The process of clinical trials: a model for successful clinical trial participation.
OBJECTIVE
To present barriers and strategies related to successful clinical trial participation and integrate them into a model for successful trial participation.


METHODS
The proposed model was developed based on a literature review related to clinical trial participation, review of empirical studies related to clinical trials, and experiences with subject participation.


RESULTS
Successful clinical trial participation depends on study design, participant factors, issues related to ethnic diversity, the informed consent process, and physician factors.


CONCLUSIONS
Clinical trial participation is critical for all disciplines. However, nurses either are researchers or co-investigators with physicians on clinical trials, and it is critical for them to understand specific barriers and success strategies for patient participation. Future studies need to be conducted related to participation in nursing clinical trial research. These study results will facilitate successful nursing clinical trials.


CONCLUSIONS
This model can be used in implementation of clinical trials across disciplines prior to and during enrollment of patients into studies.
Lengacher
C A
CA
College of Nursing, University of South Florida, Tampa, USA. clengach@hsc.usf.edu
Gonzalez
L L
LL
Giuliano
R
R
Bennett
M P
MP
Cox
C E
CE
Reintgen
D S
DS
D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D007400:Interprofessional Relations; D008962:Models, Theoretical; D018579:Patient Selection; D012107:Research Design