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Precision cancer medicine has the potential to dramatically improve the outcomes of patients with cancer; however, despite the precise nature of the therapies involved, generating reliable evidence of efficacy is often challenging. In this Perspective, the authors describe the challenges and potential solutions that might address the need for evidence in precision cancer medicine.
Accurate detection and monitoring of treatment responses is an essential element of the management of patients with lymphoma. In this Perspectives, the authors describe the evolution of lymphoma staging criteria and highlight unaddressed questions, which, if answered, will substantially improve the management of patients with lymphoma.
Precision medicine has dramatically changed the landscape of drug development in oncology, but this paradigm shift remains to be adopted in early phase clinical trials of molecularly targeted agents and immunotherapeutic agents in children with cancer. The authors, members of the Innovative Therapies for Children with Cancer (ITCC) Consortium, describe trial design strategies to enable drugs with promising activity to progress rapidly to randomized studies and, therefore, substantially accelerate drug development for children and adolescents with cancer.
The costs of both newly approved, and established anticancer drugs have risen dramatically in the past decade, to the point where the costs of such treatments are becoming unsustainable. In this perspective, the authors outline the extent of this problem, and how it is likely to continue, while also suggesting measures that could be taken in future to address these rising costs.
The expansion of research and development of anticancer drugs in China has resulted in considerable delays in the approval of both clinical trials of novel agents, and the marketing approval of these agents once tested. In this Perspective, the authors describe the measures taken by the Chinese FDA to address these challenges in a rapidly developing research environment.
Clinical trial design has dramatically evolved with the advent of precision medicine. As a result, expedited drug-approval decisions have been made on the basis of evidence obtained in uncontrolled clinical trials. Herein, Saad et al. discuss the need to conduct randomized controlled trials at all phases of drug development in oncology, and present strategies to facilitate a seamless transition between phases of drug and/or biomarker development.
