Guidelines for Proposals
The ASA Biopharmaceutical Section recognizes the value of cross-community efforts in advancing statistical and regulatory science. To enable this, the executive committee encourages members to submit research topics that contribute to the goals of advancing the science, enabling innovation, and leveraging the expertise of the broad membership affiliations of the section. Members are encouraged to submit proposals to the Scientific Working Group Proposal Committee for review and if appropriate, subsequent consideration by the section executive committee. The proposal should be formal in nature, so that, if acceptable, it can be used as the basis of a scientific working group charter, and it should include at a minimum the following items as part of a submission (additional information beyond the bulleted items presented here is welcome):
- Who is proposing it?
- Topic and primary goal of the scientific working group
- Why is this an important topic to research (e.g. potential impact)?
- Why is this an appropriate topic for ASA Biopharm Section sponsorship?
- Are there any other known scientific working groups currently addressing this topic? If yes, what unique values will this SWG bring? If yes, please discuss potential opportunity for linkage to another group if other groups already exist. If “don’t know”, please state how you will follow-up to make sure there is not a redundancy in the statistical community.
- Estimate of the initial # of members for the working group, and if any non-statistician consultants will be part of the effort.
- How long will do you anticipate it will take the group to reach its goals?
- Is financial support needed from BIOP?
- What will be the best avenues of communication to advertise the efforts, accomplishments, papers, presentations, etc. of this SWG?
It is also important to include the name(s) of the chair/co-chairs of the group, who should be chosen through an election of the scientific working group members. For example, sponsor(s) of a proposal can put together a list of members of the working group, but once the proposal is approved, an election among the scientific working group members should be held to choose the working group chair(s) from among the group's members. While the working group can continue to work as long as it has a charter approved by the Section, the Section has imposed a time limit for scientific working group chairs of no more than three years with a possibility of a one-term extension via election within the working group, consistent with the rules applied to all committee chairs within the section.
Scientific Working Group Annual Health Check Form can be found here.