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Research Overview

Disease Site Group Policies and Procedures
DSG CHARTER V4 | 12/01/2025

For additional clarification regarding the Disease Site Groups (DSGs) or for the DSG submission forms, please contact dsg-support@cancer.ufl.edu.

Overview

The University of Florida Health Cancer Institute (UFHCI) has developed a systematic and organized process for the review and conduct of cancer-relevant clinical trials. This system supports multi-level reviews of all trials to ensure they receive appropriate consideration in the areas of clinical alignment, feasibility, scientific merit, and Catchment Area (CA) impact, as defined by the UFHCI. The groups and committees comprising UFHCI’s Research Oversight System (ROS) work together to provide a complementary review, but each has a distinct and clearly defined role. These reviews result in a thorough evaluation for each clinical trial to determine alignment with overarching UFHCI strategic objectives. The likelihood of successful completion of each trial is maximized through the DSG review process.

A component of the UFHCI ROS are the Disease Site Groups (DSGs) that each provide an integrated, multidisciplinary approach to guide the selection and endorsement of high-quality cancer clinical trials. They are charged with establishing a portfolio of studies that serves the needs of individuals within the CA through deployment of the framework described in this document.

Each DSG has at least one designated clinical and research leader while the Cancer Control Population Sciences DSG and Experimental Therapeutics Group DSG have research co-leaders. DSG leaders are appointed by and serve at the discretion of the UFHCI Director. The DSGs routinely meet (minimum 6 times per year) to review all new and ongoing studies under their purview. All new interventional trials must be reviewed and endorsed by the applicable group of record prior to submission to the SRMC as a component of NCI required first-stage scientific review. For example, any clinical trials conducted exclusively in a breast cancer patient
population must be vetted through the breast DSG.

These functional units of UFHCI clinical research are organized into 10 disease-specific groups and three disease-agnostic groups for a total of 13 DSGs. Disease-specific DSGs are defined as groups that target one disease area, while disease-agnostic DSGs are defined as groups that target two or more disease areas OR conduct population sciences research across the cancer control continuum.

  1. Breast
  2. Cutaneous
  3. Gastrointestinal
  4. Genitourinary
  5. Gynecologic
  6. Head and Neck
  7. Malignant Hematology
  8. Neuro-Oncology
  9. Pediatric
  10. Sarcoma
  11. Thoracic
  12. Cancer Control and Population Sciences
  13. Experimental Therapeutics Group

DSGs are responsible for ensuring that adequate resources are available to support proposed clinical research studies. The sponsoring DSG Research Leader must attest to the projected annual accrual, allocation of UFHCI Clinical Research Office (CRO) resources, presence or absence of competing studies, CA impact, and overall endorsement of support from the group. Metrics including, but not limited to, studies declined and endorsed, accruals, and attendance will be reviewed twice per year as a component of DSG productivity and effectiveness.

Scope of Application

All interventional cancer-relevant clinical trials at the UFHCI must be reviewed and approved by their respective primary DSG prior to initial review by the SRMC. UF uses the following definitions:

  • Interventional study: A study where individuals are assigned prospectively by an investigator based on a protocol to receive specific interventions. The participants may receive diagnostic, treatment, behavioral, or other types of interventions. The assignment of the intervention may or may not be random. The participants are followed and biomedical and/or health outcomes are assessed.
  • Cancer-relevant study: A study that specifies enrollment of individuals with a known or suspected cancer diagnosis as part of the eligibility criteria, or that includes research endpoints related to cancer, its symptoms, or established risk factors such as tobacco use, viral infections (e.g., hepatitis, HPV), obesity, and other factors. Another way for a study to be cancer relevant is if the local principal investigator (PI) plans to exclusively enroll current, former, or potential cancer patients into the study.

Non-interventional cancer-relevant clinical research can also be reviewed by a DSG to promote awareness of the study but are not required to be endorsed by the DSG prior to SRMC submission.

DSG Leadership and Members

Leadership

The UFHCI Director is responsible for approval of the formation of each DSG and their leaders. Each DSG is co-led by a faculty team consisting of a clinical leader and a research leader, supported by a multidisciplinary roster of attendees. The DSG research leader reports to the UFHCI Associate Director for Clinical Research (ADCR) while the DSG clinical leader reports to the UFHCI Associate Director for Medical Affairs (ADMA). DSG leadership positions are reviewed annually by the Director, Deputy Director, Associate Director for Administration, and ADCR. Leadership terms are for three years, renewable upon the Director’s re-approval.

