The Power of Investigator-Initiated Trials
When standard treatment options run out, clinical trials can provide a vital path forward for oncology patients. However, not all clinical trials begin with a pharmaceutical company. Many start with a question posed by a physician or researcher: What if this could work better? How could we better support this patient subset? Could combining these treatments improve outcomes?
These questions become the first step in investigator-initiated trials (IITs), an essential driver of cancer innovation that Moffitt scientists regularly conduct. These trials reflect the innovative spirit of our faculty and are designed to address unmet clinical needs, explore novel hypotheses, and advance personalized cancer treatment. Their goal isn’t commercial, it’s clinical. They address gaps in care, test new combinations, and explore overlooked populations to improve outcomes and expand options for cancer patients.
What Are Investigator-Initiated Trials, and Why Do They Matter?
Investigator-initiated trials are clinical studies designed and led by physicians or researchers at Moffitt rather than commercial sponsors. These studies are often inspired by what doctors and scientists see in their daily practice and driven by Moffitt science. They are supported by grants, academic funding, or philanthropic gifts, rather than by a pharmaceutical company’s internal development timeline.
Unlike industry-sponsored trials, IITs are driven by the scientific curiosity, clinical insight, and commitment to patient-centered care of our investigators. Moffitt has the expertise and resources to support IITs, including a strong research infrastructure with interdisciplinary teams, and collaborative tumor boards. There are two dedicated outpatient Clinical Research Unit infusion centers, where patients receive treatment on clinical trials in a specialized outpatient setting and dedicated inpatient treatment space designed for complex inpatient clinical trials, including those involving CAR T, TIL, and bispecific antibody therapies. This environment promotes an efficient flow of ideas from concept to implementation ensuring Moffitt can support the full spectrum of clinical research.
IITs promote innovative thinking and allow researchers to explore new uses for existing drugs, whether through different dosage regimens, combination therapies, or targeted studies in specific patient populations. These trials also generate valuable clinical data that help pharmaceutical companies better understand how their drugs perform in real-world settings. In some cases, IITs contribute to refining drug safety profiles and treatment guidelines.
Solving Real-World Problems
IITs often begin when physicians identify a problem that existing treatments do not solve. These trials can explore off-label uses of approved drugs, test promising combinations, or focus on specific patient populations that may be excluded from larger trials.
For example, rare cancers often receive less research attention due to their lower prevalence. Moffitt has used IITs to explore treatments for mesothelioma, sarcoma, and rare neuroendocrine tumors, providing new options for patients with limited choices.
IITs are also used to study treatment resistance, advanced or recurrent cancers, and unique genetic markers that may respond to novel therapies. These trials can be a lifeline for patients who have exhausted standard treatments.
Driving Access and Outcomes for Referred Patients
For community providers, knowing about Moffitt’s IIT program can open the door to additional treatment possibilities for their patients. These trials may offer earlier access to innovative therapies, particularly for patients who don’t match existing commercial trial criteria.
Moffitt works closely with referring physicians to ensure patients are evaluated quickly and cared for collaboratively throughout the process. Providers are encouraged to consult with Moffitt even before a formal diagnosis is confirmed.
Patients do not need to wait for a pharmaceutical-sponsored trial match. Moffitt’s clinical trial navigators can work with community providers to discuss patient options and help identify the best fit, considering each patient’s clinical background, goals, and previous treatments.
A Shared Commitment to Progress
Investigator-initiated trials reflect Moffitt’s mission to improve cancer care through research and collaboration. These trials push the boundaries of what’s possible, ask questions that matter, and often lead to insights that benefit future patients.
Collaborating with Moffitt on IITs allows referring providers to extend patient treatment options and drive meaningful change. By staying connected with Moffitt’s research programs, community physicians can ensure their patients receive comprehensive care at the forefront of cancer innovation.
To explore active IITs or refer patients, submit a clinical trials inquiry form or contact a Clinical Trial Navigator at 813-937-6988 or 1-877-527-5590 (toll-free).