ASA Connect

                                                        INVITATION FOR MANUSCRIPT SUBMISSION:
                                                                  SPECIAL ISSUE ON ESTIMANDS
The Journal of Biopharmaceutical Statistics invites authors to submit manuscript that are relevant to the discussion of estimands and associated sensitivity analysis. We welcome manuscripts on the topic of estimands in broad context, not just for efficacy but also for safety and benefit-risk evaluation, in pre-marketing and post-marketing settings, throughout product development life cycle.

ICH E9 (R1) states that "An estimand is a precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective". Wikipedia provides a more general definition, namely "An estimand is a variable which is to be estimated in a statistical analysis." In drug development setting the estimand of interest might be different for patients, regulators and payors. As drug development and negotiation with payors becomes more complex, it is important to carefully understand the estimand of interest, the intercurrent events and the associated sensitivity analysis. As stated in Phillips et al (2016) "The statistical community needs to take a lead here in raising awareness and understanding of the impact of using different estimands on the interpretation and decision-making processes in drug development." In light of this, the Journal of Biopharmaceutical Statistics has decided to dedicate a especial issue to this topic.

Phillips A, Abellan‐Andres J, Soren A, et al. Estimands: discussion points from the PSI estimands and sensitivity expert group. Pharm Stat. 2017 Jan; 16(1): 6‐ 11.

Deadline for submission: rolling
Submission Instructions:
Go to https://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: Estimands]" 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 yodit.seifu@merck.com, or william.wang@merck.com.
Looking forward to your submissions!
Guest Editors:
Yodit Seifu, PhD
Email: yodit.seifu@merck
and
William Wang, PhD
Email: william.wang@merck.com