Ancillary study proposals are defined as projects that involve the collection of new data directly from patients or from clinical investigators, or new biologic samples. Analysis of existing data, existing biological samples, and the resulting publications are the purview of the Working Groups and the Publications Committee, and can be requested using the process of preparing and submitting an analysis concept proposal (see Concept Proposals).
Purpose
The CCSS cohort is a unique resource to be used widely to facilitate the conduct of high quality research. Concurrently, we recognize the importance of protecting the integrity of the cohort and the need to avoid excessive contact of the cohort with low-priority requests. The overall objective is to achieve an appropriate balance between future demands made upon the cohort members and feasibility research needs.
Criteria for Use of the Cohort
All proposals for ancillary studies must fulfill four overarching criteria:
- the proposed research addresses a key question on the etiology, therapy, follow-up, survival, etc. in childhood cancer or on the health of offspring of survivors;
- this is a unique opportunity - i.e. a question that is either only answerable, or best answered, using the CCSS cohort;
- the proposed methodologies must be state-of-the-art; and
- the proposed research team has outstanding qualifications to conduct the research to address the hypotheses of the proposed study.
Who Can Use the Cohort?
Proposals to utilize the CCSS cohort can be submitted by any investigator, regardless of their direct involvement in the CCSS. The objective is to ensure that the most scientifically important hypotheses are addressed, by the most qualified investigators. Prior to submitting a proposal, investigators will be encouraged to discuss their research plan with the CCSS Principal Investigator, appropriate Working Group Chair(s), and the CCSS Statistical Center.
Process for Submitting an Ancillary Study to CCSS
There are two kinds of proposals a) pilot studies with funding in hand, and b) larger studies for which funding will be sought. In both cases, CCSS must be the most appropriate resource for the ultimate question.
As a first step an investigator should submit an Application of Intent (AOI). The CCSS Steering Committee will review the AOI and determine the appropriate Working Group assignment.
Investigators proposing an ancillary study will need to be teamed up with a member of relevant Working Group or other CCSS investigator for input on both science and CCSS process. The full proposal will be written and submitted to the Steering Committee via the CCSS Principal Investigator or other route. The opinion of the chair of the relevant Working Group will be sought. S/he will consult with other WG members with appropriate expertise and they will render a joint recommendation that will take into account:
- quality of the ultimate scientific question and methods,
- impact on cohort members,
- impact on CCSS resources,
- uniqueness of the capacity of CCSS to answer the ultimate question.
Review of Proposals
The following procedure will be employed for review of proposals:
- An initial 3-page brief proposal, describing the study and identifying why the proposal fulfills the overarching criteria, will be submitted to Dr. Robison (include Aims, Hypothesis, Methods and Relative Background).
- The proposal will be reviewed by the CCSS Steering Committee and ad hoc reviewers with specific expertise relevant to the grant if needed.
- The outcome of this initial review will be either "Rejected" or "Preliminarily Approved". The Working Group chair responsible for the proposal will report its decision to the CCSS PI.
- Proposals that receive preliminary approval will then need to be expanded into a NIH-style proposal.
- These final proposals will always include:
- a clear description of how the additional data or samples will be collected (usually via the CCSS Coordinating Center - and, if not via the Coordinating Center, a clear rationale for a different approach);
- a clear description of how the Statistical Center will be involved in the proposed ancillary study including involvement of the senior statistician; and
- a budget that covers these ancillary study-specific costs.
- The detailed (NIH-style) proposals will be reviewed at a teleconference by the Steering Committee.
A decision will be rendered on the proposal as follows:- approved
- approved following specified modifications
- not approved but with agreement to reconsider a revision
- not approved
- Approved proposals that are then submitted to a funding agency will be accompanied by a letter guaranteeing access to CCSS cohort members. In situations where funding has not been secured, approval will be re-reviewed on an annual basis and the project either renewed or discontinued.
