SWOG External Translational Medicine Proposal and Application Process

This webpage provides information for the proposal and application process for translational medicine proposals requesting utilization of specimens from SWOG-led trials that do not appear in the NCTN Navigator System (most SWOG-led Phase 2, some Phase 2/3, and older Phase 3 studies), with the exception of the Prostate Cancer Prevention Trial (PCPT) and Selenium and Vitamin E Cancer Prevention Trial (SELECT) trials.

In order to encourage, optimize, and prioritize the use of the specimens banked via legacy studies, SWOG invites applications for its use through the process outlined below. It is hoped that making these tissues widely available will help advance research and collaboration.

It is advised that SWOG investigators develop the correlative science proposal in consultation with the relevant disease committee including the translational medicine chair(s), statistician(s), and committee chair(s).

For more information about biospecimens and their associated data elements from SWOG-led clinical trials, please see: Clinical Trials Search | SWOG.

Purpose

SWOG Policy 39: Acquisition, Maintenance and Use in Research of Tissue and Other Biologic Patient Specimens is designed to ensure compliance with current NCI guidelines for specimen banking from cooperative groups while making SWOG specimens available to a broader research base. The goal of this process is to obtain a commitment for the use of available materials.

Eligibility

Investigators within SWOG as well as external investigators are welcome to submit a proposal for consideration. Please note for SWOG investigators, translational medicine proposals which are not integrated into the original clinical study protocol should be submitted in accordance with this process.

Specimen Availability

To confirm the existence and availability of specific biospecimens: Complete the SWOG Biospecimen Query Form and submit to biospecimens@swog.org.

Proposal Submission Process

After confirmation of biospecimen availability, complete the Proposal for an External Translational Medicine Study and submit to translationalmedicine@swog.org.
In the event that the translational medicine proposal is requesting utilization of slide images alone (and does not involve retrieval of actual physical specimens), complete the Data Request Template and submit to translationalmedicine@swog.org.

Proposal Review Process

The SWOG Executive Review Committee will review the proposal, and an outcome letter will be communicated to the applicant via email.
After full SWOG Executive Review Committee approval is obtained, the Protocol Project Manager for the respective disease or research committee will provide instructions for obtaining NCI approval for use of the specimens for translational medicine objectives external to the primary clinical trial.

Distribution of specimens

The release of samples from SWOG biorepositories will be authorized after the following have occurred;

Material and/or Data Use Agreement(s) are executed,
Funding is secured and any associated funding contracts are executed,
Documentation of IRB approval for the project is provided.

Questions

For questions or clarification: Contact the SWOG Network Operations Center (NOC) in San Antonio via Email: translationalmedicine@swog.org or at 210-614-8808.