Council of Biopharmaceutical Statisticians (CBS)

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Introduction:

Please note! This is still a draft and has not yet been endorsed.

Goal/Vision Statement:

The goal of the Council of Biopharmaceutical Statisticians (CBS) is to harmonize efforts among the many organizations that statisticians are part of and create a unified statistical community regardless of professional statistical organization affiliation. These other organizations need to have similar goals and visions to have this effort be sustainable. This should be done in an efficient manner, and redundancies of efforts will undermine opportunities to advance innovation. Working together across these professional statistics organizations will give us the focus and coordination needed to speak with one voice on topics of common interest to our respective professional organizations.

Problem/Opportunity:

Professional organizations such as American Statistical Association, Drug Information Association, Society for Clinical Trials, Statisticians in the Pharmaceutical Industry, European Federation of Statisticians in the Pharmaceutical Industry and International Society for Biopharmaceutical Statistics are created so statisticians have a place to share information and further our profession. These organizations are useful for keeping up-to-date on things affecting our profession through meetings, education, outreach and publications, as well as providing opportunities for networking. These organizations are also a great venue for scientific collaboration to advance the technical side of our profession. In order to make these organizations successful, volunteers and active members are needed. Statisticians should be able to collaborate on issues beyond just their own organizations.

However, there is no concerted and coordinated effort across these different organizations to promote the best interests of the statistical community and more specifically the best interests of statisticians working on medical products towards benefits for patients worldwide. Statisticians should not be marginalized to the role of data managers and data analysts. It is important that statistician’s intellectual contribution to the scientific process is recognized by other disciplines. Statisticians need to recognize their value as leaders and their positive impact to the industry. Statisticians must leverage their technical skills and harness their strengths. Lack of collaboration among members of these organizations leads to inefficiency due to competing and/or redundant activities which detract from a clear and strong voice among its members and inhibits the ability to effectively communicate to stakeholders. Among other problems, such inefficiency leads to a delay in the advancement of statistical innovations.


Expected Benefits:

Effectively addressing the challenges of multiple professional organizations should:

  • Establish a shared goal or vision
  • Creation and maintenance of an open, shared website
  • Establish a plan that outlines how these organizations can stay coordinated, increase efficiency, and eliminate redundancy, including avoiding conferences/workshops on similar topics in similar timeframes in the same region
  • Assist Health Authorities on having a manageable number of requests for their participation
  • Create consensus among these stakeholders in the statistics community
  • Help facilitate and coordinate the efforts across different organizations in following areas:
  • Scientific working groups
  • Meetings/conferences
  • Publications
  • Education including webinars
  • Mentoring
  • Establish metrics that clarify the interpretation of this vision
  • Prioritize statistical issues having a larger impact on development of new medical product that needing further research and facilitate collaboration in those areas across organizations
  • Promote the sharing and management of knowledge
  • Solicit through increased awareness more volunteers and active participants for each individual organization
  • Promote biopharmaceutical statistics profession and best practices across the globe

Steering Committee

  • Leaders from the ASA BIOP, QSPI, DIA Stat Comm, PSI, EFSPI, ISBS will comprise a steering committee charged with two-way communication to/from their respective organizations, as well as monitoring achievement of the goals set forth within this charter.
  • Monthly teleconferences among the steering committee members


Scope:

  • In scope: Phase 1: ASA-BIOP, SCT/QSPI, DIA Stat Community, PSI, EFSPI, ISBS
  • In scope: Phase 2: other statistical communities interested in medical product development and approval.
  • Out of scope: non-statistical communities

Working Group Linkages/Dependencies:

Working Groups with summaries available

Group Name Affiliation Contact
ASA Biopharmaceutical Safety WG ASA Biopharm Olga Marchenko (Quintiles) Qi Jiang (Amgen)
ASA Alzheimer's Disease SWG ASA Biopharm Hong Liu-Seifert (Lilly) Steve Wilson (FDA)
Adaptive Design SWG DIA Robert Beckman (Georgetown U.)
Bayesian SWG DIA Karen Price (Eli Lilly)
Missing Data SWG DIA Craig Mallinckrodt (Eli Lilly)
Medical Devices SIG EFSPI Roland Marion-Gallois (Medtronic)
Benefit Risk SIG EFSPI/PSI Alexander Schact (Eli Lilly)
Biomarkers SIG EFSPI/PSI Athula Herath (MedImmune)
Health Technology Assessment SIG EFSPI/PSI Christine Fletcher (Amgen)
Integrated Data Analysis SIG EFSPI/PSI Byron Jones (Novartis)
Regulatory Committee EFSPI/PSI Lesley France (AstraZeneca)
Subgroup Analysis WG (EFSPI/PSI) EFSPI/PSI Aaron Dane (AstraZeneca)
Working Group on Estimands EFSPI/PSI Alan Phillips
Toxicology SIG EFSPI/PSI Gareth Thomas (Huntingdon)
Multi-Regional Clinical Trial SWG QSPI Bruce Binkowitz
Subgroup Analysis WG (QSPI) QSPI Ilya Lipkovich (Quintiles)

Working Groups without summaries available

Group Name Affiliation Contact
Comparative Effectiveness Research SWG DIA Matt Rotelli (Eli Lilly)
Data Sharing Working Party EFSPI/PSI Hans-Ulrich Berger (Roche)
Modeling and Simulation SIG EFSPI/PSI Chris Campbell (Mango Solutions)
Real World Data EFSPI/PSI George Quartey (Genentech)
Benefit Risk WG QSPI Qi Jiang (Amgen) Weili He (Merck)
Multiplicity WG QSPI Alex Dmitrienko (Quintiles)




Events:

MediaWiki Table Editing Guide

The purpose of the MediaWiki Table Editing Guide image is to give a graphical example of how to add meetings to the upcoming meetings table using the editor. In the image are two screenshots: 1) Wiki Page View 2) Wiki Table Editor View

In the Wiki Page View are blue balloon labels H1-H7 showing the static table headers and red balloon labels B1-B7 showing the first actual entry in the table. The Wiki Editor View shows the code for the table header and first table entry with the corresponding blue and red labels.

In order to add a meeting to this table you will need to copy all of the text from B1-B7 in the editor, then paste the copied code directly below that entry. From there, make the necessary changes to that new table entry. Please note, you will not see the blue H1-H7 labels and red B1-B7 labels in the actual MediaWiki editor. They are used in the image to show the example.

Meetings/Workshops:

Screenshot of MediaWiki Table Editing Guide
Host Institution Event Title Event Type (conference / meeting / training / webinar) Location Date(s) Other Dates* Additional Information
ASA ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop Conference Maryland, US 12-14 September 2018 Hotel Reservation Deadline: 14 August 2018 [1]
PSI Sample Size Re-estimation - dealing with those known unknowns! One Day Meeting RSS, Errol Street, London 2 Nov 2016 2 Nov 2016 PSI One Day Meeting
EFSPI European Statistical Meeting on Evidence Synthesis One Day Meeting BMS, Brussels, Belgium 22 Nov 2016 22 Nov 2016 EFSPI One Day Meeting