  • Research Leader Qualifications:
    • Established record in clinical or translational cancer research.
    • Demonstrated history of externally peer-reviewed grant funding or oversight of investigatorinitiated, cooperative group, and/or industry sponsored clinical trials.
    • Capacity to collaborate effectively with clinical leaders to align research with patient population and catchment area needs.
    • Capacity to support research staff and other professionals involved in the successful conduct of high-quality, interventional, cancer therapeutic trials.
    • Ability to secure and advocate for resources to support the successful deployment of research in clinical settings.
    • Research expertise that complements the breadth of disease sites and scientific priorities represented within the DSG.
  • Clinical Leader Qualifications:
    • Physician with an active clinical practice in the disease site area.
    • Demonstrated record of participation in and support for clinical trials.
    • Experience in multidisciplinary cancer care and patient management including focus on quality assurance metrics and/or regulatory requirements for external accreditation.
    • Ability to represent the DSG across institutional and external forums.
    • Clinical expertise that balances across modalities (medical, surgical, radiation oncology) and subspecialties relevant to the DSG.

DSG Members

DSG members come from and represent various academic and clinical departments that are engaged in cancer research. To ensure a multidisciplinary perspective, the DSG composition includes a broad range of specialties, including but not limited to basic science, medical oncology and hematology, pathology, radiation oncology, radiology, interventional radiology, laboratory research, surgery, and population-based science. DSG member attendance is maintained by the DSG leaders in conjunction with CRO support staff.

DSG membership is voluntary, open and inclusive. All DSG members are expected to review and participate in the discussions related to proposed and ongoing trial activities. However, DSG leaders have the responsibility to identify key stakeholders who serve as voting members on topics related to clinical trial portfolio management. These key stakeholders are expected to attend the majority of meetings held throughout the year.

DSG meeting attendees are disease-focused (or for CCPS, thematically research-focused) and may include:

  • Clinical and Non-Clinical Faculty
  • Clinical staff involved in research (e.g. advanced practice providers, nurses, navigators)
  • UFHCI staff & administrators

Responsibilities

The DSGs have the responsibility to review all interventional cancer-relevant clinical trials at the UFHCI, or otherwise supported with institutional resources, prior to initial review by the SRMC.

All DSGs are responsible for the following:

  • Creation and maintenance of a clinical research portfolio, tailored to the needs of individuals within our clinical and CA populations, that is capable of supporting the DSG’s treatment accrual goals;
  • Review and endorsement of initial study concepts for UF investigator-initiated trials (IITs);
  • Review and endorsement of all new interventional trials which are proposed for activation prior to Scientific Review and Monitoring Committee (SRMC) submission;
  • Collaboration with a multi-disciplinary team including individuals such as investigators within the DSG, UFHCI Research Program members, clinical teams, Community Outreach and Engagement (COE) staff and clinical research staff to assess trials for resource utilization, feasibility, CA impact, and ability to integrate the research components of each study with clinical algorithms or pathways;
  • Ongoing review and internal prioritization of the interventional clinical research portfolio, including thorough assessment of accrual rates for existing trials;
  • Optimization of population subgroup recruitment focusing on efforts to improve gender and racial/ethnic diversity and inclusion across the lifespan, with particular emphasis on the UFHCI CA;
  • Maintenance of a priority list of pending and active protocols for their clinical research portfolio;
  • Maintenance of a clinical research portfolio with diverse sponsorship so as to support sustainability of resource allocation.

DSG Research Leaders

The Research Leader for each DSG is charged with the following responsibilities:

  1. Create and facilitate a collaborative and inclusive environment across all treatment modalities, specific to the diseases served by the assigned DSG.
  2. Serve as the gatekeeper and authorizing signatory for study development and endorsement prior to SRMC submission of all disease-specific interventional research at the institution. The NCI requires that individuals with expertise in a disease or discipline be responsible for first-stage scientific review of concepts and protocols. DSG review and endorsement is intended to fulfill these expectations.
  3. Establish priorities for clinical research topics that need to be investigated.
  4. Understand the critical needs for our CA, and provide studies for high burden cancers or those that are otherwise priorities for the UFHCI’s region.
  5. Establish achievable action plans to meet annual targets and expectations for:
    • Accruals and enrollments to interventional clinical trials, with particular focus on treatment trials
    • Protocol selection in alignment with available resources
    • Letters of intent (LOIs) submitted and IIT concepts developed into full protocols
    • Protocols closed by the DSG and SRMC for poor enrollment
  6. Be innovative and supportive of IITs that are our highest priority in clinical trials research, particularly those that are treatment in classification and translational.
  7. Conduct/lead meetings amongst DSG members consistent with UFHCI policies (minimum 6 per year).
  8. Report to the UFHCI Leadership semi-annually on the following items:
    • DSG makeup, membership, and attendance/participation
    • Accrual to interventional protocols within the review period
    • Demographic-based reporting (gender, age, race, ethnicity)
    • Portfolio mix (e.g., IIT, Industry, and National studies)
    • Strategic planning with regard to portfolio coverage, competing studies, low-accruing studies, barriers to accrual, prioritizing studies, and portfolio flowcharts
    • LOI tracking, withdrawn/abandoned study tracking, and studies the DSG decided to “pass” on.
  9. Attendance is required at:
    • DSG meetings
    • DSG leadership meetings with UFHCI leaders
    • Assigned UFHCI Research Program meetings
    • At least 70% of either UFHCI Grand Rounds or UFHCI Research Seminar Series, per academic year

