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Individual Investigator Research Awards for Clinical Trials

Cancer Prevention and Research Institute of Texas

The goal of the IIRACT is to promote clinical research that will lead to a better understanding of the clinical efficacy of a cancer therapy or diagnostic device. Applications submitted under this mechanism should propose innovative clinical studies that are hypothesis driven and involve patients enrolled prospectively on a clinical trial.

Clinical studies of new or repurposed drugs, hormonal therapies, immune therapies, surgery, radiation therapy, stem cell transplantation, combinations of interventions, or therapeutic devices are all responsive to this RFA

Applications that propose the development and validation of a biomarker prior to use of that biomarker in a prospective clinical trial are not responsive to this RFA and should be directed to the CPRIT IIRA mechanism RFA R-26.1-IIRA. Applications that propose only correlative or biomarker studies in the context of a clinical trial conducted under other funding mechanisms are not responsive to this RFA.

Early-phase clinical trials of agents or combinations of agents for which there are robust nonclinical data that suggest there may be clinical activity are responsive to the RFA, even if there is no biomarker, as long as the early-phase clinical trial will lead to determining if the activity observed in the laboratory can be replicated in patients.

Additional examples of the types of studies appropriate for the IIRACT include, but are not limited to, phase 1 or small phase 2 trials of new agents, repurposed agents, radiation therapy, surgery, or combinations of interventions where the trial design incorporates biomarker and/or imaging strategies to determine one or more of the following: presence of the drug target, target inhibition, biological pathway inhibition, or pathophysiological alteration by the investigational drug or device. CPRIT recognizes the value of supporting trials sponsored by pharmaceutical companies. In this situation, the applicant should provide documentation from the industry partner as to what is being provided by the industry partner, ie, drug(s) only versus drug and funds for study conduct (may be partial funding) versus drugs and funds for study conduct and funds for correlative or translational studies or other resources.

Specialties

Cancer

Oncology

Eligibility Requirements

• The applicant must be a Texas-based entity. Any not-for-profit institution or organization that conducts research is eligible to apply for funding under this award mechanism. A public or private company is not eligible for funding under this award mechanism; these entities must use the appropriate award mechanism(s) under CPRIT’s Product Development Research Program.

• The PI must have a doctoral degree, including MD, PhD, DDS, DMD, DrPH, DO, DVM, or equivalent, and must be a full-time resident of Texas during the time the research that is the subject of the grant is conducted.

• The PI must hold an appointment at the rank of assistant, associate or professor tenure track or tenured (or equivalent) at an accredited academic institution, research institution, industry, government agency, or private foundation. The PI must also have appropriate designated laboratory or clinical space, or other facilities in which to conduct the proposed studies. This award mechanism allows MIs for projects that require a team science approach (see the IFA for guidelines on CPRIT rules for MI awards).

• For applications that include 1 PI, the PI is required to maintain a minimum of 15% level of effort through the duration of the entire award period. For applications that include MIs, each PI is required to maintain a minimum of 10% effort through the duration of the entire award period.

• A PI may not submit applications to this RFA and to RFA R-26.1-IIRA, RFA R-26.1- IIRACSBC, RFA R-26.1-IIRACCA, RFA R-26.1-IIRAP, or RFA R26.1- IIRAEOC.

• A PI may not submit more than 1 application, either a new, resubmission, or renewal application under this RFA during this funding cycle.

• A PI may be a part of only one application, whether as a single applicant or as an MI on an application, under this RFA and RFA R-26.1-IIRA, RFA R-26.1-IIRACCA, RFA R-26.1- IIRACSBC, RFA R-26.1-IIRAP, or RFA R-26.1-IIRAEOC.

• An individual may serve as a PI on no more than 3 active CPRIT Academic Research grants. Recruitment grants and Research Training Awards do not count toward the 3-grant maximum; however, CPRIT considers MIRA Project MIs equivalent to a PI. For the purpose of calculating the number of active grants, CPRIT will consider the number of active grants at the time of the award contract effective date (for this cycle expected to be December 1, 2025).

• Applications that address prevention and early detection, cancers in children and adolescents, or computational systems biology of cancer should be submitted under the appropriate targeted RFA. As noted in section 4, applications that propose the development and validation of a biomarker prior to use of that biomarker in a prospective clinical trial are not responsive to this RFA and should be directed to the CPRIT Individual Investigator Research Award mechanism RFA R-26.1-IIRA.

• Collaborating organizations may include public, not-for-profit, and for-profit entities. Such entities may be located outside of the State of Texas, but non-Texas-based organizations are not eligible to receive CPRIT funds.

• An applicant is eligible to receive a grant award only if the applicant certifies that the applicant institution or organization, including the PI, any senior member or key personnel listed on the grant application, or any officer or director of the grant applicant’s institution or organization (or any person related to 1 or more of these individuals within the second degree of consanguinity or affinity), has not made and will not make a contribution to CPRIT or to any foundation specifically created to benefit CPRIT.

• An applicant is not eligible to receive a CPRIT grant award if the applicant PI, any senior member or key personnel listed on the grant application, or any officer or director of the grant applicant’s organization or institution is related to a CPRIT Oversight Committee member.

• The applicant must report whether the applicant institution or organization, the PI, or other individuals who contribute to the execution of the proposed project in a substantive, measurable way, regardless of whether those individuals are slated to receive salary or compensation under the grant award, are currently ineligible to receive federal grant funds or have had a grant terminated for cause within 5 years prior to the submission date of the grant application.

• CPRIT grants will be awarded by contract to successful applicants. Certain contractual requirements are mandated by Texas law or by administrative rules. Although applicants need not demonstrate the ability to comply with these contractual requirements at the time the application is submitted, applicants should make themselves aware of these standards before submitting a grant application. Significant issues addressed by the CPRIT contract are listed in section 12 and section 13. All statutory provisions and relevant administrative rules can be found at www.cprit.texas.gov.

Eligible Countries:

United States

Sponsor Details

Sponsor Institute/Organizations: Cancer Prevention and Research Institute of Texas

Sponsor Type: Corporate

Address: 1701 North Congress Avenue, Suite 6-127 Austin, TX 78701 United States

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