Document Type : Perspective, opinion, and commentary
Authors
1 Faculty of Pharmacy, Jadara University, Jordan
2 Faculty of Law, Jadara University, Jordan
Abstract
The drug development process has seen significant advancements in recent decades; however, it remains costly and time-consuming due to regulatory and ethical constraints. While regulatory bodies aim to balance safety, efficacy, and innovation, emerging challenges such as antimicrobial resistance, precision medicine, and artificial intelligence (AI) in drug discovery necessitate rethinking traditional approaches. This commentary explores key obstacles in drug development, including regulatory bottlenecks, ethical dilemmas, and disparities in global drug access.
The integration of AI and adaptive clinical trial designs offers promising avenues for streamlining drug approval processes while maintaining safety standards. However, concerns regarding algorithmic bias, data privacy, and transparency require regulatory oversight. Additionally, equitable access to life-saving medications remains a pressing issue, with high-income countries benefiting first while lower-income regions face affordability and supply chain challenges. Patent laws further exacerbate disparities by restricting generic competition.
Ethical considerations permeate every stage of drug development, from clinical trials to post-market surveillance. The increasing involvement of pharmaceutical companies in regulatory decisions raises concerns about conflicts of interest and potential industry bias. As personalized medicine expands, regulatory bodies must ensure that ethical principles such as transparency, fairness, and patient autonomy are upheld.
Addressing these challenges requires a multidisciplinary approach that integrates scientific innovation with regulatory reforms and ethical vigilance. By embracing AI-driven drug discovery, adaptive trial designs, and real-world evidence, while ensuring equitable access and ethical integrity, the future of drug development can be both efficient and just.
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