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FROM THE WORLD OF CLINICAL RESEARCH |
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Year : 2012 | Volume
: 3
| Issue : 3 | Page : 118 |
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From the World of Clinical Research
Arun Bhatt
India
Date of Web Publication | 5-Sep-2012 |
Correspondence Address: Arun Bhatt India
 Source of Support: None, Conflict of Interest: None  | Check |
PMID: 23125965 
How to cite this article: Bhatt A. From the World of Clinical Research. Perspect Clin Res 2012;3:118 |
Jacobsen PB, Wells KJ, Meade CD, Quinn GP, Lee JH, Fulp WJ, et al. Effects of a brief multimedia psychoeducational intervention on the attitudes and interest of patients with cancer regarding clinical trial participation: A multicenter randomized controlled trial. J Clin Oncol 2012;30:2516-21.
The purpose of this study, conducted in 472 adults with cancer who had not been asked previously to participate in a clinical trial, was to evaluate whether a brief psychoeducational intervention would be effective in improving patients' attitudes as well as their knowledge, self-efficacy for decision making, receptivity to receiving more information, and general willingness to participate in clinical trials.
The patients were randomly assigned to receive printed educational information about clinical trials or a psychoeducational intervention that provided similar information and also addressed misperceptions and concerns about clinical trials.
Patients who received the psychoeducational intervention showed more positive attitudes toward clinical trials and greater willingness to participate at follow-up than patients who received printed educational information. The benefits of psychoeducation on willingness to participate were probably due to the positive impact of psychoeducation on attitudes toward clinical trials.
Cohen MS, McCauley M, Sugarman J. Establishing HIV treatment as prevention in the HIV Prevention Trials Network 052 randomized trial: An ethical odyssey. Clin Trials 2012;9:
340-7.
The objective of the study was to describe and analyze the major ethical challenges faced in HPTN 052.
The ethical issues and modifications of HPTN 052 in response to ethical challenges were cataloged by the study team and the ethicist working on the trial. The major ethical issues that unique to the trial were analyzed in light of the published literature as well as guidance and policies.
The ethical questions/challenged that emerged during the trial were as follows:
- Relevance of the research question, given data from observational research.
- Range of beliefs about the appropriate means of preventing and treating HIV infection and AIDS.
- Determination of the appropriate prevention package for all of those enrolled.
- New guidance documents and policies emerging during the course of trial that were of direct relevance to the research questions, calling for a balancing of concerns for the research subjects and trial integrity.
- Need to ensure access to the treatment shown to be effective that in some cases differed from the guidelines.
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