Frequently Asked Questions:
Investigator Initiated Studies (IIS)
The application process begins with the Concept. Click Register/Sign In to register for an account within the AbbVie portal, or to log into your registered account. Enter the requested Concept details into the AbbVie portal and submit the information. Once submitted, a tracking number will be assigned to the proposal.
A Concept is a synopsis of your study that will be reviewed by the AbbVie IIS Review Committee. It has specific sections (objective, hypothesis, primary and secondary endpoints, etc) that will provide the elements necessary to allow our review team to assess if the Concept may meet our requirements for scientific merit, alignment with our areas of research interest, and available funding. A full Protocol describes the objective(s), design, methodology, statistical considerations, and organization of a study and aligns with the requirements outlined in the ICH E6 Guidelines. Final assessment of scientific merit and alignment with our areas of interest is based on the review of the protocol.
Concepts are collected over a defined period and reviewed by the review committee. You can expect to hear back from AbbVie within 10 business days following the review meeting.
The AbbVie IIS Review Committee meets approximately monthly to review submitted protocols. You can expect to hear back from AbbVie within 30 days following the review meeting. The date you submit your protocol will affect its addition to the next meeting agenda. Protocols received less than 2 weeks prior to the submission deadline may be deferred until the following month.
AbbVie works with alliance partners in the review of IIS proposals for some compounds (e.g., Venetoclax (ABT-199). In these cases, reviews may follow a different timeframe that has been agreed upon by AbbVie and the alliance partner. Expectations to hear back on the status of your proposal will be communicated to you by an AbbVie representative.
Yes. The AbbVie IIS Review Committee applies the same review process for all clinical proposals. Proposals may request product only, funding only, or both product and funding. A full protocol, as described in the response to Question #2, is not required for preclinical proposals.
It is recommended to follow the Application Process and first submit a Concept. A Concept is a synopsis of your study that will be reviewed by the committee. Therefore, if the Concept is rejected, you will not have spent a significant amount of time developing the Protocol. If the Concept is found to be of interest, the committee will request a full protocol for further review, which may or may not be accepted for approval.