analysis of data from a multicenter project, the Maternal Lifestyle Study, designed to determine infant outcomes of in utero cocaine or opiates exposure. Four centers of the National Institute of Child Health and Human Development Neonatal Research Network enrolled 11,811 maternal-infant dyads.

Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure.

Objective: We previously demonstrated that antenatal phenobarbital does not decrease the risk of intracranial hemorrhage or early death in premature infants. The objective of the present study was to evaluate the impact of antenatal phenobarbital exposure on the neurodevelopmental outcome of premature infants born to women who were participating in the randomized clinical trial of antenatal phenobarbital exposure.

Study Design: Infants were evaluated at 18 to 22 months corrected age with a standard neurologic examination and the Bayley scales of infant development measuring the mental developmental index and the psychomotor developmental index.

The Maternal Lifestyle Study: drug exposure during pregnancy and short-term maternal outcomes.

Objective: Reports of maternal effects resulting from drug exposure during pregnancy are inconsistent. The Maternal Lifestyle Study (MLS) is a multicenter, prospective, observational study that was initiated to better define the effects of exposure to illicit drugs during pregnancy on the mother, fetus, and infant.

Methods: Between May 1993 and May 1995, of 19,079 mother-infant dyads that were screened after delivery for cocaine and opiate exposure at four clinical centers (Brown University, University of Miami, University of Tennessee, Memphis, and Wayne State University), 16,988 (89%) met eligibility criteria and 11,811 (70%) of those eligible agreed to participate in the study.