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Phase 0 clinical trials in oncology new drug development

机译：肿瘤学新药开发的0期临床试验

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Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.
机译：在过去的几十年中，制药工业的研究重点已经扩大到更大的范围，为临床开发投入了更多的新分子，尤其是靶向药物。另一方面，由于临床研究中新分子的高失败率，研究人员正面临严峻挑战。美国食品药品监督管理局（FDA）与学术界和行业专家共同确定了造成新分子失败的许多因素，并以将传统药物开发模型向创新范式转变的愿景发布了关于探索性行为的监管指南研究性新药（探索性IND）研究通常称为0期临床试验，需要减少的临床前检测，这与诸如癌症等威胁生命的疾病特别相关。利用低得多的药物剂量进行的0期试验提供了机会，可以在药物开发途径的早期就探索新分子的临床行为，从而帮助确定有前途的候选药物并消除不希望的分子，从而提高整体药物开发的效率大量节省资源。然而，由于这些研究本质上是非治疗性的，因此带来了某些伦理学挑战，需要进行仔细的研究设计和知情同意程序。本文回顾了针对0期临床试验的可行性，实用性，规划，设计和实施的见解和观点，以及针对肿瘤学新药开发的伦理问题和工业观点。

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