While the Alliance for Clinical Trials in Oncology conducts many studies through the National Cancer Institute’s National Clinical Trials Network (NCTN), Alliance Foundation Trials, LLC (AFT) is a separate, nonprofit research organization established in 2014. AFT enables investigators across the Alliance network to conduct cancer clinical trials supported by non-NCI sources, including pharmaceutical companies and independent research organizations such as the Patient-Centered Outcomes Research Institute (PCORI).
Although AFT has separate funding and operations, it leverages the Alliance’s established network of investigators, researcher professionals, and academic and community institutions. This model expands opportunities to conduct promising studies beyond NCI-funded research and supports trials that benefit from a different funding or sponsoring structure.
How an AFT trial becomes a reality
An AFT trial begins with an important, unanswered question in cancer care. The study may evaluate a new treatment, a combination of existing therapies, or an approach to improving patients’ quality of life.
The researcher develops the idea into a concept and presents it to the appropriate Alliance disease committee. Committee experts review its scientific merit, feasibility, and potential benefit to patients, helping determine whether the concept is ready for further development.
Once a concept is approved, the study team develops a detailed protocol that defines who can participate, how the treatment will be given, what information will be collected, and how participants will be monitored. Alliance biostatisticians also determine the appropriate sample size and statistical design to ensure the study can reliably answer its research question.
Unlike NCI-funded Alliance studies, AFT trials are supported through non-NCI funding. Depending on the study, funding may come from pharmaceutical or biotechnology companies, nonprofit organizations, or independent research grants, including support from the Patient-Centered Outcomes Research Institute (PCORI).
Before enrollment begins, the trial undergoes appropriate ethical and regulatory review. When required, the study is reviewed by the U.S. Food and Drug Administration (FDA). An independent Institutional Review Board (IRB) also reviews the protocol and informed consent documents to help protect particicpants’ rights, safety, and welfare.
Once scientific, funding, ethical, and regulatory requirements are complete, the trial opens for enrollment. The study is registered on ClinicalTrials.gov, participating sites complete study-specific training, and eligible patients can be considered for enrollment.
By using the Alliance’s nationwide network of academic and community cancer centers, AFT can offer participating patients access to innovative clinical trials in a range of care settings.
Explore current AFT trials actively enrolling patients.