**5. Conclusions**

The development of a new antiparasitic agent against *T. cruzi* to improve the lives of patients with Chagas disease is an urgent priority and one of the most challenging in infectious diseases. Despite the discovery of the disease over a century ago, substantial knowledge gaps persist in disease biology and the pathophysiology of disease progression. Clinical trials face a wide range of challenges that include disease and response heterogeneity and operational challenges associated with early diagnosis, patient access, intervention, and prolonged follow-up. The clinical impact of the benznidazole and nifurtimox in chronic disease settings has been disappointing, but decades of research provide valuable insights that can be applied to new drug development. This discourse highlights the Chagas disease associated pitfalls to be

*New Therapeutics for Chagas Disease: Charting a Course to Drug Approval DOI: http://dx.doi.org/10.5772/intechopen.102891*

navigated and risks that need to be managed. Ultimately, achieving improved patient outcomes requires a multidisciplinary approach encompassing novel compound classes, rapid diagnostics, early progression biomarkers, rigorous drug candidate selection, and efficient, focused clinical development plans. The advent of new digital technologies and trial methodologies has significant potential to improve clinical trial efficiency and patient access. The WHO, PAHO, Mundo Sano, the Oswaldo Cruz Foundation (FIOCRUZ), Chagas' Coalition, the Barcelona Institute for Global Health (ISGlobal), DNDi, and various private sector companies are among the many international institutions dedicated to conquering this disease. The long and complex path to the approval of new drugs will best be served by broad, long-term collaborative engagement, knowledge sharing, and partnerships between stakeholders in private and public sectors.
