- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00729534
Research Participants Perceptions of Their Experience in Clinical Studies
Research Participant Perception of Care Project: Part 1: Focus Groups of Research Participants and Research Professionals to Identify Key Dimensions of the Research Participant Experience
This study will examine how research volunteers experience their participation in studies in order to develop surveys to be used by research centers trying to improve the experience of their participants.
People 18 years of age and older who have participated in an NIH research protocol within the past 2 years as someone with a medical condition under study may be eligible for this study.
Eight participants will participate in a moderator facilitated focus group in a discussion about being in research studies. An observer audiotapes the discussion and takes written notes. The focus group discussion lasts about 1 to 1 (Omega) hours.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
The conduct of high quality clinical research is dependent on the ability to recruit and retain subjects who are invested in, understand, and have confidence in the clinical research process. Understanding subjects experiences as research volunteers is critical to the continual improvement of the processes of clinical research and, subsequently, to enhancing the subject s experience. Heretofore, studies evaluating the subject s comprehension of the informed consent process have served as, at best, an indirect measure of the quality of the subject s experience. Few, if any, studies have assessed the quality and efficacy of the entire clinical research process from the subject s perspective. This study is the first phase of a two-part study designed to directly measure research participants perceptions of all aspects of the clinical research process (e.g., recruitment, informed consent, education, autonomy and subject's rights, provision of clinical care) for the purposes of improving the clinical research subject s experience.
Obtaining robust, validated data requires a partnership between those with expertise in the design and analysis of surveys, and those who can articulate the needs of research participants and improve the way in which clinical research is conducted. For the former, we will be greatly advantaged by our partnership with NRC Picker, which has committed the resources necessary to assist the survey project development; conduct the focus groups, telephone interviews, and expert advisory group sessions required to further optimize the survey; collaborate in the analysis; and fund the second-stage formal validation of the survey. For the latter, we have assembled a collaborative team of research professionals from the CTSA award recipient centers, and interested GCRCs, with expertise in human subject protections, research ethics, research conduct, education and performance improvement.
The current study entails the recruitment and conduct of up to a total of 22 Focus Groups, each consisting of either 8-10 research subjects (12-16 groups) or 6-10 research professionals (6 groups), in order achieve the first goal: to assess the key dimensions of the research experience upon which to test the second part of the research, a perception of the research experience survey. The current study will involve 8-11 academic medical centers, enrolling a total of 100-128 research subjects, and 45-60 research professionals in total. A second goal of the project is to describe the process, obstacles and successes of implementing a multi-center protocol across the GCRCs and the CTSA consortium. A subsequent research protocol will concern the fielding and validation of that survey in approximately 3,700 subjects at up to 10 academic medical centers (CTSA and GCRC awardees).
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
- INCLUSION CRITERIA:
You may be eligible to participate in this study if you:
- Are at least 18 years old.
- Are able to give informed consent.
- Have participated in an NIH research study within the past 2 years as someone with a medical condition under study.
- Can participate constructively and non-disruptively in the group discussion, in the opinion of the investigator.
- Are fluent in English
EXCLUSION CRITERIA:
You will not be able to be in this study if you:
- Do not sign the informed consent form.
- Do not agree to honor the confidentiality of others in the focus group.
- Do not agree to be recorded on audiotape.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
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To identify key dimensions of the clinical research process that influence participants' perception of their experience as a study participant
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Sekundära resultatmått
Resultatmått |
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To describe the process, obstacles and successes of implementing a multi-center protocol across the GCRCs and the CTSA consortium.
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Samarbetspartners och utredare
Utredare
- Huvudutredare: David K Henderson, M.D., National Institutes of Health Clinical Center (CC)
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 080193
- 08-CC-0193
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