Developing an ETCTN Study

The initial concept for an ETCTN clinical trial is either developed by a Drug Development Project Team consisting of Project Team Member Applicants (PTMA) or it begins as an unsolicited Letter of Intent (LOI).  The major steps in the review process are outlined in the diagram below.  Click on any one of the steps for more information. 

A flow diagram detailing the entire ETCTN study development and activation process can be found here.

To expand support for ETCTN studies, a US laboratory network capable of providing centralized, robust assays was established. The National Clinical Laboratory Network (NCLN) will offer validated assays following harmonized SOPs while implementing uniform assay workflow, instrumentation, and data analysis across network labs. The NCLN will feature a centralized specimen biorepository and the support of centralized data reporting.

To access the NCLN, an investigator can request collaboration with the NCLN in their Letter of Intent (LOI). As part of an LOI review, CTEP might also recommend use of the NCLN. The specific NCLN assays to be performed for a trial will be agreed upon by a consensus process among the trial investigators, the NCLN laboratories, and CTEP. This process will happen in parallel with drug commitment. The use of the NCLN is voluntary. The alternative option of an entirely investigator-driven biomarker plan, through BRC review if necessary, is still completely open.

Utilizing the NCLN, provides such benefits as world-class laboratory collaborators with state-of-the-art platforms. Assays will be performed at the NCI’s expense with no need to identify a funding source. Validated SOPs and workflows, including biorepository support, are already in place.