The Power of Policy
What one policy change would accelerate progress in drug development and manufacturing? We asked the 2026 Power List.
Clinical Scorecard: The Power of Policy
At a Glance
| Category | Detail |
|---|
| Condition | Clinical Development and Regulatory Frameworks |
| Key Mechanisms | Operational changes, global regulatory harmonization, and innovative trial designs. |
| Target Population | Biotech and pharmaceutical companies involved in advanced therapies. |
| Care Setting | Clinical research and development environments. |
Key Highlights
- Faster clinical trial approval can accelerate evidence generation.
- Global regulatory alignment could enhance innovation and patient access.
- Use of biomarker-based trial endpoints may enable earlier drug approvals.
- Real-world evidence should be utilized more effectively in rare diseases.
- Regulatory frameworks need modernization to support complex therapies.
Guideline-Based Recommendations
Diagnosis
Management
- Adopt flexible health technology assessment and reimbursement decisions.
Monitoring & Follow-up
- Implement independent strategic assessments by CROs.
Risks
- Avoid reliance on randomized trials in early phases for rare diseases.
Patient & Prescribing Data
Patients requiring advanced therapies, particularly in rare diseases.
Long-term value and cost savings of therapies should be reflected in payment models.
Clinical Best Practices
- Encourage collaboration in therapeutic development.
- Utilize adaptive manufacturing rules for advanced therapies.
- Support broader adoption of human-relevant predictive models.
Related Resources & Content
