Management, Policy-Analysis and Entrepreneurship in Health and Life Science
Clinical Development and Clinical Trials (AM_1180)
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General info:
- Public faith in the healthcare system should be the norm, so new medicines should be
developed in a way that provides public assurance of the protection of trial participants
and reliability of trial results
- In your 3-minute video, explain the framework with which the regulated world of Clinical
Research works to provide that assurance and earn that faith.
- In your words, explain how the ethical and scientific standards are ensured, from design
to report, from development plan to marketing. Demonstrate your insight into how
quality is regulated and explain why public faith is warranted.
- If you feel that public faith is NOT warranted you argue, supported by arguments, how
the regulated world of clinical research, in your opinion, fails to make its case to provide
the public assurance that decisions are made based on reliable trial results.
- ADD REFERENCES
What needs to be in there →
- ICH-GCP (ICH-E6) → risk-based approach (data identification and risk identification,
evaluation, control, communication, review and reporting), quality assurance and
control, audits and inspections.
- EU-CTR → centralised monitoring through CTIS (database of all clinical trials of
investigational medical products (IMPs)).
- Declaration of Helsinki (most important principles) → informed consent.
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