Clinical Trials, Phase III as Topic

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.

Author(s): 
Koblin, B. A.
Avrett, S.
Taylor, P. E.
Stevens, C. E.
Publication Title: 
Journal of Acquired Immune Deficiency Syndromes (1999)

This study examined perceived risks, benefits, and desired information related to willingness to volunteer in preventive HIV vaccine trials. SAMPLE: Purposive sampling was used to select 90 participants among injecting drug users (Philadelphia, PA, U.S.A.); gay men (San Francisco, CA, U.S.A.); and black Americans (Durham, NC, U.S.A.). METHODS: A qualitative interview guide elicited perceived benefits, risks, and desired information relating to trial participation. Themes were developed from the transcribed texts and from freelists.

Author(s): 
Strauss, R. P.
Sengupta, S.
Kegeles, S.
McLellan, E.
Metzger, D.
Eyre, S.
Khanani, F.
Emrick, C. B.
MacQueen, K. M.
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.

Author(s): 
Nappo, Solange A.
Iafrate, Giovanna B.
Sanchez, Zila M.
Publication Title: 
European Journal of Cancer Care

It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation.

Author(s): 
Godskesen, T.
Hansson, M. G.
Nygren, P.
Nordin, K.
Kihlbom, U.
Publication Title: 
The Oncologist

BACKGROUND: In this paper, we provide background and context regarding the potential for a new data-sharing platform, the Project Data Sphere (PDS) initiative, funded by financial and in-kind contributions from the CEO Roundtable on Cancer, to transform cancer research and improve patient outcomes. Given the relatively modest decline in cancer death rates over the past several years, a new research paradigm is needed to accelerate therapeutic approaches for oncologic diseases.

Author(s): 
Green, Angela K.
Reeder-Hayes, Katherine E.
Corty, Robert W.
Basch, Ethan
Milowsky, Mathew I.
Dusetzina, Stacie B.
Bennett, Antonia V.
Wood, William A.
Publication Title: 
Tropical medicine & international health: TM & IH

The synergistic antifolate combination of chlorproguanil with dapsone (CPG-DDS; LAPDAP) is being developed by a public-private partnership as a low-cost treatment for uncomplicated falciparum malaria. LAPDAP is rapidly eliminated from the body, giving it low selection pressure for drug resistance. Clinical cases with sulphadoxine-pyrimethamine (SP)-resistant infections acquired in Africa have been predicted to be responsive to LAPDAP, and clinical evidence is available to support this.

Author(s): 
Winstanley, P.
Publication Title: 
Malaria Journal

BACKGROUND: Home-based management of malaria (HMM) is promoted as a major strategy to improve prompt delivery of effective malaria treatment in Africa. HMM involves presumptively treating febrile children with pre-packaged antimalarial drugs distributed by members of the community. HMM has been implemented in several African countries, and artemisinin-based combination therapies (ACTs) will likely be introduced into these programmes on a wide scale.

Author(s): 
Hopkins, Heidi
Talisuna, Ambrose
Whitty, Christopher Jm
Staedke, Sarah G.
Publication Title: 
Malaria Journal

BACKGROUND: Pyronaridine-artesunate (PA) is indicated for the treatment of acute uncomplicated Plasmodium falciparum and Plasmodium vivax malaria. METHODS: Individual patient data on safety outcomes were integrated from six randomized clinical trials conducted in Africa and Asia in patients with microscopically confirmed P. falciparum (five studies) or P. vivax (one study) malaria. Efficacy against P. falciparum was evaluated across three Phase III clinical trials.

Author(s): 
Duparc, Stephan
Borghini-Fuhrer, Isabelle
Craft, Carl J.
Arbe-Barnes, Sarah
Miller, Robert M.
Shin, Chang-Sik
Fleckenstein, Lawrence
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