The Cost of Ignoring Health Equity in Clinical Trials
1. Regulatory compliance: Regulatory bodies such as the FDA in the United States require evidence that new drugs are safe and effective across various populations with requirement of Diversity Action Plans. Meeting these requirements helps ensure a smoother path to approval. Diverse trial data reduces the risk of adverse events post-market, which can lead to costly recalls, lawsuits, and reputational damage.
2. Regulatory delay: Poort quality planning for clinical trial reputation that can lead to yearlong regulatory delays and delays a medical product or drug’s market entry.
3. Scientific and Clinical Benefits: Improved Drug Efficacy and Safety Profiles leads to a greater understanding of how a drug works across genetic, racial, and ethnic differences improves the overall robustness of its clinical profile. This data reduces the risk of biased results that could lead to ineffective or harmful recommendations for underrepresented groups.
4. Post-market analyses & additional trials: If there is not diverse data in the trial drug developers will need often need to conduct a prolonged phase 4 study or post-marketing analysis with the FDA releasing new guidance relating to this in 2024.
5. Market access & penetration: By demonstrating efficacy and safety in all populations, companies can market their drugs to a wider range of demographic groups and there will be better reception from payers. Representation in clinical trials builds trust with underrepresented populations, potentially increasing adoption and sales within these groups.
6. Competitive advantage: Companies that prioritize health equity position themselves as leaders in innovation and inclusivity, attracting partnerships and investment, addressing unmet needs in specific subpopulations and can lead to early market entry.
7. Health equity is a selling point: Demonstrating a commitment to health equity aligns with public expectations and can enhance brand loyalty as part of a company’s corporate social responsibility, positive media coverage and consumer goodwill.
8. Cost Avoidance: Drugs with clinical trials that include at-risk populations are less likely to face post-market criticism for overlooking efficacy or safety issues in certain demographics, this minimizes litigation risk as these trials can reduce liability by showing diligence in assessing the drug's impact on the relevant groups.
9. Access to Incentives: Governments and organizations provide financial incentives or grants for research that includes representative populations, regulatory agencies may offer expedited review or other benefits for trials that address diversity concerns.
10. Response from Patient Advocacy: Advocacy organizations and community leaders increasingly push for inclusivity in medical research that centers patients. Responding to this helps companies align with patient expectations, grows stronger relationships and can speed up the recruitment process.