Over the past decade, the field of heart failure (HF) has witnessed remarkable progress in drug development, resulting in the approval of numerous groundbreaking drugs by the U.S. Food and Drug Administration. To address some of these challenges, the U.S. Food and Drug Administration has issued guidance documents that have been critical in contemporary HF drug development; however, there are still many challenges in need of investigation. This paper leverages efforts of the Heart Failure Collaboratory and the scientific community to discuss the critical need for innovative trial designs, important concepts in clinical trials in the modern era, and the utilization of big data to accelerate HF drug development. At this inflection point in HF drug development, it is imperative that, as a global scientific community, we foster increased collaboration among researchers, clinicians, patients, and regulatory bodies. Only through such unified efforts can we navigate the complexities of HF, accelerate the development process, and ultimately deliver effective therapies that transform patient outcomes.

中文翻译：

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各个时代的心力衰竭药物开发：来自心力衰竭合作实验室


在过去十年中，心力衰竭 （HF） 领域的药物开发取得了显著进展，导致美国食品和药物管理局批准了许多开创性药物。为了应对其中一些挑战，美国食品和药物管理局发布了对当代 HF 药物开发至关重要的指导文件;然而，仍有许多挑战需要调查。本文利用心力衰竭合作实验室和科学界的努力，讨论了对创新试验设计的迫切需求、现代临床试验中的重要概念以及利用大数据加速 HF 药物开发。在 HF 药物开发的这个转折点上，作为全球科学界，我们必须加强研究人员、临床医生、患者和监管机构之间的合作。只有通过这种统一的努力，我们才能驾驭 HF 的复杂性，加速开发过程，并最终提供改变患者预后的有效疗法。