A Study of Practical Parameters and Their Relative Importance as Perceived by Various Stakeholders in Clinical Trials
2011
Importance of Practical Parameters in Clinical Trials
Sample size: 80
publication
Evidence: moderate
Author Information
Author(s): Pant R, Y Joshi
Primary Institution: Himalayan Institute of Pharmacy & Research
Hypothesis
What are the practical parameters perceived as important by various stakeholders in clinical trials in India?
Conclusion
The study identified key practical parameters that contribute to the successful conduct of GCP clinical trials in India.
Supporting Evidence
- The scientific rationale of the study is crucial for conducting GCP clinical trials.
- Protection of the rights and safety of trial participants is a top priority.
- The quality of protocol, case report form, and informed consent document design is essential.
- Trial management capabilities and communication skills of personnel are important for success.
Takeaway
This study asked people involved in clinical trials what factors are most important for running successful trials in India.
Methodology
The study used a survey with a questionnaire administered to 80 clinical trial stakeholders in Bangalore and New Delhi.
Participant Demographics
Participants included 15 Sponsors/CROs, 27 Investigators/Monitors, and 38 Ethics Committee members.
Digital Object Identifier (DOI)
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