To ensure all vaccines and medications intended for human use undergo comprehensive, non-accelerated clinical trials, thereby safeguarding public health through rigorous scientific validation.
Key Elements:
Mandatory Trial Phases:
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Phase I: Initial safety studies in a small group of healthy volunteers to determine any immediate adverse reactions, dosage tolerance, and pharmacodynamics.
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Phase II: Wider trials involving hundreds of participants to assess efficacy, further evaluate safety, and determine optimal dosing. This phase must last at least 18 months to observe for late-onset side effects.
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Phase III: Large-scale trials involving thousands of participants to confirm efficacy, monitor side effects, compare with existing treatments, and gather more information on safety. This phase should extend over a minimum of 3 years to capture long-term effects adequately.
Ban on Fast-Tracking:
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No Fast-Track: Eliminate the option for fast-tracking or emergency use authorizations without going through the standard trial process unless under exceptional circumstances declared by a global health emergency panel independent of pharmaceutical interests.
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Exception Criteria: Exceptions would require approval from an international panel of medical experts, public health officials, and ethicists, with transparency in decision-making processes.
Transparency and Data Sharing:
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Public Access: All trial data must be made publicly available in a digestible format post-approval for independent analysis by third-party researchers and the public.
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Real-Time Monitoring: Implement real-time data monitoring systems where anomalies or unexpected side effects can trigger immediate reviews by regulatory bodies.
Post-Market Surveillance:
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Longitudinal Studies: Mandate companies to conduct long-term follow-up studies on all new drugs and vaccines for at least 10 years post-marketing to catch any rare or long-term adverse effects.
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Adverse Event Reporting: Enhance systems for adverse event reporting and ensure these systems are accessible to healthcare providers and the public directly.
Financial Incentives and Penalties:
Funding for Trials: Provide government subsidies or tax incentives for conducting comprehensive trials, encouraging companies to invest in thorough research rather than cutting corners.
- Penalties for Non-Compliance: Severe financial penalties or revocation of market authorization for failure to adhere to trial protocols or falsification of data.
Independent Oversight:
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Regulatory Body: Establish or empower an independent body, free from pharmaceutical industry influence, to oversee the entire process from trial design to post-market surveillance.
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Ethical Review Boards: Ensure every trial has an independent, strictly ethical review board, including lay members, to consider the human rights implications of the research.
Public and Stakeholder Engagement:
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Community Input: Incorporate mechanisms for public and community input in the policy-making process concerning trial protocols, especially for global health issues.
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Education Campaigns: Launch public health campaigns to educate on the importance of clinical trials and the risks associated with bypassing them.