Dear ASA members,
(please excuse cross-posting)
The Journal of Biopharmaceutical Statistics (JBS) cordially invite authors to submit papers for a special issue on real-world evidence (RWE). This special issue will feature innovative statistical methodologies and case studies that incorporate real-world data (RWD) or RWE into medical product development and regulatory decision-making, especially in areas of unmet medical needs. For instance, in clinical trials for treatment of rare diseases or rare, genetically targeted subsets of common diseases, randomization may not be feasible due to timeline, budget, and ethical concerns. Using external controls by borrowing information from RWD sources or historical trials can provide relevant evidence (i.e., RWE) to examine the treatment effect from single-arm trials. Further, innovative adaptive designs enable trialists to utilize historical information from adults or children of other age groups in their planning for pediatric trials, provided that these reference data provide the basis and prior knowledge for extrapolation and inferences of the treatment effect. With the advances of technology and increasingly available RWD/RWE, there is more room for improvement in clinical trial designs and data analysis strategies.
Deadline for submission: rolling
Contribution types: original research, and/or reviews
Submission Instructions:
Go to mc.manuscriptcentral.com/lbps. Follow the submission steps under "Author" tab.
In Step 1, for Type, please select "Special Issue"; for Title, please include the wording "[Special Issue: RWE]" before the main title. The rest of the steps will be similar to other submissions.
All manuscripts will be peer-reviewed. For further questions regarding submission, please contact junjing.lin@takeda.com, or Qian.Li@bms.com.
Looking forward to your submissions!
Guest Editors:
Junjing (Jane) Lin, PhD
Email: junjing.lin@takeda.com
and
Qian (Helen) Li, PhD
Email: Qian.Li@bms.com
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Junjing (Jane) Lin, PhD
Takeda Pharmaceutical Co. Limited
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