TITLE

INFORMAL DIALOGUE WITH PROSPECTIVE VOLUNTEERS: A TOOL TO IMPROVE SUBJECT RECRUITMENT IN CLINICAL TRIALS

AUTHOR(S)
RUCKMANI, A.; KUMAR, R. ARUN; LAKSHMIPATHY, R. PRABHU; RAMYA, N.; MAIGNANA, R. KUMAR
PUB. DATE
April 2014
SOURCE
Asian Journal of Pharmaceutical & Clinical Research;2014, Vol. 7 Issue 2, p29
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Objective: To find out the impact of informal dialogue on the subjects' willingness to participate in clinical trials. Methodology: The awareness, previous participation and willingness to participate in clinical trials were recorded randomly from the patients' relatives who attended Chettinad hospital & Research institute. The participants who responded negatively were selected with their consent and given a leaflet containing information about clinical trials. Sufficient time was given for them to read the leaflet and clarify doubts. Their willingness to participate in clinical trial was recorded. The subjects who were not willing to participate were individually met and explained about the clinical trials outside the official environment. Willingness to participate in clinical trials was recorded again and the difference between before and after personal interaction was statistically analyzed. Results: 200 subjects (99-males, 101-females) participated in this study. Before informal dialogue, 188 subjects (94%) were unwilling to participate and 12 (6%) expressed their willingness. After personal dialogue 137 (68.5%) were ready to participate and 63 (31.5%) were still unwilling to participate. The data was analyzed using Fisher's exact test which showed that informal dialogue significantly improved the willingness to participate in clinical trials. Conclusion: Informal dialogue outside the formal official environment has positively influenced the decision to take part in clinical trials.
ACCESSION #
96427802

 

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