The Cooperative Group Clinical Trials Program recognizes the importance of translational medicine projects with the aims of better understanding patients' prognoses, predicting response to specific therapies, and better understanding of basic sciences.
The specimens available from SWOG specimen banks are a limited and unique resource. In order to encourage, optimize, and prioritize the use of this resource, 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.
Purpose This policy 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.
To Apply for Use of Biospecimen Resources To confirm the existence and availability of specific biospecimens, complete the SWOG Biospecimen Query Form and submit to firstname.lastname@example.org. Once you have received confirmation about biospecimen availability, complete the Proposal for an External Translational Medicine Study and submit to email@example.com. Contact the SWOG Operations Office at 210-614-8808 for clarification or to obtain forms.
It is advised that SWOG investigators develop the correlative science proposal in consultation with the relevant disease committee including the translational medicine chair, statistician, and committee chair.
SWOG members may view the Translational Medicine Tracking Spreadsheet which shows the status of TM studies, from proposal submission through publication.
More information about the PCPT and SELECT biorepositories and their associated data elements is available at swog.org/select and swog.org/pcpt.
Your proposal will be reviewed based on clinical and scientific import, preliminary data, statistical support showing feasibility, and demonstration that use of this unique and limited resource is crucial to the research proposed.
Once received, your proposal will be reviewed by the relevant disease committee chair if it is unclear that it has been approved within the committee already. With Committee Chair approval, a SWOG Review Committee ("Triage"), which has a standing weekly teleconference, will consider your proposal. That committee's decision will be communicated to the applicant via email or fax. Additional approvals may be required if the treatment study was part of an intergroup trial.
The authorization for use of specimens is not considered final until the applicant enters into a Specimen Use Agreement, agreeing to standard procedures for data analysis, data confidentiality, authorship, and intellectual property sharing.
Proposals which are not approved may be resubmitted if concerns are addressed or circumstances become more favorable.
Funding for proposed work is not part of this application process or approval consideration. Funding does not need to be applied for or obtained in order to submit a proposal. However, funding must be obtained for the proposed work in order for materials to be released. If funding is not obtained within a year of SWOG Review Committee approval, your proposal will be re-reviewed and approval may be withdrawn.
Distribution of specimens
The release of samples from SWOG biorepositories is authorized by the SWOG Tumor Bank Director once the following have occurred;
- A Specimen Use Agreement is signed by all parties
- Funding for the proposed work is obtained
- Evidence of IRB approval for the project is provided.
SWOG Policy 39 outlines this application process and provides additional information.
For questions or comments regarding this process, contact the SWOG Operations Office at 210-614-8808 or email firstname.lastname@example.org.
Other Biospecimen Resources
Applicants whose request for biospecimens is found not to be within the scope of SWOG clinical research may wish to consult Human Biologic Specimen Resources for Cancer Research for additional resource information on research involving biospecimens.