Quantum Leap Healthcare Collaborative

Proposal Submissions

Widely hailed as the future of phase II drug development, the adaptive I-SPY2 platform trial has set a new benchmark for efficiency, through innovation in trial design and clinical operations.

I-SPY2 accepts proposals from investigators interested in accessing I-SPY data or clinical specimens for original research. The following information describes the general requirements, application process and review processes. Interested applicants should familiarize themselves with this information prior to submission.

General Information

  • To receive trial data or biospecimens, an investigator must fill out a Concept Proposal Form.
  • The development of a concept proposal generally involves a number of discussions with the I-SPY 2 DAPC Program Manager, relevant I-SPY 2 Working Group Chairs, and I-SPY 2 Data Managers and Statisticians. These individuals will evaluate a concept for its feasibility in terms of data and sample availability, scientific merit balanced against other proposals and initiatives, and any contracting or budgetary requirements.
  • After a submitter completes a concept proposal, the concept is discussed and evaluated at the relevant monthly I-SPY 2 Working Group meeting (Biomarker, Safety, Quality of Life, etc) and is an opportunity for the investigator to present preliminary data and refine concept proposals.
  • Finalized concepts are evaluated by the I-SPY 2 Data Access and Publications Committee (DAPC) before any further action is taken. This meeting is approximately once a quarter. Once the DAPC approves a concept, the I-SPY 2 DAPC Manager will provide information about timelines and the method of execution.
  • Note: Arm-specific data and biospecimens are not available until the investigational agent is no longer active in the trial and its results have been publicly published.

Data-Only Requests

  • Requests for data should be submitted using the standard I-SPY 2 Concept Proposal Form. There are I-SPY 2 statistical templates available and I-SPY 2 statisticians available for consult. Data is only released once an arm has left the trial.
  • The statistical plan should be as detailed as possible.
  • The request for data variables and time points should be specific, clear, and concise.
  • At this time, standard assay data is only available at the T0 time point, except for RNA-seq data which has been performed in the veliparib arm in 2 time points.
  • Concepts can request specified data for future arms as it becomes available.
  • Before data release, all investigators and their institutional representative requesting data are required to sign the I-SPY 2 Data Use Agreement following approval of their concept.

Requests for Biospecimen and Derivatives

  • Access to patient biospecimen or derivatives in a concept requires approval from both the I-SPY 2 Biomarker Working Group and the I-SPY 2 DAPC and must be weighed against the priorities for the trial.
  • If a biospecimen is requested, in addition to data, all investigators and their institutional representative will be required to sign and develop an I-SPY 2 Research Collaboration Agreement.
Concept Proposal Form
MS Word (217 kb)