DSG Clinical Leaders

The Clinical Leader for each DSG is charged with the following responsibilities:

  1. Create and facilitate a collaborative and inclusive environment across all treatment modalities, specific to the diseases served by the assigned DSG.
  2. Define treatment pathways for the DSG’s major diseases by stage in UF patients by doing the following:
    • Establish these pathways in light of national guidelines, such as the NCCN
    • Foster more robust UF-specific guidelines
    • Establish a mechanism to monitor adherence to these pathways
  3. Facilitate multidisciplinary and coordinated care.
  4. Facilitate incorporation of clinical and basic research in the assigned DSG’s clinical pathways.
  5. Lead and coordinate an effective multidisciplinary tumor board for the assigned DSG that complies with the guidelines of the Hospital Cancer Committee.
  6. Serve as agents of the Hospital Cancer Committee to ensure UF compliance with the metrics determined by the various accrediting agencies (e.g., Commission on Cancer, National Accreditation Program for Breast Cancer, etc.).
  7. Responsible for the development or delegation of quality metrics important to the assigned DSG outside of national agencies.
  8. Identify a major group quality project to complete annually.
  9. Identify a major group patient experience project to complete annually.
  10. Work with stakeholders, business development, and marketing to improve market share.
  11. Present bi-annually to the Cancer ICAP on quality, patient experience, clinical pathway development, and adherence.
  12. Attendance is required at:
    • DSG meetings
    • DSG leadership meetings with UFHCI leaders
    • Assigned Cancer ICAP and/or UFHCI committee meetings.
    • At least 70% of either UFHCI Grand Rounds or UFHCI Research Seminar Series, per academic year.

Meetings and Administrative Coordination

DSGs are scheduled to regularly meet at least every other month (6 times per year). Meetings should include new study discussion(s) and review of current studies within the DSG portfolio, with overview of trials that are actively accruing, status updates, or trials experiencing issues in the clinic that could impact research.

Discussions should also include review of concepts/trials declined since the last meeting as well as gaps and opportunities within the research portfolio. Ad hoc meetings can also be called at the discretion of the DSG leaders to ensure protocol development is not impeded or to address urgent needs. Any DSG meeting or official communication can occur in-person, virtually, or through other electronic means.

In preparation for scheduled DSG meetings, meeting materials will be sent out to attendees approximately one week prior to the DSG meeting. These meeting materials may include the agenda, previous meeting minutes, the current DSG study portfolio, a summary of DSG performance, and new trial information, as applicable. Meetings where a new trial will be discussed (first-stage review) must have at least 2 DSG physician faculty members present who qualify as key stakeholders for voting purposes. Attendance will be noted during the meeting through sign-in sheet or electronic attendance indicators. A Qualtrics survey will be sent out to capture DSG endorsement or declination.

In addition to routine DSG meetings, UFHCI and DSG leaders meet quarterly, alternating between individual and group meetings. The Deputy Director, the ADCR, the Administrative Director of the CRO, and the Assistant Director of Regulatory Affairs and Compliance meet with each DSG leadership team to review its research portfolio performance, challenges, and strategic goals as part of these individual meetings. Alternating with these, the Deputy Director convenes the DSG Leadership Committee, which is comprised of the research program leaders, shared resource leaders, Center Director, Associate Director for Community Outreach and Engagement (COE), Director, Office of COE, Associate Director for Population Sciences, and the Associate Director for Basic Sciences. The Committee monitors the progress and impact of UFHCI clinical research on the CA, identifies systemic obstacles to trial initiation and accrual, receives updates from the DSGs, discusses new UFHCI resource needs or best practices, and establishes and reviews policies. These quarterly individual and group meetings are critical working components of the ROS.

Review Process

DSG review is not required for cancer-relevant clinical trials that are considered non-human or are student led projects initiated to fulfill degree requirements. The DSG research leader for each group can determine if a new study should be reviewed at the next regularly scheduled DSG meeting or through an ad hoc review process.

Concepts considered by investigators and new trials moved forward for first-stage review must be submitted to the DSG leaders and the DSG administrator prior to the meeting. The content of each submission depends on the type of review, which is detailed below.

