From Small Data to Big Data, from
RCT to RWE, the Impact of Statistics

September 23–25, 2019
Washington Marriott Wardman Park

Submit a Proposal

Parallel Session, Short Course, and Town Hall Proposal Submissions
November 13 – December 14, 2018

This year, up to eight half-day short courses will be available at the workshop, though full-day short courses may be considered.

Roundtable discussion topic proposals will be accepted between January 22 and March 29, 2019.

Poster proposals will be accepted between January 22 and April 12, 2019.


Workshop Guidelines

When inviting speakers for your session, please keep in mind that parallel sessions are only 75 minutes in length (plenary are 90 minutes). Plan for no more than three speakers for a parallel session, two speakers plus a discussant, or two speakers plus a small panel.

To encourage a diverse set of presenters, the following restrictions will apply. These should be communicated to speakers, so they do not inadvertently accept too many invitations.

Each individual may do any or all the following activities labeled (a), (b) or (c):

(a) Parallel sessions
1. Organize up to two sessions or have any other active role (see below #2–5) in up to two parallel sessions:
2. Chair† one session, which can be a session they organized
3. Give a presentation in one session, but not in a session for which they are serving as chair
4. Serve as a panelist in one session, which could be in the same session in which they present
5. Serve as a discussant in one session, but not in the same session in which they present or chair

(b) Roundtable leader
Lead one roundtable discussion

(c) Short course teacher
Teach one short course

Under (a), a person cannot hold multiple roles within one session. For example, one person cannot serve as both the chair and a speaker in the same session. However, the session’s organizer may serve as a presenter, discussant, panelist, or chair in that session, but not more than one of these roles.

The chair is responsible for keeping time for each presentation, introducing the speakers, and starting and ending the session on time.

For example, it is possible for the same person to do at most the following: organize one session, be the chair of that session he/she organizes and be the presenter in another session, lead one roundtable, and teach one short course.

Plenary session: Being a speaker or panelist of a plenary session is considered being invited, and therefore exempted from the rules above. It can be done in addition to any of the roles in (a), (b), and (c).

Diversity: To ensure diversity of speakers’ affiliations, every session must have at least one presenter from industry and one from the FDA. A speaker from academia is ideal, but not required for all sessions. If two or more speakers/panelists are from industry, they must be from different companies.

Short Course Proposals Submission Guidelines

The content of short courses may involve topics relevant to workshop attendees, including statistical methods, quantitative and data science, career development, regulatory science, and drug development.

The short course proposal should include the following:

  1. Course Title
  2. Name(s) and Address(es) of Confirmed Instructor(s): Email and phone numbers should be included, as well. A contact person should be identified if there are multiple instructors.
  3. Abstract: Provide an abstract not to exceed 300 words. A brief course outline could be included if the submitter thinks it will be helpful in evaluating the proposal. The number of words in the outline is not counted for the word limit.
  4. Instructor(s) background: Provide a paragraph highlighting the instructor’s background and experience with the subject, including teaching experience and a short list of related publications, if relevant.

The selection process is competitive, as the venue can accommodate fewer than half the number of submissions we expect to receive. A workshop steering committee sub-team may pre-approve a small number of courses based on the degree of current importance of its topic, its relevance to workshop attendees, and the quality and thoroughness of the abstract and/or course outline submitted. Some proposals may be dismissed if the content is not relevant to the workshop or the proposal is insufficient. However, the selection will largely be based on the ranking of proposals by vote of the full workshop organizing committee early in 2019.

Tips for Writing a Proposal

The text portion of your submitted proposal should include a paragraph or two explaining the topic/concept, including a description of why this session would be relevant and important. Has this topic been presented in conferences before? If yes, why should this material be presented again? Proposals that include novel and important information, especially if not previously presented at this workshop, will be given a higher priority for acceptance. Often, several proposals are submitted for popular topic areas (e.g., adaptive designs and oncology). Make your session proposal stand out by describing how it would be different from others in the same general topic.

Names of potential speakers may be included in the proposal, even though they need not be contacted. If speakers are contacted about the possibility of speaking, it should be made clear to those contacted that the session has not yet been finalized or accepted.

Please note that a person cannot be both a chair/organizer and a speaker/discussant in the same session. Proposals submitted not following this guideline will still be considered and may be accepted with the expectation that the final session will follow this guideline.

Parallel Session Approval Process and Voting

Organizers submitting similar proposals may be contacted prior to the voting about merging their ideas into one proposal. Organizers may choose to keep their session proposals separate, but combining may increase the chance of one being selected. Note that steering committee members also may submit session proposals, but not for topic areas they are responsible for reviewing.

An important step in maintaining the value of this workshop is that additional organizers are assigned to aid every original session proposer to achieve a balance of speakers. This usually results in 3–4 session organizers, some from industry and some from the FDA. Because of these additional session organizers, the original session proposal can evolve somewhat, while staying true to its specific topic.

The steering committee will sort the session proposals into topic areas and perform a first round of reviews. They may preselect a few outstanding proposals for the final program and remove session proposals not meeting the submission criteria. However, most of the session proposals will be selected via voting. The authors of the proposals up for voting and the preselected proposals will be contacted by the steering committee to participate in the voting. Voting will be done electronically, and only one vote per person is permitted for any one proposal.

Key Dates

    Attend

  • September 23, 2019 – September 25, 2019
    2018 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop