Research Group Review
Over the past year, Dr. Paul Martin has worked with Consortium leadership to formalize the process of prioritizing clinical trials within Research Groups. As of December 1, 2013, a preliminary evaluation by the appropriate Research Group will be required prior to SRC review. All new clinical trials subject to SRC review should be formally evaluated during a regularly convened meeting of the Research Group.
Possible outcomes of the evaluation include a recommendation to submit the protocol to the SRC, to request revision and reevaluation by the Group, or to withdraw the protocol from further consideration. Documentation of the group’s assessment is communicated to the SRC to inform the SRC in its review.
The goal of formalizing this review is to ensure Research Groups prioritize trials for their patient population, to reduce the number of studies that are low-accruing due to competing trials and to satisfy the NCI’s expectation of a disease group-specific prioritization process.
Frequently Asked Questions
Does my study need Research Group Review?
Any proposed cancer clinical protocol that is subject to SRC review must first receive the endorsement of the relevant Research Group.
When does this requirement start?
Starting December 1, 2013, completion of Research Group Review will be required before protocols are submitted for SRC review.
Who are the Research Groups?
The Cancer Consortium has 14 established Research Groups:
|Research Disease Groups||Research Group Director|
|1. Breast Oncology||1. Julie Gralow|
|2. Gastrointestinal Oncology||2. Gabriela Chiorean|
|3. GU/Prostate Oncology||3. Pete Nelson|
|4. Gynecologic Oncology||4. Barbara Goff|
|5. Hematologic Malignancies||5. Ajay Gopal|
|6. Head and Neck Oncology||6. Renato Martins|
|7. Lung and Thoracic Oncology||7. Renato Martins|
|8. Melanoma, Renal, Merkel Cell|| 8. Scott Tykodi
|9. Neurologic Oncology||9. Jason Rockhill and Maciej Mrugala|
|10. Sarcoma||10. Robin Jones|
|11. Pediatric Oncology|| 11. Scott Baker
|Research Modality Groups||Modality Group Director|
|12. Hematopoietic Cell Transplantation||12. Frederick Appelbaum|
|13. Phase 1 Clinical Trials||13. John Thompson|
|14. Immunotherapy||14. Stan Riddell|
What is the process for Research Group Review?
The Director and other leaders of each Research Group are free to use the process that is most appropriate for the group.
How is Research Group review documented before a protocol is submitted to the SRC?
At the conclusion of the Research Group review, the Group Director or an authorized proxy must complete a form titled Research Group Information Summary for SRC. The form, managed by Clinical Research Support (CRS), is then given to the investigator or study team to include with the package submitted to CRS.
How do I know which Research Group is most appropriate for my protocol?
In most cases, the affiliation or membership of an investigator to a Research Group will be obvious (i.e., a breast cancer study will be seen by the Breast Oncology Group).
In cases where the investigator or protocol does not have a clear membership or affiliation with a Research Group, the investigator may complete the Research Group Information Summary for SRC.
In ambiguous cases, please contact CRS at CRScustomerservice@fhcrc.org.
What if my protocol involves more than one group?
If your protocol involves more than one Research Group, you should consult with the Directors of the most involved groups to decide which one should serve as the primary group. Only one completed evaluation form is needed for SRC submission.
If a protocol involves both disease and modality groups, both groups should review the protocol. Evaluation by the Modality Group should be provided to the Disease Group for its consideration. The Disease Group will provide final evaluation for submission to SRC.
Can Research Group Evaluation occur simultaneously with SRC Review?
Research Group Review must occur before scheduling the SRC review. These reviews will be sequential and not concurrent. A new study submission will not be scheduled for SRC review until the completed Research Group Information Summary for SRC is submitted.
Will a grace period be allowed for the new review process?
Starting December 1, 2013, completion of Research Group Information Summary for SRC will be required before protocols are submitted for SRC review. No grace period will be allowed with this launch date for the new review process.
How do I schedule a study for Research Group Review?
Research Group reviews are scheduled directly with the groups themselves. Program Assistants in each Research Group can provide the meeting schedule and help with review requirements.
What is needed for SRC submission?
The investigator or study team is responsible for including the completed Research Group Information Summary for SRC with the study submission to CRS for SRC review. It is expected that any changes requested by the Research Group have been incorporated into the study documents prior to submission to CRS. As such, SRC will be reviewing the final versions of the study documents accepted by the Research Group.