Review Types

New Concept Review

Interventional trial concepts that necessitate use of CRO Coordinator, Data Management or Project Management Office resources should be reviewed by the IIT Think Tank Group (I2T3) prior to obtaining DSG endorsement of the concept. The aim of this review is to provide feedback to the investigator on study design, clinical impact, scientific merit, and feasibility prior to full development. The I2T3 group is comprised of investigators, statisticians, community members, and clinical research team members so that multiple perspectives contribute to the feedback collected. Feedback from this meeting is incorporated into the final concept pre-review form,
which is then submitted to the PI for incorporation into their study plan.

The purpose of the DSG new concept review is to provide feedback to the study team and establish if the protocol concept has preliminary scientific merit and fulfills the current needs for the DSG research portfolio and the UFHCI catchment area. This is not a true first-stage review since a full protocol is not available and the next step is not SRMC submission. Feedback to the study team may be provided through formal, informal, written or verbal means.

Necessary submission components

  • Concept pre-review form, completed after I2T3 review

New Study (Full Protocol) Review

A two-stage review process is followed for all new clinical trial protocols proposed for activation at the UFHCI. The first stage is review of the protocol at the level of the DSG while the second stage is at the level of the SRMC. Prior to the initial review of a new study, the PI and/or study team should submit necessary submission materials to CRO Staff. These submission materials include a protocol synopsis OR full protocol. Upon intake of a new study, CRO Staff will confirm if the new study is disease specific or disease agnostic. The study will be forwarded to the appropriate DSG Research Leader for interest. If interest is confirmed, the DSG Research Leader for each group will determine if the study should be reviewed through an ad hoc review process or at thenext scheduled DSG meeting.

For disease-agnostic studies, CRO staff will determine if endorsement from other DSGs is needed. If interest is confirmed, the primary DSG research leader will determine if the study should be reviewed through an ad hoc review process or at the next scheduled DSG meeting. If the study is endorsed and secondary DSG endorsements are determined to be needed, the DSG coordinator will facilitate the review and whether any secondary endorsements are provided from secondary contributing DSG’s research leader(s) on behalf of their DSGs. If endorsement from secondary DSGs is not needed, the DSG coordinator will note as such.

For studies reviewed through an ad hoc review process, the DSG Research Leader will identify key stakeholders from the DSG for the DSG administrator to contact for their vote.

For studies reviewed at a meeting, it is expected for the PI or their delegate to present a short presentation during the DSG meeting. The short presentation should touch on the following:

  • Scientific Rationale
  • Prioritization
  • Community Outreach and Engagement
    • Catchment Area Impact
    • Recruitment Strategies
  • Competing trials
    • Note: It is a rare exception for a new trial to be acceptable if competing studies already exist
  • Feasibility
  • Enrollment expectations relative to study duration
  • Staffing

Continuation/Status Update

The DSG will review the status of current trials at each DSG meeting. Information that should be discussed includes accrual and any difficulties experienced for the study. Any upcoming major amendments, major protocol revisions, or changes to clinical research resources can also be discussed during each DSG meeting.

Necessary submission components:

  • Accrual status summary relative to target
  • Next SRMC continuation review date
  • Overall DSG portfolio of trials relative to diseases encountered

Decisions

After DSG (first-stage) review and discussion of a new trial, all key stakeholder members (identified by the DSG research leader) will cast their votes and have the opportunity to provide comments/feedback. Self-recusals for conflicts of interest are encouraged. Votes are compiled for the following decisions:

  • Endorsement: The study is scientifically sound and fulfills a need in the current DSG research portfolio as well as in the UFHCI catchment area. After the study is endorsed, the DSG submission form will need to be completed and signed by the DSG Research Leader.
    • If the study has a primary DSG that is disease agnostic, such as the PEDS, ETG or CCPS, and the study targets a patient population of another DSG, the primary DSG will conduct the DSG review while any other acknowledging DSGs will be provided the study protocol and opportunity to acknowledge within Qualtrics.
    • All comments will be provided to the DSG research leader who can summarize or include them in their endorsement to SRMC and/or provide feedback to the study leadership team.
    • Tabled: The PI and study team will need to make changes to address the concerns of the group. These concerns could include scientific validity or fulfillment of the DSG research portfolio and the UFHCI catchment area. Once revisions are completed, the DSG leader(s) will make the final decision. The minutes will be updated to reflect the final decision.
    • Declination: The study is not scientifically sound and does not fulfill a need in the current DSG research portfolio as well as in the UFHCI catchment area. Once the study is declined, the study will not move past the DSG.
      • If the study team chooses to re-work the concept, A new review may be conducted.
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