Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team

• Published in: Therapeutic innovation & regulatory science Vol. 58; no. 5; pp. 978 - 986
• Main Authors: Dong, Yingwen, Paux, Gautier, Broglio, Kristine, Cooner, Freda, Gao, Guozhi, He, Wei, Gao, Lei, Xue, Xiaoqiang, He, Philip
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.09.2024; Springer Nature B.V
• Subjects: Clinical trials; Clinical Trials as Topic; Decision making; Design; Drug Development; Drug Safety and Pharmacovigilance; Humans; Medical Oncology; Medicine; Neoplasms - drug therapy; Oncology; Original Research; Pharmacotherapy; Pharmacy; Polls & surveys; Research Design; Surveys; Surveys and Questionnaires; Seamless; Oncology; Survey; Clinical Trial; Trial Design
• ISSN: 2168-4790; 2168-4804; 2168-4804
• DOI: 10.1007/s43441-024-00676-9

Seamless study designs have the potential to accelerate clinical development. The use of innovative seamless designs has been increasing in the oncology area; however, while the concept of seamless designs becomes more popular and accepted, many challenges remain in both the design and conduct of these trials. This may be especially true when seamless designs are used in late phase development supporting regulatory decision-making. The Innovative Design Scientific Working Group (IDSWG) Oncology team conducted a survey to understand the current use of seamless study designs for registration purposes in oncology clinical development. The survey was designed to provide insights into the benefits and to identify the roadblocks. A total of 16 questions were included in the survey that was distributed using the ASA Biopharmaceutical Section and IDSWG email listings from August to September 2022. A total of 51 responses were received, with 39 (76%) respondents indicating that their organizations had seamless oncology studies in planning or implementation for registration purposes. Detailed survey results are presented in the manuscript. Overall, while seamless designs offer advantages in terms of timeline reduction and cost saving, they also present challenges related to additional complexity and the need for efficient surrogate clinical endpoints in oncology drug development.