Review Examines Clinical Trials For Drug Development

Wang et al. (2026) publish in BIO Integration a review examining clinical trial phases I–IV, major challenges, and mitigation strategies. The article details ethical compliance, recruitment, diversity issues, and how AI, big‑data analytics, and digital health improve trial design and data quality. It also discusses impacts of gene therapy, immunotherapy, and the need for regulatory harmonization to support global drug development.
Key Points
- 1Summarizes Phase I–IV objectives: safety, efficacy, large-scale validation, and post‑market surveillance.
- 2Highlights recruitment, ethics, and representativeness as major barriers to valid trial outcomes.
- 3Recommends AI, big‑data analytics, and digital health to improve design, efficiency, and data quality.
Scoring Rationale
Comprehensive, peer-reviewed review with broad industry relevance; novelty limited because it's synthesis rather than original findings.
Sources
Public references used for this report.
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