The Statistics and Pharmacometrics Special Interest Group (SxP) was named in 2016 and is chartered by both the American Statistical Association (ASA) and International Society of Pharmacometrics (ISoP). This Interest Group promotes collaboration between Statisticians and Pharmacometricians, to enable each discipline to learn and grow from the other and to develop innovative approaches to model informed drug development.
We have two sessions accepted for ACoP 2019 and ASA JSM 2019:
ACOP 2019: You say “to-mah-to” I say “to-may-to” – – What statisticians and pharmacometricians wished each other understood better.
JSM 2019: Trial simulations to support Proof of Concept Study Design: Application to Immunology.
In this presentation, the application of pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation will be discussed to inform the design of a proof-of-concept trial in immunology. A meta-analysis of existing therapies was used to identify the dose-response characteristics for monoclonal antibodies used to treat psoriasis. Based on the PK/PD properties of existing therapies and hypothetical cases, clinical trial simulations were conducted to evaluate the impact of trial design on the go/no go decision. A key design issue was whether to allocate patients to a single high dose cohort or to distribute patients across a range of doses better enabling the characterization of PK/PD properties. This case study will be discussed in more detail to enable deeper insights into collaborations between statisticians and pharmacometricians.
Goals of the SIG
Specifically, the goals of the Interest Group are to:
- Provide educational opportunities to learn about Statistics and Pharmacometrics
- Encourage career growth and mentoring for people new in the field
- Promote cross-disciplinary methodology research and publications, and to encourage cross participation at conferences
- Create best practices leveraging both disciplines
- Provide opportunities to discuss computing platforms and share code
Objectives of the SIG
The objectives of the group are to
- Promote collaboration between Pharmacometricians and Biostatisticians by
a. Initiating communication with statisticians about PK/PD principles and terminology and about the complexities and nuances of PK/PD data. Educate statisticians in the utility of pharmacometric modeling.
b. Initiating communication with Pharmacometricians about statistical principles, methodology and terminology.
c. Facilitating discussions with both groups for how each interprets their own roles. Explain how each other think and why. - Encourage statisticians to seek careers in Pharmacometrics.
- Bridge the gap between methodology published in Pharmacometrics journals with methodology published in statistical journals.
- Provide new forums or take advantage of existing forums for initiating scientific discourse between the disciplines.
The Leadership of this SIG is comprised of members of both ISoP and the ASA.
Committee Members
Co-chairs: France Mentré and Mike K Smith.
Committee:
- Gary Rosner
- Alfred Balch
- Jonathan French
- Efthymios Manolis
- Jingtao Wu
- Robert Bies
- Bret Musser
- Siv Jönsson
- Stacey Tannenbaum
- Vijay Ivaturi
- Matt Zierhut
- Tim Waterhouse
- Erin Dombrowsky
- Hao Zhu
- Lei Nie
- Alice Zong
- Luke Fostvedt
- Malidi Ahamadi
A complete website for this special interest group, hosted by the ASA, is available here.
A discussion forum with a category for topics specific to this joint Special Interest Group forum, and hosted by ISoP, has been created here. The goal of the discussion forum is to facilitate a civilized discourse between statisticians and pharmacometricians for topics of mutual interest.
Charter: https://community.amstat.org/sxp/aboutus/new-item
History: https://community.amstat.org/sxp/aboutus/history
Presentation material and links: https://community.amstat.org/sxp/ourlibrary
Joining
Membership in the Interest Group is open to anyone interested in establishing collaborations between statisticians and pharmacometricians. Membership in ASA or ISoP is not required. There are no dues.
Join here!