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Published on: November 21, 2013
Challenges in conducting psychiatry studies in India
Saifuddin Kharawala1, Jeroze Dalal
1Clinical Research Consultant, Consultant Psychiatrist, GlaxoSmithKline Pharmaceuticals India Ltd., Mumbai, Maharashtra, India.
Conducting psychiatry studies in India presents unique ethical and logistical challenges, including informed consent and recruitment difficulties. Addressing these requires specialized training and careful consideration of the Indian context for successful trials.
Area of Science:
- Psychiatry
- Clinical Trials
- Medical Research
Background:
- India is a significant location for conducting psychiatric studies.
- These studies face unique challenges within the Indian context.
Purpose of the Study:
- To outline the complexities and challenges encountered in psychiatric research in India.
- To provide recommendations for the successful execution of these studies.
Main Methods:
- The study identifies common ethical issues such as informed consent validity and placebo use.
- It highlights recruitment challenges including investigator training and patient eligibility.
- It discusses the high placebo response rate and its impact on trial outcomes.
Main Results:
- Ethical considerations include managing illness worsening and ensuring valid informed consent.
- Investigator training in Good Clinical Practice (GCP) is limited, impacting site selection.
- Patient recruitment is hindered by strict criteria and caregiver availability.
- High placebo response rates contribute to trial failures.
- Adaptation of rating scales and rater training is crucial for accurate assessments.
Conclusions:
- Psychiatry studies in India require specialized training and expertise.
- Addressing ethical dilemmas and logistical hurdles is key to successful research.
- Adapting methodologies to the local context is essential for valid and reliable results.
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