Clinical Trials, Phase I as Topic

Publication Title: 
Public Health Genomics

Due to the lack of other treatment options, patient candidates for participation in phase I clinical trials are considered the most vulnerable, and many ethical concerns have emerged regarding the informed consent process used in the experimental design of such trials. Starting with these considerations, this nonsystematic review is aimed at analyzing the decision-making processes underlying patients' decision about whether to participate (or not) in phase I trials in order to clarify the cognitive and emotional aspects most strongly implicated in this decision.

Gorini, Alessandra
Mazzocco, Ketti
Pravettoni, Gabriella
Publication Title: 
Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology: Official Publication of the International Retrovirology Association

Efficacy trials of candidate HIV-1 vaccines require study populations at high risk of infection who adhere to study protocols and who are willing to participate. Data from HIV-1 antibody-negative men (n = 698) enrolled in Project ACHIEVE in New York City were analyzed to assess willingness to participate in efficacy trials, factors influencing willingness, and the effect on willingness of the June 1994 media events about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials.

Koblin, B. A.
Avrett, S.
Taylor, P. E.
Stevens, C. E.
Publication Title: 
Investigational New Drugs

In the early drug development process for cancer therapy, several ethical dilemmas result from the use of cancer patients with advanced disease as the subjects of research in clinical trials studying agents of unknown toxicity and/or efficacy. Although several accepted ethical principles guide the behavior of involved physicians and investigators, many of these principles are allowed to be violated in order to achieve the overall goal of clinical research in improving medical care for future patients.

Daugherty, C. K.
Publication Title: 
Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology

PURPOSE: To identify areas of concern regarding the conduct of phase I trials, the perceived expectations and motivations of the parents of children entered, the expectations of toxicity and benefit, and the ethical concerns of pediatric hematologists and oncologists in the United Kingdom and North America. METHODS: A survey instrument consisting of 19 open- and closed-ended questions was sent to United Kingdom Children's Cancer Study Group (UKCCSG)- and Pediatric Oncology Group (POG)-affiliated pediatricians. RESULTS: Fifty-three UKCCSG- and 78 POG-affiliated pediatricians responded.

Estlin, E. J.
Cotterill, S.
Pratt, C. B.
Pearson, A. D.
Bernstein, M.
Publication Title: 
AIDS and behavior

Focus group discussions were conducted to assess factors that might impact participation of subgroups in Chennai for future HIV vaccine trials. The participants were 112 men and women representing the following: (1) transport workers; (2) clients who attended a sexually transmitted disease clinic; (3) injection drug users; (4) men having sex with men; (5) women in sex work; and (6) monogamous married women. Participants expressed an intense interest in future HIV vaccine trials.

Nyamathi, Adeline M.
Suhadev, Mohanarani
Swaminathan, Soumya
Fahey, John L.
Publication Title: 
International Journal of Clinical Pharmacology and Therapeutics

OBJECTIVE: To evaluate the personality characteristics of a group of participants in Phase 1 studies and to study the relation between the personality traits and the adverse events during participation. METHODS: Study population consisted of 139 healthy volunteers to Phase 1 studies. Personality was assessed through the Revised NEO Personality Inventory (NEO-PI-R) and adverse events were monitored during participation.

Almeida, L.
Falc„o, A.
Vaz-da-Silva, M.
Coelho, R.
Albino-Teixeira, A.
Soares-da-Silva, P.
Publication Title: 
European Journal of Cancer (Oxford, England: 1990)

BACKGROUND: Communication with patients contemplating Phase 1 cancer trial participation can be challenging. Controversy exists as to whether they are provided with sufficient information to give genuinely informed consent. We present data examining the reasons patients gave for trial entry. METHOD: Following discussions with oncologists about Phase 1 trials, participants completed a 19-item study specific 'accept or decline measure' exploring hope, expectations of benefit, altruism, concerns, and general perceptions of the trial information.

Catt, S.
Langridge, C.
Fallowfield, L.
Talbot, D. C.
Jenkins, V.
Publication Title: 
BMC public health

BACKGROUND: In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3.

Nappo, Solange A.
Iafrate, Giovanna B.
Sanchez, Zila M.
Publication Title: 
American journal of health promotion: AJHP

PURPOSE: To examine perceptions of phase-I human immunodeficiency virus (HIV) vaccine trial participation among African-Americans and Hispanics in San Francisco, California. DESIGN: Qualitative, semistructured interviews. SETTING: San Francisco Department of Health. PARTICIPANTS: Thirty-six African-American and Hispanic men and women, 18 to 50 years of age, residing in the San Francisco Bay Area. METHOD: Purposive sampling using advertisements, community-based organization rosters, and snowball referrals. Thematic analysis of transcripts identified salient themes and patterns.

Toledo, Lauren
McLellan-Lemal, Eleanor
Arreola, Sonya
Campbell, Chadwick
Sutton, Madeline
Publication Title: 
Contemporary Clinical Trials

INTRODUCTION: Phase 1 pediatric oncology trials offer only a small chance of direct benefit and may have significant risks and an impact on quality of life. To date, research has not examined discussions of risks and benefits during informed consent conferences for phase 1 pediatric oncology trials. The objective of the current study was to examine clinician and family communication about risks, benefits, and quality of life during informed consent conferences for phase 1 pediatric oncology trials.

Hazen, Rebecca A.
Zyzanski, Stephen
Baker, Justin N.
Drotar, Dennis
Kodish, Eric


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