What kinds of Phase I applications are the Novel Clinical and Translational Methods Program looking for?
The basic idea of the Novel Methods Pilot Awards is to support investigators who can’t proceed on a clinical or translational research question for the lack of an appropriate method. Developing that method may be a relatively minor matter (i.e. may cost under $25,000), but the initial investigator lacks the expertise to solve the problem themselves. Our goal is to bridge the need-expertise gap to help develop that novel method. One of our central tenets is that the breadth of novel method possibilities is tremendous, ranging from a new lab test to a statistical technique, to a new software program, to...
A small group of individuals, no matter how well intentioned, can’t identify all the novel methods needs, so Phase I of our process is to ask investigators what novel methods they need. A responsive Phase I application would be presented in terms of a research question which the requesting investigator can’t pursue because of the lack of a method that the Phase I investigator him or herself don’t have the expertise to solve.
What is the role of the Phase II applicant?
The NCTM committee will review and rank Phase I requests, releasing the highest quality Phase I applications as a specific RFA for Phase II. The Phase II RFA will look to the general CCTSI community for proposed solutions. It may be that the Phase I investigator has already talked to someone who may be in a position to provide the optimal Phase II proposal however; the RFA is open to any CCTSI member who wants to compete for the chance to solve the methodological problem.
Does the Phase I application need a budget?
The Phase I investigator does not receive funding, but, if supported by the NCTM program, should get the novel method they need. The Phase II proposal will receive a $25,000 award to help the Phase II investigator develop the method and then provide that solution to the Phase I investigator. Thus, the Phase I investigator doesn't have a budget, but the Phase II investigator does.
Can an investigator submit a Phase II application to solve their own Phase I request?
No. The NCTM is intended to support investigators who do not themselves have the expertise to solve their own methodological problem. Investigators needing financial support to solve their own methodological issues should consider requesting support through one of the other CCTSI Pilot Programs.
What type of relationship between Phase I and Phase II applicants is considered an established relationship?
The review process will favor proposals where there is not an already established relationship between the Phase I and Phase II investigators. An established relationship is defined as two individuals who share grant support or have a notable history of co-authored publications. Having talked with an individual about a specific topic at one point is not an established research relationship.