QSPI

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Contents



Introduction:

Opportunity Statement:

The QSPI is a forum where biostatisticians, statistical programmers and data managers can meaningfully engage in the discussion of scientific and regulatory issues that are critical to the development and manufacture of pharmaceutical products and biologics. Under the Society for Clinical Trials(SCT), the QSPI will further this mission by engaging in the following activities:

  • Quarterly teleconferences with the FDA:

Biostatistics leadership to discuss methodological, operational and other relevant issues related to the application of quantitative sciences in drug development.

  • An annual workshop focused on a current, relevant methodological topic in drug development and/or manufacturing, developed in partnership with FDA and in collaboration with another discipline area (e.g., Clinical Research, Clinical Pharmacology).
  • An annual meeting of leaders of quantitative sciences groups in the pharmaceutical and biotechnology industries to discuss and share information on topics of mutual interest to these industries and the FDA. This annual meeting has been held at the FDA White Oak campus since 2011.
  • Formation of working groups that tackle key issues and produce white-papers on topics relevant to the industry.

In addition the QSPI will play an active part in SCT annual meetings, and be fully engaged with the SCT Industry/FDA Affiliation Group.

Operating Principles:

SCT Membership:

The QSPI will consist of a core group, of 15 to 17 people, who are senior staff members in the biotechnology, pharmaceutical, or clinical research organization (CRO) industries. There will also be an extended membership that consists of working group members, and others who are interested in the activities of the QSPI. The QSPI core group members will be required to be members of the SCT. All interested SCT members are eligible to join the extended membership, and may apply for positions on any working group. However, members of QSPI working groups, and industry members of the extended membership, are not required to be SCT members.

Publications:

The views of the QSPI would be expressed with the caveat that their views do not necessarily represent the views of the SCT. If the QSPI wishes to publish a paper that could be interpreted as representing the views of the SCT, this paper would need to be reviewed by the SCT President, and/or his designees, before submission for publication.

Day-to-Day Functioning:

The QSPI is organized and run by volunteers, and is functionally self-sufficient. It will not require any resources from the SCT.

Diversity:

The QSPI will strive to foster diversity in membership and leadership across:

  • Geographical locations:
  • Type of industry (pharmaceuticals, biotech, CROs)
  • Areas of specialty (e.g. clinical statistics, non-clinical statistics, statistical programming, data management)

QSPI working groups will be staffed with the best available talent, regardless of affiliation (industrial, academic, or otherwise.)

Governance:

The QSPI will consist of a core group (CG) and an extended, general membership. The CG will consist of a chair, a vice-chair, a past-chair, an advisor, and representatives from clinical statistics (6), non-clinical statistics (3), statistical programming (3), and data management (3).

In order to maintain relevance in the Pharmaceutical and Biotechnology Industries, the membership of the QSPI core group will be elected by companies in these industries. However, the slate of candidates will be presented to SCT President for review and approval before the elections begin.

The CG members will be elected for three-year terms in annual staggered elections. The vice-chair is elected by the CG for a two year term and will replace the chair upon the end of his/her term. The chair will have a two year term, at the end of which she/he will continue in the CG in sequential two year terms as the past-chair, and then as an advisor. A recorder will be elected by the CG on an annual basis.

Disassociation:

In recognition of the interdependence of the SCT and QSPI, the disassociation of the QSPI from the SCT can only take place after three months advance notice from either party.


Meetings for 2014:

March 07, 2014 QSPI/FDA Summit at FDA White Oak Campus

Dec 08, 2014 QSPI F2F Meeting 12:00 PM – 5:00 PM (EST)

Leadership:

The following individuals are the Leaders and Members of this group

Working Groups:

  1. Benefit Risk Working Group (BRWG)
  2. Open Source Working Group
  3. MRCT Consistency Expert Group
  4. MRCT Defining Region Expert Group
  5. Scientific WGs


Disclaimer:

QSPI comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate the parent Companies or Institutions of the individuals. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of their respective Companies or Institutions or the Society for Clinical Trials, the employers of the individuals involved or any of their staff.

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