PRELIMINARY CONCEPT DEVELOPMENT

1. An idea for a trial is proffered within a scientific committee, by an individual or entity from outside of ACRIN, or by the ACRIN Advisory Panel or Steering Committee.

Any individual or entity may suggest an idea for a clinical trial and have it considered by a disease site committee.
 
2. The idea is considered by the appropriate disease site committee, which decides either to develop the idea into a preliminary concept or to reject it.

Decisions are based on whether the idea is important, consonant with the committee’s strategy, and, in prospect, likely to result in a successful trial.
 
3. The disease site committee appoints key individuals to develop the idea into a preliminary concept.

A preliminary concept includes the key hypotheses to be addressed, basic projections of the technologies and methods to be employed, the basic trial design, and a rough estimation of sample size. The ACRIN Preliminary Protocol Concept
Development template provides the structure for reporting this information.

4. The individual appointed by the disease site committee to be responsible for concept development presents the preliminary concept to the ACRIN Steering Committee for preliminary approval.

The Steering Committee decides whether to move forward with further development of the concept based on whether the concept is consonant with the Network’s strategy, its importance in competition with other trials that might present themselves, and the availability of resources to support trial development and implementation

Preliminary Concept Development Template for Oncologic Trials
Preliminary Concept Development Template Oncologic Trials [DOC]